Pfizer/BioNTech Coronavirus Vaccine Cleared for Use by FDA

In triumphal news after a punishing year which unfolded with the coronavirus pandemic resulting in one medical, sociological and economic crisis after another worldwide, the vaccine produced by the American firm Pfizer and the German company BioNTech cleared the final hurdle on Friday night and will soon be on its way to the public.

The vaccine, produced nearly miraculously in just several months and tested in three separate phases of trials on 44,000 patients worldwide, received the green light from a special investigative team on Thursday before being placed before the FDA for its final approval on Friday.

In the end, it took a total of only 336 days from the time that the virus’ genome was publicized online by scientists from China to the day that the American vaccine was cleared by the FDA for emergency use.

The approval for emergency use thankfully comes at a time just before Christmas and the New Year, when millions of people across America are set to celebrate the most festive time of the year.

Already approved in the United Kingdom, with the shot being given on a non-trial basis there for the first time on Monday of this week, the USFDA’s go-ahead for emergency use was awaited with a desperation that has not been seen in the world since the development of the polio vaccine many decades earlier.

The last-minute negotiations that lasted into Friday evening appeared to hinge on the occurrence of allergic reactions in two of the British people who had received the vaccine during this past week. No major allergic reactions had previously been reported in the three phases of the trials prior to it being approved in the UK and given to people there beginning on Monday.

Created by Pfizer, whose Greek-born CEO is Dr. Albert Bourla, and the German firm of BioNTech, headed by Ugur Sahin, the vaccine was the first to be placed before the FDA for its approval. Developed at unprecedented speed, it was created and underwent three phases of clinical trials over just the span of several months, as opposed to the usual years it takes to produce such vaccines.

Vaccine proven 95% effective across all ethnic groups and age cohorts

The groundbreaking RNA-based vaccine has proven to be more than 95% effective, according to Pfizer, across all ethnic groups and ages of trial participants. However, no pregnant women were given the shot in trials and they may not be allowed to receive the vaccine until more information on its safety is available for that part of the population.

Experts fear that the Thanksgiving holiday, during which an estimated six million Americans traveled back home despite being warned that doing so might spread the virus further, may have led to an acceleration in the number of infections across the country.

On Wednesday, the total number of Americans who passed away with the virus passed 3,100 for the first time since the outbreak of the pandemic in the early Spring.

However, the tide of the pandemic appears to be turning ever so slowly now as another coronavirus vaccine, from Cambridge, Massachusetts-based Moderna, appears to be close to approval as well. The Moderna vaccine, which also uses RNA technology but requires a somewhat warmer storage temperature, is also before the FDA and may also receive the green light in the next week.

Canada and Saudi Arabia have already approved the Pfizer vaccine for general use and immunizations are expected to begin there immediately.

United Airlines and American Airlines had both taken their aircraft on trial runs around the world, making sure that they could quickly deliver the vaccine, which requires ultracold storage at 92 degrees below zero Celsius, to where it is most needed.

Many thousands of doses are already in place, and were only awaiting the word from the FDA before the immunizations can begin.

During the Thursday afternoon part of the hearings, Juan Gea-Banacloche, a Mayo Clinic epidemiologist, asked the Pfizer officials how confident their firm is that the second dose of the vaccine will even be needed. Their answer was in essence that at this point, there isn’t enough evidence to determine whether or not just one dose of the vaccine would give the same long-term protection as two shots.

Additionally, it was disclosed during the hearings that the data regarding how well the vaccine protects against asymptomatic infections is expected to be released by early 2021.

Operation Warp Speed

This past May, Pfizer began testing four different coronavirus vaccines. In July, the United States Health and Human Services Department, along with the Department of Defense, entered into an agreement with Pfizer, under the auspices of the government’s project entitled “Operation Warp Speed” for the “large-scale production and delivery” of 100 million doses of a vaccine which Pfizer would develop.

The unprecedented agreement also stipulates that the government may acquire another 500 million doses of a proven vaccine on top of that number. Operation Warp Speed will now be in charge of overseeing the vaccine’s distribution to all the states.