Pfizer asks FDA to OK COVID-19 booster shots for all adults
Pfizer requested Tuesday that U.S. regulators allow COVID -19 booster shots for any adult. This request comes amid concerns about the spread of coronavirus through holiday travel and gatherings.
Older Americans, and other groups that are particularly susceptible to the virus, have been able to access a third dose from Pfizer and BioNTech since September. The Food and Drug Administration said that it will quickly expand boosters to 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 in the U.S. offer strong protection against severe COVID -19 disease and death, their effectiveness against milder infections can decrease over time.
Pfizer’s latest study found that a booster could provide protection against symptomatic infections to 95%,, even though the extra-contagious Delta variant was growing. Similar side effects to the company’s previous two shots were seen.
Participants in the trial were either given a third dose of Pfizer vaccine or a dummy shot after a median period of 11. Researchers monitored any cases that occurred more than a week after their last Pfizer vaccination. So far, they have identified five cases of symptomatic -19 in booster recipients as compared to 109 cases in dummy shot recipients. The Biden administration originally planned to offer boosters for all adults. However, the FDA’s scientific advisors rejected additional Pfizer doses in September. The panel was not convinced that young healthy adults needed another dose of vaccine, especially when the majority of the world’s population is still unvaccinated. Instead, they recommended boosters only for certain groups. This was one of several decisions regarding extra doses of all three vaccines in the U.S .
. The single-dose Johnson & Johnson vaccine is not as effective as the two-dose counterparts, so any J&J recipient can receive a booster within two months.
Anyone who is eligible for a booster does not have to get the same vaccine as their first one. They can also choose to receive a different vaccine from another company, which is called mixing and matching.
More than 194million 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 qualifications.
FDA spokeswoman Alison Hunt stated that the FDA would review Pfizer’s application “as quickly as possible” but would not give a time frame for a decision. The FDA has not yet decided whether it will convene its panel outside experts to review the data.
If the FDA approves Pfizer’s request for boosters expanded, 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 medical conditions, while others allow them for everyone. For example, Pfizer boosters are allowed in Israel for anyone 12 or older. On Tuesday, Canada’s health regulator approved Pfizer boosters to be given to 18 people over the age of 65.
AP Health Writer Matthew Perrone contributed to this report.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content is the sole responsibility of the Associated Press.