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Politics FDA panel recommends authorizing Moderna booster shot

10:46  18 october  2021
10:46  18 october  2021 Source:   thehill.com

More Americans are getting booster shots than initial doses, CDC data shows

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A key Food and Drug Administration panel on Thursday voted in favor of recommending booster doses of Moderna 's COVID-19 vaccine for a large swath of the population. Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 19-0. Broadly, panel members said they felt the company did not present enough robust evidence to justify a booster shot , but FDA had already set a precedent by authorizing boosters for the Pfizer vaccine.

A key Food and Drug Administration advisory committee on Thursday unanimously recommended giving booster shots of Moderna 's Covid-19 vaccine to people ages 65 and older and other vulnerable Americans. The vote was a crucial step before the U.S. can start administering third shots to some The nonbinding decision by the FDA 's Vaccines and Related Biological Products Advisory Committee would bring guidelines for Moderna in line with third shots of the Pfizer-BioNTech vaccine. Those shots were authorized less than a month ago to a wide array of Americans, including the elderly

A key Food and Drug Administration panel on Thursday voted in favor of recommending booster doses of Moderna's COVID-19 vaccine for a large swath of the population.

FDA panel recommends authorizing Moderna booster shot © Getty Images FDA panel recommends authorizing Moderna booster shot

Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 19-0.

The agency's vaccine advisory committee said boosters should be recommended for people over 65, people between the ages of 18 and 64 who are at high risk of severe COVID-19, as well as people who are at risk of serious COVID-19 because of their jobs, or living situation.

Next on FDA's agenda: Booster shots of Moderna, J&J vaccines

  Next on FDA's agenda: Booster shots of Moderna, J&J vaccines WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn. Federal regulators begin tackling that question this week. On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Steven Senne, File) Federal regulators begin tackling that question this week.

An outside advisory panel to the Food and Drug Administration unanimously endorsed a booster shot of the Moderna Covid-19 vaccine for seniors and those at higher risk from the virus, 3 weeks after greenlighting Pfizer jabs. The Vaccines and Related Biological Products Advisory Committee voted on Thursday in favor of Moderna ’s request for boosters , saying that adults 65 and older, as well as younger adults with health problems Though the Biden administration has announced plans to give boosters to everyone, the FDA advisory panel said there was no evidence it was yet time to do so.

An FDA advisory committee endorsed Moderna 's COVID-19 booster shot for people 65 and older and adults who are high-risk. Mireya Villarreal shares the latest. NOW PLAYING: other. FDA panel recommends Moderna booster shots . CBS News.

The population recommended for Moderna's booster is the same population that Pfizer's booster was authorized for last month. About 60 million Americans are now eligible for Pfizer's booster.

The Biden administration has made boosters for all Americans a priority, even though experts are divided on whether the general population will really benefit. Ultimately, the way to end the COVID-19 pandemic is by getting shots to the unvaccinated, rather than boosting those who are already protected.

Unlike Pfizer, Moderna is proposing to use a half-dose of the vaccine for a booster given at least six months after the prime dose, rather than an additional full dose.

That difference may make Moderna boosters less likely to trigger side effects than the first two doses in its series.

Overnight Health Care — Presented by The National Council for Mental Wellbeing — FDA panel advises Moderna booster shot for high-risk people

  Overnight Health Care — Presented by The National Council for Mental Wellbeing — FDA panel advises Moderna booster shot for high-risk people Welcome to Thursday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.What's the best way to get Moderna to share its vaccine with poor countries? According to Jimmy Kimmel, the U.S. should buy the formula, and then give it to McDonald's. "Sharing is caring!" An FDA advisory panel voted to recommend a booster dose of Moderna's COVID-19 vaccineWhat's the best way to get Moderna to share its vaccine with poor countries? According to Jimmy Kimmel, the U.S. should buy the formula, and then give it to McDonald's.

A panel of independent experts convened by the Food and Drug Administration voted unanimously Thursday in favor of a Moderna booster shot for certain people who got their shot at least six months ago. The group supported offering an extra dose to adults 65 years and older, as well as younger adults who are at high risk of severe COVID-19. The recommendation, backed by a 19-0 vote by the committee, clears the way for the FDA to authorize a booster of Moderna 's vaccine for more people.

The FDA panel will consider authorizing booster doses of Johnson & Johnson’s vaccine on October 15. The FDA will issue a formal ruling on boosters after its advisory panel has weighed in. Once the FDA rules on whether the booster doses are safe and effective, the CDC will refine the agency’s recommendations for who should receive the vaccines. COVID-19 vaccines have reached consumers in record time.

The company presented data showing its current two-shot regimen delivers robust protection more than five months after the initial vaccination. The vaccine remained 93 percent effective in preventing all virus-related illness, and 98 percent protective against severe cases of COVID-19.

Moderna argued that the potency of its vaccine wanes over time, with neutralizing antibody levels dropping six to eight months after a second dose. FDA reviewers found that while a booster did increase antibody levels, it wasn't clear whether the protection of the initial vaccination had dropped substantially.


