Justin Sullivan | Getty Images

The Centers for Disease Control and Prevention cleared reformulated Covid shots that target the latest omicron subvariants for the fall, making it possible for many people to get an extra booster within days.

The agency’s independent committee on vaccines voted 13 to 1 earlier Thursday in favor of the shots after reviewing the available safety and effectiveness data over an almost seven-hour-long meeting. CDC Director Dr. Rochelle Walensky signed off on the shots a few hours later, clearing the way for pharmacies to soon start administering the shots.

Pfizer’s omicron boosters were OKed for people ages 12 and older, while Moderna’s updated shots were authorized for people ages 18 and older. The eligible age groups can receive the boosters at least two months after completing their primary series or their most recent booster with the old shots.

Walensky said her decision followed “a comprehensive scientific evaluation and robust scientific discussion.”

“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to receive it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also authorize the new boosters for children ages 5 to 11 years old in early October, company executives told the committee Thursday.

The original vaccines will no longer be used as a booster in people ages 12 and older now that the reformulated shots are coming online.

Public health officials are expecting another wave of Covd infection this fall as immunity from the old vaccines wanes off, more contagious omicron subvariants spread, and people spend more time indoors as the weather turns colder and families gather for the holidays.

The CDC and the FDA hope the new boosters will provide more durable protection against infection, mild illness and severe disease. The reformulated shots target omicron BA.5, the dominant variant of Covid as well as the strain that emerged in China more than two years ago.

The U.S so far has secured 171 million doses of Pfizer’s and Moderna’s new boosters. More than 200 million people are eligible for the shots, according to the CDC. Dr. Sara Oliver, a CDC official, told the committee Thursday that there should be enough supply of the vaccine to meet demand this fall.

No omicron BA.5 human data

Mouse studies

Safety

Old vaccines losing effectiveness

The original vaccines, which were first authorized in December 2020, are no longer providing meaningful protection against infection because the virus has mutated so much over the past two years. The shots were developed against the first strain that emerged in China, so they are no longer matched to target the omicron subvariants that are spreading.

Infections, hospitalizations and deaths have declined dramatically since the massive wave of omicron infection last winter, but have plateaued this summer at a stubbornly high level. Omicron BA.5 is the most contagious and immune evasive variant yet, and breakthrough infections have become increasingly common as a consequence.

The old vaccines effectiveness against hospitalization also declined after omicron BA.5 became dominant. A third dose was 77% effective at prevention hospitalization four months after receiving the shot, but protection declined after 120 day to as low as 34%, according to CDC data. A fourth dose in people ages 50 and older was 56% effective at preventing hospitalization after four months.

Deaths and hospitalizations from Covid among people ages 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data during Thursday’s meeting. Deaths have risen in particular among people ages 75 and older, Scobie said.

The CDC has shifted to a more targeted public health response with an emphasis on protecting the most vulnerable — the elderly, people with serious medical conditions and those who have weak immune systems. Although there’s no data on the real-world effectiveness of the new boosters, the U.S. is moving rapidly to roll them out in the hope that they will protect people this fall.



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