Evan Steinberg, October 20, 2020
On Friday, October 16, Pfizer announced that they will not be seeking an emergency authorization of its coronavirus vaccine before the third week in November. This represents a stark shift from previous statements the company CEO, Dr. Albert Bourla, has made stating that their vaccine would be ready by the end of October.
Pfizer, along with four other pharmaceutical companies, is completing large scale vaccine clinical trials in the United States. At this moment, Pfizer has enrolled 44,000 volunteer subjects. In their trial, Pfizer gave about half of the volunteers the vaccine and the other half a placebo. Now, they are waiting to see a pre-determined number of coronavirus cases appear in their study so they can determine the efficacy of the vaccine. The safety of the vaccine has already previously been shown.
Before this announcement, Dr. Bourla has been pushing for the company’s vaccine to be completed by the end of October. This is a very aggressive timetable from when they started the process in March. Dr. Bourla has announced that they might have preliminary data/conclusions by the end of October. However, in order to receive emergency authorization from the FDA, Pfizer needs to further analyzed everything related to the trial, including data related to the vaccine’s efficacy, safety, and manufacture.
When Pfizer announced thair aggressive timetable back in March, there was pushback in the biomedical community. In fact, 60 public health experts and other members of the medial community signed a letter to Pfizer urging them not to rush the process. There was a concern that Pfizer was expediting the process. There are a few different reasons for this concern. One reason is due to President Trump’s declaration that a vaccine would be ready by the election on November 3. Because of this declaration, there was concern that Pfizer was rushing the process for political gains. Another reason is that the first company to produce an effective and safe vaccine and achieve FDA approval would win a multi-million dollar contract with the U.S. government. This brings in ethical concerns. These companies creating the vaccine has an obligation to both those using the vaccine and its shareholders. The faster the vaccine process goes the more likely Pfizer is to make more money. However, they must also make a safe and proven effective vaccine in order to make this money. The pressure Pfizer is feeling both from President Trump and the general public to create a vaccine quickly is great. However, they also have an obligation to make sure it is as safe as possible.
There is another layer of complexity in this situation. In order for the vaccine to be used in the United States, Pfizer must receive an Emergency Use Authorization (EUA) from the FDA. This EUA would bypass the traditional process for allowing medicine to be used in the United States while still ensuring that the vaccine is effective and safe. On October 6, the FDA released new guidelines for how they would evaluate a coronavirus vaccine. the FDA has these guidelines in place to protect the public and to make sure that any vaccine created is safe for general use as well as effective. These new guidelines provide government oversight over how the vaccine is manufactured, the chemicals used in the vaccine, how the clinical trial was run/designed, and the data from the trial. In order for Pfizer’s vaccine to become available, they must meet the criteria and receive FDA approval. This is one example of how Pfizer is beholden to the U.S. government. The FDA has this oversight power over Pfizer, and this oversight determines whether Pfizer makes money on its vaccine or not. The U.S. government’s relation to Pfizer is determined through this interaction.
I believe that it is very important to create a coronavirus vaccine quickly. Unfortunately, the pandemic is not going anywhere anytime soon. The best way to combat the pandemic is with a vaccine. However, the companies creating the vaccine, such as Pfizer, cannot take shortcuts. The FDA plays this oversight role overall clinical trials for a specific reason. It is how the government can provide a check on pharmaceutical companies. Technically, the FDA is already giving a shortcut by allowing the EUA. While it is understandable and necessary to use the EUA, no more shortcuts should be taken when creating this vaccine. The process is intentionally long and drawn out; this is done to painstakingly prove efficacy and safety. It is the duty of the company to adhere to the FDA guidelines so that they remain compliant with the government so create the best possible product for its consumers.
Office of the Commissioner. (2020, October 6). FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccine. U.S. Food and Drug Administration. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-guidance-emergency-use-authorization-covid-19-vaccines.
Original Source: Thomas, K., & Weiland, N. (2020, October 16). Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November. https://www.nytimes.com/2020/10/16/health/covid-vaccine-pfizer.html.