Pfizer has planned to privately brief US health officials on its case for COVID-19 booster shots, but US and global public health officials have not hesitated to publicly blast the idea, calling booster shots unnecessary at this time and unethical in the face of vast inequity in the global vaccine supply.
Pfizer and its vaccine partner BioNTech made headlines last Thursday with the announcement that it would seek authorization from the Food and Drug Administration in the coming weeks for a booster shot to its two-shot regimen. The companies suggest that a third shot will be necessary between six and 12 months after the second dose. During this window, immunity to the pandemic coronavirus declines, the companies say, particularly in the elderly. A third shot, they say, can boost antibody levels five to 10 times what is seen after the first two.
But health officials were quick to push back on the booster talk last week, and the responses have only grown more intense in the days since.
The US Department of Health and Human Services released an unusual joint statement late Thursday from the Centers for Disease Control and Prevention and the Food and Drug Administration. The statement read bluntly, “Americans who have been fully vaccinated do not need a booster shot at this time.”
The statement went on to say that US health agencies are monitoring any potential need for booster shots in the future. But health officials will not rely solely on data from vaccine makers, which clearly have a conflict of interest in deciding if more of their shots are necessary.
The agencies wrote:
FDA, CDC, and NIH [the National Institutes of Health] 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. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.
Officials with the World Health Organization went further on Monday during a regularly scheduled COVID-19 press briefing. In addition to noting the lack of evidence supporting the current need for boosters, they rebuked talk of giving third doses to people in wealthy countries while many low- and middle-income countries don’t have vaccine supply to give even first doses to their most vulnerable citizens, namely frontline health workers and the elderly.
“What part of ‘this is a global crisis’ are we not getting?” Mike Ryan, executive director of the WHO Health Emergencies Programme, said at the briefing. “This is still a global crisis, and it is a time to protect those who are most vulnerable in our society.” If we fail to protect the vulnerable and move on to talking about boosters, “then I think we will be judged… I think we will look back in anger and we will look back in shame.”
Ryan and other experts with the WHO noted that the primary goal of vaccination is to prevent severe disease and death, which the current vaccines do very well. But so far, the main impetus for considering a third dose is to protect against mild infections that may come about as vaccine efficacy wanes with time.
Preventing mild disease in those already vaccinated should not be a priority when vulnerable, unvaccinated people are still dying, Ryan and others say. The increased vaccine production that could go to boosters should instead be used “to protect the most vulnerable, protect our frontline health workers everywhere in the world, [and] take the death and the hospitalizations and the ventilators out of this pandemic,” Ryan said.
Moreover, as the pandemic coronavirus continues its rampage through unvaccinated populations, it has yet more opportunities to evolve into new, more dangerous variants. Current vaccines are largely effective against current variants, including delta, the highly transmissible variant that first appeared in India amid a mostly unvaccinated population. But vaccine efficacy may not hold out against future variants. And if a variant does arise that can entirely evade immune responses from current vaccines, it would make third doses not only ethically questionable but also pointless.
WHO Director-General Tedros Adhanom Ghebreyesus spoke at the briefing of a “two-track pandemic,” in which unvaccinated countries continue to suffer, and highly vaccinated countries have a false sense of security that the pandemic is largely over for them.
Distributing vaccines equitably is not only the right thing to do, Dr. Tedros emphasized—it’s in everyone’s self-interest.
When you consider that “many countries haven’t even started vaccinating, and another country has already vaccinated the majority of its population with two doses and [is] now moving to a third dose, which is the booster, it’s really not only disappointing,” he said. “It’s seriously disappointing. It doesn’t even make any sense. It makes no sense.”
On Saturday, The Washington Post reported that Pfizer and BioNTech plan to meet with US officials about their case for boosters. According to those familiar with the meeting plans, those invited include Anthony Fauci, President Biden’s chief medical adviser; Francis Collins, director of the NIH; Rochelle Walensky, director of the CDC; Janet Woodcock, acting commissioner of the FDA; David Kessler, chief science officer for the COVID-19 response; and Surgeon General Vivek H. Murthy. The Post reported that it wasn’t clear who among them would attend. The meeting was initially scheduled for Monday, but the Post reported that the scheduling could change.