News

FDA grants emergency use authorization for Pfizer booster shot for people 65 and older

The Food and Drug Administration (FDA) granted emergency use authorization for Pfizer COVID-19 booster shots for patients 65 and older despite top officials at the administration opposing the third dose less than two weeks ago.

As with the initial distribution of all COVID-19 vaccines, the third dose would be given under emergency use without full authorization. Pfizer suggests a third dose within 12 months may increase immunity and protect against the newest variants. Dr. Mikael Dolsten, Pfizer’s chief scientific officer, said early studies show antibody levels jump five to tenfold after a third dose.

Dolsten referred to data from Israel and Britain, noting the Pfizer vaccine “neutralizes the Delta variant very well.” Studies suggest that when antibody levels drop, the virus may cause a mild infection before the immune system kicks back in. However, the booster shot was turned down by the FDA, which said the shot is not necessary for fully vaccinated Americans.

Pharmaceutical Technology reports, “Administered at a minimum of six months following inoculation with the two-dose regimen, the booster shot will have the same formulation and dosage strength as the initial series vaccines.”

The status arrives despite international opposition for the use of booster shots. For instance, the director of the World Health Organization (WHO) suggested vaccines must be distributed to underdeveloped countries before boosters are administered in wealthy countries which have unlimited access to vaccination. Another public health agency, the Centers for Disease Control and Prevention (CDC) advised against the shot. 

The aforementioned FDA opposition was represented in an international open letter. “Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently,” a group of 18 scientists wrote in a paper published in The Lancet. The Biden administration has maintained support for the creation and distribution of booster shots.

ARTICLE: ANTOINETTE AHO

MANAGING EDITOR: CARSON CHOATE

PHOTO CREDITS: NEW YORK TIMES

The following two tabs change content below.
Antoinette is a community college student in Sacramento, California. She is a Politics Editor at Fact Based America, a correspondent for Campus Reform, and a student journalist. She previously worked for Turning Point USA as a High School Coordinator.

Leave a Reply