FDA authorizes updated COVID boosters from Moderna and Pfizer

The Food and Drug Administration (FDA) today announced that it has authorized for emergency use bivalent booster shots that target the Omicron BA.4/BA.5 subvariants, setting the stage for Centers for Disease Control and Prevention (CDC) advisory group recommendation discussions tomorrow.

In other developments, the World Health Organization (WHO) said cases and deaths declined last week, while warning that new surges could occur in the months ahead.

Another step toward September booster rollout

In a statement, the FDA said the authorizations cover the Moderna bivalent vaccine in those ages 18 and older, and the Pfizer/BioNTech vaccine covers people ages 12 and older. The updated boosters can be given at least 2 months after primary vaccination or the last booster vaccination.

BA.4 and BA.5 Omicron subvariants are still circulating widely in the United States, and health officials predict that they will remain through the fall and winter.

Robert Califf, MD, FDA commissioner, said, "As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants."

Also as part of today's announcement, the FDA pulled its authorization of monovalent boosters for most groups, except Pfizer for kids ages 5 through 11 years. However, the vaccines are still authorized for the primary series in those ages 6 months and older.

When the two companies applied for emergency use of the updated boosters, they said they had already scaled up manufacturing to be ready to deliver doses in September, if authorized.

The FDA based its authorization on clinical data from trials for a bivalent booster targeting the BA.1 Omicron subvariant, as well as preclinical data on the BA.4/BA.5 version and earlier data from primary vaccination and booster trials. Officials said the earlier data are relevant, given that those vaccines are made using the same process.

Tomorrow, the CDC's vaccine advisory group, the Advisory Committee on Immunization Practices (ACIP), will begin its deliberations on a recommendation for the updated boosters. Vaccination using the new boosters can begin as soon as the CDC signs off on any recommendations that come from ACIP.

Pfizer said today that it will begin shipping vaccine, based on an existing contract with the US government. Eligible recipients will continue to receive the vaccine for free, consistent with US policy. It added that it hopes to submit an application for emergency use of the vaccine in kids ages 5 though 11 in early October.

Meanwhile, Moderna said it expects that its update booster will become available at US vaccination sites in the coming days, with doses purchased by the US government.

WHO: BA.5 prevalence still rising amid drop in cases

In global developments, in its weekly snapshot of the pandemic, the World Health Organization (WHO) said COVID cases declined last week by 16% compared with the previous week, marking the third straight week for a drop in cases. Deaths decreased by 13%.

COVID markers were down in all six world regions, including the Western Pacific, where Japan and South Korea are still battling surges fueled by BA.5.

At a WHO briefing today, Director-General Tedros Adhanom Ghebreyesus, PhD, said it's reasonable to expect another uptick in activity as cooler weather approaches in the Northern Hemisphere. He warned that the Omicron subvariants are more transmissible than earlier versions and that the threat of more dangerous variants remains.

Tedros urged communities to close their vaccination gaps and use tools known to curb the spread of the virus, including avoiding crowds, using masks, and providing better ventilation. "Living with COVID-19 doesn’t mean pretending the pandemic is over," he said.

In its update today, the WHO said Omicron made up 99.6% of sequenced samples over the past month, with the prevalence of the BA.5 subvariant rising from 72.4% to 78.2%. It added that the prevalence of the BA.2 descendant lineage has remained stable in recent weeks, and while levels of BA.2.75 are relatively low, a number of countries have recently observed increasing trends.

 

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