FDA amends EUA for Moderna, J&J boosters; OKs ‘mix and match’ shots

The U.S. Food and Drug Administration on Wednesday amended the emergency use authorizations for COVID-19 vaccines to allow for the use of a single booster dose of the Moderna and Johnson & Johnson vaccines, and also gave the green light for the use of “mix and match” booster shots.

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Update 5:02 p.m. EDT Oct. 20: The U.S. Food and Drug Administration approved the mixing of COVID-19 shots for boosters, and OK’d booster shots for Moderna and Johnson & Johnson vaccine.

According to an FDA news release, the use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least 6 months after completion of the primary series to individuals will be approved to people 65 years of age and older, people 18 to 64 at high risk to severe COVID-19, and people 18 through 64 years of age with frequent institutional or occupational exposure toSARS-CoV-2.

The FDA added that the use of a single booster dose of the Johnson & Johnson vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

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

Original report: The Moderna and J&J boosters are expected to be approved by the agency by Wednesday evening, The New York Times reported Tuesday. An FDA advisory panel voted last week to recommend Johnson & Johnson’s and Moderna’s booster shots under emergency authorization use.

The FDA is also expected to approve the use of mix and match booster shots, or boosters from a different vaccine from the one used in initial doses, two sources familiar with the decision told The Times.

According to a National Institutes of Health study released last week, the approach was found to be effective in boosting the body’s ability to fight the COVID-19 virus.

According to the study, an extra dose of any type of vaccine ups the levels of virus-fighting antibodies.

Those who received a single dose of the J&J vaccine saw the biggest increase in protection, the NIH study showed. Those who received a J&J vaccination saw a 76-fold jump in antibody levels after getting a Moderna booster shot and 35-fold jump with a Pfizer booster.

Those who got a second shot of the J&J vaccine saw a four-fold rise in antibodies.

If the mix and match approach to vaccines is approved, the FDA would not recommend one shot over another.

The move would give state health officials more flexibility in getting people fully vaccinated against the novel coronavirus, something that has been requested for weeks, according to The Times.

Dr. Ashish Jha, the dean of the Brown University School of Public Health, on Tuesday told NBC’s “Today” show that reports that the FDA would approve a mix and match approach to vaccines was good news.

“Clinically, all the data says that mixing and matching is just fine, there’s no downside,” Jha said.

An advisory committee of the Centers for Disease Control and Prevention will review the booster issue Thursday and will report its findings to the director of the CDC with its recommendations.

CDC Director Dr. Rochelle Walensky would then announce the CDC guidance on who would be eligible for booster shots of the Moderna and J&J vaccines and if the mix and match approach to booster shots is approved.





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