Eighteen senior U.S. Food and Drug Administration (FDA) officials, including two who have said they plan to resign over this, have written a report this week in which they disagreed with the Joe Biden administration’s plans to roll out COVID-19 vaccine boosters next week.
In the report, which was published in The Lancet on Monday, the officials wrote that there isn’t any evidence that boosters are needed because those who are fully vaccinated have high levels of protection against hospitalization or death. They instead want to see these vaccine doses be donated to areas with lower vaccination rates so that it will be less likely that more COVID variants will emerge.
Two of the authors of this report are Dr. Marion Gruber and Dr. Philip Krause, who each say that they plan to resign due to disagreements over the rollout of vaccines.
“Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society,” the officials wrote in the report.
“COVID-19 vaccines continue to be effective against severe disease, including that caused by the Delta variant,” they added. “Most of the observational studies on which this conclusion is based are, however, preliminary and difficult to interpret precisely due to potential confounding and selective reporting.”
The officials went on to explain that what really matters is that the vaccines are effective at preventing severe disease and death.
“Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” they said.
The officials also warned that receiving boosters that are not needed puts people at risk for other complications.
“There could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines,” they said.
While officials said that it’s possible that boosters will be needed in the future, they do not feel that they are necessary now.
“Boosting might ultimately be needed in the general population because of waning immunity to the primary vaccination or because variants expressing new antigens have evolved to the point at which immune responses to the original vaccine antigens no longer protect adequately against currently circulating viruses,” they said.
Biden and his administration have yet to respond to this damning report. It remains to be seen if this will have any impact on their booster shot rollout plan, but knowing how the left operates, we doubt that this will stop them.
Whatever happened to following the science, Joe?