COVID-19 vaccines

US CDC expert panel backs use of redesigned Omicron COVID boosters

Reuters
US CDC expert panel backs use of redesigned Omicron COVID boosters

MODERNA. A healthcare worker fills up a syringe with a dose of Moderna's COVID-19 vaccine for a booster shot at the vaccination reference center at the Epidemiology, Biostatistics and Prevention Institute in Zurich, Switzerland, November 17, 2021.

Arnd Wiegmann/Reuters

US Food and Drug Administration officials say they believe the updated shots should be available to a broader population than the previous boosters as they may help younger people avoid long COVID

The U.S. Centers for Disease Control and Prevention (CDC) on Thursday recommended the use of redesigned COVID-19 booster shots for people aged 12 years and older to target the BA.4 and BA.5 Omicron subvariants of the coronavirus.

The green light for the use of redesigned Omicron COVID boosters will enable millions of the retooled shots to roll out by the end of the weekend as part of a nationwide revaccination campaign.

The CDC’s Advisory Committee on Immunization Practices voted 13-to-1 in favor of the updated boosters by Pfizer-/BioNTech and Moderna.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” CDC Director Rochelle Walensky said in a statement.

On Wednesday, August 31, the US Food and Drug Administration authorized the updated shots from Pfizer-BioNtech and Moderna that target the dominant BA.4 and BA.5 Omicron subvariants as well as the original virus. They are often called bivalent shots. 

FDA officials on Wednesday said they believe the updated shots should be available to a broader population than the previous boosters as they may help younger people avoid long COVID, which can leave them suffering debilitating symptoms for months.

The FDA authorized the Pfizer/BioNTech shots for people ages 12 and older and the Moderna booster for those 18 and over, if they have received a primary vaccine series or a booster at least two months prior. The previously authorized monovalent vaccine will no longer be available as a booster shot in those age groups.

Pfizer-BioNtech said on Thursday it hopes to ask the FDA for authorization in 5- to 11-year-olds in early October.

CDC and FDA officials have said they believe the shots will boost immunity against the virus ahead of the winter season, when infections tend to rise as people spend more time indoors where the virus is more easily transmitted.

Currently, a second booster is restricted largely to people over age 50 and those who are immunocompromised or at high risk.

During the meeting, CDC officials suggested people who have had COVID should wait at least until they have completed their isolation to receive a booster and may consider waiting 3 months.

Vaccine makers have yet to complete human trials for the newly authorized boosters, and some ACIP members raised reservations over the lack of data. Most of the available data on the redesigned boosters comes from lab and animal studies.

“I understand we need better vaccines because obviously we’re still having a lot of COVID despite vaccination,” said committee member Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, who voted against the recommendation. “But I’m struggling with making a recommendation for a bivalent vaccine that has not been studied in humans.”

The FDA had in June said it would not require studies testing the shots in humans for authorization, similar to how annual changes to flu vaccines are cleared. – Rappler.com

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