CDC recommends targeting BA.4/5 COVID boosters from Moderna and Pfizer [Updated]

Zoom / An Army veteran waits for the recommended 15 minutes to see if he will have any adverse reactions after receiving his second COVID-19 booster dose at Virginia’s Edward Haynes Jr. Hospital on April 1, 2022, in Haynes, Illinois.

Update 9/2/2022, 10:05AM ET: The Centers for Disease Control and Prevention signed off on updated COVID-19 boosters from Moderna and Pfizer-BioNTech Thursday, allowing for the release of second-generation vaccines in the coming days.

The Centers for Disease Control and Prevention’s advisory committee — the Advisory Committee on Immunization Practices (ACIP) — met for a Thursday meeting to review all data on updated boosters, not yet complete from clinical trials. The panel voted 13 to 1 in favor of the recommendation, which was cleared by the Food and Drug Administration on Wednesday. The only dissenting vote was for pediatrician Pablo Sanchez of Ohio State University and Nationwide Children’s Hospital. Sanchez believes second-generation shots will be safe and effective, but she felt it would be best to provide human clinical data before doses are introduced. “There is a lot of hesitation with vaccines already,” he said. “I just feel like this was a little premature.”

Although other advisors have expressed similar concerns about the lack of clinical data, the CDC — like the Food and Drug Administration — emphasized that the COVID-19 booster update worked much like the streamlined process for updating annual flu vaccines.

And Thursday night, Rochelle Wallinsky, director of the Centers for Disease Control and Prevention, endorsed the ACIP’s majority vote, the last step before the dosing goes into the fray.

“The updated COVID-19 boosters are designed to provide better protection against the latest circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has diminished since the previous vaccination, and are designed to provide broader protection against the latest variants. This recommendation came after Thorough scientific evaluation and robust scientific discussion. If you qualify, there is no bad time to receive a COVID-19 booster, and I highly encourage you to receive it.”

The updated reinforcements will take effect immediately, with supplies appearing at locations nationwide in the coming days. The updated Moderna booster will be available to everyone age 18 and older, while the Pfizer-BioNTech booster will be available to everyone age 12 and older. Both boosters should be given at least 2 months after the last COVID-19 vaccine or booster dose.

Original story on 08/31/2022, 1:47 PM ET: As expected, the Food and Drug Administration on Wednesday approved the second generation of COVID-19 boosters from Moderna and Pfizer-BioNTech. The newly authorized enhancers are bivalent, targeting the original SARS-CoV-2 strain and the BA.4/5 omicron sub variants, which share the same spike protein and are currently the dominant circulating variants.

New Pfizer-BioNTech boosters — which the FDA calls “refreshing boosters” — will be available to everyone age 12 and older. Updated Moderna boosters will be available to anyone 18 years of age or older. In either case, boosters should be given at least two months after the last COVID-19 vaccine or booster.

The FDA’s statement comes ahead of a scheduled Thursday-Friday meeting of the Centers for Disease Control and Prevention’s advisory committee. The CDC’s panel of independent expert advisors – the Advisory Committee on Immunization Practices (ACIP) – will vote early Thursday on whether the use of updated boosters should be recommended.

If the committee votes in favor of the recommendation and CDC Director Rochelle Walinsky endorses the recommendation, the boosters will become publicly available. The recommendation is expected to be implemented. The Biden administration has indicated for weeks that it expects to begin its fall campaign of support with second-generation boosters on Labor Day. States have already been able to pre-order doses of the updated boosters, and shipments can begin now that the U.S. Food and Drug Administration has issued permission.

At a news briefing Wednesday, Food and Drug Administration Commissioner Robert Califf emphasized the need for fall boosters, noting that the country continues to see more than 400 deaths a day from COVID-19 and more than 5,000 new hospital admissions a day. In addition, he also referred to interim CDC data released Tuesday indicating that the life expectancy of Americans will decline again in 2021, largely due to COVID-19 deaths. The average life expectancy of Americans born in 2021 is just 76.1 years, down 2.7 years since 2019, before the pandemic.

“COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious consequences (hospitalization and death) of COVID-19,” Califf said in a statement. “As we approach fall and begin to spend 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 variants currently circulating.”

supporter decision

While the argument for drop boosters is straightforward, the design of the updated boosters was more complex. COVID-19 vaccine makers Moderna and Pfizer-BioNTech had a large amount of data, including clinical data, on the safety and efficacy of their updated booster that targeted the original omicron strain, BA.1. They have not yet collected clinical data on BA.4/5 targeting enhancers.

However, the FDA “deliberately” decided to pursue the newest omicron sub-variants, BA.4 and BA.5, instead of BA.1, which are no longer in circulation, Peter Marks, the FDA’s top vaccine regulator, said Wednesday. In June, a panel of FDA advisors voted 19-2 in favor of redesigning the boosters to be bivalent and targeted at omicron. The Commission largely expresses support for specifically targeting BA.4/5. The BA.5 variant currently accounts for about 89 percent of US cases. Marks argued that preliminary and observational data on BA.4/5 targeted immune responses appear to provide more protection than seen with BA.1. Additionally, the agency concluded that reinforcement against the latter variant could put people in a better position to be protected from whatever comes next.

Marks also addressed concerns about the lack of clinical data to date, comparing the COVID booster authorization process to the annual flu vaccine update process. “We have had extensive experience in the past with strain changes that were made without clinical data based on the totality of available evidence. Such is the case with influenza vaccine that such strain changes are made safely and effectively every year,” Marks said. “Based on [COVID-19-related] data, the updated enhancers are expected to provide increased protection against the currently circulating omicron variant.”

Moderna and Pfizer-BioNTech in statements on Wednesday celebrated the licenses.

“Having a booster that specifically targets the Omicron BA.4/.5 variant, which is currently the most prevalent strain of SARS-CoV-2, is an important public health measure that people can take to help protect themselves, especially as we turn to Bansel,” said Stephane Bancel. The season is filled with indoor gatherings. “We are grateful to the Food and Drug Administration for its decisive leadership.”

Albert Burla, chief executive of Pfizer, said the companies were “delighted” with the FDA’s decision. “As we approach fall and winter, with SARS-CoV-2 potentially spreading further in schools and at work, it is important to keep up with vaccinations as the first line of defense against COVID-19.”

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