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FDA Approves Pfizer-BioNTech COVID-19 Vaccine

It's the first vaccine to receive full FDA approval, as Moderna's shot waits in the wings.

Video source: YouTube, ABC News

The US Food and Drug Administration (FDA) approved Pfizer-BioNTech’s (NYSE: PFE) (Nasdaq: BNTX) COVID-19 vaccine for individuals 16 and older on Monday. 

The approval had been originally targeted for Labor Day but was expedited due the recent surge of the more infectious Delta variant of the virus, according to The New York Times.

The regulatory approval makes Pfizer-BioNTech’s shot — to be marketed as Comirnaty — the first to receive full licensure from the federal government, a significant milestone in the nation’s year-and-a-half pandemic battle.

The FDA has only authorized three COVID-19 vaccines — Pfizer-BioNTech, Moderna and Johnson & Johnson — for emergency use in the US.

According to The Times, full approval of the Moderna vaccine could be weeks away as the FDA continues to review its application. 

The Biden administration is hopeful that the regulatory license will spur a wave of vaccination among holdouts who have waited for the FDA to put its formal stamp of approval on the vaccine.

Pentagon spokesman John Kirby said that the Department of Defense is preparing to require all US military service personnel to be vaccinated against COVID-19.

Vaccination rates have crept up in recent weeks as the Delta variant continues to spread, causing a surge in hospitalizations and a reinstatement of mask mandates in COVID-19 hot spots. 

There are still, however, tens of millions of vaccine hesitant Americans, mainly in hard-hit Southern and Midwestern states where the latest outbreak has stressed hospitals and public health resources.  

According to the US Centers for Disease Control and Prevention (CDC), only 170 million Americans — just 51.5% of the population — are fully vaccinated. 

Recent Kaiser Family Foundation polling shows that about 30% of those still unvaccinated said they would be more likely to take a fully approved vaccine than one only authorized for emergency use. 

In recent weeks, companies, schools, cities, government agencies and other institutions have tightened vaccine rules for workers as new cases skyrocket across the country, though some have said they would hold off on any mandate until the FDA fully approved the jab.

More than 203 million doses of the Pfizer-BioNTech vaccine have been administered nationwide, fully vaccinating more than 91 million people in the US, according to the CDC.

Pfizer-BioNTech began submitting data to the FDA in May to support its biologics license application (BLA) for the vaccine, which included the latest results from a clinical trial tracking participants 16 and older for six months after their second vaccine dose.  

The FDA also expanded the vaccine’s emergency use authorization in May to include adolescents, and the drugmakers expect to seek full approval for use in people ages 12 to 15 once more data is available. 

The companies announced earlier in August that they had begun the licensing process for a booster dose for fully vaccinated people after submitting clinical trial data to the FDA. 

Last week, the CDC, White House and FDA announced a plan to give booster shots to all Americans following recent data showing the effectiveness of mRNA vaccines declines over time. 


Source: Equities News

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