Healthcare experts are asking the Food and Drug Administration (FDA) to issue full approval of the COVID-19 vaccines currently classified for emergency use only. Authorities say that many Americans may be hesitant to get vaccinated because of the temporary approval.
According to The Hill, vaccination rates are slowing in the U.S., and with 63.4% of the population having at least one dose, according to the Centers for Disease Control and Prevention’s COVID Data Tracker, it is unlikely we will reach President Biden’s goal of 70% of the population inoculated with at least one dose by July 4th.
One of the reasons for the many unvaccinated Americans dragging their heels may be that they fear the emergency use approval (EUA) by the FDA means that the vaccines have not been proven to be safe, despite rigorous testing during clinical trials.
“I predict, as soon as we go from temporary approval to permanent approval, which just takes time…it’s going to increase the number of people willing to move as well,” Biden said. He could be right. A Kaiser Family Foundation poll conducted in May found that about one-third of Americans who are vaccine-hesitant said they would be more likely to get their shots if the vaccines received full FDA approval, according to The Hill.
Pfizer submitted data for full approval May 7 and Moderna applied June 1 for full approval of its vaccine. It is not known how long it will take the FDA to grant these requests.
“It would have a big impact on people getting vaccinated if it is FDA approved,” said Dr. Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security. “I think it’s worth asking why it hasn’t happened yet.”
Other experts pointed out that with current variants threatening to trigger a rise in COVID-19 cases, particularly among the unvaccinated, it is time for the FDA to move forward.
But Dr. Jesse Goodman, the former FDA chief scientist who is now at Georgetown University Medical Center, said that if the agency rushes its decision it could deter people from getting their shots.
“If they hurry it up and don’t complete their reviews very carefully, that will actually have the opposite effect,” he said, according to The Hill. “I think it would really undermine confidence.”
Goodman says that the FDA is striking the right balance and that their review could be completed sometime this summer. Experts noted that real-world data on the more than 170 million doses of the Pfizer vaccine and the more than 130 million doses of the Moderna drug should bolster the confidence of the FDA to grant full approval. The drugs have had an excellent report card for safety and efficacy.
Full approval may also pave the way for more employers to mandate vaccinations for their employees, according to The Hill. Dr. Kevin Tabb, president and CEO of Beth Israel Lahey Health, a large Massachusetts-based healthcare system, said that he understands that many of his staff would feel more comfortable if the FDA issues approval. “After the EUA is lifted, it will be a requirement that all staff be vaccinated against COVID-19 as a condition of employment.”
According to CNBC, Rogge Dunn, a Dallas-based attorney, says that employers can mandate that their workers get vaccinated, but unless the FDA gives full approval to the current shots, it may be difficult to legally enforce.
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