Use any needed extra time for vaccine safety
U.S. Food and Drug Administration officials and scientists are in a race against death. It is one they must undertake in a cautious sprint.
At least two COVID-19 vaccines appear to be nearing readiness. Before doses already on the production line can be distributed, the FDA must approve them.
Effectiveness in the 95 percent range is being touted by both developers, Moderna and the Pfizer-BioNTech partnership. That would be a godsend to millions of Americans who remain at great risk from the coronavirus.
The two developers are seeking emergency authorization for distribution of the vaccines. A mechanism exists for the FDA to provide that, bypassing some of the requirements with which drug companies must comply in normal times.
These are not normal times. Every day of delay in getting vaccines will — not may, but will — result in hundreds, perhaps thousands, of deaths from the virus.
Emergency use authorization, the FDA process being used to approve the two vaccines, in effect allows the FDA to give the go-ahead if the drugs’ effectiveness outweighs risks associated with them. Preliminary data from tests involving thousands of people indicates these two candidates are far more effective against COVID-19 than had been expected. So far, it also shows extremely minimal risk.
Still, FDA officials and scientists must not bow to pressure over the vaccines by sidestepping safety considerations. A few cases of serious side effects once the vaccines are distributed could wreck public confidence in the process. That, in turn, could mean many Americans who need protection against COVID-19 would decide against being vaccinated.
A few days of fail-safe testing regarding risk could be invaluable.
Even if distribution of the vaccines is delayed, additional safety checkoffs appear to be a good idea. FDA officials should proceed on that basis.