This graph is from the FDA documents for tomorrow's (12/10) hearing. The red line represents COVID-19 incidence in volunteers who received the placebo. The blue line represents COVID-19 incidence in volunteers who received the Pfizer vaccine.
The M.D. who wrote the following letter has chosen to remain anonymous, but encourages sharing. The links inserted were added by your JABSOM librarians.
The FDA is likely going to approve the Pfizer Covid vaccine when they meet on December 10th. The Moderna vaccine will probably be approved shortly thereafter. This is an incredible feat of modern medicine, and our best chance to hopefully get our lives back to near normal relatively soon. However, it is new and it was done quickly, so understandably, people may be hesitant to get it; even people who vaccinate against all other diseases.
Will I be getting the vaccine? ABSOLUTELY.
But, it is a new vaccine technology and done in record time, so aren't I worried about its safety? Nope, not any more so than any other vaccine or other medical intervention.
Why? Let's start with how this vaccine works. This is an mRNA vaccine. Past vaccines typically use a live but weakened "attenuated" virus, or dead viral material "inactivated" virus, or a piece of the virus's protein or even a toxin produced by the virus. The Covid vaccine is very different. It contains mRNA (messenger genetic material) that encodes for the Covid spike protein. This causes your cells to then produce the Covid spike protein. In contrast, when you are sick with Covid, the virus hijacks your cell to produce many copies of the entire virus. Then it destroys the cell, busting it open to release its newly formed viral particles. When your cells release just the spike protein, it will stimulate your immune system to form antibodies to the Covid spike protein without you getting sick. There is no possibility of getting Covid from the vaccine. When your body is subsequently exposed to Covid, it will quickly recognize the spike protein and destroy it before it can make you sick. This was 95% effective in preventing Covid, which is an even better percentage than most other vaccines. However, you must take both doses (about 3-4 weeks apart).
Am I concerned about it being new? And previously untested? No, I'm not. This type of technology is not entirely new. It has been studied and used in cancer research. They have been making mRNA vaccines and studying them to specifically target proteins on tumor cells and train your immune system to then destroy the tumor. In this case, it is not a vaccine in the preventive sense, as it is targeted to a tumor that you already have. It is not currently widespread because it has to be custom made for each tumor. But, it has been "around the block" for a while now. The technology was also being studied for other Coronaviruses. It never came to fruition, because the diseases never reached pandemic proportions, and then the funding dried up. The mRNA does not enter the nucleus of the cell, and it does not affect your DNA, and therefore has no lasting impact on your cell.
Am I concerned about the speed with which it was developed? Weren't significant corners cut in order to get this out so quickly? No and no. What was cut out of the equation was mostly red tape, and what was added was technology and funding. We were given the genetic code by scientists in China to start vaccine production in January; before Covid was even documented to have reached our shores. From there, the vaccine was developed from the technology we had from the prior Coronavirus and cancer research, and was completed in March. Normally, there would be months of waiting for the FDA to even look at the work done prior to approving Phase 1 trials. Because of the urgent nature of this, it was essentially put on the top of the wait pile, which cut out months of waiting, but did not cut any corners. Between the Moderna and Pfizer vaccines (both mRNA, with a slightly different delivery system), they were tested in 37,000 people in Phase 3 (and an additional 37,000 received a placebo). That is on par with, if not better than the vaccines currently available.
Aren't I concerned that the FDA is about to approve it, and there may be side effects that haven't been seen yet? Nope on this one too. We know from decades of vaccine research, since you typically just get 1, 2 or 3 doses and then you are done with it, that nearly all side effects from vaccines occur in the first 6 weeks. Like other vaccines, minor side effects may occur (soreness at injection site, muscle aches, fever). Severe adverse reactions are extremely rare, and again, occur quickly if they are going to occur at all. As a healthy 50-something year old woman, my risk of dying from Covid is about 1 in 250 to 1 in a 1,000. That is not a rare event! And even if I don't die from it, I could have long term lung damage and other issues that affect my quality of life. Because vaccines are given to healthy people (unlike medications for treating a disease that is already present) they are held to a much higher standard for approval. My risk of having a significant adverse reaction from the Covid vaccine is minuscule in comparison to my risk with Covid. In fact, there have been no severe reactions to the Pfizer or Moderna vaccine to date.
For the rest of the population (outside of healthcare workers or those in nursing homes), who will likely be able to get the vaccine in February or March, there will be even more time passed and more people who have received the vaccine to be the "guinea pigs" here.
Anyone who is pregnant - it has not yet been tested in your group (although I do know that many pregnant front line health care workers are planning to take it). For those under 18 years old - it is also not yet tested. Moderna will be starting a trial shortly. Hopefully it will be approved by summer. But for everyone else, I highly recommend getting it as soon as you can; for you, for your loved ones, for those who cannot (perhaps because they are immunocompromised), for the many businesses that are on the verge of permanent shut down, and for kids to safely return to schools. I will be rolling up my sleeve for it as soon as it is offered.
If you'd like, please do feel free to cut and paste on your own social media sites. Sharing of information is so important to combating this pandemic. We will soon surpass 15 million documented Covid cases in our country (5 million of which were in the last 30 days; more than 170,000 new cases per day) and over 1,000 people are dying per day.
Anonymous, M.D.
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