Top scientists across the world — including experts at the FDA and the World Health Organization — pushed back against the need for widespread coronavirus vaccine booster shots on Monday.
In a review published in the top medical journal The Lancet, the scientists argued that booster shots are not needed in the general population since vaccines still remain highly effective at preventing severe illness and death. They also mentioned the urgent need to administer doses to unvaccinated people worldwide to save lives and prevent the emergence of more dangerous variants.
The review comes as the US nears the Biden administration's controversial proposed start date for a booster rollout, recommended eight months after an individual's second shot of the Pfizer or Moderna COVID-19 vaccines. The report also comes one week after the White House announced a massive push to mandate vaccination among nearly two-thirds of the US workforce, as pockets of unvaccinated individuals continue to drive high numbers of hospitalizations and deaths nationwide.
The FDA's external panel of experts is holding a highly anticipated meeting this Friday to discuss Pfizer's application for a booster dose.
The 18 coauthors of the Lancet review include Marion Gruber, the director of the FDA’s vaccines office, and Philip Krause, her deputy at the agency, both of whom announced they would be resigning in the fall, reportedly in part due to their opposition to the Biden administration's booster plan. The review was also coauthored by several experts at the World Health Organization, which has called for a global booster shot moratorium in order to maximize vaccinations worldwide — especially in developing countries, where vaccination rates remain very low.
The Lancet paper reviews the current evidence on the protection offered by existing vaccines. While the vaccines all offer less protection against infection with the Delta variant compared with the previously dominant Alpha, they still offer very good protection against severe disease. And while the ability to prevent infection or even symptomatic illness may decrease over time, protection against severe disease appears so far to hold strong.
Three CDC reports published last week confirmed these findings across most age groups, declining more significantly in people 75 or older. One of the studies reviewed nearly 570,000 US COVID-19 cases from April to July, showing that unvaccinated people were nearly 5 times more likely to get infected, and more than 10 times as likely to be hospitalized or die compared to people who received a vaccine.
"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," the authors of the Lancet paper wrote.
Data out of Israel, which has already begun a rollout of booster shots, showed an increase in protection against infection and severe disease after a third shot of the Pfizer vaccine, which was originally given in two doses. But the Lancet authors noted that the data was only collected for a week after the booster dose was administered, and it's unclear how long that protection will last.
The Lancet authors argued that boosters may ultimately be needed if immunity wanes over time, but more research was needed to determine when that will be necessary. For now, they argued, there is a more urgent need to administer existing doses among the unvaccinated. They also suggested that booster doses designed specifically against the main circulating variants of the coronavirus might be more powerful and longer lasting.
"Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated," the authors wrote. "If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants."
Mike Ryan, head of the WHO's Health Emergencies Program, condemned booster shot rollouts in stark terms last month. "We're planning to hand out extra life jackets to people who already have life jackets, while we're leaving other people to drown without a single life jacket," Ryan said. "That's the reality."
This story has been updated to include information about the FDA advisory committee meeting this Friday.