Moderna Asks FDA For Emergency Authorization

(FiveNation.com)- Last week, Moderna requested the Food and Drug Administration grant emergency use authorization for a fourth dose of its COVID vaccine as a booster shot for people over the age of 18.

Currently, the FDA has only given emergency use authorization to a single booster dose of Moderna’s mRNA vaccine.

This is a broader request than the one made by Pfizer for its vaccine just a few days before.

Two days earlier, Pfizer and BioNTech also requested the FDA allow them to provide an additional booster dose of their COVID vaccine Comirnaty, but only for people over the age of 65.

Moderna said it made its request for FDA emergency use authorization for all adults as a way to provide the Centers for Disease Control and Prevention and medical providers more “flexibility” in determining the “appropriate use” of a second booster shot.

The FDA has not said how long it will take it to review either Moderna or Pfizer’s requests. Nor did it indicate whether it would convene its expert panel to review the requests.

Moderna said it requested emergency use authorization based partly on recently published data out of Israel and the United States following the emergence of the omicron variant.

Moderna did not specify what this recently published data showed. However, in January, Israel approved a fourth dose of the COVID vaccine for vulnerable people over the age of 18.

A recent study of over one million Israelis over the age of sixty revealed that those who received a fourth dose of the Pfizer-BioNTech vaccine were half as likely to become infected and four times less likely to because seriously ill than those who only received three doses. That study, however, has not as yet been peer-reviewed.

Other studies into the mRNA vaccines show that they begin to lose their effectiveness after about three months following the third dose.

According to data from the Centers for Disease Control and Prevention, as of March 2022, over 216 million Americans, or 64.2 percent of the population, have been fully vaccinated, and 44.4 percent have received a booster shot.