Month: September 2021

FDAPharmaceutical

Pharmaceutical Medicine: Pfizer Vaccine Granted FDA Approval

On Monday, August 23, 2021, the Pfizer-BioNTech COVID-19 vaccine was granted approval by the Food and Drug Administration (FDA) for individuals 16 and older. Due to its newly approved status, what was known as the Pfizer-BioNTech COVID-19 vaccine will now be advertised as Comirnaty (koe-mir’-na-ty). According to the BBC, “The approval ultimately came less than four months after the Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.” The abrupt onset of the Coronavirus last year served as the impetus for a necessary response by medical professionals to reduce spread, infections, and deaths. Even though the vaccine has been distributed since December 11th, 2020, Acting FDA Commissioner, Janet Woodcock, M.D., hopes the FDA approval will cement certainty for concerned individuals to get vaccinated. With insight from FDA Expert Witness, Mr. Alan Schwartz of mdi Consultants, Inc., this blog post will examine the approval process for vaccines before and during COVID-19 as well as enlighten readers about reasons behind Comirnaty’s FDA approval.

Alan Schwartz is a seasoned expert in FDA protocols. He has over 50 years of experience in the field . When asked about the FDA’s general approval process, he states, “The process is NORMALLY very extensive. It could take years from the start of development through laboratory bench testing, animal safety studies, then human safety, and finally efficacy studies.” Mr. Schwartz also noted the avergage costs companies pay for these trials can reach up to $100 million, which these companies were able to actualize due to the Emergency Use Authorization (EUA). “The FDA under the EUA gave the companies a BULLET TRAIN path to get these through the emergency use approval,” he stated. In an ideal situation, the FDA would contact the clinical study participants throughout the duration of a year after receiving a vaccine. However, because of COVID-19, the vaccine has been officially approved after it has been administered to approxiamtely 100 million people. This was most likely due to political pressure and, more importantly, ensuring the well-being of citizens around the globe. In this situation, the long-term follow up was missing in the approval process. Nevertheless, the fact that roughly 100 million people received the Pfizer-BioNTech vaccine before its approval provided the necessary data on its efficacy and safety in real time. “So, did the FDA expedite the approval or did they have more data to use in their decision making process… we hope that they used good science to get this through the approval process since it was already being used for a year,” Mr. Schwartz mentioned.

Some concerns from those expressing doubt include whether the Pfizer vaccine was changed or modified for the purpose of an expedited approval process. Schwartz reassured there was an absence of changes regarding the production and formula of both the EUA and approved vaccinations. “This was all new to the FDA and in the industry… Normally when a vaccine or a drug is under FDA review there are many questions and back and forth that take a lot of time. I don’t think this was necessary under these conditions.” However, since Pfizer is currently manufacturing and advertising Comirnaty, the pharmaceutical company is allowed to continue using the EUA vaccine. The EUA is considered an experimental drug, but as soon as Comirnaty is ready for vaccine administration, Pfizer will be held liable if any problems arise.

A New York Times article stated, “Regulators are still reviewing Moderna’s application for full approval of its vaccine.” Since both Pfizer-BioNTech and Moderna vaccines are based on similar mRNA technology and both had emergency use authorization, there are questions regarding when the public can expect or not expect Moderna’s approval by the FDA. “I would be very surprised if we did not see Moderna approved,” Mr. Schwartz commented. Moderna has submitted their application for full FDA approval which is currently pending review. Announcements about its approval should occur in the near future (NPR).

The FDA has stated that the immunization will continue to be available for children aged 12-15 under Emergency Use Authorization (EUA). It remains uncertain when Comirnaty will be FDA approved for younger people, as the CDC recently announced its vaccine recommendation for said demographic back in May. Although there is not an official timeline, Mr. Schwartz predicts, “It may take until next year to obtain all required safety and efficacy data for pediatric indication.” The lack of data amid clinical trials is the primary reason as to why Comirnaty has not received approval for young people. However, this is not an obstacle for the Los Angeles Board of Education, the second-largest school district, who recently voted on September 9th to require students 12 and older to get vaccinated.

Current protocols include a mask mandate during in-person classes and frequent COVID-19 testing as a precaution against the virus. According to U.S. News, “Under LA Unified’s plan, all students age 12 and up will be fully vaccinated by the time they return to class following winter break on Jan.11. Those who are participating in sports and other activities need to receive a first dose of vaccine by Oct. 3 and a second dose by Oct. 31, while other students need to get their first dose by Nov. 21 and a second dose no later than Dec. 19.” Board members believe the implementation of this plan is the best course of action to responsibly protect children under the age of 12, the demographic not yet eligible for vaccinations. There are some parents who agree with the Los Angeles Board of Education’s vote, as it is similar to other immunizations students are required to receive such as chickenpox, polio, and measles to name a few. Other parents not only think the vote was rushed, but also believe the choice for their child receiving COVID-19 vaccine or not should be a parental decision.

So, we continue on this journey of uncertainty with COVID-19, the vaccines, and their aftereffects. It is only a matter of time before future vaccine mandates are implemented in school districts and businesses across the country. A special thanks to Mr. Alan Schwartz for his insight on the FDA approval process of the Pfizer-BioNTech produced Comirnaty vaccine.