Pfizer COVID-19 third blow: FDA panel rejects boosters for the general public

A meeting of the Food and Drug Administration advisory committee on Friday voted against the recommendation of the Pfizer recall for the general public. However, the panel approved an alternative plan to give boosters to people 65 and older, as well as people at higher risk of severe COVID-19, at least six months after the second dose. The move was a rejection of the White House’s commitment to provide vaccine booster shots universally as early as next week.

If you have been fully vaccinated with the vaccine from Pfizer-BioNTech, it means that you can only get a reminder now if you fall into the “high risk” category. The The FDA has given full approval to the two-dose Pfizer vaccine in August and had already cleared a third dose of Pfizer or Moderna for some people with weakened immune systems. But federal scientists have yet to adopt a booster shot for everyone.

With recent studies showing that vaccine efficacy can start to decline after six to eight months, a vaccine booster would provide additional immune protection against COVID-19 and its variants. This week, the government said it was working with state and local health officials and other partners to help with transparency and planning for a more widespread recall deployment. He also indicated that he has a sufficient supply of all three vaccines available in the United States, including Johnson & johnson and Moderna.

The booster shot debate is ongoing, but we’ll outline what we know so far. For more on COVID-19, here’s what we know about COVID-19 vaccine for children, the last advice on masks and breakthrough infections. And here’s what you need to know about the new federal COVID-19 vaccination mandates.

Why would I need a Pfizer recall?

If you are fully vaccinated, the Centers for Disease Control and Prevention says you will continue to be protected against infections and especially serious illnesses. All COVID-19 vaccines authorized by the FDA continue to be “very effective in reducing the risk of serious illness, hospitalization and death,” according to the CDC.

However, recent studies – like that from Israel and one from the UK – suggest that the effectiveness of COVID-19 vaccines may decline after six or eight months, requiring a booster to maintain high levels of protection against Revolutionary COVID-19 infections.

This week, Pfizer released data from its FDA claim, saying immunity wanes over time and giving boosters is a way to get a head start and contain the pandemic. Pfizer also presented what it considers to be proof that a booster will be safe and effective for the majority of adults.

What are the different opinions on COVID booster injections?

President Joe Biden has said he wants everyone in the United States who is already fully vaccinated to be eligible for a booster. But the FDA committee has voted against it for now, arguing that the data needs to be further examined by experts. Instead, they recommend that people aged 65 and over be eligible, as well as those at high risk of severe symptoms of COVID-19 – which include frontline and healthcare workers.

The tension over who should get callbacks remains high. More recently, leading scientists argued in the medical journal The Lancet that widespread distribution of booster shots was not appropriate at this time.

Meanwhile, Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, has called for a moratorium on booster doses until each country is able to immunize at least 40% of its population. . “I will not remain silent when the companies and countries that control the global vaccine supply think the world’s poor should be content with leftovers,” Tedros said earlier this month.

White House press secretary Jen Psaki has repeatedly said that having enough boosters for the United States does not reduce the number of vaccines the United States provides to other countries. “We believe this is a wrong choice and that we can do both,” Psaki said in August, adding that the United States has donated more vaccines globally than all other countries combined.

During a COVID-19 briefing at the White House on September 17, Jeffrey Zients, the White House coronavirus response coordinator, said the United States had distributed 140 million doses of the vaccine to nearly 100 countries and that they had purchased 500 million doses of Pfizer to give to the countries that need it most in order to accelerate a global exit from the pandemic.

When can I get a Pfizer recall?

The timing is not fully confirmed. In August, Biden said government health officials were recommending that those who are fully vaccinated be considered eligible for a booster eight months after their last vaccine, pending FDA and CDC approval. “As soon as they are cleared, eligible people will be able to get a recall immediately,” Biden said during his recent speech on federal vaccine mandates.

Since Biden first announced recall plans, the proposed timeline has changed. Pfizer’s report to the FDA called for a booster to be made available to most people six months after their second dose. The first step in rolling out the recall would be for the FDA to change its vaccine approval. Next, a CDC advisory committee should give a recommendation on who can get the extra hit and when. The final step would be for the director of the CDC to give his approval, according to ABC News.

Whenever this happens, Pfizer’s booster will likely be the first to walk out the door. According to Dr.Anthony Fauci, chief medical adviser to the president, this is because the Pfizer recall is further along in the FDA approval process than the other two formulations.

Who is already eligible for a Pfizer or Moderna recall?

Some immunocompromised people are already eligible according to CDC guidelines and can go out now to receive their third dose. The CDC’s recall recommendation is for ages 12 and older for the Pfizer vaccine. For the Moderna vaccine, the CDC recommends 18 years and older. The FDA has not authorized a second dose of the Johnson & Johnson vaccine for immunocompromised people, due to a lack of data.

The CDC recommends that you discuss your condition with your health care provider and find out if an additional dose is appropriate. See our guide to the booster vaccine to learn more about a booster injection for people who are moderately to severely immunocompromised.

Is the Pfizer booster the same as the first two shots?

Yes. According to Pfizer, its COVID-19 booster would be a third vaccine of the same vaccine you received with the first two doses.

In addition, Pfizer is working with its partner BioNTech on a version of the COVID-19 vaccine that targets the delta variant.

Where can I get a reminder?

According to Zients, the boosters will be available in approximately 80,000 locations across the country, including more than 40,000 local pharmacies. About 90% of Americans have a vaccination site within 5 miles of where they live, Zients said, and getting a booster will be just as easy as getting the first vaccine. And the callback will be free too.

You can visit Vaccines.gov to see which vaccines are available where or call 800-232-0233 for vaccine information.

For more on coronavirus treatments and vaccines, here’s what we know about monoclonal antibody treatments, new federal vaccine mandates and why people may not want the shot.

The information in this article is for educational and informational purposes only and is not intended for health or medical advice. Always consult a doctor or other qualified healthcare professional with any questions you may have about a health problem or health goals.