The FDA may not fully approve a COVID-19 vaccine until January. here’s why – .

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The FDA may not fully approve a COVID-19 vaccine until January. here’s why – .



It appears that the first full approval of a COVID-19 vaccine will take place no later than January, according to the typical schedule for new therapies considered a priority by US regulators.

Pfizer Inc. PFE,
+0.91%
announced Friday that the Food and Drug Administration had accepted the drugmaker’s request for approval, granted the company’s vaccine a faster type of designation called a “priority review” that requires a decision within six months, and set a decision date in the month of January. (However, President Joe Biden said during an event on CNN on Wednesday that he believed approval for a COVID-19 shot would take place in the fall.)

It’s all part of the normal process of bringing new drugs to Americans.

What is not part of the standard process is that over 186 million people in the United States have already been vaccinated with at least one authorized injection under the emergency regulatory process underway since March 2020. This includes vaccines developed. by BioNTech SE BNTX,
+6.22%
et Pfizer, Moderna Inc. MRNA,
+0.19%,
et Johnson & Johnson JNJ,
+0,87%.

And now some doctors are pushing for full vaccine approval from the FDA, citing the widespread use of COVID-19 injections in the gray area between clinical trials and full approval which is clearance for emergency use, stalled vaccination rates in the United States and increasing rates of infections, hospitalizations and deaths among Americans.

“A lot of us think it’s a very high priority for them to get full approvals for the vaccines they’ve already licensed,” Dr. Lynn Goldman, epidemiologist and dean of the Milken Institute School of Public Health. George Washington University, told me recently. “Full approval won’t mean they’re safer, in my opinion, but because, again, of the communication challenge around the fact that many people are reluctant to get the vaccine. One of the reasons they will give is that they want to wait until it is fully authorized.

“Pfizer and Moderna mRNA vaccines have been shown to be extremely safe and effective through clinical trials, independent research and the experience of millions of people around the world who have received them,” Dr. Eric Topol wrote on July 1. , director of the Scripps Research Translational Institute. in the New York Times.

Dr Ashish Jha, dean of the Brown University School of Public Health, said on Tuesday that he believes several things will increase vaccination rates in the United States, including full FDA approval. “Yes, that will help a lot”, he said. tweeted.

However, regulators say speeding up the approval process, long considered the gold standard in global drug regulations, defeats the goal of getting more people vaccinated.

“Any vaccine approval without the completion of the high-quality review and evaluation that Americans expect from the agency would undermine the statutory responsibilities of the FDA, affect public confidence in the agency, and fail to much to help fight vaccine reluctance, ”Dr. Peter Marks, director of the FDA’s Biologics Evaluation and Research Center, wrote in a July 9 letter in response to Topol’s editorial. .

A full approval is a much longer and more in-depth type of authorization. None of the vaccines have been officially approved, and only one COVID-19 treatment – Gilead Sciences Inc.’s GILD,
+0.38%
Veklury – received full approval during the pandemic.

The subject of “when” was raised again Tuesday during a hearing of the Senate Committee on Health, Education, Labor and Pensions.

“These [vaccines] really got the full press when it comes to the assessment and the study, and they went through the FDA process and they went to ACIP – the CDC advisory board – and they strongly recommended that people take them, ”said Dr. Janet Woodcock, the acting commissioner of the FDA, testified. “Having said that, it’s public that one of the companies is submitting a marketing request to us, and we’ll do our best to review it in a timely manner. “



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