The Food and Drug Administration (FDA) is now looking to authorize booster shots of Pfizer’s Wuhan coronavirus (COVID-19) vaccine for adults. The Centers for Disease Control and Prevention‘s (CDC) committee of vaccine experts has also scheduled a meeting where they will discuss the safety and efficacy of the booster.
If both agencies sign off, any adult who received a second dose of the Pfizer vaccine at least six months prior will be eligible for a booster as early as this weekend.
Some states are already expecting the authorization and have begun encouraging adults to seek out boosters. More than 30 million people so far have already received their third shots.
It is unprecedented for individual states and cities to get ahead of FDA and CDC recommendations, especially considering that both had resisted President Joe Biden’s boosters-for-all push amidst concerns of global equity and debates regarding their necessity. The agencies also expressed worries about undermining confidence in the vaccines at a time when millions of Americans have yet to receive their first dose.
However, as federal officials watch states and cities opening up the eligibility on their own and absorbing information about the waning durability of the two-dose vaccine regimen, they decided to reconvene and reconsider their stance.
Dr. Ashish K. Jha, dean of the Brown University School of Public Health, said that infections and hospitalizations are rising. “The holidays are approaching. The data is becoming increasingly clear. It is time for every adult six months out to get a booster.”
The Biden administration initially tried to roll out the booster campaign in September, but public health experts said that the regulators needed more time before deciding whether or not the vaccine data supported the program.
FDA vaccine advisory committee member Dr. Paul Offit said that they needed to show why a booster dose is beneficial to 18 to 29-year-olds. If not, the committee will have to consider that myocarditis, which was a second dose phenomenon, may also appear after the third dose. “Do the benefits clearly and definitively outweigh risks for 18 to 29-year-olds?”
Myocarditis, an inflammation of the heart muscle, was an observed side effect of the vaccine – especially on young men who received their second dose of the mRNA vaccines.
In its filing last week, Pfizer noted that new data from a large clinical trial of more than 10,000 fully vaccinated individuals found that a booster dose was over 95 percent effective against COVID-19.
A press release issued by the company said that during the study period, there were only five cases of COVID-19 in the booster group, while there were 109 cases in the non-boosted group. The company also said that the efficacy of the booster dose was consistent across different ages and racial and ethnic groups. (Related: BOMBSHELL: Pfizer lied about death count in key covid “vaccine” clinical trial – fatalities were MUCH higher.)
The Pfizer and Moderna vaccine boosters are currently recommended only for people aged 65 and older, and adults who have underlying health conditions or work or live in high-risk settings. Individuals 18 and older who received the Johnson & Johnson single-dose vaccine are also eligible for a second shot.
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