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Tag: Immunizations

  • This city is hailed as a vaccination success. Can it be sustained?

    This city is hailed as a vaccination success. Can it be sustained?

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    LOUISVILLE, Ky. — On his first day of school at Newcomer Academy, Maikel Tejeda was whisked to the school library. The 7th grader didn’t know why.

    He soon got the point: He was being given make-up vaccinations. Five of them.

    “I don’t have a problem with that,” said the 12-year-old, who moved from Cuba early this year.

    Across the library, a group of city, state and federal officials gathered to celebrate the school clinic, and the city. With U.S. childhood vaccination rates below their goals, Louisville and the state were being praised as success stories: Kentucky’s vaccination rate for kindergarteners rose 2 percentage points in the 2022-2023 school year compared with the year before. The rate for Jefferson County — which is Louisville — was up 4 percentage points.

    “Progress is success,” said Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention.

    But that progress didn’t last. Kentucky’s school entry vaccination rate slipped last year. Jefferson County’s rate slid, too. And the rates for both the county and state remain well below the target thresholds.

    It raises the question: If this is what success looks like, what does it say about the nation’s ability to stop imported infections from turning into community outbreaks?

    Local officials believe they can get to herd immunity thresholds, but they acknowledge challenges that includes tight funding, misinformation and well-intended bureaucratic rules that can discourage doctors from giving kids shots.

    “We’re closing the gap,” said Eva Stone, who has managed the county school system’s health services since 2018. “We’re not closing the gap very quickly.”

    Public health experts focus on vaccination rates for kindergartners because schools can be cauldrons for germs and the launching pad for community outbreaks.

    For years, those rates were high, thanks largely to mandates that required key vaccinations as a condition of school attendance.

    But they have slid in recent years. When COVID-19 started hitting the U.S. hard in 2020, schools were closed, visits to pediatricians declined and vaccination record-keeping fell off. Meanwhile, more parents questioned routine childhood vaccinations that they used to automatically accept, an effect that experts attribute to misinformation and the political schism that emerged around COVID-19 vaccines.

    A Gallup survey released last month found that 40% of Americans said it is extremely important for parents to have their children vaccinated, down from 58% in 2019. Meanwhile, a recent University of Pennsylvania survey of 1,500 people found that about 1 in 4 U.S. adults think the measles, mumps and rubella vaccine causes autism — despite no medical evidence for it.

    All that has led more parents to seek exemptions to school entry vaccinations. The CDC has not yet reported national data for the 2023-2024 school year, but the proportion of U.S. kindergartners exempted from school vaccination requirements the year before hit a record 3%.

    Overall, 93% of kindergartners got their required shots for the 2022-2023 school year. The rate was 95% in the years before the COVID-19 pandemic.

    Officials worry slipping vaccination rates will lead to disease outbreaks.

    The roughly 250 U.S. measles cases reported so far this year are the most since 2019, and Oregon is seeing its largest outbreak in more than 30 years.

    Kentucky has been experiencing its worst outbreak of whooping cough — another vaccine-preventable disease — since 2017. Nationally, nearly 14,000 cases have been reported this year, the most since 2019.

    The whooping cough surge is a warning sign but also an opportunity, said Kim Tolley, a California-based historian who wrote a book last year on the vaccination of American schoolchildren. She called for a public relations campaign to “get everybody behind” improving immunizations.

    Much of the discussion about raising vaccination rates centers on campaigns designed to educate parents about the importance of vaccinating children — especially those on the fence about getting shots for their kids.

    But experts are still hashing out what kind of messaging work best: Is it better, for example, to say “vaccinate” or “immunize”?

    A lot of the messaging is influenced by feedback from small focus groups. One takeaway is some people have less trust in health officials and even their own doctors than they once did. Another is that they strongly trust their own feelings about vaccines and what they’ve seen in Internet searches or heard from other sources.

    “Their overconfidence is hard to shake. It’s hard to poke holes in it,” said Mike Perry, who ran focus groups on behalf of a group called the Public Health Communications Collaborative.

    But many people seem more trusting of older vaccines. And they do seem to be at least curious about information they didn’t know, including the history of research behind vaccines and the dangers of the diseases they were created to fight, he said.

    Some of the CDC’s recent communications take a gentle approach.

    One example is a digital media ad that depicts a boy playing with a toy Tyrannosaurus rex. The caption reads, “He thinks ‘diphtheria’ is the name of a dinosaur.” It’s an attempt to use humor while sending a message that children no longer know much about the infections that used to be common threats — and it’s better to keep it that way.

    Dolores Albarracin has studied vaccination improvement strategies in 17 countries, and repeatedly found that the most effective strategy is to make it easier for kids to get vaccinated.

    “In practice, most people are not vaccinating simply because they don’t have money to take the bus” or have other troubles getting to appointments, said Albarracin, director of the communication science division within Penn’s Annenberg Public Policy Center.

    That’s a problem in Louisville, where officials say few doctors were providing vaccinations to children enrolled in Medicaid and fewer still were providing shots to kids without any health insurance. An analysis a few years ago indicated 1 in 5 children — about 20,000 kids — were not current on their vaccinations, and most of them were poor, said Stone, the county school health manager.

    A 30-year-old federal program called Vaccines for Children pays for vaccinations for children who Medicaid-eligible or lack the insurance to cover it.

    But in a meeting with the CDC director last month, Louisville health officials lamented that most local doctors don’t participate in the program because of paperwork and other administrative headaches. And it can be tough for patients to get the time and transportation to get to those few dozen Louisville providers who do take part.

    The school system has tried to fill the gap. In 2019, it applied to become a VFC provider, and gradually established vaccine clinics.

    Last year, it held clinics at nearly all 160 schools, and it’s doing the same thing this year. The first was at Newcomer Academy, where many immigrant students behind on their vaccinations are started in the school system.

    It’s been challenging, Stone said. Funding is very limited. There are bureaucratic obstacles, and a growing influx of children from other countries who need shots. It takes multiple trips to a doctor or clinic to complete some vaccine series. And then there’s the opposition — vaccination clinic announcements tend to draw hateful social media comments.

    But there’s also a lot of support. The local health department and nursing schools are crucial partners, and city leaders support the endeavor.

    At the recent vaccination celebration, Mayor Craig Greenberg acknowledged access problems and that vaccinations have become politicized.

    But “to me, there’s nothing political about improving public health, about improving the health of our kids,” said Greenberg, a Democrat. “There should be no debate about that.”

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    AP video journalist Mary Conlon contributed to this report.

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    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • France’s Macron, African leaders push for vaccines for Africa after COVID-19 exposed inequalities

    France’s Macron, African leaders push for vaccines for Africa after COVID-19 exposed inequalities

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    PARIS — French President Emmanuel Macron is joining several African leaders on Thursday to kick off a planned $1 billion project to accelerate the rollout of vaccines in Africa, after the coronavirus pandemic exposed gaping inequalities in access to them.

    The launch of the African Vaccine Manufacturing Accelerator, which will provide financial incentives to vaccine manufacturers, offered a momentary break for Macron from domestic political concerns as legislative elections loom on June 30 and July 7.

    Many African leaders and advocacy groups say Africa was unfairly locked out of access to COVID-19 treatment tools, vaccines and testing equipment — that many richer countries bought up in huge quantities — after the pandemic swept the world starting in 2020.

    WHO, advocacy groups and others want to help Africa get better prepared for the next pandemic, which many health experts say is inevitable. When the coronavirus pandemic began, South Africa was the only country in Africa with any ability to produce vaccines, officials say, and the continent produced a tiny fraction of all vaccines worldwide.

    WHO failed in its efforts to help countries agree to a “pandemic treaty” — to improve preparedness and response to pandemics — before its annual meeting last month. The project was shelved largely over disagreements about sharing of information about pathogens that cause epidemics and the high-tech tools used to fight them.

    Negotiators will resume work on the treaty in hopes of clinching a deal by the next WHO annual meeting in 2025.

    Thursday’s event in Paris also aims to give a funding shot-in-the-arm to Gavi, the Vaccine Alliance, a public-private partnership that helps get needed vaccines to developing countries around the world.

    Gavi says the project aims to make up to US$ 1 billion available over the next ten years help boost Africa’s manufacturing base, to improve global vaccines markets and improve preparedness and response to pandemics and outbreaks like HIV, malaria, TB and COVID-19.

