Pfizer asked the U.S. regulators Tuesday for permission to give COVID-19 boosters to anyone aged 18 or older. This comes amid concerns about holiday travel and gatherings spreading the coronavirus.
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 said that it will quickly expand boosters to younger age groups if necessary.
Pfizer has submitted early results from a booster study of 10,000 people in order to support its argument that it is time to expand the booster campaign.
All three vaccines in the U.S. offer strong protection against COVID-19-related death and illness, but the effectiveness of shots against milder infections can decrease over time.
Pfizer's latest study found that a booster could provide protection against symptomatic infections of up to 95%. This was even while the extra-contagious Delta variant was exploding. Similar side effects to the first two shots were seen by Pfizer.
Participants in the trial received either a third dose of Pfizer vaccine or a dummy shot after a median of 11 months. Researchers monitored any infection that occurred more than a week after their last Pfizer vaccination. So far, five cases of COVID-19 were recorded among booster recipients. This compares to the 109 cases in people who received dummy shots.
Although the Biden administration originally intended boosters for all adults in its original plan, it was hampered by a disappointing setback in September from the FDA's scientific advisors who rejected additional Pfizer doses. Although the panel was not convinced that young healthy people required another dose, especially when the majority of the world's population is still unvaccinated. Instead, they recommended boosters only for specific groups. This was one of several decisions regarding extra doses of all three vaccines in the U.S.
Current rules: Anyone who received Moderna or Pfizer vaccines at the time of their first dose is eligible for a booster six-month later if they are 65 years old or more likely to contract COVID-19 due to health issues, job or living conditions. A booster can be obtained by any J&J recipient at least two months after the initial Johnson & Johnson vaccine was administered. The single-dose Johnson & Johnson vaccine is not as effective as its two dose counterparts.
Anyone who is eligible for a booster does not have to get the same vaccine as their first one. They can also receive a different vaccine from a different company, which is called mixing and matching.
Around 194 million Americans have been fully vaccinated. According to current policies, about 2/3 of all vaccinated adults could be eligible for a booster in the next few months. Many people who do not meet the criteria are eligible for an additional shot. This is because vaccine providers often don't verify their qualifications.
Alison Hunt, an FDA spokeswoman, said that Pfizer's request would be reviewed "as quickly as possible" but did not give a time frame for a decision. She said that the FDA is still deciding whether to convene an outside panel to review the data.
If Pfizer requests expanded boosters from the FDA, then the Centers for Disease Control and Prevention will make recommendations on how to use them.
Globally, boosters are also a mixed bag. Some countries have restrictions on boosters for older people or those with medically compromised patients, while others allow them without restriction. For example, Pfizer boosters are now allowed in Israel for people 12 years and over. On Tuesday, Canada's health regulator approved Pfizer boosters for adults 18 years and older.