Video: This is when an FDA panel will take up Moderna, J&J booster talks (WCNC-TV Charlotte)

Moderna did not argue that its vaccine requires a booster to prevent severe disease or hospitalization. Instead, the company said one was needed to prevent infection and mild to moderate disease.

FDA official: Booster announcements coming Wednesday

  FDA official: Booster announcements coming Wednesday WASHINGTON (AP) — U.S. regulators expect to rule Wednesday on authorizing booster doses of the Moderna and Johnson & Johnson COVID-19 vaccines, a Food and Drug Administration official said at a government meeting. The FDA's Doran Fink previewed “some announcements later today,” which were expected to include allowing the mixing and matching of COVID-19 booster doses among the three U.S. manufacturers — Pfizer, Moderna and J&J. Fink appeared at aThe FDA's Doran Fink previewed “some announcements later today,” which were expected to include allowing the mixing and matching of COVID-19 booster doses among the three U.S. manufacturers — Pfizer, Moderna and J&J.

On Thursday, a panel of medical experts at the Food and Drug Administration ( FDA ) voted unanimously to recommend a half-dose Moderna booster shot for people over age 65 or otherwise deemed to be at high risk from COVID due to other medical conditions. "These data suggest that if a vaccine is approved or authorized as a booster , an immune response will be generated regardless of the primary Covid-19 vaccination regimen," researchers wrote in the study. "Heterologous prime boost strategies may offer immunological advantages to optimize the breadth and longevity of protection

Investing.com — On Thursday, an FDA advisory panel voted unanimously to give booster shots of Moderna 's (NASDAQ:MRNA) Covid-19 vaccine to people aged 65 and older and other vulnerable citizens. The non-binding decision got 19 yes votes after a two-day meeting based on whether The FDA ’s Vaccines and Related Biological Products Advisory Committee has brought Moderna 's booster shot in line with Pfizer (NYSE:PFE) and BioNTech’s vaccine, which was authorized for the same group less than a month ago. As the approval has come from an advisory committee, the FDA doesn't have

Some panel members questioned whether there was a justification for recommending boosters for people at risk because of their jobs, since there wasn't data to show higher exposure risk equated to a higher risk of severe COVID-19.

Broadly, panel members said they felt the company did not present enough robust evidence to justify a booster shot, but FDA had already set a precedent by authorizing boosters for the Pfizer vaccine.

Patrick Moore, a vaccine expert at the University of Pittsburgh, said he had "real issues" with the vote, and recommended authorization "on a gut feeling, rather than based on really, truly serious data."

"The data itself is not strong but it is certainly going in the direction that is supportive of this vote," Moore said.

The panel's vote is not binding, but the FDA is likely to follow the recommendation. A final agency decision on Moderna boosters could come within days. A Centers for Disease Control and Prevention vaccine advisory committee is expected to vote on the proposal next week.

Following the vote, panelists made it clear that while they voted in favor of boosters for the vulnerable, they were not comfortable with the possibility of widespread availability for either Pfizer or Moderna boosters- even though that was the Biden administration's initial intention.

FDA OKs mixing COVID vaccine boosters, backs Moderna, J&J boosters

  FDA OKs mixing COVID vaccine boosters, backs Moderna, J&J boosters The CDC still needs to sign off before booster shots of the Moderna and Johnson and Johnson vaccines become available. A vaccine advisory panel, meeting Thursday, will consider the same expansion of boosters, which would then need approval from the CDC's director. People who got the Pfizer-BioNTech vaccine can already get a booster shot if they meet certain criteria. The Moderna booster dose would be half the original dose, at 50 micrograms, while doses of the other vaccines would remain unchanged. Plenty of booster doses will be available for people who want them, the White House has said.

Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said the administration needs to define its goals. He said he's concerned officials are making the public afraid they're not protected unless they get a booster, which is not true.

"If we're trying to prevent what is inevitable, which is a decline in neutralizing antibodies and an erosion in protection against mild or asymptomatic infection, that is a high bar to which we hold no other vaccine," Offit said.

Peter Marks, director of FDA's vaccine division, said the agency "heard pretty loud and clearly that there was not a lot of appetite for moving down the age range very significantly, if at all."

But he also noted that FDA has to think ahead, and there are models showing the pandemic may worsen over the winter.

"The problem here is we don't know what we don't know ... we can't simply look at what's going on with the pandemic curve and just calling it a day," Marks said.

-Updated at 4:47 p.m.

African effort to replicate mRNA vaccine targets disparities .
CAPE TOWN, South Africa (AP) — In a pair of Cape Town warehouses converted into a maze of airlocked sterile rooms, young scientists are assembling and calibrating the equipment needed to reverse engineer a coronavirus vaccine that has yet to reach South Africa and most of the world's poorest people. The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities. By working to replicate Moderna's COVID-19 shot,The energy in the gleaming labs matches the urgency of their mission to narrow vaccine disparities.

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