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Tag: COVID boosters

  • Ron DeSantis Rules Out Funding COVID Boosters If He Becomes President

    Ron DeSantis Rules Out Funding COVID Boosters If He Becomes President

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    Florida Gov. Ron DeSantis (R) on Wednesday said the U.S. government will not pay for COVID boosters if he gets elected president in 2024.

    “Certainly we’re not going to fund them,” DeSantis told “ABC News Live Prime.”

    His comments came after Florida advised residents under age 65 to skip the updated COVID-19 vaccine this fall, even though coronavirus hospitalizations and deaths related to the virus are rising across the U.S.

    DeSantis took issue with the studies done on the mRNA boosters, claiming “they have not demonstrated the benefit” of the shots.

    ABC News’ Linsey Davis pressed DeSantis on the issue, noting his remarks contradict the guidance of the Centers for Disease Control and Prevention. The CDC recommends that anyone over 6 months old receive an updated mRNA COVID vaccine manufactured by either Pfizer or Moderna.

    The Florida Republican, who is currently trailing in the 2024 presidential race, proceeded to attack the health agency, saying the American people have lost faith in it.

    “The trust that’s been lost, I think, has been incalculable. And one of the things that I said is when I come in, we’re going to have a reckoning about all these COVID policies,” DeSantis said. “We’re going to hold people accountable who got it wrong.”

    Biden, on the other hand, has backed the CDC’s recommendations and urged Americans to stay up to date on their vaccinations.

    The CDC’s Advisory Committee on Immunization Practices approved the latest COVID-19 booster earlier this month, shortly after the Food and Drug Administration authorized the updated vaccine.

    But Florida’s surgeon general, Dr. Joseph A. Ladapo, last week expressed skepticism about the safety of those shots.

    “I just think that at this point, with the amount of immunity that’s in the community, with virtually every walking human being having some degree of immunity, and the questions we have about safety and about effectiveness ― especially about safety ― my judgment is that it is not a good decision for young people and for people who are not at high risk, at this point in the pandemic,” he said.

    CDC Director Dr. Mandy Cohen has rebutted Ladapo’s criticism, saying both her agency and the FDA have reviewed the shots.

    “Public health experts are in broad agreement about these facts, and efforts to undercut vaccine uptake are unfounded and dangerous,” Cohen said.

    COVID cases appear on the rise across the country. The CDC reported COVID hospitalizations were up 7.7% for the week ending Sept. 9, while COVID-related deaths increased by 4.5% during the same period.

    Meanwhile, DeSantis has been struggling to get traction for his presidential bid.

    A new poll released Wednesday by CNN and the University of New Hampshire showed the governor down by 13% compared to the last survey done in the state in July. Apart from former President Donald Trump, DeSantis now also appears to be trailing businessman Vivek Ramaswamy, former United Nations ambassador Nikki Haley and former New Jersey Gov. Chris Christie when it comes to the respondents’ first choice for GOP nominee in New Hampshire.

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  • FDA Panel Backs Shift Toward One-Dose COVID Shot

    FDA Panel Backs Shift Toward One-Dose COVID Shot

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    Jan. 26, 2023 – A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

    The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the current complex landscape of options for vaccinations, and thus help increase use of these shots. 

    COVID remains a threat, causing about 4,000 deaths a week recently, according to the CDC. 

    The 21 Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single question posed by the FDA: 

    “Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

    In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines – such as a two-shot primary series then a booster containing different combinations of viral strains.

    The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

    In explaining their support for the FDA plan, panel members said they hoped that a simpler regime would aid in persuading more people to get COVID vaccines.

    Pamela McInnes, DDS, MSc, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated. 

    “That is a real challenge,” said McInness, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

    “The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

    The Plan

    In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine- composition for the primary series and booster vaccination. 

    This would require:

    • Harmonizing the strain composition of all COVID-19 vaccines;

    • Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all other individuals;

    • Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.

    During the discussion, though, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the division of viral products at FDA’s Center for Biologics Evaluation and Research. 

    “We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines. 

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  • Is It Time for Yet Another COVID Booster? It’s Complicated

    Is It Time for Yet Another COVID Booster? It’s Complicated

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    SOURCES: 

    Peter Hotez, MD, PhD, dean, National School of Tropical Medicine, Baylor College of Medicine; co-director, Center for Vaccine Development, Texas Children’s Hospital, Houston.

    Paul Offit, MD, director, Vaccine Education Center and professor of pediatrics, Children’s Hospital of Philadelphia.

    Michael T. Osterholm, PhD, director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis.

    Ground Truths. Eric Topol, MD: “The bivalent vaccine booster outperforms.” 

    CDC: “COVID Data Tracker: Weekly Review,” “Rates of Laboratory-Confirmed COVID-19 Hospitalizations by Vaccination Status,” “Trend in the Number of COVID-19 Vaccinations in the U.S.”

    FDA: “Vaccine and Related Biological Products Advisory Committee January 26 Meeting Announcement.”

    The New England Journal of Medicine: “Immunogenicity of BA.5 Bivalent mRNA Vaccine Boosters,” “Antibody Response to Omicron BA.4-BA.5 Bivalent Booster,” “Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster,” “Bivalent Covid-19 Vaccines – A Cautionary Tale.”

    Nature Medicine: “Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1 and XBB.1 by parental mRNA vaccine or a BA.5 bivalent booster.”

