Friday's FDA advisory panel unanimously voted that booster doses for the Pfizer vaccine should now be available to all people over 65 years old and those at high risk of serious disease. This recommendation will likely be modified to include healthcare workers and other groups. If the FDA accepts the panel recommendation, it means that the plan to give booster shots on September 20 could be approved. However, not everyone will get them.
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This was the second vote at the meeting. It came after the panel had decided not to extend Pfizers vaccine approval to include an additional booster dose for everyone 16 years and older. The vote was defeated 16 to 2.
Why can't we all get boosters, oh my!
For a long time, the booster question was controversial among public and medical health professionals. There was hope that FDA would be able to obtain additional data that would resolve some of the unanswered questions. We knew that people who received two doses of booster were still protected from severe diseases, including death. However, some data suggest that their protection against mild infections may be diminishing.
This data can be difficult to understand. The increased number of breakthrough cases could be attributed to the fading of immunity from the vaccine. You could also argue that the vaccine remains as effective as ever, and that Delta is doing better in evading immune protection. It is not possible to know which one or a combination of them.
The meeting's data didn't help to clarify matters. Officially, the panel was supposed to only consider the results of a Pfizer clinical trial, which was small at just over 300 participants. The FDA also presented data from Israel on vaccine effectiveness. Israel saw a rise in COVID cases despite having a large population vaccinated. They began to give boosters in July, and found that vaccine effectiveness was improving. Nevertheless, panel members were skeptical that this data proved boosters work.
A second concern was the uncertainty of whether the booster would have any positive effects on young people. Myocarditis is a rare condition that affects young men. It occurs in approximately 1 out of every 20,000 people who receive the vaccine. The benefits of COVID-19 protection are clear for older adults; the booster dose poses a small risk to younger people. However, panelists were not convinced that the vaccine was worth the risk.
Finally, panelists were questioned about whether universal boosters would have any impact on the pandemic. Unlike Israel, we have a large proportion of the population who isn't vaccinated. This is the group that spreads the most virus. Even if vaccinated individuals are sometimes able to transmit coronavirus to others, a booster will not make that much of an impact on the whole population. Because they are already protected against severe diseases, it is not going to help them.
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Although vaccine equity was not discussed at the meeting, it has been brought up elsewhere. If you look at the world from a global perspective, it is unfair to give vaccine doses only to those who have been vaccinated. You could also give them to others who have not yet been vaccinated. The majority of Americans who wish to receive a vaccine have had it available. The opposite is true in other countries, where vaccines are often scarce. This is why the World Health Organization recommends against boosters.
What's next?
If the FDA agrees with their panel recommendation (which technically, they aren't required to), then they will likely announce that Pfizer boosters can be considered emergency-authorized for.
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P eople 65 years and older
P eople at higher risk of severe diseases as a consequence of COVID infection (probably defined in the same way as CDC, which includes people with a variety medical conditions).
Healthcare workers and other professionals who are at risk from COVID as a result of their jobs.
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After the vote, this last caveat was added. Some members suggested that healthcare workers should be protected from even mild infections, as they can transmit the disease to patients. Hospitals cannot afford to have more staff.
Expect the CDCs advisory panel ACIP to meet after the FDA announcement to make official recommendations about who should receive booster doses. The White House's plans to give booster doses on Sept. 20 have always been subject to the FDA and CDC going through their normal processes first. ACIPs meeting is still not announced. So expect this to change over the weekend.
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