COVID Omicron Boosters Authorized By FDA: What MD Should Know

MARYLAND — The nation's first variant-specific COVID-19 vaccines are days away from being available to the public after the U.S. Food and Drug Administration granted emergency authorizations Wednesday for booster shots that target omicron subvariants BA.4 and BA.5.

The new booster dose will tweak the existing vaccines produced by Pfizer and Moderna to target two of the most prevalent COVID strains in the United States. BA.5 alone accounted for 88.7 percent of the nation's new cases for the week ending Saturday and has been the most common COVID strain in the U.S. since late June, according to Centers For Disease Control and Prevention estimates.

The new shots are known as "bivalent" vaccines, since they're designed to protect against the original virus and the omicron strains. Officials hope the updated boosters will help curb another winter surge.

Before the booster doses can be available to the public, the CDC must recommend who should get the additional shot. An advisory panel is expected to review the evidence and make a decision Thursday, according to The Associated Press.

Here is current vaccine and booster eligibility outlined by the CDC.

The original omicron wave brought Maryland record-breaking case totals and a near-record number of COVID hospitalizations. The state peaked at 3,452 COVID patients in the hospital on Jan. 10, including 544 in intensive care units.

COVID testing in Maryland also peaked as the omicron wave arrived in early January, with more than 89,000 tests done on Jan. 2, with 26 percent of them positive for the respiratory disease, according to the Maryland Department of Health's COVID dashboard.

Nationwide, the coronavirus pandemic has killed 1.04 million people since the pandemic began in 2020, including 14,919 in Maryland.

Currently, 95 percent of Marylanders — about 4.29 million people — have received at least one dose of a COVID vaccine. The state dashboard shows 618,482 residents have received their second booster dose as of Aug. 25.

If the FDA's decision stands, people 12 and older will become eligible for the new Pfizer booster, while those 18 and older could receive the updated Moderna shot. Patients can receive either of the bivalent boosters at least two months after they've completed their primary vaccination series or received their most recent booster.

The FDA planned for the possibility that vaccine makers would need to modify their original shots to address circulating variants — much like flu vaccines. The composition of flu vaccines changes each year since the virus constantly changes.

"The FDA has extensive experience with strain changes for annual influenza vaccines," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "We are confident in the evidence supporting these authorizations."

The Biden administration obtained 105 million doses of Pfizer's new boosters and 66 million doses of the updated Moderna shots in late June for the nation's fall vaccination campaign.