    The Geneva-based alliance says the accelerator will inject funds into manufacturers in Africa once they hit supply and regulatory milestones, with an aim to use market forces to drive down prices and encourage investment upstream.

    Officials say the project will explore issues like technology transfer — which has been resisted by some Western countries with powerful pharmaceutical companies — as well as the possible creation of a African medicines agency and tackling regulatory hurdles faced in Africa’s patchwork of legal systems.

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    AP journalist Jamey Keaten in Geneva contributed to this report.

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  • Trump repeatedly booed during Libertarian convention speech

    Trump repeatedly booed during Libertarian convention speech

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    WASHINGTON — WASHINGTON (AP) — Donald Trump was booed repeatedly while addressing the Libertarian Party National Convention on Saturday night, with many in the crowd shouting insults and decrying him for things like his COVID-19 policies, running up towering federal deficits and lying about his political record.

    When he took the stage, many jeered while some supporters clad in “Make America Great” hats and T-shirts cheered and chanted “USA! USA!” It was a rare moment of Trump coming face-to-face with open detractors, which is highly unusual for someone accustomed to staging rallies in front of ever-adoring crowds.

    Libertarians, who prioritize small government and individual freedoms, are often skeptical of the former president, and his invitation to address the convention has divided the party. Trump tried to make light of that by referring to the four criminal indictments against him and joking, “If I wasn’t a Libertarian before, I sure as hell am a Libertarian now.”

    Trump tried to praise “fierce champions of freedom in this room” and called President Joe Biden a “tyrant” and the “worst president in the history of the United States,” prompting some in the audience to scream back: “That’s you.”

    As the insults continued, Trump eventually hit back, saying “you don’t want to win” and suggesting that some Libertarians want to “keep getting your 3% every four years.”

    Libertarian candidate Gary Johnson won about 3% of the national vote in 2016, but nominee Jo Jorgensen got only a bit more than 1% during 2020’s close contest.

    Libertarians will pick their White House nominee during their convention, which wraps on Sunday. Trump’s appearance also gave him a chance to court voters who might otherwise support independent presidential candidate Robert F. Kennedy, Jr. who gave his own Libertarian convention speech on Friday.

    Polls have shown for months that most voters do not want a 2020 rematch between Trump and President Joe Biden. That dynamic could potentially boost support for an alternative like the Libertarian nominee or Kennedy, whose candidacy has allies of Biden and Trump concerned that he could be a spoiler.

    Despite the raucous atmosphere, Trump continued to press on with his speech, saying he’d come “to extend a hand of friendship” in common opposition to Biden. That prompted a chant of “We want Trump!” from supporters, but more cries of “End the Fed!” — a common refrain from Libertarians who oppose the Federal Reserve. One person who held up a sign reading “No wannabe dictators!” was dragged away by security.

    Trump tried to win over the crowd by pledging to include a Libertarian in his Cabinet, but many in the crowd hissed in disbelief. The former president did get a big cheer when he promised to commute the life sentence of the convicted founder of the drug-selling website Silk Road, Ross Ulbricht, and potentially release him on time served.

    That was designed to energize Libertarian activists who believe government investigators overreached in building their case against Silk Road, and who generally oppose criminal drug policies more broadly. Ulbricht’s case was much-discussed during the Libertarian convention, and many of the hundreds in the crowd for Trump’s speech hoisted “Free Ross” signs and chanted the phrase as he spoke.

    Despite those promises, many in the crowd remained antagonistic. One of the candidates vying for the Libertarian presidential nomination, Michael Rectenwald, declared from the stage before the former president arrived that “none of us are great fans of Donald Trump.” After his speech, Rectenwald and other Libertarian White House hopefuls took the stage to scoff at Trump and his speech.

    Those for and against Trump even clashed over seating arrangements. About two hours before the former president’s arrival, Libertarian organizers asked Trump supporters in the crowd to vacate the first four rows. They wanted convention delegates — many of whom said they’d traveled from around the country and bought expensive tickets to the proceedings — could sit close enough to hear the speech.

    Many of the original seat occupants moved, but organizers eventually brought in more seats to calm things down.

    The Libertarian split over Trump was reflected by Peter Goettler, president and chief executive of the libertarian Cato Institute, who suggested in a Washington Post column that the former president’s appearance violated the gathering’s core values and that “the political party pretending to be libertarian has transitioned to a different identity.”

    Trump’s campaign noted that Biden didn’t attend the Libertarian convention himself, and argued that the former president’s doing so was part of an ongoing effort to reach would-be supporters in places that are not heavily Republican — including the former president’s rally Thursday in the Bronx during a pause in his New York hush money trial.

    The Libertarian ticket will try to draw support from disaffected Republicans as well as people on the left. Such voters could also gravitate toward Kennedy.

    Trump didn’t dwell on Kennedy on Saturday night. But, after previously praising him and once considering him for a commission on vaccination safety, the former president has gone on the attack against Kennedy. He suggested on social media that a vote for Kennedy would be a “wasted protest vote” and that he would “even take Biden over Junior.”

    The former president, while in office, referred to the COVID-19 vaccine as “one of the greatest miracles in the history of modern-day medicine.” He’s since accused Kennedy of being a “fake” opponent of vaccines.

    In his speech at the Libertarian convention, Kennedy accused Trump and Biden of trampling on personal liberties in response to the pandemic. Trump bowed to pressure from public health officials and shut down businesses, Kennedy said, while Biden was wrong to mandate vaccines for millions of workers.

    For his part, Biden has promoted winning the endorsement of many high-profile members of the Kennedy family, in an attempt to marginalize their relative’s candidacy.

    Kevin Munoz, a spokesperson for Biden’s reelection campaign, slammed Trump and top Republicans for opposing access to abortion and supporting limits on civil society, saying in a statement Saturday, that “freedom isn’t free in Trump’s Republican Party and this weekend will be just one more reminder of that.”

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  • Brazil’s Bolsonaro indicted over alleged falsification of his own vaccination data

    Brazil’s Bolsonaro indicted over alleged falsification of his own vaccination data

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    SAO PAULO — Former Brazilian President Jair Bolsonaro was formally accused Tuesday of falsifying his COVID-19 vaccination data, marking the first indictment for the embattled far-right leader, with more allegations potentially in store.

    The federal police indictment released by the Supreme Court alleged that Bolsonaro and 16 others inserted false information into a public health database to make it appear as though the then-president, his 12-year-old daughter and several others in his circle had received the COVID-19 vaccine.

    Police detective Fábio Alvarez Shor, who signed the indictment, said in his report that Bolsonaro and his aides changed their vaccination records in order to “issue their respective (vaccination) certificates and use them to cheat current health restrictions.”

    “The investigation found several false insertions between November 2021 and December 2022, and also many actions of using fraudulent documents,” Shor added.

    The detective said in the indictment that Bolsonaro’s aide-de-camp, Mauro Cid, told investigators the former president asked him to insert the false data into the system for both himself and his adolescent daughter. Cid also said he delivered the vaccination certificates to Bolsonaro personally.

    During the pandemic, Bolsonaro was one of the few world leaders who railed against the vaccine. He openly flouted health restrictions and encouraged other Brazilians to follow his example. His administration ignored several offers from pharmaceutical company Pfizer to sell Brazil tens of millions of shots in 2020, and he openly criticized a move by Sao Paulo state’s governor to buy vaccines from Chinese company Sinovac when no other doses were available.

    Brazil’s prosecutor-general’s office will have the final say on whether to use the indictment to file charges against Bolsonaro at the Supreme Court. The case stems from one of several investigations targeting Bolsonaro, who governed from 2019 to 2022.

    Bolsonaro’s lawyer, Fábio Wajngarten, called his client’s indictment “absurd” and said he did not have access to it.

    “When he was president, he was completely exempted from showing any kind of certificate on his trips. This is political persecution and an attempt to void the enormous political capital that has only grown,” Wajngarten said.

    The former president denied any wrongdoing during questioning in May 2023.

    Police accuse Bolsonaro and his aides of tampering with the health ministry’s database shortly before he traveled to the U.S. in December 2022, two months after he lost his reelection bid to Luiz Inácio Lula da Silva.

