Pfizer was granted the Emergency Use Authorization for their Covid-19 vaccine late last week. Gustave F. Perna. The Chief Operating Officer for “Operation Warpspeed” said vaccines will arrive at the first administration sites on Monday morning with hopes of health care workers receiving the first doses. Peter Marks, the head of the FDA’s office that oversees vaccines, said, “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.”
FDA Commissioner Stephen Hahn said, “We worked quickly because of the urgency of this pandemic, not because of any external pressure.” He continued to note that the FDA “conducted a fast but incredibly thorough review,” adding that they worked “around the clock including holidays, weekends and nights.”
Pfizer Chief Executive Officer Albert Bourla said “We’re pretty convinced that we can make this happen here” When talking about the cold storage required for the vaccine. Pfizer has developed a special dry-ice container for facilities without the proper equipment to store the vaccine. Many health systems around the US are preparing for administration in the coming days with many receiving confirmation orders from the manufacturer. Sanford Health spokeswoman Angela Dejene said, “We could receive the vaccine in our hospitals in North Dakota and South Dakota as early as Sunday, and be putting shots in arms as soon as Monday.”
After the allergy concerns related to the vaccine were raised, as we mentioned in a previous blog, officials in the UK have told people with a history of significant allergic reactions not to get the vaccine. With new administrations of the vaccine patients are now being warned from the FDA that “there is a remote chance” the vaccine could cause a severe allergic reaction. The CDC says they will make sure that each site distributing the vaccine will have the proper medication on hand to treat allergic reactions.
Richard Besser, the president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC said, “As a physician, I have no hesitation recommending that my parents and my patients’ families receive the vaccine, and I encourage all Americans to get vaccinated in the order recommended by the CDC. When my group is called, I will gladly roll up my sleeve.”
While the data shows us that the covid-19 vaccine is effective at preventing the disease, we do not have any data on whether or not it will prevent the spread of the disease. The FDA expects more data on this in a few months’ time. A concern among the general public is that the vaccine from Pfizer was not tested on pregnant or lactating women, and did not have much data on 16-17 year olds, however the FDA is leaving it up to those groups as to whether or not they will get the shot.
Pfizer-BioNTech is the only vaccine developer of the main front-runners that did not take any funding from “Operation Warp Speed” program. Nevertheless, they have secured a deal to provide 100 million doses to the US with an option for 500 million more. One of the issues facing the vaccine now is the demand. Sean Marett, BioNTech’s chief business and commercial officer said, “Everybody wants all their doses on January 2nd of next year, but that’s not practical. This is a new technology, there does not exist a manufacturing network. We are building it.”
For more updates on the covid-19 vaccine development be sure to check back at the ABN Blog regularly.