    BioRxiv: “Bivalent mRNA vaccine improves antibody-mediated neutralization of many SARS-CoV-2 Omicron lineage variants,” “Improved Neutralization of Omicron BA.4/5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent BA.4/5 Vaccine.”

    Kaiser Family Foundation: “ How Much Could COVID-19 Vaccines Cost the U.S. After Commercialization?”

    Alison Chartan, spokesperson, Novavax.

    Pfizer Media Relations.

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  • Fauci Addresses ‘The Pandemic Is Over’

    Fauci Addresses ‘The Pandemic Is Over’

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    Several days after President Joe Biden declared that “the pandemic is over,” Anthony Fauci weighed in on the president’s controversial remarks during an interview at The Atlantic Festival, an annual live event in Washington, D.C.

    “He was saying we’re in a much better place with regard to the fulminant stage of the pandemic,” Fauci, the president’s chief medical adviser, said. “It really becomes semantics and about how you want to spin it.”

    By “the fulminant stage,” he meant the phase of the coronavirus pandemic during which we saw sudden, unpredictable spikes in disease and death. Thanks in large part to vaccines and antivirals, Fauci explained, we are now in a new phase, one in which even as case counts and hospitalization numbers fluctuate, death tolls hold fairly constant. The United States is no longer seeing thousands of deaths a day, and for many Americans, the risk of serious illness has declined dramatically.

    Still, the idea that declaring the pandemic over is truly a matter of semantics is a fraught message coming from the nation’s top public-health communicator. Especially during the rollout of the country’s first Omicron-specific boosters, some experts and insiders worry that the declaration could have real consequences: Six administration officials told The Washington Post that the president’s comments would likely make the tasks of persuading Americans to get shots and securing funding from Congress even more challenging than they already were.

    Watch: Atlantic deputy editor Ross Andersen in conversation with Anthony Fauci

    Fauci is not the only administration official who has walked back the president’s remarks, which came just a few days after Tedros Adhanom Ghebreyesus, the head of the World Health Organization, said, “We are not there yet, but the end is in sight.” According to Politico, Biden’s remarks caught senior administration health officials off guard, and indeed, in the following days, the White House clarified that the president was referring to public sentiment, not epidemiological reality. “The president,” Health and Human Services Secretary Xavier Becerra told Yahoo Finance, “was reflecting what so many Americans are thinking and feeling.” (In today’s interview, Fauci built on Ghebreyesus’s sentiment with a trademark Fauci-ism: Easing up on our efforts to fight the pandemic now, he said, would be like saying, “Just because I see what the finish line is, I’m gonna stop and get a hot dog. No, you don’t want to do that.”)

    Fauci himself is no stranger to the delicate art of discussing the pandemic’s end. In a late-April interview with PBS NewsHour, he said that the United States was “out of the pandemic phase,” only to reverse course the next day and say that the country (along with the entire world) was “still experiencing a pandemic.” Last month, when he announced that he would step down from his government position by the year’s end, Fauci said that he was not satisfied with this state of affairs. “I’m not happy about the fact that we still have 400 deaths per day,” he said. “We need to do much better than that … But I hope that over the next couple of months, things will improve.”

    So far, they have not. Statistically speaking, not a whole lot has changed since last month—or, for that matter, since late April: Average daily cases, which Fauci acknowledged are an underestimate, are up slightly, from about 50,000 to just under 60,000. The numbers of people hospitalized and in ICUs rose to a peak in late July and have slowly declined since. Death tolls have held fairly constant, as Fauci said, at about 400 a day. And modelers think they may remain there for a while yet. “I’ll say it even today,” Fauci repeated. “Four hundred deaths per day is not an acceptable number as far as I’m concerned.”

    Meanwhile, America has done away with nearly all of its pandemic precautions, and Congress has declined to renew funding for vaccines and therapeutics. Whether or not the pandemic really is behind us, many people are living as if it is. An Axios/Ipsos poll released last week found that nearly half of Americans have returned to their pre-COVID lives, and 66 percent only occasionally or never wear a mask in public indoor spaces—by far the highest percentage that has given that answer since pollsters first posed the question in May 2021.

    In his wide-ranging interview at The Atlantic Festival, Fauci touched on a number of other topics, including his decades of work on the HIV/AIDS crisis, the politicization of public health, and how during the pandemic he’s become something of a larger-than-life figure—to both those who adore him and those who despise him. He laughed about the Dr. Fauci–themed candles, bobbleheads, and other paraphernalia that are sent to him. “That is as unrealistic in many respects as the craziness of people who want to decapitate me because I’m ruining the economy,” he said.

    Fauci also addressed the origins of the coronavirus, repeating his oft-cited position that while he keeps an open mind to theories that the virus leaked out of a lab in Wuhan, China, evidence points toward natural spillover from animals in a market in the city. It’s unlikely that we’ll ever get definitive proof in either direction, he said, but one thing that would help is greater transparency from the Chinese government, beginning with answers to the question of what exactly happened at the Wuhan wet market to which some of the earliest COVID cases have been traced.

    “The thing I think would be the best thing to do would be to open up those markets,” which are now closed to investigation, Fauci said. “If we were able to go and do surveillance easily in China, we would get a lot more information than we have now.”

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    Jacob Stern

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