    Bolsonaro needed a certificate of vaccination to enter the U.S., where he remained for the final days of his term and the first months of Lula’s term. The former president has repeatedly said he has never taken a COVID-19 vaccine.

    If convicted for falsifying health data, the 68-year-old politician could spend up to 12 years behind bars or as little as two years, according to legal analyst Zilan Costa. The maximum jail time for a charge of criminal association is four years, he said.

    “What Bolsonaro will argue in this case is whether he did insert the data or enable others to do it, or not. And that is plain and simple: Either you have the evidence or you don’t. It is a very serious crime with a very harsh sentence for those convicted,” Costa told The Associated Press.

    Shor also said he is awaiting information from the U.S. Justice Department to “clarify whether those under investigation did make use of the false vaccination certificates upon their arrival and stay in American territory.”

    If so, further charges could be leveled against Bolsonaro, Shor wrote without specifying in which country.

    The indictment sheds new light on a Senate committee inquiry that ended in October 2021 with a recommendation for nine criminal charges against Bolsonaro alleging that he mismanaged the pandemic. Then prosecutor-general Augusto Aras, who was widely seen as a Bolsonaro ally, declined to move the case forward.

    Brazilian media reported that Aras’ successor, Paulo Gonet, was scheduled to meet lawmakers later Tuesday to discuss the possibility of filing charges.

    Bolsonaro retains staunch allegiance among his political base, as shown by an outpouring of support last month, when an estimated 185,000 people clogged Sao Paulo’s main boulevard to decry what they — and the former president — characterize as political persecution.

    The indictment will not turn off his backers and will only confirm his detractors’ suspicions, said Carlos Melo, a political science professor at Insper University in Sao Paulo.

    “It is definitely worse for him in courts,” Melo said. “He could be entering a trend of convictions, and then arrest.”

    Brazil’s top electoral court has already ruled Bolsonaro ineligible to run for office until 2030, on the grounds that he abused his power during the 2022 campaign and cast unfounded doubts on the country’s electronic voting system.

    Other investigations include one seeking to determine whether Bolsonaro tried to sneak two sets of expensive diamond jewelry into Brazil and prevent them from being incorporated into the presidency’s public collection. Another relates to his alleged involvement in the Jan. 8, 2023, uprising in the capital of Brasilia, soon after Lula took power. The uprising resembled the U.S. Capitol riot in Washington two years prior. He has denied wrongdoing in both cases.

    Shor wrote that the indictment will be folded into the investigation of Jan. 8, which is being overseen by Supreme Court Justice Alexandre de Moraes. That justice authorized the unsealing of the indictment.

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  • WHO’s new COVID guidelines see fewer patients requiring hospitalization

    WHO’s new COVID guidelines see fewer patients requiring hospitalization

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    Most patients are unlikely to develop severe disease or die if they get the current variants of COVID-19 as immunity levels have climbed given higher levels of vaccination.

    That’s according to the World Health Organization, which updated its COVID-19 guidelines on Friday for the 13th time.

    The guidelines highlight that fewer patients will require hospitalization as they are more likely to have non-severe COVID.

    “The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease,” the agency said in a statement.

    People who are immunosuppressed remain at higher risk, however, with an estimated hospitalization rate of 6%. But people who are older than 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.

    And patients who belong to neither of those groups are at low risk of hospitalization, at an estimated rate of just 0.5%. Most people are now considered low-risk, said the WHO.

    The agency continues to recommend the use of Paxlovid for anyone at high or moderate risk of hospitalization. The antiviral developed by Pfizer Inc.
    PFE,
    -1.20%

    is still the best choice for most eligible patients, given its therapeutic benefits, ease of use and fewer concerns about potential harms.

    In cases where Paxlovid is not available, the WHO recommends molnupiravir, an antiviral developed by Merck
    MRK,
    -1.11%
    ,
    or remdesivir, an antiviral developed by Gilead Sciences Inc.
    GILD,
    +0.92%

    Read now: Pfizer to more than double price of its COVID antiviral once drug moves to commercial market

    “For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol,” said the agency.

    The WHO said it recommends against the use of a new antiviral called VV116 for patients, apart from those who are enrolled in clinical trials.

    That oral antiviral is being developed by Junshi Biosciences and Vigonvita in China.

    It issued a warning against the use of ivermectin for people with non-severe COVID. The drug used to treat parasites in animals proved highly controversial during the pandemic when many people were persuaded by fraudulent research and online misinformation that it was an effective treatment.

    From the archive: ‘You will not believe what I’ve just found.’ Inside the ivermectin saga: a hacked password, mysterious websites and faulty data.

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  • Heather McDonald finds creative and financial freedom with popular ‘Juicy Scoop’ podcast

    Heather McDonald finds creative and financial freedom with popular ‘Juicy Scoop’ podcast

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    When “Chelsea Lately” aired its final episode on E! in 2014, Heather McDonald, a staff writer and regular panelist on the show, needed a new gig. As a stand-up comedian, her performance schedule wasn’t as consistent as a full-time job — then she heard about a fellow comic who launched a podcast to get his name out there and sell more tickets.

    “I was like, ‘If a podcast can help do that, I’m going to do that,’” McDonald says.

    She launched “ Juicy Scoop with Heather McDonald ” in 2015. Now, nearly 800 episodes later with more than 200 million downloads, it regularly ranks among the top comedy podcasts on Apple’s charts.

    Twice a week, McDonald releases a free episode sharing the latest celebrity gossip and pop culture headlines, TV recaps, and anecdotes. She bounces topics off guests and interviews people with juicy stories.

    McDonald strives to avoid anything truly divisive — like politics. But despite her best efforts, she found herself in the middle of a debate about the coronavirus vaccine after she collapsed during a 2022 stand-up set in Arizona. Footage of her fainting was used in a video compilation that peddled misinformation about vaccine side effects.

    Before she collapsed, McDonald had joked that she’d never contracted the virus.

    “I fainted right after that. And I have never fainted before or after,” she says calling the timing “unbelievable.” For the record, she says, she still hasn’t had the coronavirus and is indeed vaccinated.

    She’s still not sure why she fainted and a variety of tests have indicated that there’s nothing wrong. But despite being debunked, the video of her collapse still goes viral every few months, she says.

    “It has done nothing but hurt my career because the pro-vaccination people think that I am like a puppet for the anti-vaxxers. And the anti-vaxxers call me names for getting vaccinated,” McDonald says. “I say everyone make their decisions for themselves and I have no say in the matter.”

    What she does have say in is the creative direction of her podcast, a freedom that McDonald says is rare.

    “I love working for myself. I love saying whatever I want to say and knowing that if I never get hired to do another TV job, it doesn’t really matter,” she says.

    The free episodes are also recorded on video and uploaded to YouTube. With her job security, McDonald likes to keep some of her opinions within a tighter, paying circle. There are exclusive “Juicy Scoop” episodes available via subscription through Patreon for options ranging from $5 to $50 per month.

    “When you have a TV show, even if you wrote and created and starred in it, it can still get canceled. When you have something like this, it just doesn’t,” she says of podcasts as a medium.

    The show is about fun, not hard facts, she maintains.

    “I am a comedian with an opinion. I do not have a journalistic background. I do as much research as I find interesting. I screw up names, things pop in my head in the moment, so they’re not thought out,” she says.

    Spencer Pratt is one of McDonald’s popular guests. A former cast member on MTV’s “The Hills,” he is willing to play up a villainous side on reality TV. On “Juicy Scoop,” he’s charming and funny.

    Pratt said people approach him now to bring up his “Juicy Scoop” appearances.

    “It’s why I keep driving out to the Valley,” he joked (that’s where McDonald records her podcast.)

    McDonald fosters an intimacy with her guests and fans alike, bookmarking her stories with directives like “Don’t tell anyone this” or “Keep this between us” to solidify the closeness she says she feels to her subscribers.

    “They say, ‘I feel like you’re my friend.’ I’m from a generation of women that we really did talk on the phone a lot,” she says. “It comes naturally for me to talk, be a storyteller.”

    McDonald does still tour and perform comedy gigs — even if it’s not her main job anymore.

    “As popular and as successful as the podcast gets, I never want to stop (stand-up) because such a small, tiny percent of entertainers can do stand up,” she says. “A lot of people are able to have podcasts and do well at it, but to stand in front of a stage and have a captive audience and make them laugh for an hour and a half is a skill that took a long time for me to get to.”

