By Fiona Rutherford | Bloomberg

Moderna Inc’s Covid-19 Accelerators and the partnership of Pfizer Inc. and BioNTech SE, which are tailored for the latest variants of omicron, have received US regulatory approval, a step towards added protection as concerns about potential new waves in the autumn and winter grow.

The emergency use approval is for use of Moderna’s injection dose in people 18 and older, while Pfizer’s can be used in people 12 and older, the Food and Drug Administration said in a statement Tuesday. The booster must be administered at least two months after recipients’ last Covid vaccine. Advisers to the US Centers for Disease Control and Prevention will meet Thursday and Friday, when they are expected to discuss the vaccines, and Director Rochelle Walensky must make a recommendation before they are rolled out nationwide.

Current vaccines are designed to prevent the Wuhan strain of SARS-CoV-2, but the new mutants are increasingly diverging from the original version in ways that allow them to evade immunity provided by vaccines and previous infections. The Biden administration has made plans to start offering the new boosters as soon as the Labor Day weekend, Bloomberg reported last week.

“As we move into fall and begin spending more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose of the bivalent COVID-19 vaccine to provide better protection against the currently circulating variants.” , FDA Commissioner Robert Califf said in the statement.

Moderna shares were up 0.6% as of 10:39 a.m. in New York. Shares of Pfizer were little changed.

New U.S. cases averaged about 88,000 in the seven days ending Aug. 29, according to the CDC, but hospitalizations and deaths have declined as more people acquire immunity through vaccination and earlier exposures to the virus. The redesigned booster shots are designed to provide immunity against the omicron BA.4 and BA.5 subvariants, the versions of the virus that cause most cases worldwide.

Voting on Thursday

The CDC’s Advisory Committee on Immunization Practices will hold a two-day meeting where members are expected to make their own recommendations about who should get the vaccines. The vote is scheduled for Thursday.

Pfizer and BioNTech plan to file for approval of the omicron-targeted vaccine for children ages 5 to 11 in early October, according to a separate statement from the companies. They are preparing an application for a similar vaccine in children from 6 months to 4 years.

Omicron-tailored boosters are likely to face a jaded public that is skeptical of their added benefits. Only 32% of people have bothered to get a first booster dose, and fewer have received fourth shots, which have been available since the end of March.

Meanwhile, there are still no human efficacy data to show the benefit of the BA.4 and BA.5 personalized boosters, as these trials are still ongoing at Moderna and Pfizer.

“I’m afraid this vaccine has been oversold,” Paul Offitt, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview. “We have data on mice. We need human data. I don’t think that’s asking too much.”

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FDA clears way for boosters targeting latest Covid variants

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