Pfizer/BioNTech COVID-19 Vaccine Receives FDA’s Emergency Use Authorization
By: Dr. Zach Zachariah
Tags: Tech, Covid-19, Pfizer Vaccine, Science, Biontech

Pfizer/BioNTech COVID-19 Vaccine Receives FDA’s Emergency Use Authorization

A new vaccine in just eleven months is an unprecedented scientific feat.

Friday night, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech. This authorization follows a recommendation by an independent panel of experts commissioned by the FDA to review Pfizer’s application. Top FDA officials took steps on Saturday to assure the public that the vaccine was safe and that politics did not drive the clearance process. The agency followed all protocols before issuing the EUA. The United Kingdom, Bahrain, Canada, Saudi Arabia, and Mexico have also approved the Pfizer/BioNTech vaccine for emergency use.

Based on data from the Phase 3 clinical trials that involved over 43000 participants, the Pfizer/BioNTech COVID-19 vaccine was 95% effective against the disease. It was “well-tolerated across all populations and no severe safety concerns observed.” Britain began administering the vaccine on Tuesday, and two healthcare workers had anaphylactic reactions after getting the vaccine. Both had a history of severe allergic reactions, and the symptoms were relieved using EpiPens. FDA officials assured concerned Americans that medical sites would stock EpiPens and other supplies to counter possible allergic reactions.

An earlier story about the Pfizer/BioNTech vaccine can be accessed from here.

What happens next?

Operation Warp Speed is a public-private sector initiative that the U.S. government has entrusted with the manufacture and distribution of a COVID-19 vaccine. The operation kicked into high gear with the logistics and distribution of the Pfizer/BioNTech vaccine. General Gustave Perna, the chief operating officer of Operation Warp Speed, said Saturday, “D-Day was the beginning of the end, and that’s where we are today.” This weekend, FedEx and UPS will transport 2.9 million doses of the initial supply of vaccines to all the states, Puerto Rico, and U.S. territories. Kits containing needles, alcohol swabs, gloves, and PPE have already been sent to the states. States have designated hospitals with ultracold temperature freezes to store the vaccine. Smaller quantities will be delivered to other parts of the state in special containers using dry ice to maintain the low temperature (-94 degrees Fahrenheit) required. The first injections are expected to be given by Monday to high-risk healthcare workers. Next to receive the vaccine would be those living in long-term care facilities and the workers that serve them.

People will require two doses for full immunity.

The Pfizer/BioNTech vaccine needs a booster shot in three weeks. The vaccine produces antibodies to the coronavirus in the body to ward off infection. “We know that a second dose leads to a higher concentration of the neutralizing antibody that we want the body to produce,” Dr. Carlos Malvestutto, an infectious disease specialist at the Ohio State University Wexner Medical Center, said. “So, the higher the neutralizing antibody concentration, the better the protection.” Another 2.9 million doses of the vaccine required for the booster shots will be shipped to the same locations before three weeks. Pfizer has said it can provide up to 25 million doses to the U.S. by the end of this month.

New York Times reports that the states receive initial allocations according to a federal formula based strictly on their adult population. The Times maintains an interactive website [1] that compiles data from the states to tally the number of vaccine doses that each state would receive. The Los Angeles Times reports that California has an estimated 2.4 million healthcare workers. The state expects only 327,000 doses of the vaccine. But many hospitals say they still don’t know exactly how much they will get or when the shipments will arrive. The Cleveland Clinic, one of the ten hospital groups in Ohio receiving the first batch of vaccines, expects only 975 doses in an initial shipment, even though it has more than 40,000 employees. The Clinic will vaccinate workers in intensive care units at four hospitals treating the highest volumes of Covid patients.

According to StatNews, while the vaccine reduces the risk of developing symptomatic infection, it may not reduce the virus’s transmission. Therefore, health officials urge everyone, including the vaccinated, to continue to practice social distancing measures and to wear masks. After a Thanksgiving travel surge, the new daily reported cases rose 11.2%, daily reported deaths rose 13.1%, and COVID-19 related hospitalizations rose 6.8%. The positivity rate was 12.3% among reported tests, while the number of tests reported rose just 9.7%. These are sobering statistics, and it is not time to let the guard down.

How BioNTech and Pfizer pulled off this medical miracle?

On December 11, 2020, the Wall Street Journal published a detailed account of how Pfizer pulled off the almost impossible feat of cutting the typical time to produce a vaccine from more than ten years to under one. The researchers at the German biotech firm BioNTech had already synthesized the messenger RNA (mRNA) using the coronavirus’s genetic sequence. This mRNA would instruct cells to make a harmless version of the spike protein of the virus. In turn, these spike proteins would prompt a person’s immune system to produce antibodies that could fight off the real virus. BioNTech was already working with Pfizer on a flu vaccine, and Pfizer agreed to collaborate in the COVID-19 vaccine project.

Who should get the credit?

Pfizer invested more than $2 billion, and the scientists of Pfizer and BioNTech R & D divisions developed the vaccine. The company agreed to sell 100 million doses of the vaccine to the U.S. government for $1.95 billion. It is an advance purchase agreement, and the company will receive the money only when the vaccine is delivered. President Trump made this claim at a press conference on November 13, 2020, “As a result of Operation Warp Speed, Pfizer announced on Monday that its China virus vaccine is more than 90 percent effective.” Trump cannot take any credit for this vaccine. All credit should go to the ingenuity and hard work of the brilliant scientists and the company that invested its own money.

In just eleven months, the scientists have developed, tested, and manufactured an effective vaccine against COVID-19. This is an unprecedented and historical public health achievement.

— — — — -

[1] How Many Vaccine Doses Will Your State Get? https://www.nytimes.com/interactive/2020/12/11/us/covid-19-vaccine-doses.html?action=click&module=Top%20Stories&pgtype=Homepage