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Tag: Booster Dose

  • How FDA’s top vaccines official is timing his COVID booster and flu shot for fall 2023

    How FDA’s top vaccines official is timing his COVID booster and flu shot for fall 2023

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    A top-ranking Food and Drug Administration official, responsible for overseeing the approvals of the new vaccines now rolling out for this fall and winter’s three respiratory virus threats, said this month he is personally planning to space out his vaccinations over the coming weeks. 

    “Some people are saying, ‘Well, could I get RSV, COVID and the flu vaccine on the same day?’ Yes, indeed, you could. But honestly, I might not,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

    Instead, he said he intended to get the COVID shot right away and the flu shot in early October.

    Marks, who was speaking during a recent call with FDA stakeholders, stressed that he did not disagree with guidance from the Centers for Disease Control and Prevention which allows giving multiple different routine shots during the same visit. Doctors refer to this as “coadministration” or “simultaneous administration” of vaccines.

    However, he acknowledged that getting up to three of the different vaccines at the same time could lead to more side effects — like stronger fatigue or a small fever — in the days after getting the shots. 

    Spacing out the shots by around two weeks could “minimize the chance of interactions, and minimize confusing side effects from one with another,” he said. They might be a good option for people who did not mind multiple trips to the pharmacy or their doctor’s office.

    “I might just want to space them out a little bit. But if you had to drive a lot of miles to get the vaccines, then it might not be unreasonable to get all three of them at once,” said Marks.

    Getting an updated COVID-19 vaccine now

    Of the currently available options, Marks said that his plan was to get a dose of the updated COVID-19 vaccine first.

    Health authorities have been fortunate to have a vaccine that appears likely to work well for protecting against the currently circulating strains of the virus, he said.

    “It’s like having a bird in the hand. I have a bird in the hand, good match, a lot of COVID around, great time to go get vaccinated,” said Marks. 

    The FDA had selected the strain to target in the current batch of shots back in June, clearing the way for vaccine makers to ramp up their production ahead of a fall rollout. 

    Marks cited recent data suggesting that these updated vaccines, which have been revised from previous designs to now target the XBB.1.5 strain of the virus, would also work to boost protection against its closely-related descendants now dominant nationwide.

    Early results shared by the vaccine makers with a CDC panel earlier this month also suggests that these updated shots will also work against the highly mutated BA.2.86 variant, which has been reported in a growing number of states. 

    Several leading COVID trends, like emergency department visits, have started to slow in recent weeks following a summer wave that began to accelerate last month. Another “moderate” wave is predicted to begin over the coming colder months, the CDC’s disease forecasters say, with that surge’s peak expected to arrive potentially earlier than it did last season.

    Marks said it was possible that health authorities might allow for another dose to be offered to some vulnerable groups later in the fall and winter. 

    “I think if we saw that it appeared that people might benefit in a few months from an additional dose, we would probably work with our CDC colleagues to issue a recommendation at that time. But right now we are just talking about a single recommendation, a single dose,” he said.

    Scheduling a flu shot for early October

    By early next month, Marks said he plans to have received his flu shot. 

    “I usually get my influenza vaccine around October 1st,” Marks said. 

    This is later than some other health officials within the Biden administration. CDC Director Dr. Mandy Cohen posted on social media on Sept. 6 to say she had gotten vaccinated for the flu.

    Similar to previous seasons, CDC’s official recommendations for this year are that “[flu] vaccination should ideally be offered during September or October.” 

    Marks said that the boost in protection offered by flu vaccines can wane, underscoring why the shots should not be given too early in the season, before the threat of infections ramps up. Flu season in the U.S. typically peaks between December and February, but can stretch into the spring.

    The protection from a flu shot “has a little bit of a shorter life than we might like, in some ways it’s a little like the COVID vaccines,” Marks said.

    Right now, weekly CDC data suggests flu activity remains at low levels in most parts of the country. 

    New options for RSV

    Some Americans also have new options to be immunized for RSV, or respiratory syncytial virus, for the first time this year. 

    Older adults, ages 60 and older, can get a dose of the new vaccines developed by Pfizer or GSK. The CDC recommends that shots be offered “as early as vaccine supply becomes available” this year.

    CDC data suggests RSV infections have begun to accelerate in some parts of the country, with the steepest rises in the Southeast. 

    A panel of CDC advisers on Friday recommended that Pfizer’s new RSV vaccine should be given during pregnancy as well, in hopes of passing on protection to newborns during their most vulnerable early months of life. The panel recommended that pregnant people take one dose of the vaccine between weeks 32 and 36 of pregnancy. 

    A new antibody injection from Sanofi and AstraZeneca is also available for babies this year, which is recommended to be given to infants born ahead of this coming RSV season.

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  • Looking for the new COVID vaccine booster? Here’s where to get the shot.

