Promising Finding for Potential COVID-19 Vaccine

The early data from Pfizer’s COVID-19 vaccine showed that it could be up to 90% effective. Pfizer still needs to submit its late staged data to the Food and Drug Administration (FDA), but officials in the U.S. say that they are prepared to distribute the vaccine as soon as they are given the green light.

The only hurdle for the vaccine, it needs to be stored at or around -70 degrees Celsius (-94 degrees Fahrenheit). Senior director of Premier, Inc. Soumi Saha has said that the freezers needed to properly store Pfizer’s vaccine are, “almost like unicorns in health care, they’re far and hard to find.” Saha also said, “Nobody has any experience working with a vaccine at that temperature and so this is going to be the greatest drug distribution challenge that our country has ever faced because of the unique circumstances around the temperature requirement.”

Scientists at Pfizer don’t believe that maintaining the vaccine at a stable temperature is an impossible challenge due to the company’s advanced delivery system. Pfizer’s chief scientist of viral vaccines, Dr. Phil Dormitzer stated that, “ We have a series of packaging- we call them pizza boxes because they have roughly that shape full of vaccines and they’re packed around dry ice in these very insulated containers.”

On Friday, Pfizer became the first company to seek emergency authorization from the FDA. This landmark moment and a signal that a powerful tool to help control the pandemic could be available by late December. Now, the vaccine will move to the deliberative phase, a weeks long process in which career scientists at the FDA scrutinize data and determine whether the vaccine is safe and effective to be used in a very broad population On the eve of Pfizer’s announcement, top U.S. infectious disease expert, Dr. Anthony Fauci said, “ Help is on the way”.  He also added, “We need to actually double down on the public health measures as we’re waiting for that help to come.”

Pfizer’s filing has set off a chain of events at the FDA and its independent advisers are contemplating whether the vaccines are ready, and if they are, another government group will have to decide how the initial limited supplies are rationed out to Americans who are anxiously waiting for a vaccine. Globally, Pfizer has estimated it could have up to 50 million doses available by the end of 2020.

People are still worried about the vaccine and its effectiveness. A Gallup poll in November showed that 58% of Americans say that they would get a COVID-19 vaccine, that is up from 50% in September, but the worries from the speed of the development of the vaccine to testing could have compromised their scientific integrity. Clinical trials are usually made up of 3 phases, but not all vaccine trials are the same. The bigger the trials are and the more diverse they are can show what a vaccine can do to different populations. Larger trials could also show any serious safety issues with the vaccine.

The FDA requires vaccine developers to submit two months of follow up safety data as a part of the application for emergency use. This can help monitor any serious side effects a vaccine could have to a patient who took the vaccine. Then the vaccine will be reviewed by independent scientists at the FDA known as the Vaccines and Related Biological products Advisory Committee. This group of people are physicians, scientists, infectious disease specialists and a consumer representative. None of the people in the committee are associated with any vaccine developers and they are not employed by the FDA. Once the committee has made recommendations, the FDA will then decide whether or not to grant authorization for emergency use. Then, the Advisory Committee on Immunization Practices will make guidelines for the CDC about to prioritize who gets the vaccine first.

For the record, both advisory committees for the CDC and the FDA do not have any authority to make decisions, but both the CDC and the FDA follow the recommendations form both committees. Then the public will be able to view trial data and observe any discussions as the Vaccines and Related Biological Products Advisory Committee conducts its review of the vaccine in early December. This transparency will help build the trust of the public and will combat any type of misinformation.