The Biden administration plans to offer the next generation of coronaviruses booster shots to Americans 12 and older soon after Labor Day, a campaign that federal officials hope will reduce deaths from Covid-19.
The top vaccine regulator for the Food and Drug Administration said in an interview on Tuesday that his team was close to authorizing updated doses that would target the versions of the virus now circulating.
The agency's data shows that the shots are safe and will work, even though they haven't been tested in humans. He wanted to know how confident he was. I have a lot of confidence.
Moderna and Pfizer-BioNTech submitted their final submissions to the F.D.A. asking for emergency authorization of booster shots aimed at BA.5 and Omicron, which together account for most coronaviruses cases in the United States.
A death toll that now averages 450 Americans per day could rise in the coming months as people spend more time indoors, according to federal health officials.
The chief medical adviser to the president said in an interview on Tuesday that they need to do better to protect the American public. We are nowhere near where we want to be due to the BA.5 outbreak.
The Biden administration has a hard time convincing Americans of the need for more than one vaccine. Only about two-thirds of the population has been inoculated with the primary series of two shots.
Some outside scientists say the government is moving too fast to clear the new shots because they don't provide the same protection as the old ones.
Unvaccinated people and people with serious health conditions are more likely to die from a vaccine-related disease. He said that the new shots might not be enough to protect against infections.
Many people had immunity due to recent infections, and that's why Jeremy Kamil supports new boosters. If we get this out in the next 10 days, how many people still haven't gotten Omicron?
The government's plan made sense because of how the virus has changed and the evidence that immunity fades over time, according to other scientists. If regulators waited for additional data or recommendations from outside experts, the virus might evolve further and we may have lost a bunch of individuals who could otherwise be sitting at the dinner table together.
A two-day meeting of its advisory panel of experts on the matter will be held on Sept. 1 and 2. Rochelle P. Walensky would make a final decision on the new doses. It's possible that shipments to states could start next week.
The new Pfizer booster will only be offered to people over the age of 12 while the new Moderna shot will only be given to adults. People who have received the first two shots of either vaccine are eligible. Those who have received the initial shots would also. Younger children could be part of the new booster campaign.
The F.D.A. might suggest that people who have recently received a Covid vaccine dose wait a few months before getting the new shot, even if they are otherwise eligible. He said that the C.D.C. could weigh in on the matter.
The updated version of the vaccines had been purchased by the federal government. The C.D.C. laid out detailed plans to offer the shots, warning that the supply would be "sufficient but finite" and that doses should be directed to providers with expected demand among eligible patients.
There are new shots that combine the original vaccine with components from Omicron. The new vaccines will give a stronger boost to the immune system than the old ones, according to officials.
The companies have submitted data from mice trials rather than testing the new shots on humans. Regulators should wait for the results of human clinical trials, according to some vaccine experts.
Updating the flu vaccine is always done using animal data, according to Dr. Fauci. There is an extensive track record with the existing vaccines and a series of human trials with variant-specific versions.
He said that he takes issue with people who say that they approve it with mouse data. We have all the evidence that we need to authorize this.
Moderna and Pfizer have submitted clinical data from human studies of new shots. Britain approved the Moderna vaccine last week, but the U.S. regulators asked for a different version.
Key questions about the protection that the new vaccines give are still being answered by researchers. Moderna and Pfizer started human trials of their new vaccines this month. Data from those trials will be available later this year.
If the fall or winter brings a wave of disease despite the new boosters, the administration's plans could backfire.
Is there enough data to support the effort? The doctor said that. Is there a risk that the public will change their behavior to increase their exposure if they think that the Omicron booster will protect them from infections?
The F.D.A. usually doesn't make new vaccines available until it gets a recommendation from a panel of experts. Regulators have bypassed the panel at important steps.
The late June meeting of the advisory panel gave regulators everything they needed, according to Dr. Marks. In favor of updating the vaccines to work better against Omicron, the committee voted overwhelmingly, but it didn't consider specific versions of the vaccine.
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