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  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%

    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%
    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • New vaccine expected to give endangered California condors protection against deadly bird flu

    New vaccine expected to give endangered California condors protection against deadly bird flu

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    LOS ANGELES — Antibodies found in early results of a historic new vaccine trial are expected to give endangered California condors at least partial protection from the deadliest strain of avian influenza in U.S. history.

    The California condor is the only bird species in the U.S. that has been approved for the new emergency-use vaccine, which was administered this summer to condors bred in captivity during a trial at the Los Angeles Zoo, the San Diego Zoo Safari Park and the Oregon Zoo.

    Authorities launched the study after the avian influenza deaths earlier this year of 21 free-flying condors in Arizona, part of a Southwest flock usually accounting for a third of the wild population.

    Wildlife officials feared that the outbreak’s toll on the California condor population could erase any gains made to rebuild the wild population, spurring the efforts to fast-track the vaccine.

    After 40 years of recovery efforts to prevent the extinction of the iconic vulture with a 10-foot (3-meter) wingspan, the wild population today has fewer than 350 condors in flocks spanning from the Pacific Northwest to Baja California, Mexico.

    “Losing 20 birds is effectively akin to setting the recovery program back by 10 years,” said Dr. Hendrik Nollens, vice president of wildlife health for the San Diego Zoo Wildlife Alliance.

    The so-called bird flu reached the U.S. in February 2022 after wreaking havoc across Europe. U.S. agriculture officials consider this year’s cases to be part of last year’s outbreak, which was recorded as the country’s deadliest ever.

    Authorities confirmed the flu’s presence earlier this month in commercial poultry flocks in South Dakota and Utah, heightening concerns ahead of the spring migratory season. The outbreak cost poultry producers nearly 59 million birds across 47 states, including egg-laying chickens and turkeys and chickens raised for meat. The flu also caused spikes in egg and turkey prices for consumers and cost the federal government more than $660 million.

    Early results indicate that when 10 condors were vaccinated with half a milliliter (0.016 fluid ounces) on two occasions — an initial injection and a booster administered 21 days later — 60% of the birds showed measurable antibodies expected to protect them from avian flu after exposure.

    “We’re thankful that we’re getting any immune response,” said Ashleigh Blackford, the California condor coordinator for the U.S. Fish and Wildlife Service.

    The population was nearly wiped out by hunting during the California Gold Rush in the mid-1800s, as well as by poisoning from toxic pesticide DDT and lead ammunition.

    In the 1980s, only 22 California condors were left in the wild. They were captured and placed in captive breeding programs to save the species. Zoo-bred birds were first released into the wild in 1992 and in the years since have been reintroduced into habitats from which they had disappeared. The ongoing re-wilding efforts are considered a conservation success.

    The bird flu trial’s progress will allow wildlife officials to move forward and release roughly two dozen vaccinated condors into the wild in California and Arizona by the end of the year. The government is awaiting additional results before deciding whether free-flying condors should be captured and inoculated. Officials already vaccinate condors in captivity and in the wild for West Nile virus.

    Dr. Carlos Sanchez, the Oregon Zoo’s director of animal health, said wildlife officials faced questions about undertaking the bird flu vaccine study.

    “Human intervention, veterinary intervention, is not something we do all the time or take lightly,” he said. “It wasn’t an easy decision.”

    The shots initially were tested on black vultures to make sure they could be safely injected into condors in managed care beginning in July. The post-inoculation monitoring and testing lasted 42 days and officials said no adverse reactions occurred.

    Dr. Dominique Keller, the LA Zoo chief veterinarian, said participating in the historic trial was one of her career’s highlights. She hopes the condor study will lead to bird flu vaccines for other endangered species.

    “It was just so incredible to be the first one to hold the vaccine in my hand and actually give it to the first bird,” she said.

    The trial’s second test group includes 10 condors vaccinated with one dose of a single milliliter (0.03 fluid ounces). Results from those birds will determine whether condors in the wild will get the shot.

    “We want to look at the data more holistically before we kind of jump ahead to what’s next,” Blackford said.

    The condor is intrinsically tied to several Native American tribes in the West and is considered by tribal members to be equal or even superior to humans. The condor disappeared from the Yurok Tribe’s ancestral lands in Northern California in the late 1800s but returned in 2021 after major conservation efforts from a team led by Tiana Williams-Claussen, the tribe’s wildlife department director.

    Watching the avian flu wipe out 21 birds in Arizona just a few years later was “deeply impactful” to members of the tribe, Williams-Claussen said. The study and vaccine could prevent a repeat of the devastation.

    “We’re all kind of waiting with bated breath to see what the final results are going to be,” she said.

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  • Pfizer trims expectations for 2023 with sales of COVID-19 vaccine, treatment, weaker than thought

    Pfizer trims expectations for 2023 with sales of COVID-19 vaccine, treatment, weaker than thought

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    Shares of Pfizer are falling before the opening bell as the company cut its full-year outlook, citing declining sales of its COVID-19-related products

    ByMICHELLE CHAPMAN AP business writer

    October 16, 2023, 8:21 AM

    FILE – The Pfizer logo is displayed at the company’s headquarters, Friday, Feb. 5, 2021, in New York. Shares of Pfizer are falling before the market opened on Monday, Oct. 16, 2023, as the company cut its full-year outlook, citing declining sales of its COVID-19-related products.(AP Photo/Mark Lennihan)

    The Associated Press

    Shares of Pfizer are in retreat on the first day of trading after the drug company said sales of its COVID-19 vaccine and its coronavirus treatment are weaker than it had expected and cut revenue projections by $9 billion for the year.

    Falling sales of both clipped sales in the second quarter, but Pfizer said in August that it expected a rebound in the second half of 2023.

    Shares of Pfizer slipped more than 1% before the opening bell Monday and Moderna, which is heavily reliant on the competing vaccine it makes, slid nearly 5%.

    Pfizer said Friday that global usage of Paxlovid is trending slightly above last year, but that it’s still below expectations.

    The fall vaccination period just began and the New York City drugmaker said that it’s too soon to get a handle on vaccination rates for the year.

    Full-year revenue for Paxlovid and Comirnaty is expected to be approximately $12.5 billion, short $9 billion of what it had expected.

    Pfizer is lowering its full-year revenue expectations for Paxlovid by approximately $7 billion. That number also accounts for delayed commercialization of the product, which was pushed to January 2024 from the company’s previous expectation of commercialization in the second half of this year. Pfizer is also lowering its 2023 revenue expectations for Comirnaty by approximately $2 billion due to lower-than-expected vaccination rates.

    Pfizer Inc. now foresees 2023 revenue in a range of $58 billion to $61 billion, down from its prior forecast for $67 billion to $70 billion. It now projects full-year adjusted earnings between $1.45 and $1.65 per share due to lower-than-anticipated revenue for COVID-19-related products and inventory write-offs.

    That is short of the full-year revenue of $63.61 billion and earnings of $2.77 per share that Wall Street was expecting, and far short of the company’s previous projections of per-share earning between $3.25 and $3.45.

    JPMorgan said the company’s update solves an ongoing U.S. Paxlovid inventory debate and it anticipates the company’s bigger-than-expected cuts to its sales projections will help put a floor under per-share earnings expectations for next year.

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  • Pfizer cuts full-year outlook due to declining sales of Covid-19-related products

    Pfizer cuts full-year outlook due to declining sales of Covid-19-related products

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    Shares of Pfizer are falling before the opening bell as the company cut its full-year outlook, citing declining sales of its COVID-19-related products

    ByMICHELLE CHAPMAN AP business writer

    October 16, 2023, 8:21 AM

    FILE – The Pfizer logo is displayed at the company’s headquarters, Friday, Feb. 5, 2021, in New York. Shares of Pfizer are falling before the market opened on Monday, Oct. 16, 2023, as the company cut its full-year outlook, citing declining sales of its COVID-19-related products.(AP Photo/Mark Lennihan)

    The Associated Press

    Shares of Pfizer are in retreat on the first day of trading after the drug company said sales of its COVID-19 vaccine and its coronavirus treatment are weaker than it had expected and cut revenue projections by $9 billion for the year.

    Falling sales of both clipped sales in the second quarter, but Pfizer said in August that it expected a rebound in the second half of 2023.