    Looking for the new COVID vaccine booster? Here’s where to get the shot.

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    Pharmacies across the U.S. have started administering new COVID-19 booster formulations from drugmakers Pfizer and Moderna.

    The Food and Drug Administration approved the revised mRNA vaccine shots Monday as several COVID variants spread and hospitalizations rise. The Centers for Disease Control and Prevention recommends the shots for everyone 6 months and older. The vaccine is similar to previously approved formulas but it was updated to target the XBB variants that became prevalent last winter.

    Spokespeople for Moderna and Pfizer said people who want to get booster shots can contact pharmacies and hospitals directly for an appointment. 

    “Moderna’s updated COVID-19 vaccine is being shipped to major retail pharmacies nationwide, and consumers can reach out to them directly to make their vaccination appointments,” a Moderna spokesperson said in a statement to CBS MoneyWatch. 

    Pfizer said it has been “manufacturing this season’s vaccine in advance of the FDA’s decision to ensure supply readiness ahead of the fall and winter season. Doses will be available in pharmacies, hospitals and clinics across the U.S.”

    Here’s more information on where to get the latest COVID vaccine.

    CVS

    CVS on Wednesday announced that the newly authorized vaccines were in stock and available to consumers at its pharmacies. 

    “Pharmacies and retail medical clinics will begin receiving the new vaccine today and will continue to receive inventory on a rolling basis throughout the week,” the drugstore chain said in a statement.

    CVS said it expects all pharmacy locations across the U.S. to have doses of the new vaccine in stock by early next week. You can make an appointment at CVS.com or simply got to the most convenient location. If pharmacies have the vaccine in stock, they’ll accept walk-ins.

    Rite-Aid

    A Rite-Aid spokesperson said it expects to have the updated COVID vaccine in all of its pharmacy locations “soon,” without specifying exactly when. 

    Customers can schedule appointments beginning Friday. Walk-ins will be permitted once the vaccine becomes available in its stores. 

    Walgreens

    Walgreens told CBS MoneyWatch that it is now offering the jabs at locations nationwide. Consumers can schedule appointments immediately, with the first openings falling on Monday of next week. 

    Walgreens may add earlier appointments if vaccine supplies arrive earlier than expected. Doses of both brands’ formulas are currently being shipped to the company’s locations nationwide. 

    As with previous versions of the COVID-19 vaccine, the shots are available at no cost to consumers. 

    Because the CDC’s Advisory Committee on Immunization Practices has recommended the vaccine for children, the government is required to administer it to kids as well as commercially insured adults for free.

    The federal government’s Bridge Access Program will also cover the cost of shots for the 25 million to 30 million uninsured adults in the U.S., according to KFF Health News. The program will pay for pharmacies like Walgreens and CVS to provide the shots for free, while Pfizer and Moderna will also donate a certain number of doses, according to the CDC. 

    Visit Vaccines.gov to identify pharmacies with available doses, as well as those participating in the Bridge Access Program.

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  • FDA approves new COVID boosters

    FDA approves new COVID boosters

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    FDA approves new COVID boosters – CBS News


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    The FDA has approved new COVID-19 boosters designed to target the current dominant variant. The new shots could roll out as early as this week if the Centers for Disease Control and Prevention also approves them.

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  • Life Is Worse for Older People Now

    Life Is Worse for Older People Now

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    Last December, during a Christmas Eve celebration with my in-laws in California, I observed what I now realize was the future of COVID for older people. As everyone crowded around the bagna cauda, a hot dipping sauce shared like fondue, it was clear that we, as a family, had implicitly agreed that the pandemic was over. Our nonagenarian relatives were not taking any precautions, nor was anyone else taking precautions to protect them. Endive spear in hand, I squeezed myself in between my 94-year-old grandfather-in-law and his spry 99-year-old sister and dug into the dip.

    We all knew that older people bore the brunt of COVID, but the concerns seemed like a relic from earlier in the pandemic. The brutal biology of this disease meant that they disproportionately have fallen sick, been hospitalized, and died. Americans over 65 make up 17 percent of the U.S. population, but they have accounted for three-quarters of all COVID deaths. As the death count among older people began to rise in 2020, “a lot of my patients were really concerned that they were being exposed without anyone really caring about them,” Sharon Brangman, a geriatrician at SUNY Upstate University Hospital, told me.

    But even now, three years into the pandemic, older people are still in a precarious position. While many Americans can tune out COVID and easily fend off an infection when it strikes, older adults continue to face real threats from the illness in the minutiae of their daily life: grocery trips, family gatherings, birthday parties, coffee dates. That is true even with the protective power of several shots and the broader retreat of the virus. “There is substantial risk, even if you’ve gotten all the vaccines,” Bernard Black, a law professor at Northwestern University who studies health policy, told me. More than 300 people still die from COVID each day, and the overwhelming majority of them are older. People ages 65 and up are currently hospitalized at nearly 11 times the rate of adults under 50.

