Pfizer Inc. is asking the US Food and Drug Administration to approve the company’s COVID-19 vaccine for use in people 18 years old and older. Here, compiled from Globe wire reports, is what you need to know about how the process will work:
The shots could be available within weeks
The FDA is considered likely to grant the request, perhaps before Thanksgiving.
The path to approval may be more direct this time
Previous COVID-19 vaccine booster authorizations have come from the FDA and US Centers for Disease Control and Prevention after expert advisory panels for both agencies weighed in. But the FDA has the authority to expand the previous authorizations without the panel reconvening, and it’s expected to do so. It’s not clear if CDC Director Rochelle Walensky will consult with her agency’s panel before making her recommendation, The Washington Post reported.
Moderna is also expected to seek a broader authorization for its vaccine
Moderna is expected to ask for broader authorization, but experts say that request may be more complicated because of concerns about certain rare complications affecting young men under 30. In the end, Moderna may seek to lower the age, though not as far as 18, The New York Times reported.
A large number of people are already eligible for boosters
Under the current authorizations, about 2 of every 3 vaccinated adults is expected to qualify within the next few months — and some people have gotten extra shots anyway, because most vaccine providers don’t check qualifications, The Associated Press reported.
Here’s who qualifies for boosters now
People who initially received Pfizer or Moderna vaccinations are eligible for a booster six months later if they’re 65 or older, or are at high risk of COVID-19 because of underlying health problems or their job or living conditions. Anyone who got the single-dose Johnson & Johnson vaccine can get a booster at least two months later. Regulators have also authorized people receiving a booster of a different company’s vaccine, or “mixing and matching” doses.
The Biden administration has supported boosters for everyone
President Biden announced in August he wanted boosters for everyone because of concerns that the vaccines’ protection fades over time. But his administration suffered a setback when regulators approved them for specific groups. Some experts have questioned whether the shots are needed for younger people without underlying conditions. But other experts are saying that the case for booster shots for the general population is now stronger. They’ve cited reasons ranging from more data from Israel on the boosters’ safety and effectiveness to requests from some health practitioners to simplify the eligibility categories.
The move comes at a time of concern about the winter
Pfizer’s move comes at a time of concern about the possibility of increased spread of the coronavirus as colder weather approaches and people gather inside and travel for the holidays. Experts say both initial vaccinations and boosters are key. “If we get the overwhelming proportion of unvaccinated people vaccinated, and we get those who are vaccinated and eligible to get a booster, we can go a long way to preventing a new surge as we go into the winter,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday in an interview on Bloomberg Television.
Material from Globe wire services was used in this report.
Martin Finucane can be reached at email@example.com.