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Tags: coronavirus | vaccine | full approval

Some Experts Urge Faster Pace For FDA Fully Approving Vaccines

Some Experts Urge Faster Pace For FDA Fully Approving Vaccines

A doctor holds up a vial of AstraZeneca COVID-19 vaccine before giving the inoculation in Hanoi, Vietnam on Sunday, June 27, 2021. Vietnam is ramping up the vaccination program against COVID-19 as new cases increase. (Hau Dinh/AP)

By    |   Sunday, 27 June 2021 08:09 PM

Some experts are urging the Food and Drug Administration (FDA) to increase its coronavirus vaccine approval pace in order to help convince unvaccinated individuals to receive the shots, The Hill reported on Sunday.

According to polls, full approval could help convince some unvaccinated individuals to get the shots because they view the current emergency use authorizations for the vaccines as a sign that they are still experimental and not fully tested.

The calls for the quicker pace to fully approve the coronavirus vaccines come as the spread of the delta variant means unvaccinated people are at a greater risk and also as the U.S. is poised to miss President Joe Biden’s goal of vaccinating 70% of adults by July 4.

Pfizer started submitting data for full approval on May 7, but it is unclear when the FDA will act. Moderna applied on June 1 for full approval.

Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, pressed to find out what is the reason for the FDA’s delay, saying full approval “could have a big impact” on people getting vaccinated.

Brown University School of Public Health dean Ashish Jha wrote on Twitter that it has been six weeks since Pfizer initiated its request “Data is in. Vaccines are safe and effective. It’s time for full approval.”

However, Jesse Goodman, a former FDA chief scientist who is currently at Georgetown University, disagreed with that train of thought, telling The Hill that  “If they hurry it up and don’t complete their review very carefully, that will actually have the opposite effect. I think that would really undermine confidence.”

He added that the FDA is “moving quickly, but they're requiring a careful review,” saying he thinks the review could take “three or four months” and be completed during the summer.  

Nancy Allen LaPointe, faculty fellow at the Duke-Margolis Center for Health Policy, also stressed that it is important for confidence in the vaccines that there is not “any perception or actuality of cutting a corner” in the granting of the full approval.

Experts do acknowledge, however, that full approval will most likely lead to more employers requiring the vaccine for their employees, a step which could further increase the vaccination numbers.

The hesitancy for some to get the vaccination without full approval also exists in the health care field, with, for example, major hospital systems in Boston announcing last week that they would require their employees to be vaccinated, but only once the FDA gives its full approval. 

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Some experts are urging the Food and Drug Administration (FDA) to increase its coronavirus vaccine approval pace in order to help convince unvaccinated individuals to receive the shots, The Hill reported on Sunday.
coronavirus, vaccine, full approval
419
2021-09-27
Sunday, 27 June 2021 08:09 PM
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