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

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A Pfizer COVID-19 vaccine booster is now available to those most likely to benefit, according to the FDA. 


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A Food and Drug Administration advisory committee meeting Friday voted against recommending the Pfizer booster shot for the general public. However, the panel did endorse an alternative plan to administer boosters to those 65 and older, as well as to individuals at a higher risk of severe COVID-19, at least six months since the second dose. The move was a rejection of the White House’s pledge to deliver vaccine booster shots universally as early as next week. 

If you’ve been fully vaccinated with Pfizer-BioNTech’s vaccine, that means you can only get a booster shot now if you fall into the category of “high risk.” The FDA gave its full approval to Pfizer’s two-dose vaccine in August and had already authorized a third Pfizer or Moderna dose for certain people with compromised immune systems. But federal scientists haven’t yet embraced a booster shot for everyone else. 

With recent studies showing the effectiveness of vaccines may start to decline after six to eight months, a vaccine booster would allow for added immune protection against COVID-19 and variants. This week, the government said it’s been working with state and local health officials and other partners to assist with transparency and planning a more widespread booster rollout. It has also indicated that it has a sufficient supply of all three vaccines available in the US, including Johnson & Johnson and Moderna. 

The debate over booster shots is ongoing, but we’ll lay out what we know so far. For more on COVID-19, here’s what we know about COVID-19 vaccine for kids, the latest guidance on masks and breakthrough infections. And here’s what you should know about the new federal COVID-19 vaccination mandates.


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Why would I need a Pfizer booster shot?

If you are fully vaccinated, the Centers for Disease Control and Prevention say you will continue to be protected from infection and especially against serious illness. All the COVID-19 vaccine shots authorized by the FDA continue to be “highly effective in reducing risk of severe disease, hospitalization, and death,” according to the CDC.

However, recent studies — such as one from Israel and another from the UK — suggest that the effectiveness of COVID-19 vaccines may decrease after six or eight months, necessitating a booster shot to maintain high levels of protection against breakthrough COVID-19 infections.

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

What are the different opinions over COVID booster shots?

President Joe Biden said he wants everyone in the US who is already fully vaccinated to be eligible for a booster shot. But the FDA committee voted against that for now, arguing that the data needs to be reviewed more thoroughly by experts. Instead, they recommend that those who are age 65 and older should be eligible, as well as those who are at a high risk of severe COVID-19 symptoms — that includes frontline and health care workers. 

The tension over who should get boosters remains high. Most recently, leading scientists argued in the medical journal The Lancet that carrying out a widespread distribution of booster shots is 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 every country is able to vaccinate at least 40% of its population. “I will not stay silent when the companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers,” Tedros said earlier this month.

White House Press Secretary Jen Psaki has repeatedly said having enough boosters for the US does not reduce the number of vaccines the US supplies to other countries. “We feel that it’s a false choice and that we can do both,” Psaki said in August, adding that the US has donated more vaccines globally than all other countries combined.

At a COVID-19 White House briefing on Sept. 17, Jeffrey Zients, the White House’s coronavirus response coordinator, said that the US has distributed 140 million vaccine doses to almost 100 countries, and that it had purchased 500 million Pfizer doses to donate to the countries most in need in order to accelerate a global exit from the pandemic. 

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Already vaccinated? A booster could be in your future.


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When might I be able to get a Pfizer booster shot?

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

Since Biden first announced booster plans, the proposed timeline has shifted around. Pfizer’s report submitted to the FDA requested that a booster shot be made available to most people six months after their second dose. The first step in the booster rollout would be for the FDA to amend its vaccine approval. Then a CDC advisory committee would have to give a recommendation on who can receive the extra shot and when. The final step would be for the CDC director to stamp approval, according to ABC News. 

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

Who’s already eligible to get a Pfizer or Moderna booster shot?

Some immunocompromised people are already eligible under guidelines from the CDC and can go out now to get their third dose. The CDC’s booster recommendation is for those 12 and older for the Pfizer vaccine. For the Moderna vaccine, the CDC is recommending 18 and older. The FDA hasn’t authorized a second dose of the Johnson & Johnson vaccine for immunocompromised people, because of a lack of data.

The CDC recommends you should talk with your health care provider about your medical condition and whether an additional dose is appropriate. See our guide on the booster vaccine for more on a booster shot for moderately to severely immunocompromised people.

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

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

Separately, 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 booster shot?

According to Zients, boosters will be available at roughly 80,000 places across the country, including over 40,000 local pharmacies. Some 90% of Americans have a vaccine site within 5 miles of where they live, Zients said, and getting a booster shot will be just as easy as getting the first shot. And the booster shot will be free too. 

You can check 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, the new federal vaccine mandates and why people may not want the shot.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

source: cnet.com