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FDA Expands Booster Dose Usage Authorization for COVID-19 Vaccines

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said acting FDA commissioner Janet Woodcock, MD.

Video source: YouTube, ABC News

The US Food and Drug Administration (FDA) signed off Wednesday on extending COVID-19 boosters to the millions of Americans who received the Moderna Inc (Nasdaq: MRNA ) or Johnson & Johnson (NYSE: JNJ ) vaccines and said anyone eligible for an extra shot can mix and match doses from different drug providers. 

Specifically, regulators amended the emergency use authorizations to permit a half dose of Moderna’s vaccine as a booster shot for seniors and others at high risk from the virus six months after their last shot.

For J&J’s single-shot vaccine, the FDA said all recipients, no matter their age, could get a second dose at least two months after their initial vaccination.

As for mixing and matching, the agency said it is OK to use any brand for the booster, regardless of which vaccination people received initially.

Before providers can start administering the shots, the US Centers for Disease Control and Prevention (CDC) must consider the FDA’s amended authorization and offer their own advice. 

According to NBC News, the CDC’s vaccine advisory panel is meeting Thursday to discuss the boosters and its director Dr. Rochelle Walensky is expected to issue official recommendations shortly theraafter.

In a statement, acting FDA commissioner Dr. Janet Woodcock said, “Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic. As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.”

Woodcock added, “The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

Dr. Peter Marks, director of the FDA's vaccine arm, the Center for Biologics Evaluation and Research, said it believes the ability to use any authorized vaccine as a booster will make it simpler for people to get another dose.

"Being able to interchange these vaccines is a good thing. It's like what we do with flu vaccines. Most people don't know what brand flu vaccine they received," Marks told reporters in a telephone briefing. 

The FDA said its decision to allow mix-and-match boosters was based on preliminary findings from the National Institutes of Health that showed an extra dose of any brand revs up levels of virus-fighting antibodies.  

Researchers also found that recipients of the single-shot J&J vaccine had a far bigger response if they received a full-strength Moderna booster or Pfizer-BioNTech booster, rather than a second J&J shot.

As of Wednesday, the vast majority of the nearly 190 million Americans who are fully vaccinated against coronavirus have received either the Pfizer or Moderna options, while about 15 million have gotten the J&J shot. 

Following last month’s approval of Pfizer’s booster shot for those aged 65 and other high risk groups, about 11.2 million Americans have received a third dose of the vaccine, according to the CDC.

Public health officials have said that, while vaccinating the 65 million Americans who remain unvaccinated is the priority, shoring up protection among the country’s fully vaccinated population is also key to fighting the pandemic.


Source: Equities News