Update 9/2/2022, 10:05 am ET: The Centers for Disease Control and Prevention signed off on updated COVID-19 boosters from Moderna and Pfizer-BioNTech on Thursday, allowing second-generation vaccines to begin rolling out in the coming days. The CDC’s advisory panel — the Advisory Committee on Immunization Practices (ACIP) — convened for a daylong meeting Thursday to review all the data on the updated boosters, which have yet to complete clinical trials. The committee voted 13 to 1 in favor of recommending the boosters, which were approved by the Food and Drug Administration on Wednesday. The only negative vote was from pediatrician Pablo Sánchez of Ohio State University and Nationwide Children’s Hospital. Sánchez believes the second-generation shots will be safe and effective, but he thought it would be better to have the human clinical data in hand before the doses are released. “There’s already a lot of vaccine hesitancy,” he said. “I just feel like this was a little premature.” Although other advisors raised similar concerns about the lack of clinical data, the CDC—like the FDA—stressed that the COVID-19 booster update worked much like the simplified process for updating annual flu shots. On Thursday night, CDC Director Rochelle Walensky approved the majority of the ACIP, the final step before the doses can go into effect. “The updated COVID-19 boosters are designed to better protect against the latest variant of COVID-19 that is circulating,” said Walensky. “They can help restore protection that has been weakened by previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific review and robust scientific debate. If you qualify, there is no bad time to to get the COVID-19 souvenir and I strongly encourage you to get it.” The updated boosters will start rolling out immediately, with supplies appearing in locations across the country in the coming days. Moderna’s updated booster will be available to everyone 18 and older, while the Pfizer-BioNTech booster will be available to everyone 12 and older. Both boosters must be given at least two months after the last COVID-19 vaccine or booster. Advertising
Original story on 8/31/2022, 1:47 pm ET: As expected, the Food and Drug Administration on Wednesday approved second-generation COVID-19 boosters from Moderna and Pfizer-BioNTech. The newly approved enhancers are bivalent, targeting both the original strain of SARS-CoV-2 and the BA.4/5 omicron subvariants, which share the same spike protein and are currently the predominant circulating variants. The new Pfizer-BioNTech boosters — which the FDA calls “updated boosters” — will be available to everyone 12 years and older. Updated Moderna boosters will be available to anyone 18 years of age or older. In both cases, boosters should be given at least two months after the last COVID-19 vaccine or booster. The FDA authorization comes ahead of a scheduled meeting Thursday and Friday of an advisory committee to the Centers for Disease Control and Prevention. The CDC’s panel of independent experts — the Advisory Committee on Immunization Practices (ACIP) — will vote as early as Thursday on whether the updated boosters should be recommended for use. If the committee votes in favor and CDC Director Rochelle Walensky approves the recommendation, the boosters will then be available to the public. It is expected that the recommendation will take place. The Biden administration has signaled for weeks that it expects the fall boost campaign with these second-generation boosters to begin around Labor Day. States have already been able to pre-order doses of the updated boosters, and shipments can begin now that the FDA has issued the authorization. At a press briefing Wednesday, FDA Commissioner Robert Califf emphasized the need for fall boosters, noting that the country is still seeing more than 400 deaths a day from COVID-19 and more than 5,000 new hospitalizations each day. In addition, he also cited interim CDC data released on Tuesday suggesting that Americans’ life expectancy fell again in 2021, largely due to deaths from COVID-19. Life expectancy for Americans born in 2021 is just 76.1 years, a drop of 2.7 years from 2019, before the pandemic. “Covid-19 vaccines, including vaccines, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” Califf said in a statement. “As we head into fall and begin spending more time indoors, we strongly encourage anyone who qualifies to consider getting a booster dose of a bivalent COVID-19 vaccine to provide better protection against circulating variants.” Advertising

Reinforcement decision

While the argument for the drop-out amps is simple, the design for the updated amps was more complicated. COVID-19 vaccine makers Moderna and Pfizer-BioNTech had a large amount of data, including clinical data, on the safety and efficacy of an updated booster targeting the original omicron strain, BA.1. They have not yet gathered clinical data for the BA.4/5 targeting enhancers. However, the FDA “very deliberately” decided to go with the latest omicron subvariants, BA.4 and BA.5, rather than BA.1, which is no longer in circulation, the FDA’s top vaccine regulator, Peter Marks, said Wednesday. In June, an FDA advisory panel voted 19 to 2 in favor of redesigning the enhancers to be bivalent and target the omicron. The committee is largely supportive of targeting BA.4/5, specifically. The BA.5 subvariant currently accounts for approximately 89 percent of cases in the US. Marks argued that preliminary and observational data on BA.4/5-targeted immune responses appeared to offer more protection than was seen with BA.1. Additionally, the agency argued that boosting against the latest variant could lead to people being better protected against whatever comes next. Marks also expressed concern about the lack of clinical data so far, comparing the approval process for the COVID booster to the update process for annual flu shots. “We’ve had a lot of experience in the past with strain changes made without clinical data based on all the available evidence. This is the case with the flu vaccine for which such strain changes are made safely and effectively every year,” Marks said. “Based on [COVID-19-related] data, the updated boosters are expected to provide increased protection against the circulating omicron variant.” In statements Wednesday, Moderna and Pfizer-BioNTech celebrated the authorizations. “Getting an enhancer 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 protecting themselves, especially as we head into a season filled with indoor gatherings,” said Moderna CEO Stéphane Bancel. “We are grateful to the FDA for its decisive leadership.” Pfizer CEO Albert Bourla said the companies were “thrilled” by the FDA’s decision. “As we head into the fall and winter season, with the potential for greater spread of SARS-CoV-2 in schools and at work, it is important to stay up-to-date with vaccines as the first line of defense against COVID-19 disease. “