UPDATE September 2, 2022 at 10:05 AM ET: The Centers for Disease Control and Prevention approved the latest COVID-19 boosters from Moderna and Pfizer-BioNTech on Thursday, allowing it to begin rolling out second-generation vaccines in the coming days.
The CDC’s advisory committee, the Advisory Committee on Immunization Practices (ACIP), held a full-day meeting on Thursday to review all the data on the updated boosters that have not yet completed clinical trials. The committee voted in favor of Booster’s recommendation, he voted 13 to 1, and Booster was approved by the Food and Drug Administration on Wednesday. The only dissenting vote came from Pablo Sanchez, a pediatrician at Ohio State University and Nationwide Children’s Hospital. Sánchez believes the second-generation shots are safe and effective, but felt it would be better to have human clinical data on hand before rolling out doses. There is hesitation about,” he said. “I think this was a little premature.”
While other advisors have expressed similar concerns about the lack of clinical data, the CDC (such as the FDA) believes that updating COVID-19 boosters is much like a streamlined process for updating annual flu vaccines. I emphasized that it works for
On Thursday night, CDC Director Rochelle Wallenski endorsed the ACIP majority vote.
“Our latest COVID-19 booster is formulated to provide enhanced protection against the recently circulating COVID-19 variant,” Walensky said in a statement. variant. This recommendation is based on a comprehensive scientific evaluation and robust scientific arguments. If you qualify, there’s never a bad time to get a COVID-19 booster. Highly recommend getting it. ”
The updated boosters will begin rolling out soon, with supplies coming to locations across the country in the coming days. available to all users of Both boosters should be given at least 2 months after his last COVID-19 vaccine or booster dose.
Original story on August 31, 2022 at 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 boosters are bivalent, and both the original strain of SARS-CoV-2 and the BA.4/5 omicron subvariant, which shares the same spike protein and is currently the dominant variant in circulation, I am targeting.
The new Pfizer-BioNTech booster, which the FDA calls an “updated booster,” is available to everyone 12 years and older. The updated Moderna Booster is available to anyone over the age of 18. In both cases, the booster should be administered at least two months after his last COVID-19 vaccine or booster.
FDA approval comes ahead of the Centers for Disease Control and Prevention’s Advisory Committee meetings scheduled for Thursday and Friday. A CDC panel of independent expert advisors, the Advisory Committee on Immunization (ACIP), will also vote Thursday on whether to recommend using the updated boosters.
If the committee votes in favor and CDC Director Rochelle Walensky upholds the recommendation, the booster will be released to the public. It is expected that the recommendation will pass. The Biden administration has hinted for weeks that it expects a fall booster campaign using these second-generation boosters to begin around Labor Day. States can already pre-order updated booster doses and can begin shipping now that the FDA has issued approval.
At a press conference on Wednesday, FDA Commissioner Robert Calif noted that COVID-19 is still killing more than 400 people every day in the country and adding more than 5,000 new hospitalizations each day, citing a fall booster. emphasized the need for He also cites preliminary CDC data released Tuesday that suggests American life expectancy has fallen again in 2021, largely due to deaths from COVID-19. Life expectancy for Americans born in 2019 is just 76.1 years, down 2.7 years from pre-pandemic 2019.
“COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious consequences of COVID-19 (hospitalizations and deaths),” the Caliph said in a statement. urges all eligible persons to consider a booster dose with the bivalent COVID-19 vaccine to provide better protection against the currently circulating variant as they begin to spend more time indoors. It is recommended.”
While the fall booster argument is simple, the updated booster design is more complicated. We had a fair amount of data, including clinical data, on safety and efficacy. They have not yet collected clinical data on boosters targeting BA.4/5.
But the FDA decided “very intentionally” to pursue the latest Omicron subvariants, BA.4 and BA.5, instead of the no-longer-circulated BA.1, says FDA’s top vaccine Regulator Peter Marks said Wednesday.In June, a panel of FDA advisers voted 19 to 2 in favor of redesigning the booster to bivalent and target omicron. The committee specifically expresses support for targeting BA.4/5. The BA.5 subvariant currently accounts for approximately 89% of US cases. Marks argued that preliminary and observational data on immune responses targeting BA.4/5 appear to offer more protection than seen with BA.1. Additionally, the agency reasoned that the boost against the latest variants could make people better protected from what comes next.
Marks also noted concerns about the lack of clinical data to date, comparing the COVID booster approval process to the annual flu vaccine renewal process. We have had extensive experience in the past with strain changes, and this is the case with influenza vaccines where such strain changes have been done safely and effectively every year,” Marks said. [COVID-19-related] According to the data, the updated booster is expected to provide better protection against the Omicron variants currently in circulation. ”
In a statement Wednesday, Moderna and Pfizer-BioNTech celebrated the approval.
“Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, can be taken by people to protect themselves. “This is an important public health measure. We thank the FDA for its decisive leadership,” said Stephan Bancel, CEO of Moderna.
Pfizer CEO Albert Bourra said both companies were “thrilled” by the FDA’s decision. “Throughout the fall and winter, he could see SARS-CoV-2 spread at school and work, so it’s important to keep vaccines up to date as the first line of defense against COVID-19 disease.”