New COVID-19 vaccine booster, treatment applications submitted to FDA


(NewsNation Now) — Two drug companies are seeking approval to bring new weapons into the fight against COVID-19.

Johnson & Johnson applied for authorization to distribute booster doses, and says the effectiveness of its shots can reach more than 90%.

A Phase 3 study that found, “A booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19.”

Nobody in the study who got a booster dose had severe COVID-19.

J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

AstraZeneca also applied for FDA emergency use authorization for a treatment similar to other antibody cocktails that have come to market.

If authorized, the drug would likely be limited to people with compromised immune systems who don’t get sufficient protection from vaccination.

Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77%. More than three-quarters of the participants had suppressed immune systems due to cancer, lupus and other conditions that made them more susceptible to severe disease.

“First and foremost we want to protect those vulnerable populations that haven’t been adequately protected by the vaccine,” said Menelas Pangalos, AstraZeneca’s head of research and development. “But ultimately it will be up to health authorities to work out who they choose to immunize.”

Scientists say in the face of a vocal anti-vaccine movement across the country, it’s important to clarify what these COVID-19 treatments are and what they are not.

“Any time you get this illness, you are rolling the dice with what can happen with complications and the progress of the disease,” Dr. Dana Hawkinson, an infectious disease physician with the University of Kansas Health System, told NewsNation. “So, it is not something to be put in place of vaccination.

“Vaccination continues to be our most important weapon against this disease.”

A new report from the Department of Health and Human Services shows COVID-19 vaccinations may have prevented more than 265,000 cases and nearly 39,000 deaths among senior citizens in the U.S.

J&J rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.

The Associated Press contributed to this report.

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