BREAKING: Pfizer Submits FDA Application for FOURTH Dose of COVID-19 Vaccine for Americans Age 65 and Over
- The Washington Post reports that Pfizer has submitted data to the FDA to seek approval for a fourth dose of the COVID-19 vaccine for Americans aged 65 and over.
- The authorization will allow all American adults to receive a fourth shot in the coming months.
Pfizer has submitted data to the Food and Drug Administration (FDA) to begin rolling out the fourth dose of its COVID-19 vaccine to Americans aged 65 and over.
The Washington Post reports that on Tuesday, the company submitted data to regulators about the shot, which is a joint project with German firm BioNTech.
A fourth shot has been hinted at for months now, and Pfizer CEO Albert Burla said during a television appearance last week that his company would soon apply for a fourth shot.
While the initial authorization will only apply to older Americans, it will open the door for a fourth shot available to all American adults at some point this year.
The Post also reports that permission could be obtained as early as Tuesday.
All Americans 12 years of age and older are now allowed and recommended to get a booster shot for COVID-19 in accordance with FDA guidelines.
The Centers for Disease Control and Prevention (CDC) also recommends that immunocompromised Americans receive a second booster dose, which will be the fourth dose for the vast majority of Americans who receive one of the two-dose vaccination regimens, whether Pfizer or Moderna shots.
Pfizer reportedly included data from Israel in its package sent to regulators on Tuesday as the Middle Eastern country is one of the few countries in the world that already allows its oldest residents to receive a second booster dose.
It is unlikely that the FDA would require an external convening panel to discuss this issue, and the agency could even green-light an additional dose on the very same day that the data was submitted.
Health experts have warned that there will be more Covid injections and that they could remain an integral part of people’s lives for years to come.
While the mRNA vaccines made by Pfizer and Moderna are not only safe, but also the most effective Covid vaccines on the market, they are not very long-lasting.
Last year’s data showed that protection against infection in people who received the initial two-dose series of the vaccine waned after just five to six months.
It is believed that the protection restored by booster doses then weakens after three to four months.
This is an evolving story that will be updated