Pfizer Asks FDA to OK COVID-19 Booster Shots for All Adults
Pfizer sought approval from the U.S. to permit boosters of COVID-19 vaccine Tuesday, amid growing concern over increased coronavirus spread during holiday travel and events.
Since September, older Americans and those in vulnerable groups have been able to access a third dose from BioNTech and Pfizer. The Food and Drug Administration (FDA), however, has stated that it will quickly expand boosters for younger age groups if necessary.
Pfizer is submitting early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign.
While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time.
Pfizer’s new study concluded a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots.
Trial participants received either the third dose or a mock shot at 11 months. Researchers monitored any infection that developed at least seven days later and have so far found only five cases in booster recipients of symptoms like COVID-19, compared with 109 cases for those who had dummy shot.
The Biden Administration had originally envisioned boosters for all adults, but faced a stinging setback in September when the FDA’s scientific advisers rejected extra Pfizer doses for everyone. The panel wasn’t convinced that young healthy people needed another dose, particularly when most of the world’s population remains unvaccinated, and instead recommended boosters just for certain groups—one of a series of decisions about extra doses for all of the three vaccines used in the U.S.
The current rules: 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 health problems or their job or living conditions. Because the single-dose Johnson & Johnson vaccine hasn’t proven as effective as its two-dose competitors, any J&J recipient can get a booster at least two months later.
Also, anyone eligible for a booster doesn’t have to stick with their initial vaccination type and can get a different company’s vaccine, what’s called mixing and matching.
Around 194 million Americans have been fully vaccinated. Under today’s policies, authorities already estimated about 2 of every 3 vaccinated adults could qualify for a booster within the next few months. Many who don’t meet the criteria often score an extra shot because many vaccine providers don’t check qualifications.
FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application “as expeditiously as possible,” but would not set a timeline for a decision. She also said the FDA hasn’t yet decided whether to convene its panel of outside experts to vet the data.
If the FDA authorizes Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention then will make recommendations for how to use them.
Globally boosters are also a mixed bag. While some countries have restrictions on boosters for older people or those with medical conditions, others allow them. Pfizer boosters have been allowed for everyone 12 and above in Israel. Canada’s health regulator on Tuesday authorized Pfizer boosters for people 18 and older.
Matthew Perrone (AP Health Writer) contributed to this report.