    Compounding this sickness are all the ways that, COVID aside, this pandemic has changed life for older adults. Enduring severe isolation and ongoing caregiver shortages, they have been disproportionately harmed by the past few years. Not all of them have experienced the pandemic in the same way. Americans of retirement age, 65 and older, are a huge population encompassing a range of incomes, health statuses, living situations, and racial backgrounds. Nevertheless, by virtue of their age alone, they live with a new reality: one in which life has become more dangerous—and in many ways worse—than it was before COVID.


    The pandemic was destined to come after older Americans. Their immune systems tend to be weaker, making it harder for them to fight off an infection, and they are more likely to have comorbidities, which further increases their risk of severe illness. The precarity that many of them already faced going into 2020—poverty, social isolation and loneliness, inadequate personal care—left them poorly equipped for the arrival of the novel coronavirus. More than 1 million people lived in nursing homes, many of which were densely packed and short on staff when COVID tore through them.

    A major reason older people are still at risk is that vaccines can’t entirely compensate for their immune systems. A study recently published in the journal Vaccines showed that for vaccinated adults ages 60 and over, the risk of dying from COVID versus other natural causes jumped from 11 percent to 34 percent within a year of completing their primary shot series. A booster dose brings the risk back down, but other research shows that it wears off too. A booster is a basic precaution, but “not one that everyone is taking,” Black, a co-author of the study, told me. Booster uptake among older Americans for the reengineered “bivalent” shots is the highest of all age groups, but still, nearly 60 percent have not gotten one.

    For every COVID death, many more older people develop serious illness. Risk increases with age, and people older than 70 “have a substantially higher rate of hospitalizations” than those ages 60 to 69, Caitlin Rivers, an epidemiologist at Johns Hopkins University, told me. Unlike younger people, most of whom fully recover from a bout with COVID, a return to baseline health is less guaranteed for older adults. In one study, 32 percent of adults over 65 were diagnosed with symptoms that lasted well beyond their COVID infection. Persistent coughs, aches, and joint pain can linger long after serious illness, together with indirect impacts such as loss of muscle strength and flexibility, which can affect older people’s ability to be independent, Rivers said. Older COVID survivors may also have a higher risk of cognitive decline. In some cases, these ailments could be part of long COVID, which may be more prevalent in older people.

    Certainly, some older adults are able to make a full recovery. Brangman said she has “old and frail” geriatric patients who bounced back after flu-like symptoms, and younger ones who still experience weakness and fatigue. Still, these are not promising odds. The antiviral Paxlovid was supposed to help blunt the wave of old people falling sick and ending up in the hospital—and it can reduce severe disease by 50 to 90 percent. But unfortunately, it is not widely used; as of July, just a third of Americans 80 or older took Paxlovid.

    The reality is that as long as the virus continues to be prevalent, older Americans will face these potential outcomes every time they leave their home. That doesn’t mean they will barricade themselves indoors, or that they even should. Still, “every decision that we make now is weighing that balance between risk and socialization,” Brangman said.


    Long before the pandemic, the threat of illness was already very real for older people.  Where America has landed is hardly a new way of life but rather one that is simply more onerous. “One way to think about it is that this is a new risk that’s out there” alongside other natural causes of death, such as diabetes and heart failure, Black said. But it’s a risk older Americans can’t ignore, especially as the country has dropped all COVID precautions. Since Christmas Eve, I have felt uneasy about how readily I normalized putting so little effort into protecting my nonagenarian loved ones, despite knowing what might happen if they got sick. For older people, who must contend with the peril of attending similar gatherings, “there’s sort of no good choice,” Black said. “The world has changed.”

    But this new post-pandemic reality also includes insidious effects on older people that aren’t directly related to COVID itself. Those who put off nonemergency visits to the doctor earlier in the pandemic, for example, risked worsening their existing health conditions. The first year of the pandemic plunged nearly everyone into isolation, but being alone created problems for older adults that still persist. Before the pandemic, the association between loneliness and higher mortality rates, increased cardiovascular risks, and dementia among older adults was already well established. Increased isolation during COVID amplified this association.

    The consequences of isolation were especially profound for older adults with physical limitations, Naoko Muramatsu, a community-health professor at the University of Illinois at Chicago, told me. When caregivers or family members were unable to visit, people who required assistance for even the smallest tasks, such as fetching the mail and getting dressed, had no options. “If you don’t walk around and if you don’t do anything, we can expect that cognitive function will decline,” Muramatsu said; she has observed this firsthand in her research. One Chinese American woman, interviewed in a survey of older adults living alone with cognitive impairment during the pandemic, described the debilitating effect of sitting at home all day.“I am so useless now,” she told the interviewer. “I am confused so often. I forget things.”

