The great news of how effective the first two vaccine candidates were in the phase three trials gave all of us a burst of hope. Finally, we began to believe that this demoralizing pandemic would finally end. However, there is a hurdle that we need to get over to make this come true, the surprising hesitancy of many in America to take the vaccine. The fact of the matter is, we need somewhere between 60 and 70% of a community to be vaccinated to obtain herd immunity, the point where the virus quits spreading. A poll a few weeks ago showed that less than 50% of the people polled said they were going to get vaccinated as soon as it came available. A more recent poll showed the number increased to above 50%, a step in the right direction but not the participation numbers we need to stop this pandemic. There has been much discussion about why people are hesitant, with many possible reasons put forth. There are two oft sited reasons that deal with the safety of the vaccine that seem to be at the top of the list that I would like to discuss. Hopefully, it will shed some light on why these vaccines are safe.
1. The Vaccine was developed to quickly.
Historically, vaccine development has taken four or more years to be approved for human use. While we have had vaccines for hundreds of years, the science behind vaccines has been slow to progress but in the last few decades it has accelerated at a breathtaking speed. While the approach taken by these first two COVID-19 vaccines is new, it wasn’t discovered this year. Two married scientists, Ugur Sahin and Ozlem Tureci, co-founders of BioNTech, the firm that has teamed with Pfizer, have been working on this vaccine approach since 2001 and have been working on a COVID-19 vaccine since January. With the funding and worldwide logistical support of Pfizer and the commitment of the FDA to cut through the bureaucratic red tape, the new vaccine has gone through all of the required testing in record time. Their phase III testing had over 40,000 participants. They had to jump through all the hoops any new vaccine was required to accomplish. They proved that it works and that it’s safe.
2. The FDA was pressured by politicians to cut corners.
The FDA is recognized worldwide as the gold-standard in the process of approving the safety and efficacy of prescription drugs. The FDA is made up of career scientists who have maintained this reputation for decades and they did it from a commitment to excellence, not through a commitment to any administration or political party. America is the leader in drug development because of the high standards required by the FDA. One of the ways the FDA assures the absence of any political influence is the approval review by an advisory committee made up of external scientists and experts. The committee that will meet on December 10th to review the Pfizer/BioNTech vaccine is the Vaccines and Related Biological Products Advisory Committee (VRBPAC). These committees are thorough and transparent. I have personally testified many times during the public comment portion of various advisory committee meetings and can attest to their attention to detail and their commitment to transparency. The FDA is not about to jeopardize their gold-standard reputation, to say nothing of the health and wellbeing of the whole world, due to the pressure of a lame duck administration.
Three past United States presidents have committed to getting vaccinated as soon as it becomes available. They, more than anyone, understand the workings of the FDA and they trust them to protect us, as we should. The only way we can beat this virus is to take advantage of the great scientific minds and amazing manufacturing capabilities that have made this vaccine a reality. Let’s all get vaccinated as soon as we can, so we don’t lose the chance to once again gather together.
p.s. I would be remiss if I didn’t recognize the importance of this day of infamy and those who made the ultimate sacrifice at Pearl Harbor. In the space of six months, while serving as a B-52 crew member in the Air Force, I lost fellow aviators and friends in two separate airplane crashes. I am honored to have served with these heroes and I use December 7th as a time recognize and remember all who serve or have served.