FDA advisory committee rejects Pfizer COVID booster outside of high-risk groups

FDA's Vaccines and Related Biological Products Advisory Committee rejected Pfizer's application to add a third booster shot to its two-dose coronavirus vaccine for patients age 16 years old and older.
Sandra Levy
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Vaccine advisers to the Food and Drug Administration on Friday rejected Pfizer's application to add a third, booster dose of its coronavirus vaccine to the two-dose regimen for people 16 and older. They unanimously voted, however, to recommend emergency use authorization of a booster six months after full vaccination in people age 65 years old and older and those at high risk of severe COVID-19, according to a CNN report,

Members of the FDA's Vaccines and Related Biological Products Advisory Committee voted on the question of whether safety and effectiveness data from a clinical trial supports approval of Pfizer's booster dose administered at least 6 months after completion of the primary series in people 16 years of age and older. They rejected the application by a vote of 16 to 2.

The committee, which is comprised of a group of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts  were discussing whether to consider a revised question, possibly for a narrower age group.

[Read more: Pharmacy chains offering COVID vaccine to adolescents]

Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of Sept. 20, pending signoff from the FDA and Centers for Disease Control and Prevention. 

During the meeting, Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said several studies indicate that people's immunity can and does wane and that giving booster doses restores that immunity -- sometimes to levels higher than seen at initial vaccination. He said people who got the boosters did not have any more side effects than seen after the first two doses, the report said.

Gruber said while the two-dose Pfizer vaccine continues to protect well against severe infection, hospitalizations and deaths, there are hints that could change.

[Read more: Trial: Pfizer's COVID-19 vaccine is 100% effective in 12 to 15 year olds]

The company relied heavily on data from Israel, where vaccinated people started to get breakthrough infections. Israeli researchers earlier told the meeting that adding booster shots in Israel helped keep many people out of the hospital.