Thursday, October 21, 2021
Getting a COVID-19 booster shot could soon become much simpler for those who received Moderna or Johnson & Johnson vaccines, thanks to the U.S. Food and Drug Administration’s clearance given on Wednesday.
The FDA decision calls for the allowance of any vaccine as a booster shot regardless of initial completed dose, so long as eligibility requirements are met. For Pfizer and Moderna boosters, the criteria includes those aged 65 and older, or those over 18 who work in high-exposure occupations. The Johnson & Johnson booster is cleared for anyone 18 and older.
The news comes just one week after an initial FDA advisory committee voted in favor of allowing both Moderna and Johnson & Johnson booster shots.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in an Oct. 20 statement. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
The FDA advisory committee held multiple hearings and, based on available information, supported amending existing emergency use authorizations to include allowing a booster shot for eligible populations. Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, addressed the FDA’s additional decision to vote in favor of mixing and matching booster shots.
“We are also taking action today to include the use of mix and match boosters to address this public health need,” Marks said. “We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”
Pfizer Study Reports 95% Efficacy
A third shot of Pfizer’s COVID-19 vaccine may have 95% disease reduction efficacy against COVID-19, according to a study reported today. The study, which included more than 10,000 fully vaccinated people, showed 109 cases of COVID-19 among those who received a placebo shot, with only five reports of the virus among those who received the booster shot.
“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Albert Bourla, Chairman and Chief Executive Officer for Pfizer said. “In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic. We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.”
“These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech. “Based on these findings we believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy.”
Pfizer conducted the study during the Delta variant’s preeminence among infections, suggesting high efficacy against the deadly strain.
The Centers for Disease Control and Prevention must decide whether to sign off on both the booster and mix-and-match decisions, however, before they can be cleared for use. That deliberation is happening in an all-day advisory committee meeting today, after which CDC Director Rochelle Walensky must make the final call.
Email Reporting Fellow Julian Mills at [email protected].