    Shares of Pfizer slipped more than 1% before the opening bell Monday and Moderna, which is heavily reliant on the competing vaccine it makes, slid nearly 5%.

    Pfizer said Friday that global usage of Paxlovid is trending slightly above last year, but that it’s still below expectations.

    The fall vaccination period just began and the New York City drugmaker said that it’s too soon to get a handle on vaccination rates for the year.

    Full-year revenue for Paxlovid and Comirnaty is expected to be approximately $12.5 billion, short $9 billion of what it had expected.

    Pfizer is lowering its full-year revenue expectations for Paxlovid by approximately $7 billion. That number also accounts for delayed commercialization of the product, which was pushed to January 2024 from the company’s previous expectation of commercialization in the second half of this year. Pfizer is also lowering its 2023 revenue expectations for Comirnaty by approximately $2 billion due to lower-than-expected vaccination rates.

    Pfizer Inc. now foresees 2023 revenue in a range of $58 billion to $61 billion, down from its prior forecast for $67 billion to $70 billion. It now projects full-year adjusted earnings between $1.45 and $1.65 per share due to lower-than-anticipated revenue for COVID-19-related products and inventory write-offs.

    That is short of the full-year revenue of $63.61 billion and earnings of $2.77 per share that Wall Street was expecting, and far short of the company’s previous projections of per-share earning between $3.25 and $3.45.

    JPMorgan said the company’s update solves an ongoing U.S. Paxlovid inventory debate and it anticipates the company’s bigger-than-expected cuts to its sales projections will help put a floor under per-share earnings expectations for next year.

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  • Pharmacist shortages and heavy workloads challenge drugstores heading into their busy season

    Pharmacist shortages and heavy workloads challenge drugstores heading into their busy season

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    A dose of patience may come in handy at the pharmacy counter this fall.

    Drug and staffing shortages haven’t gone away. Stores are starting their busiest time of year as customers look for help with colds and the flu. And this fall, pharmacists are dealing with a new vaccine and the start of insurance coverage for COVID-19 shots.

    Some drugstores have addressed their challenges by adding employees at busy hours. But experts say many pharmacies, particularly the big chains, still don’t have enough workers behind the counter.

    Chris Adkins said he left his job as a pharmacist with a major drugstore chain a couple years ago because of the stress. Aside from filling and checking prescriptions, Adkins routinely answered the phone, ran the register and stocked pharmacy shelves.

    “I just didn’t have time for the patients,” he said. “I am OK working hard and working long hours, but I just felt like I was not doing a good job as a pharmacist.”

    In recent years, drugstores have struggled to fill open pharmacist and pharmacy technician positions, even as many have raised pay and dangled signing bonuses.

    Larger drugstore chains often operate stores with only one pharmacist on duty per shift, said Richard Dang, an assistant professor of clinical pharmacy at the University of Southern California. That kind of thin staffing can make it hard to recruit employees.

    “I think that many pharmacists in the profession are hesitant to work for a company where they don’t feel supported,” said Dang, a former president of the California Pharmacists Association.

    Customers have noticed.

    John Staed, of Pelham, Alabama, said a CVS pharmacist gave him the wrong prescription about a decade ago: the pills were a different color than usual. He worries the chances for another mistake could increase as pharmacists take on more work.

    “These pharmacists always look stressed,” he said.

    A CVS spokeswoman said the company is focused on addressing concerns raised by its pharmacists and has taken several actions, including “providing additional pharmacy resources” in markets that need support. She declined to say how many pharmacists or technicians the company has hired.

    Former Walgreens CEO Rosalind Brewer said in late June that the company had added more than 1,000 pharmacists in the second quarter, but was running into a shortage of job candidates. Walgreens is adding processing centers around the country to ease some of the prescription workload for its stores.

    Brewer, who left in late August, also said the company was limiting hours at 1,100 pharmacies, or about 12% of its U.S. locations. That was down from 1,600 earlier this year, but a company executive has said it doesn’t expect to return all pharmacies to normal operating hours by year’s end.

    Labor strife and staffing shortages in health care are not isolated to drugstores, as the recent Kaiser Permanente strike shows.

    But drugstores have some additional challenges in the fall. Many customers come to them for vaccines for COVID-19, flu and pneumonia. Plus, federal officials have approved a new shot for people ages 60 and older for a virus called RSV.

    All told, CVS touts in a pharmacy counter brochure that the company can offer more than 15 vaccines to customers.

    Ongoing drug shortages also have kept pharmacy workers on the phone more.

    Jonathan Marquess said one of his drugstores fielded 100 questions one day last fall about the antibiotic amoxicillin and the attention deficit-hyperactivity disorder treatment Adderall, two drugs in short supply.

    Marquess runs several independent pharmacies in Georgia and serves on the National Community Pharmacists Association board. He has done a few things to help his stores adapt to the extra workload, he said, including training all employees to answer basic questions about vaccines.

    Marquess also adds extra staff when he knows they will have an influx of customers, like when a nearby company sends its employees over for vaccines.

    “We learned from our experiences,” he said. “Training your entire staff is very, very important.”

    Pharmacists say customers aren’t powerless and can help things run smoothly.

    People should bring all their insurance cards to vaccine appointments, especially since insurance coverage is new for the COVID-19 shots, Marquess said.

    Dang said customers should avoid showing up right after pharmacies reopen from a lunch break or just before they close, times when pharmacists and technicians are especially busy.

    Making appointments for vaccines gives pharmacy workers a better sense for their workload. Calling several days in advance for a prescription refill also helps, said Jen Cocohoba, a pharmacy professor at University of California San Francisco.

    “That tiny piece of control can help, because there’s so many things you cannot predict when you’re inside the community pharmacy,” Cocohoba said.

    ___

    AP Business Writer Josh Funk contributed to this report.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Nobel in medicine goes to scientists whose work led to mRNA vaccines against COVID

    Nobel in medicine goes to scientists whose work led to mRNA vaccines against COVID

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    STOCKHOLM — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the creation of mRNA vaccines against COVID-19 that were critical in slowing the pandemic and whose technology could be used in the future to develop shots against non-infectious diseases like cancer.

    Hungarian-American Katalin Karikó and American Drew Weissman were cited for contributing “to the unprecedented rate of vaccine development during one of the greatest threats to human health,” according to the panel that awarded the prize in Stockholm.

    The panel said the pair’s “groundbreaking findings … fundamentally changed our understanding of how mRNA interacts with our immune system.”

    Traditionally, making vaccines required growing viruses or pieces of viruses and then purifying them before next steps. T he messenger RNA approach starts with a snippet of genetic code carrying instructions for making proteins. Pick the right virus protein to target, and the body turns into a mini vaccine factory.

    But simply injecting lab-grown mRNA into the body triggered a reaction that usually destroyed it. Karikó, a professor at Szeged University in Hungary and an adjunct professor at the University of Pennsylvania, and Weissman, of the University of Pennsylvania, figured out a tiny modification to the building blocks of RNA that made it stealthy enough to slip past immune defenses.

    Karikó, 68, is the 13th woman to win the Nobel Prize in medicine. She was a senior vice president at BioNTech, which partnered with Pfizer to make one of the COVID-19 vaccines. Kariko and Weissman, 64, met by chance in the 1990s while photocopying research papers, Kariko told The Associated Press.

    Dr. Paul Hunter, a professor of medicine at Britain’s University of East Anglia, described the mRNA vaccines made by BioNTech-Pfizer and Moderna Inc. as a “game changer” in shutting down the coronavirus pandemic, crediting the shots with saving millions of lives.

    “We would likely only now be coming out of the depths of COVID without the mRNA vaccines,” Hunter said.

    Dr. Bharat Pankhania, an infectious diseases expert at Exeter University, predicted the technology used in the vaccines could be used to refine vaccines for other diseases like Ebola, malaria and dengue, and might also be used to create shots that immunize people against certain types of cancer or auto-immune diseases including lupus.

    Peter Maybarduk, at the Washington advocacy group Public Citizen, welcomed the recognition of mRNA vaccines, but said the award should also be deeply embarrassing for Western countries.

    “This is a technology that should have been available to all of humanity but it was almost exclusively available only in the richest countries in the world,” he said, adding that much of the funding that led to the development of mRNA technology came from U.S. public funds.

