As the FDA has just granted Pfizer’s COVID vaccine emergency approval, I have begun to see a lot of questions surrounding this shot and, unfortunately, many inaccuracies. Briefly, I’d like to provide some insight into what we know about Pfizer’s immunization for COVID-19.
First, I think there is benefit in understanding the process required for a vaccine to be brought through approval and then to market. One of the largest concern that I’ve heard in recent days is that the vaccine was rushed and therefore not tested enough. Thankfully, this is largely not accurate. One of the main issues with getting a vaccine approved is recruiting enough people on whom you may test it. The COVID-19 vaccines have not suffered from this limitation. The FDA typically requires up to 3,000 participants in late-phase vaccine trials. Pfizer’s COVID-19 vaccine had approximately 43,000 participants enrolled in a double-blind study; which is widely considered the most effective type of study for immunization trials. Observing this number of participants over multiple months of the trial is what ultimately lead to an early approval.
Another pair of key considerations are safety and side effects. As noted above, there were several thousand more participants in the COVID-19 vaccine trial than typical trials. This size lets researchers have a much clearer idea of the types and rates of reactions to this shot. The main side effects observed were fever and fatigue with up to 50% of recipients reporting such symptoms. Interestingly, people under 55 years of age were much more likely to report side effects – especially muscle pain and injection site soreness. I think there may be something to be said about the older generation being a bit tougher based on these statistics…
Finally, some words about the more bizarre claims surrounding the COVID shot:
• The shot is not able to cause sterilization—there is actually not a substance that can cause sterilization when injected or we would already be using it medically.
• The shot does not contain a microchip. There is no evidence that anyone has ever wanted to or pursued putting a chip in the shot. There are a host of watchdog organizations to help prevent such things from occurring also—from the FDA to various physician’s organizations such as the American Medical Association (AMA) as well as medical agencies such as the New England Journal of Medicine (NEJM). My research on this topic only yields a claim from the Russian Government and domestically by Roger Stone, a political lobbyist. There are many sites that claim this but none of them give any real data to support their claims.
• People have questioned the integrity of the CDC in the approval process of this immunization. Simply, the CDC does not have a say in the COVID shot’s approval. This authority belongs to the FDA which is famously among the most stringent in the world. In fact, this extra caution is why other countries started using Pfizer’s shot before we did.
• The COVID vaccine does not alter human DNA. Fair warning: this next part gets a little intense. Pfizer’s COVID shot uses messenger RNA (mRNA). This RNA enters human cells to help direct production of proteins. Messenger RNA doesn’t have access to the nucleus of the cell, so it can’t get to our DNA. In the case of the COVID immunization, the proteins that are made look like certain pieces of COVID-19. By making these proteins, our immune system can see them and begin to make antibodies. Think of this like teaching your body what the right weapon to fight COVID-19 is. Once your immune system recognizes these proteins, when it sees similar structures on the virus, it can begin attacking it and killing it off before it can cause a significant infection.
Lastly, a word towards how we may help each other. This shot will never be required by law. What that means is that each of us has to weigh the risks and benefits. I hope this short article may provide a little bit of clarity, but I also hope that I can encourage you to think about how our actions affect our neighbors. The COVID shots that will be coming out give us a chance to return to normal but will not replace the need for masking and social distancing for those who have not received the shot. Because it will take months to make the vaccine widely available, it will be very important for us as a community to keep working hard to remain masked and protect our most vulnerable. I fear that we forget this sometimes, but the sad truth is that many of us that are young or healthy are spreading it to those that are not as young or healthy. Wearing a mask will reduce your chance of accidentally spreading this infection. Getting a COVID shot will greatly reduce your risk of spreading this infection. I’ve never known our community to be afraid to work, especially when it means helping each other out, so whatever you choose to do, make sure you do something.