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Health leaders hope full FDA approval will sway people hesitant to get COVID-19 vaccine

Three vaccines have emergency use authorization, Pfizer and BioNTech are first to submit request for full approval
Updated: May. 19, 2021 at 3:07 PM CDT
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BIRMINGHAM, Ala. (WBRC) – Vaccination rates are steadily declining in Alabama and it’s not because everyone is vaccinated. Daily doses peaked in April at more than 44,000, according to data from the Alabama Department of Public Health (ADPH). For the week of May 11, daily doses averaged around 15,000.

ADPH conducted a survey in March to better understand reasons for hesitancy. It found, “The primary driver of vaccine resistance among all groups is the speed with which the vaccine was developed. People are worried about long-term side effects they perceive to have not been studied or identified. Lack of trust in the government also appeared as driver of reluctance, as did general skepticism of all vaccines.”

Health leaders also believe some people are hesitant to get the vaccine because it doesn’t have full FDA approval.

The FDA has given Emergency Use Authorization (EUA) to three COVID-19 vaccines and in early May, Pfizer and BioNTech became the first to apply for full approval through a Biologics License Application (BLA).

Dr. Paul Goepfert leads UAB’s Alabama Vaccine Research Clinic and said the major difference between an EUA and a BLA is additional safety data.

“[Both] require a Phase 1 study, which is first in human studies to make sure it’s safe. [In] Phase 2 studies… continue to make sure it’s safe but now you make sure that it induces immune responses and induces the right immune responses that you think are going to be useful for whatever pathogen you have. And now you go into efficacy studies which are synonymous with Phase 3 studies,” said Dr. Goepfert.

“After that, what normally happens is you have to wait another six months to make sure the safety still holds up six months after the last dose has been administered and then you can apply for FDA approval.”

Companies are also required to submit details of the manufacturing process and facilities for a BLA.

“FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved,” according to the FDA.

When applying for an EUA, companies are required to submit two months of safety data, compared to six months for a BLA.

“Vaccines in general, you’re going to see the side effects within two weeks or a month from the last dose. Beyond that, I can’t think of any vaccine that’s caused a side effect beyond that,” said Dr. Goepfert, who has researched vaccines for 25 years.

“It would be unprecedented to see something six months, a year out afterwards that we didn’t see early on for a vaccine.”

He added, “It will benefit from more safety than almost any other product because now they’ve given it to millions of people because of the EUA, so I’m sure that will be part of the safety packet that the FDA will review.”

While Dr. Goepfert said it usually takes the FDA six months to review a BLA, he expects this review will only take a few months.

Pfizer and BioNTech are asking for full approval of its vaccine for people 16 and older. It said it will ask for full approval for those 12-15 once it has 6 months of safety data to submit.

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