    “The future is just so incredible,” Weissman said. “We’ve been thinking for years about everything that we could do with RNA, and now it’s here.”

    Karikó said her husband was the first to pick up the early morning call, handing it to her to hear the news. She then watched the announcement to make sure she wasn’t being pranked.

    “I was very much surprised. But I am very happy.”

    Kariko said she was the one to break the news to Weissman, since she got in touch before the Nobel committee could reach him.

    The two have collaborated for decades, with Kariko focusing on the RNA side and Weissman handling the immunology: “We educated each other,” she said.

    Before COVID-19, mRNA vaccines were already being tested for other diseases like Zika, influenza and rabies — but the pandemic brought more attention to this approach, Karikó said.

    “There was already clinical trials before COVID, but people were not aware,” she said.

    Karikó’s family are no strangers to high honors. Her daughter, Susan Francia, is a double Olympic gold medalist in rowing, competing for the United States.

    The prize carries a cash award of 11 million Swedish kronor ($1 million) — from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel. The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

    ___

    This story has been updated to correct that Karikó is a professor at Szeged University, not Sagan’s University.

    ___

    Corder reported from The Hague, Netherlands. Associated Press writers Maria Cheng in London, Maddie Burakoff in New York and Lauran Neergaard in Washington contributed to this report.

    ___

    Follow all AP stories about the Nobel Prizes at https://apnews.com/hub/nobel-prizes

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  • Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

    Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

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    STOCKHOLM (AP) — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the development of effective mRNA vaccines against COVID-19.

    The award was given to Katalin Karikó, a professor at Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania, and Drew Weissman, who performed his prizewinning research together with Karikó at the University of Pennsylvania.

    “Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel that awarded the prize said.

    Thomas Perlmann, secretary of the Nobel Assembly, announced the award and said both scientists were “overwhelmed” by news of the prize when he contacted them shortly before the announcement.

    The Nobel Prize in physiology or medicine was won last year by Swedish scientist Svante Paabo for discoveries in human evolution that unlocked secrets of Neanderthal DNA which provided key insights into our immune system, including our vulnerability to severe COVID-19.

    The award was the second in the family. Paabo’s father, Sune Bergstrom, won the Nobel Prize in medicine in 1982.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

    The prizes carry a cash award of 11 million Swedish kronor ($1 million). The money comes from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel, who died in 1896.

    The prize money was raised by 1 million kronor this year because of the plunging value of the Swedish currency.

    The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death. The prestigious peace prize is handed out in Oslo, according to his wishes, while the other award ceremony is held in Stockholm.

    Corder reported from The Hague, Netherlands.

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  • What to know as fall vaccinations against COVID, flu and RSV get underway

    What to know as fall vaccinations against COVID, flu and RSV get underway

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    WASHINGTON — Updated COVID-19 vaccines may be getting a little easier for adults to find but they’re still frustratingly scarce for young children. Health officials said Thursday the kid shots have started shipping — and reminded most everyone to get a fall flu shot too.

    About 2 million Americans have gotten the new COVID-19 shot in the two weeks since its approval despite early barriers from insurance companies and other glitches, according to the Department of Health and Human Services.

    For the first time, the U.S. has vaccines to fight a trio of viruses that cause fall and winter misery. But health officials worry that shot fatigue and hassles in getting them will leave too many people needlessly unprotected.

    “We need to use them,” Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention, said Thursday. “Right now is the right time.”

    A flu vaccination and that updated COVID-19 shot are urged for just about everyone, starting with babies as young as 6 months.

    Also this year, a vaccine against another scary virus called RSV is recommended for people 60 and older and for certain pregnant women. And for babies, a vaccinelike medicine to guard against that respiratory syncytial virus is expected to arrive next month.

    “These vaccines may not be perfect in being able to prevent absolutely every infection with these illnesses, but they turn a wild infection into a milder one,” said Dr. William Schaffner of Vanderbilt University and the National Foundation for Infectious Diseases.

    Some things to know:

    This year’s vaccine is updated to protect against newer versions of the constantly evolving coronavirus. Already there’s been a late summer jump in infections, hospitalizations and deaths. And so far the new vaccine recipe appears to be a good match to the variants currently circulating.

    Protection against COVID-19, whether from vaccination or from an earlier infection, wanes over time — and most Americans haven’t had a vaccine dose in about a year. Everyone 5 and older will need just one shot this fall even if they’ve never had a prior vaccination, while younger children may need additional doses depending on their vaccination and infection history.

    The rollout’s start has been messy. This time the government isn’t buying and distributing shots for free. Now drugstores, doctors’ offices and other providers had to place their own orders, and sometimes canceled appointments if supplies didn’t arrive in time. Some people had to wait for their insurance companies to update the billing codes needed to cover them or risk paying out of pocket.

    Manufacturers Pfizer and Moderna have shipped millions of doses, and say there’s plenty of supply — and in recent days, more appointments have started opening, at least for people 12 and older. In a Wednesday meeting, insurance companies told HHS Secretary Xavier Becerra they’ve largely resolved the paperwork issues blocking some patients’ vaccinations.

    The shots are supposed to be provided free in-network to the insured. For the uninsured or underinsured, CDC has opened what it’s calling a “bridge” program to provide free shots at certain sites.

    Adult doses got shipped first, CDC’s Cohen said. Doses for the under-12 set have begun shipping, and “the supply is filling out,” she said.

    Drugstore chain CVS said its doses for ages 5 and older began arriving last week, although supplies vary by location, while its MinuteClinic locations anticipate opening appointments for tots as young as 18 months in the coming days.

    As for pediatricians, they’ve had to guess how many doses to buy up-front while waiting to learn how much insurance companies would reimburse them for each shot, said Dr. Jesse Hackell of the American Academy of Pediatrics. He said early parent demand is heartening but that pediatricians expect to spend lots of time this fall explaining to hesitant families how important COVID-19 vaccination is even for healthy children.

    In Redmond, Washington, Ania Mitros got herself, her husband and her 13-year-old vaccinated pretty easily but despite calls to multiple pharmacies and clinics can’t find anyone to tell her when shots for her 8- and 11-year-old will be available. “There need to be clear expectations,” she said.

    Fewer Americans got a flu vaccine last year than before the coronavirus pandemic –- a discouraging gap that CDC hopes to reverse.

    People need a flu vaccine every fall because influenza also mutates each year. Like with COVID-19, flu is most dangerous to older adults, the very young and people with weak immune systems, lung, heart or other chronic health problems, or who are pregnant.

    There are multiple kinds of flu vaccines, including a nasal spray version for certain younger people. More important, three kinds are specifically recommended for seniors because they do a better job revving up an older adult’s immune system.

    Yes, although one in each arm might be more comfortable.

    RSV is a cold-like nuisance for most people, and not as well-known as the flu. But RSV packs hospitals every winter and kills several hundred tots and thousands of seniors. The CDC says already, RSV cases are rising in the Southeast.

    RSV vaccines from GSK and Pfizer are approved for adults 60 and older.

    Drugstores have adequate supplies but some seniors are reporting hurdles such as requirements to get a prescription. That’s because the CDC recommended that seniors talk with their doctors about the new vaccine. Cohen said it was meant just for education about a virus that people may not know much about.

    “We want folks to … get access to the vaccine as quickly as possible,” she said.

    The FDA also has approved Pfizer’s RSV vaccine to be given late in pregnancy so moms-to-be pass virus-fighting antibodies to their fetuses, offering some protection at birth. The CDC is recommending that pregnancy vaccinations be offered between September and January, when RSV tends to be most common.

    There’s no vaccine for children but babies whose mothers didn’t get vaccinated in pregnancy may get an injection of lab-made antibodies to guard against RSV. Called Beyfortus, the one-dose shot from Sanofi and AstraZeneca is different than a vaccine, which teaches the body to make its own infection-fighting antibodies, but is similarly protective. Cohen said it should be available in October.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • RSV vaccine recommended during pregnancy as a second option to protect newborns

    RSV vaccine recommended during pregnancy as a second option to protect newborns

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    NEW YORK — U.S. health officials on Friday recommended RSV vaccinations for moms-to-be, a second new option to protect newborns from serious lung infections.

    The shots should be given late in pregnancy but only during RSV season, the Centers for Disease Control and Prevention said.

