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

It looks as though the first full approval of a COVID-19 vaccine will happen by January at the latest, according to the typical timeline for new therapies that are considered a priority by U.S. regulators. Pfizer Inc.
PFE,
1.05%
announced last week that the Food and Drug Administration has accepted the drug manufacturer’s application for approval, granted the company’s vaccine a type of speedier designation called “priority review” that requires a decision within six months, and set a decision date for some time in January. (President Joe Biden, however, said Wednesday during a CNN event that he thinks approval of a COVID-19 shot will occur in the fall.)

All of this is part of the normal process for bringing new drugs to Americans.  What isn’t part of the standard process is that more than 186 million people in the U.S. have already been vaccinated with at least one shot authorized as part of the emergency regulatory process that has been under way since March 2020. This includes the vaccines developed by BioNTech SE
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working with Pfizer; Moderna Inc.
MRNA,
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; and Johnson & Johnson
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And now some physicians are pushing hard for full FDA approval of the vaccines, citing that widespread use of COVID-19 shots in the gray area between clinical trials and full approval that is emergency-use authorization; stalled immunization rates in the U.S.; and rising rates of infections, hospitalizations and deaths among Americans. “Many of us think it’s a very high priority for them to actually do full approvals for the vaccines that they’ve already authorized,” Dr. Lynn Goldman, an epidemiologist and dean of the Milken Institute School of Public Health at George Washington University, recently told MarketWatch. “Full approval will not mean that they’re safer, in my view, but because, again, of the communication challenge around the fact that many people are hesitant about taking the vaccine. One of the reasons they will give is that they want to wait until it’s fully authorized.” Additional context: Full FDA approval of Pfizer’s and Moderna’s COVID-19 shots would reinvigorate the U.S. vaccination push — but it could still be months away Pfizer and Moderna’s mRNA-based vaccines “have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them,” Dr. Eric Topol, director of the Scripps Research Translational Institute, wrote July 1 in the New York Times. Dr. Ashish Jha, dean of the Brown University School of Public Health, said Tuesday that he thinks several things will boost vaccine rates in the U.S., including full FDA approval. “Yes, this will help a lot,” he tweeted.

However, regulators say that speeding up the U.S. approval process, long considered the gold standard for pharmaceutical regulations worldwide, essentially defeats the purpose of getting more people vaccinated. “Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the FDA’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, wrote in a July 9 letter responding to Topol’s op-ed. A full approval is a much more in-depth type of authorization that takes a longer time. None of the vaccines has been formally approved, and only one COVID-19 therapeutic — Gilead Sciences Inc.’s
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0.42%
Veklury — has received full approval during the pandemic. The topic of “when” came up again Tuesday during a Senate Committee on Health, Education, Labor and Pensions hearing. “These [vaccines] have really gotten the full-court press as far as evaluation and study, and they’ve gone through the FDA process and they’ve gone to the ACIP — the CDC advisory committee — and they strongly recommended that people take them,” Dr. Janet Woodcock, the FDA’s acting commissioner, testified. “That said, it is public that one of the companies put a marketing application before us, and we are going to do everything we can to review that in a timely manner.” Opinion: What you need to know about an emergency-use authorization for a COVID-19 vaccine

                  

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