    Even older adults who have weathered the direct and indirect effects of the pandemic still face other challenges that COVID has exacerbated. Many have long relied on personal caregivers or the staff at nursing facilities. These workers, already scarce before the pandemic, are even more so now because many quit or were affected by COVID themselves. “Long-term care has been in a crisis situation for a long time, but it’s even worse now,” Muramatsu said, noting that many home care workers are older adults themselves. Nursing homes nationwide now have nearly 200,000 fewer employees compared with March 2020, which is especially concerning as the proportion of Americans over age 65 explodes.

    Older people won’t have one single approach to contending with this sad reality. “Everybody is trying to figure out what is the best way to function, to try to have some level of everyday life and activity, but also keep your risk of getting sick as low as possible,” Brangman said. Some of her patients are still opting to be cautious, while others consider this moment their “only chance to see grandchildren or concerts or go to family gatherings.” Either way, older Americans will have to wrestle with these decisions without so many of their peers who have died from COVID.

    Again, many of these people did not have it great before the pandemic, even if the rest of the country wasn’t paying attention. “We often don’t provide the basic social support that older people need,” Kenneth Covinsky, a clinician-researcher at the UCSF Division of Geriatrics, said. Rather, ageism, the willful ignorance or indifference to the needs of older people, is baked into American life. It is perhaps the main reason older adults were so badly affected by the pandemic in the first place, as illustrated by the delayed introduction of safety precautions in nursing homes and the blithe acceptance of COVID deaths among older adults. If Americans couldn’t bring themselves to care at any point over the past three years, will they ever?

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  • FDA and CDC clear updated COVID boosters for kids as young as 5 years old

    FDA and CDC clear updated COVID boosters for kids as young as 5 years old

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    The Food and Drug Administration announced Wednesday that it had granted emergency use authorization for updated COVID-19 vaccine boosters for Americans as young as 5 years old, and the Centers for Disease Control and Prevention officially signed off on their use. The boosters can be given at least two months after their previous shot of the vaccine.

    “FDA’s authorization of updated (bivalent) COVID-19 vaccines for this younger age group, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program—a program that has helped provide increased protection against severe COVID-19 disease and death,” CDC Director Dr. Rochelle Walensky said in a statement. 

    “Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” Dr. Peter Marks, the FDA’s top vaccines official, said in a statement.

    The FDA said it had considered data on the immune response and safety from the shots in children who had gotten a booster of the previous formulation to make its decision.

    These new bivalent shots are manufactured in a nearly identical process from Pfizer-BioNTech and Moderna, aside from adding in a component designed to target the BA.4 and BA.5 variants.

    “As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” Pfizer’s CEO Albert Bourla said in a statement.

    Pre-ordering wrapped up last week for the new vaccines from Pfizer and BioNTech formulated for this younger age group. A spokesperson for Pfizer said they have the ability to ship up to 6 million doses for younger children within the coming week, following their final quality-control checks.

    A spokesperson for the Department of Health and Human Services did not respond to a request for comment on how many shots were requested of the new Pfizer vaccines for younger ages.

    Moderna’s booster for kids is simply a smaller dose of the same formulation that is already being distributed for older age groups, and did not need to be pre-ordered.

    Compared to adults, a smaller share of children will be eligible to get the updated booster, because fewer have gotten the vaccine to begin with.

    Only around 60.8% of adolescents 12 and older and 31.5% of children 5 and older have so far received even their first two COVID vaccine doses, according to CDC data.

    Marks acknowledged that the virus “tends to be less severe in children than adults,” but warned that kids still faced a risk of hospitalization or long-term effects from the virus and would benefit from the shots.

    The CDC recently estimated that some 86.3% of children in the U.S. have survived at least one COVID-19 infection, based on surveying for antibodies in blood samples.

    “We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible,” said Marks.

    Wednesday’s decision leaves only children under 5 years old ineligible to receive the updated COVID booster.

    Federal health officials have previously said they expected these shots could be made available for the next youngest age group, down to 6 months old, by the winter.

    Moderna said Wednesday in a release that it expected to complete its application for emergency use authorization in this youngest age group “later this year.”

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  • Holiday travel, gatherings could spread COVID-19 infections as Delta variant maintains grip on U.S.

    Holiday travel, gatherings could spread COVID-19 infections as Delta variant maintains grip on U.S.

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    Holiday travel, gatherings could spread COVID-19 infections as Delta variant maintains grip on U.S. – CBS News


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    As America celebrates the last days of summer, health experts watch for new COVID-19 outbreaks tied to Labor Day gatherings. Dr. Peter Hotez, of Baylor College of Medicine, shares his view of the pandemic’s future course and the latest on booster vaccines

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