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Pfizer Granted Priority Review for FDA Vaccine Approval

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The Pfizer/BioNTech vaccine has received priority review designation in its bid for FDA approval. Credit: Facebook/Pfizer Corporation

Last Friday, the US Food and Drug Administration granted pharmaceutical companies Pfizer and BioNTech priority review designation for their coronavirus vaccine for those who are age 16 and older.

This step marks the last hurdle that must be cleared in order for the vaccine — the very first to come onto the world scene, being approved for emergency use back in December of 2020 — to be distributed and marketed like any other inoculation.

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Until now, the products, like the other two coronavirus vaccines used in the US, have had emergency use authorization (EUA) only — a legal sticking point that has led to some questioning their efficacy and safety and adding to the vaccine hesitancy that continues to plague some areas of the country and the world.

Anti-vaccine proponents argue that they refuse to accept a product that has not been fully cleared by the FDA, and many corporate entities along with the federal government, will not require coronavirus inoculations while they are still under EUA-only status.

This status allows for vaccine doses to be shipped to hospitals, clinics, pharmacies and other organizations to be administered to the general public — but not distributed and marketed.

Although the vaccine came out in a little more than 300 days since the genome of the virus was determined — an amazing feat of modern medical technology — the perceived delay in the granting of full authorization has led many to speculate that this feeds into an anti-vaccination narrative which may be partly responsible for the spike in infections in the last month worldwide.

As the Delta variant, first detected in India, continues to sweep across the world, the lack of formal approval of the vaccines has sparked concern that a window of opportunity may have been lost, as people for the most part are allowed to gather together without restrictions across the US while sizable pockets of vaccine resistance remain.

Just how much more transmissible is the Delta variant?

The Centers for Disease Control and Prevention reported on Friday that the number of new coronavirus cases were up by nearly 70% in just one week, while hospitalizations are up by nearly 36%, after weeks of steeply declining numbers all over the US.

The Delta variant appears to be approximately 225% more transmissible than the original strains of the coronavirus. NPR reports that one recent study from China found that those who are infected with Delta have on average about 1,000 times more copies of the virus in their respiratory tracts than those who were infected with the original strain.

Not only that but they also become infectious earlier in the course of their illness, leading to much more transmission since many do not realize they have become infected.

The emergency use authorization vaccines that are currently on the market, however, are strikingly effective against the Delta variant.

Pfizer Vaccine 95 % effective against Delta

One UK study shows that the Pfizer vaccine is 96% effective against hospitalization from the variant after the full series of two doses.

Despite figures like this showing that there is broad protection from the virus and its variants as long as one is vaccinated, concern is mounting over those who cannot be vaccinated — especially children under 12 — as the variant spreads across the world.

Los Angeles County announced that it will reimplement their prior mandate calling for indoor masking, even for those who are inoculated — because of the increase in cases.

Whether or not the public needs booster shots is another, closely related issue lingering over the country and the world as some, including in Israel, have already received a third Pfizer shot in a bid to “top off” their protection.

“The CDC and the FDA are working very hard to get as much data as they possibly can to adequately address that question,” Dr. Anthony Fauci told NPR’s “Here & Now.” US health officials and vaccine producers are following participants who were enrolled in their initial clinical trials to see how well their immunity holds up against the variants that are active now.

At this point, experts say the picture looks fairly rosy. “The level of antibodies seem to be holding up pretty well, so we have to watch and see what happens over the course of the coming months,” stated National Institutes of Health Francis Collins, in an interview with NPR.

Full approval may be granted in January 2022

The New York-based pharma giant must now go through a rigorous review process that experts believe will be completed in January of 2022. Even with expedited handling of the approval process, speeded up from its usual 10 months, the lightning-fast spread of the Delta variant, which is so many more times as transmissible as the original coronavirus, is rushing past that timeline.

The US, the UK and many other nations are experiencing spikes in coronavirus cases that are reminiscent of the worst days of the pandemic — although the rates of hospitalizations and deaths are much lower as of this point.

While some believe that gaining that coveted full approval by the FDA may spur some unvaccinated people to finally take the plunge and get the shot, scientists maintain that it is more important that the FDA make it clear that the eventual green light they bestow on the vaccine is motivated by science alone — not by public pressure.

“I’m not sure that it’s helpful for us to be advocating from the outside, saying: Hey, please approve, please approve,” states Dr. Céline Gounder, an epidemiologist who advised President Biden’s transition team on coronavirus policy.

“I think the FDA is aware of the urgency.”

Physician-researcher Eric Topol, among others, has accused the FDA of dragging its feet in the approval process, adding that as the weeks and months go on, this feeds into vaccine hesitancy at a time when the Delta variant is sweeping across the world.

“Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” Topol stated last week in a New York Times op-ed. He urged the FDA to quickly issue its full approval of the Pfizer product, which he believes would help those who are still hesitant to finally get the inoculation.

Others, however, are defending the regulatory agency as it makes its way through the vaccine approval process. Just as they did last year, in the run-up to the emergency authorization, some hold that any pressure on the FDA could harm its credibility at a time when variants are continuing to spread.

“In the long term, a careful, thorough FDA review will probably benefit us more,” according to Dorit Reiss, a law professor at the University of California, Hastings, who specializes in vaccine law. “The people who have concerns won’t be reassured by something that looks like a hasty approval.”

Such a measured process, independent of political pressure, is seen as critical, especially now, experts say, when many in the South, including a sizable number of Republicans, continue to voice concerns over the vaccine.

The FDA’s full and complete authorization, granted without any perceived influence, could give corporations, educational institutions, and other government agencies more leeway regarding vaccine mandates for their students and employees.

The US Department of Defense, has already stated that is willing to impose a vaccine mandate for military service members as long as the FDA gives the vaccine its approval.

“It is not FDA-approved,” stated John Kirby, a Department of Defense spokesperson, last week. “Therefore, it is still a voluntary vaccine.”

In normal times, even an accelerated approval for a vaccine can be a matter of waiting six months, and Pfizer began its “rolling” application for full approval in early May, so the process appears more or less on track. The Moderns corporation, which produced the second approved vaccine in the United States, went for its own approval just one month after Pfizer.

A Pfizer spokesperson, in a statement provided to STAT, said the company had given the agency all the information it needed, meaning the FDA was free to proceed. However, a spokesman for Moderna stated that that company had not yet submitted all of the necessary information the FDA requires.

Officials at the regulatory agency have publicly acknowledged the need to move quickly during this time of rising unease over the spread of the variants.

“The FDA recognizes that vaccines are key to ending the Covid-19 pandemic and is working as quickly as possible to review applications for full approval,” FDA spokesperson Abby Capobianco told STAT in its own statement.

In a separate New York Times letter to the editor, Peter Marks, a top FDA regulator, also pushed back explicitly on Eric Topol’s prior criticism.

“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” he wrote.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in his own letter to The New York Times that full approval of the vaccine was one of its “highest priorities.” However, he explained that this requires an exhaustive investigation into the mechanics and clinical trials of the fairly new jab that should not be delayed.

“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency, and do little to help combat vaccine hesitancy,” Marks wrote.

“If we truly want our lives to return to normal, the fastest way to do so is simple—get vaccinated right now,” he added.

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