    “This is another new tool we can use this fall and winter to help protect lives,” said CDC Director Dr. Mandy Cohen in a statement.

    Cohen signed off after a CDC advisory panel backed the vaccine. The only opposition came from a panel member who found the recommendation “incredibly complicated.”

    A month ago, the agency recommended another option for infants to guard against severe RSV: lab-made antibodies given to babies younger than 8 months before their first RSV season. A single dose is given to babies by injection after they are born.

    Most infants will likely only need protection from one — either the mom’s vaccine or the antibodies — but not both, Cohen said.

    There is no head-to-head study that answers which is more effective, and no published research on how safe it is to give both. And they are both expensive, although the cost will be ultimately covered by insurance.

    The RSV vaccine, made by Pfizer, should only be given between 32 weeks and 36 weeks of pregnancy. The shot prompts the moms-to-be to develop virus-fighting antibodies that pass through the placenta to the fetus. Protection in newborns likely drops after 6 months of age, so the shot is for use between September and January in most of the U.S., to coincide with the time of year when RSV infections tend to be most common.

    A baby born in April, for example, may not have much immunity left from the mother’s vaccination by the time the fall RSV season comes around.

    “It really depends on when the due date is as to how impactful this vaccination will be,” said Dr. Grace Lee, chair of the CDC advisory panel.

    RSV, or respiratory syncytial virus, is a common cause of coldlike symptoms. A surge last year filled hospitals with wheezing children, but far more U.S. seniors are hospitalized and die from the virus.

    Two new vaccines were recently approved for Americans age 60 and older. There isn’t a vaccine for children.

    Some CDC panel members who ultimately supported the recommendation expressed reservations. Available data suggests the antibodies are a more cost-effective — and probably longer-lasting — way to prevent severe illness in infants. Several also balked at the $295-a-dose price Pfizer has been charging for the same RSV vaccine for seniors, called Abrysvo.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • 5 things to know about the new COVID-19 vaccine

    5 things to know about the new COVID-19 vaccine

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    It may be time to get your COVID-19 vaccine again.

    There’s a new booster that’s coming out to guard against the virus. The Centers for Disease Control and Prevention said Tuesday that it was recommending the vaccine, which is being produced in versions by Moderna
    MRNA,
    +3.18%

    and Pfizer
    PFE,
    -0.20%

    -BioNTech
    BNTX,
    -2.06%
    ,
    for people 6 months of age and older.

    Here are answers to some common questions about the shot — and what you may need to know before you receive it.

    Why are we seeing another booster?

    Boosters are all about maintaining protection against the virus as new COVID-19 variants emerge. The CDC said: “The updated vaccines should work well against currently circulating variants of COVID-19, including BA.2.86, and continue to be the best way to protect yourself against severe disease.” The CDC also noted that “protection from COVID-19 vaccines and infection decline over time. An updated COVID-19 vaccine provides enhanced protection against the variants currently responsible for most hospitalizations in the United States.”

    So, everyone who is 6 months or older should receive it?

    That’s the CDC’s recommendation, but not everyone sees this booster as a firm requirement, depending on various medical and other factors.

    Dr. Paul A. Offit, a pediatrician with the Children’s Hospital of Philadelphia who specializes in infectious diseases, told MarketWatch that the new vaccine is a must for some who are at higher risk for developing serious illness, such as people who are over 75, people who have certain health problems (including diabetes, obesity or chronic lung or heart disease) and people who are immune compromised.

    And what about the others? Offit said it can be a case of “low risk, low reward.” Meaning there’s little harm in getting the booster and it may buy “a few months protection against mild disease,” Offit said. But he stops short of saying the booster is an absolute necessity for such people.

    Still, CDC director Dr. Mandy K. Cohen counters such an argument. In a column for the New York Times, Cohen noted that all the members of her family, including her 9- and 11-year-old daughters, would be getting the booster. “Some viruses…change over time. This coronavirus is one of them. It finds ways to evade our immune systems by constantly evolving. That’s why our vaccines need to be updated to match the changed virus,” Cohen explained.

    What if you recently had COVID? Or have just gotten the previous COVID booster?

    Offit said you should wait at least two months — and possibly as long as four months — before receiving the new vaccine.

    The CDC said, “You should get a COVID-19 vaccine even if you already had COVID-19,” adding “you may consider delaying your next vaccine by 3 months from when your [COVID] symptoms started or, if you had no symptoms, when you received a positive test.”

    When and where can you get the new booster?

    The CDC said the vaccine “will be available by the end of this week at most places you would normally go to get your vaccines.”

    How much will it cost?

    The new shots are expected to have list prices of $110 to $130, but the CDC said, “Most Americans can still get a COVID-19 vaccine for free.” That is, most health-insurance plans will cover the cost.

    As for those without insurance, the CDC said there are still plenty of free options, including programs run by local health centers and health departments as well as pharmacies participating in the CDC’s Bridge Access Program. For more information about where to get the booster, go to Vaccines.gov.

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  • CDC recommends updated COVID shots for people 6 months of age and older

    CDC recommends updated COVID shots for people 6 months of age and older

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    The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.

    Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc.
    MRNA,
    -0.53%

    and Pfizer Inc.
    PFE,
    +0.62%

    -BioNTech
    BNTX,
    -1.97%

    should become available later this week.

    “We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

    The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.

    The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.

    The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines. 

    The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.

    Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.

    Under the Bridge Access program, CVS Health Corp.
    CVS,
    +2.57%

    will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc.
    WBA,
    +1.35%

    will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.

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  • FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

    FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

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    A health-care worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, Jan. 26, 2022.

    Vanessa Leroy | Bloomberg | Getty Images

    The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna, putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise.

    The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for children 6 months through 11 years old, according to an FDA release.

    The updated vaccines from Pfizer and Moderna won’t be available to Americans just yet.

    A CDC advisory panel is scheduled to meet Tuesday to vote on a recommendation on the use of those jabs. After the CDC director signs off on those recommendations, the shots can be administered at pharmacies, health clinics and other vaccine distribution sites.

    The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September

    The FDA did not announce a decision Monday on an updated Covid shot from Novavax, but the company said in a statement that the agency is still reviewing its vaccine. Shares of Novavax closed nearly 13% lower Monday following the approval of the other updated jabs.

    Novavax’s vaccine uses protein-based technology, a decades-old method deployed in routine vaccinations against hepatitis B and shingles. Meanwhile, Pfizer’s and Moderna’s shots use messenger RNA, which teaches cells how to make proteins that trigger an immune response against Covid.

    The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations.

    While the shots do not target the variants dominant now, the vaccine makers have said the shots will still offer protection against those strains as children return to school and the weather gets cooler.

    “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities,” Pfizer CEO Albert Bourla said in a release following the approval.

    Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.

    Hospitalizations have increased for seven straight weeks, and rose more than 15% for the week ending Aug. 26, to 17,418, according to the latest data from the CDC. But that number remains below the surge the nation saw in summer 2022, when hospitalizations climbed to more than 40,000.

    The uptick is fueled by newer — but closely related to XBB.1.5 — strains of the virus such as EG.5, or Eris. That omicron strain accounted for 21.5% of all cases as of Sept. 2, according to the CDC. 

    Meanwhile, XBB.1.5 is declining in the U.S., the CDC said. 

    A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pennsylvania, U.S, on Tuesday, Apr. 5, 2022.

    Hannah Beier | Bloomberg | Getty Images

    Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris.

    Both Pfizer and Moderna have also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are watching closely.

    “The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA said in the release Monday.

    The agency noted that last year’s Covid boosters from Pfizer and Moderna are no longer authorized in the U.S.

    The upcoming vaccine rollout will be the first since the end of the U.S. Covid public health emergency, which expired in May. 

    The end of that declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated shots directly to health-care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free. 

    Private insurers and government payers such as Medicare, which cover the vast majority of Americans, are expected to provide the vaccines to people for no fee. Federal efforts such as the Biden administration’s Bridge Access Program aim to provide free Covid shots to uninsured people.

    The Biden administration will urge Americans to receive an updated Covid shot this fall, White House press secretary Karine Jean-Pierre said last week.

    “Vaccinations against Covid-19 remains the safest protection for avoiding hospitalization, long-term health outcomes, and death,” Jean-Pierre said during a briefing.

