FDA must get it right, and fast, with vaccines
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.
Two COVID-19 vaccines appear nearly ready to go. Before doses already on the production line can be distributed, the FDA has to approve them.
Effectiveness in the 95% range is being touted by both developers, Moderna and the Pfizer-BioNTech partnership. That would be a godsend to the millions of Americans are great risk from the coronavirus.
Another vaccine by AstraZeneca and Oxford University so far shows around 70% effectiveness but also could hold great promise. Its approval process is underway in the United Kingdom.
In the U.S., both Moderna and Pfizer-BioNTech 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 the two candidates are far more effective against COVID-19 than had been expected. It also shows extremely minimal risks.
Still, FDA officials and scientists simply 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.