The evidence on the COVID-19 vaccines was promising, with some participants reporting temporary consequences such as a fever, headache, or sore arm — nothing serious or long-lasting.
But for full approval of the vaccines, the agency has gone even further, saying that trial participants must be monitored for an additional four months (that is, a total of six months following full vaccination).
Health systems under pressure to require vaccines for employees
It also is reviewing any adverse events in the general population. Those have included rare cases of myocarditis (a type of heart inflammation) in people who have received the Pfizer and Moderna vaccines, and rare cases of blood clots in those who got a vaccine made by Johnson & Johnson.
Infectious-disease specialists generally agree that these risks are small, especially when balanced against the potential for much greater consequences from a case of COVID-19.
Still, the FDA is well within its rights to exercise caution, said Ellenberg, who once worked for the agency. Regulators also conduct a careful review of a drug-maker's manufacturing processes.
"I think the regulators feel the intense external pressure to complete the full approval, and have to balance that against the concern they always have about new products, about missing something," she said.
Will it make a difference?
In June, a group of Indiana University students filed a lawsuit against the school, contending that it was violating their constitutional rights by requiring vaccination for those enrolling in the fall.
In a preliminary ruling this month, federal judge Damon Leichty found in favor of the school, writing that the university had a rational basis for protecting the public health in a pandemic. He acknowledged legal precedents that establish a person's right to refuse unwanted medical treatment in certain circumstances — yet stressed that vaccines protect not just the recipient, but the community at large.
"Vaccines address a collective enemy, not just an individual one," he wrote.
What's more, the students were not being forced to get the vaccines, the judge noted. They have the option of requesting a medical or religious exemption, or they can go to school elsewhere.
Others have come to a similar conclusion on the law. Also this month, the U.S. Justice Department found that public and private entities may require vaccines that are authorized for emergency use.
Assuming the FDA grants full approval for the vaccines in the coming months, the case would become even stronger.(c)2021 The Philadelphia Inquirer Distributed by Tribune Content Agency, LLC.