The US FDA and CDC have made an unexpected announcement on COVID-19 vaccine boosters, downplaying hints that a third shot might be necessary to protect against coronavirus variants. Just how long the current COVID-19 vaccinations can actually be expected to remain effective has been a contentious point over the past twelve months, amid the accelerated push to begin immunizations during the global pandemic.
With clinical trials ahead of public vaccination programs by a matter of months, pharmaceutical companies like Pfizer and Moderna – and indeed government agencies like the Food and Drug Administration and the Centers for Disease Control – have held off from making long-term promises about the efficacy of the drugs. However it’s been broadly acknowledged, including by Dr. Fauci, that an annual COVID-19 booster injection may well be necessary.
Still, it came as a surprise nonetheless when Pfizer announced on Thursday this week that it planned to publish study results around the impact of a third injection of its vaccine developed with BioNTech imminently. A submission to the US FDA, along with the European Medicines Agency and other global regulators would follow after that, the pharmaceutical company said. In August, Pfizer suggested, it would seek the go-ahead for public deployment under the US emergency use authorization program.
Shortly after that announcement, the CDC and FDA delivered a joint statement regarding booster shots. While the two agencies continue to encourage those who have not been vaccinated to make that a priority, and highlight the danger of the growing COVID-19 Delta variant, they are also blunt about third injections.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies insisted. “FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.”
While the statement does not name Pfizer-BioNTech specifically, it’s not hard to read some scolding into the CDC and FDA’s phrasing. All the same, the agencies do concede that this doesn’t mean a booster shot won’t ever be required.
“We continue to review any new data as it becomes available and will keep the public informed,” the statement continues. “We are prepared for booster doses if and when the science demonstrates that they are needed.”
The reality is that the overwhelming majority of deaths from COVID-19 are now among those people who have not been vaccinated. Fatality rates in the US in June 2021 increased, a change in trend blamed in no small part on the Delta variant, but according to Dr. Fauci a whopping 99.2-percent of deaths were of people who had not received the vaccine.