    But it’s unclear how many Americans will actually roll up their sleeves to get another shot in the coming months.

    Only around 17% of the U.S. population — around 56 million people — have received Pfizer’s and Moderna’s latest boosters since they were approved in September 2022, according to the CDC. 

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  • Babies should get new drug that prevents RSV, CDC panel says

    Babies should get new drug that prevents RSV, CDC panel says

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    A panel of U.S. health advisers is recommending that babies get a new drug to protect them against a respiratory virus

    ByCARLA K. JOHNSON AP Medical Writer

    FILE – This illustration provided by AstraZeneca depicts packaging for their medication Beyfortus. On Thursday, Aug. 3, 2023, a panel of outside advisers to the Centers for Disease Control and Prevention recommended that babies get the drug to protect them against a respiratory virus that sends tens of thousands of American children to the hospital each year. (AstraZeneca via AP, File)

    The Associated Press

    Infants should get a new drug to protect them against a respiratory virus that sends tens of thousands of American children to the hospital each year, heath advisers recommended Thursday.

    An infection with RSV is a coldlike nuisance for most healthy people, but it can be life-threatening for the very young and the elderly. There are no vaccines for babies yet so the new drug, a lab-made antibody that helps the immune system fight off the virus, is expected to fill a critical need.

    The drug, developed by AstraZeneca and Sanofi, is expected to be ready in the fall before the RSV season, typically November through March. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die.

    A panel of outside advisers to the Centers for Disease Control and Prevention recommended the one-time shot for infants born just before or during the RSV season and for those less than 8 months old before the season starts. They also recommended a dose for some 8- to 19-months-olds at higher risk of a serious illness from RSV.

    The CDC director was expected to sign off on the panel’s recommendations.

    The drug, to be sold under the brand name Beyfortus, is expected to cost $495 per dose, and to be covered by insurance. Panelists acknowledged that it will be a challenge at first to give the shot and for providers to be reimbursed by insurers.

    In May, the Food and Drug Administration approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women, with the aim of passing along protection to their newborns.

    Although the new drug is not a vaccine, the expert panel also supported including it in Vaccines for Children, a government program providing free immunizations. The American Academy of Pediatrics is urging hospitals to stock Beyfortus so that newborns can get it during RSV season before they go home.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Watchdog calls for House committee to uninvite RFK Jr. after his comments are blasted as antisemitic

    Watchdog calls for House committee to uninvite RFK Jr. after his comments are blasted as antisemitic

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    NEW YORK — A Democratic watchdog group has called for a U.S. House committee to rescind an invitation to Robert F. Kennedy Jr. after the Democratic presidential candidate was filmed falsely suggesting COVID-19 could have been “ethnically targeted” to spare Ashkenazi Jews and Chinese people.

    Kyle Herrig, executive director of the Congressional Integrity Project, sent a letter to Ohio Republican Rep. Jim Jordan, chairman of the House Select Subcommittee on the Weaponization of the Federal Government, asking him to disinvite Kennedy from a hearing scheduled for Thursday after the candidate’s comments at a New York City dinner last week prompted widespread accusations of antisemitism and racism.

    In the filmed remarks first published by The New York Post, Kennedy said “there is an argument” that COVID-19 “is ethnically targeted” and that it “attacks certain races disproportionately.”

    “COVID-19 is targeted to attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese,” he added. “We don’t know whether it was deliberately targeted at that or not but there are papers out there that show the racial or ethnic differential of impact for that.”

    After the video was made public, Kennedy posted on Twitter that his words were twisted and denied ever suggesting that COVID-19 was deliberately engineered to spare Jewish people. He asserted without evidence that there are bioweapons being developed to target certain ethnicities, and called for the Post’s article to be retracted.

    Researchers and doctors pushed back on the assertion, including Michael Mina, a medical doctor and immunologist.

    “Beyond the absurdity, biological know-how simply isn’t there to make a virus that targets only certain ethnicities,” Mina wrote on Twitter.

    Democrats and anti-hate groups quickly condemned Kennedy’s comments in the video.

    “These are deeply troubling comments and I want to make clear that they do not represent the views of the Democratic Party,” read a Saturday tweet from Jaime Harrison, chair of the Democratic National Committee.

    “Last week, RFK Jr. made reprehensible anti-semitic and anti-Asian comments aimed at perpetuating harmful and debunked racist tropes,” US Rep. Suzan DelBene, chair of the Democratic Congressional Campaign Committee, said in a statement on Sunday. “Such dangerous racism and hate have no place in America, demonstrate him to be unfit for public office, and must be condemned in the strongest possible terms.”

    The Anti-Defamation League also responded to the comments with a statement saying Kennedy’s claim is “deeply offensive and feeds into sinophobic and antisemitic conspiracy theories about COVID-19 that we have seen evolve over the last three years.”

    And another anti-hate watchdog, Stop Antisemitism, tweeted, “We have no words for this man’s lunacy.”

    On Monday, Kerry Kennedy issued a statement saying, “I strongly condemn my brother’s deplorable and untruthful remarks last week about Covid being engineered for ethnic targeting,” adding that the remarks don’t represent “what I believe or what Robert F. Kennedy Human Rights stands for.” She is president of the human rights organization.

    Kennedy is set to address the GOP-led House subcommittee during a hearing Thursday to examine “the federal government’s role in censoring Americans.”

    He has long railed against social media companies and the government, accusing them of colluding to censor his speech during the COVID-19 pandemic when he was suspended from multiple platforms for spreading vaccine misinformation.

    Herrig’s letter to Jordan called Kennedy “a total whack job whose views and conspiracy theories would be completely ignored but for his last name.”

    It asked the chairman to disinvite the candidate from Thursday’s hearing because of “video evidence of his horrific antisemitic and xenophobic views which are simply beyond the pale.”

    The subcommittee didn’t immediately answer an inquiry about how it would respond, but House Speaker Kevin McCarthy threw cold water Monday on the idea of disinviting the presidential candidate from testifying before Congress.

    “I disagree with everything he said,” McCarthy said. “The hearing that we have this week is about censorship. I don’t think censoring somebody is actually the answer here. I think if you’re going to look at censorship in America, your first action to censor probably plays into some of the problems we have.”

    Kennedy has a history of comparing vaccines – widely credited with saving millions of lives – with the genocide of the Holocaust during Nazi Germany, comments for which he has sometimes apologized.

    His first apology for such a comparison came in 2015, after he used the word “holocaust” to describe children whom he believes were hurt by vaccines.

    But he continued to make such remarks, ramping up during the COVID-19 pandemic. An AP investigation detailed how Kennedy has frequently invoked the specter of Nazis and the Holocaust in his work to sow doubts about vaccines and agitate against public health efforts to bring the COVID-19 pandemic under control, such as requiring masks or vaccine mandates.

    In December 2021, he put out a video that showed infectious disease expert Anthony Fauci with a mustache reminiscent of Nazi leader Adolf Hitler. In an October 2021 speech to the Ron Paul Institute, he obliquely compared public health measures put in place by governments around the world to Nazi propaganda meant to scare people into abandoning critical thinking.

    In January 2022, at a Washington rally organized by his anti-vaccine group Children’s Health Defense, Kennedy complained that people’s rights were being violated by public health measures that had been taken to reduce the number of people sickened and killed by COVID-19.

    “Even in Hitler’s Germany, you could cross the Alps to Switzerland. You could hide in an attic like Anne Frank did,” he said.

    The comment was condemned by the head of the Anti-Defamation League as “deeply inaccurate, deeply offensive and deeply troubling.” Yad Vashem of the World Holocaust Remembrance Center in Jerusalem said it “denigrates the memory of its victims and survivors,” as well as others.

    After initially sticking by his remarks, Kennedy ultimately apologized, tweeting, “I apologize for my reference to Anne Frank, especially to families that suffered the Holocaust horrors.”

    Then, days after he launched his presidential campaign this April, he wrote on Twitter that “the onslaught of relentless media indignation finally compelled me to apologize for a statement I never made in order to protect my family.”

    ___

    Associated Press writers Farnoush Amiri in Washington and Michelle R. Smith in Providence, Rhode Island, contributed to this report.

    ___

    The Associated Press receives support from several private foundations to enhance its explanatory coverage of elections and democracy. See more about AP’s democracy initiative here. The AP is solely responsible for all content.

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