Why Hasn’t the FDA Approved the COVID Vaccines?

The number one public health question that could make or break the war against this pandemic is why the Food and Drug Administration (FDA) has not given its full approval to the COVID-19 vaccines that are available in the U.S. The vaccines have been granted emergency use authorization (EUA) only and healthcare experts say that if the FDA gives the drug an official green light, millions of those who are sitting on the fence would get their shot.

According to The New York Times, this is the most discordant part of our government’s handling of the pandemic. As President Biden, the Centers for Disease Control and Prevention, and countless infectious disease experts plead with the public to get vaccinated, especially now that COVID-19 cases are rising due to the highly contagious and dominant Delta variant, the FDA still has not made an announcement as to when we can expect their full stamp of approval for the vaccines.

According to Axios, the more transmissible and dangerous Delta variant is moving quickly among unvaccinated communities.

“We’ve hit the wall in the number of vaccinations in recent weeks,” said Dr. Eric Topol, a noted cardiologist and director and founder of the Scripps Research Translational Institute. “Just trying to deduce from other countries where we’re headed, if we don’t get a big jump up in our vaccination rate, we’re going to be vulnerable for a lot more cases.”

Topol adds that this would also mean more hospitalizations and deaths from COVID-19. While infectious disease experts vary on the percentage of vaccinated people needed to achieve herd immunity against COVID-19, it could be as high as 85% of the population.

Topol says that some are hesitant to get the vaccine because it has not received full approval by the FDA, thinking that the EUA status means the vaccines were rushed through the system without full scientific testing.

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. In April, the FDA issued a warning amending the EUA for the Johnson & Johnson vaccine to include information about a rare but serious type of blood clot in people who received the vaccine.

According to the Times, granting full approval could make a huge difference in the vaccination rate. The “lack of FDA licensure leaves schools, colleges, businesses in a legal quandary,” said Dr. Jerome Adams, a former surgeon general. It would be difficult for organizations to mandate vaccinations if the drugs are not fully approved by the government.

Topol says that lack of FDA approval is “the No. 1 issue in American public health,” adding that he estimates 20 million more Americans would get their shots once full authorization is granted.

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 may deter people.

“If they hurry it up and don’t complete their reviews very carefully, that will actually have the opposite effect,” he said recently. “I think it would really undermine confidence.”

Goodman says that the agency is striking the right balance and that their review could be completed sometime this summer. Experts note 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.

Currently, approximately 34% of Americans who are eligible for the vaccine have not received one shot, according to the Times. The number of COVID-19 cases has tripled this month, causing concern among healthcare officials that we may have to reset pandemic protocols.

Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, said, “We want to assure the public that the review of applications for full approval of COVID-19 vaccines is one of the highest priorities at the Food and Drug Administration.”

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