Iowa Specialty Hospital

COVID-19 Update from Dr. Michael McLoughlin 12/7/2020

December 7, 2020

The most significant updates related to COVID-19 over the next several weeks are likely to be related to vaccinations, so I’m going to focus on a few of the most significant details related to the vaccines.

There are two vaccinations that are likely to get an emergency use authorization from the FDA within the next two weeks. The vaccines have been developed by Pfizer and Moderna respectively. Both have been shown to be very effective (about 95% for each) in preventing COVID-19. Health care workers with direct patient care responsibilities and residents of long-term care facilities are likely to be the first people vaccinated and it is likely that vaccinating these groups will start in our area the week of December 21st.

Many people have heard about the effectiveness from news reports, but safety is every bit as important and that’s what I’d like to focus on now. It is understandable (and good!) to have concerns about safety when we’re talking about a vaccination that has been developed in less than a year. You simply can’t have long-term safety information when the studies done to establish safety have been ongoing for less than half a year. However, there’s still a lot of good information we do have about the safety of these vaccinations.

Even though the development has been remarkably fast, these vaccines will have gone through the same steps as a vaccine would in normal circumstances. Many of the steps have been done simultaneously or more quickly than usual, but there are still many opportunities for serious side effects to be detected along the way. For example, approximately 43,000 people in the case of Pfizer’s vaccine and 30,000 people for Moderna’s vaccine have been enrolled in Phase 3 trials. The FDA has required at least half of these people to have a full 2 months of safety information before the companies could ask for their emergency use authorization. So there are at least 15,000 people who have already received each vaccine and been monitored closely for more than two months (and this is still ongoing) for any side effects. The FDA committees who review the information from the companies are full of experts who are not beholden to any political entity and care deeply about making sure an approved treatment is as safe as possible.

Symptoms that have been seen with these two vaccines include fatigue, muscle pain, joint pain, headache, and fever. None of these occurred in more than 10% of participants with either vaccine. But even 5% having any of these symptoms is quite a bit higher than what we see with most vaccines, so anyone receiving the vaccines should expect the possibility of these transient symptoms. They could even be severe in some people. But they aren’t permanent and they aren’t because the vaccine gave a person COVID. The way these vaccines work can not give a person COVID. It’s simply that when the immune system gets ramped up while learning how to recognize an infection from a vaccine, it can sometimes cause symptoms that are similar to a natural infection. It’s also important to recognize that some people will get COVID after having received the vaccine. Again, this will not be because the vaccine caused it, but will be either because the person was exposed before the full protection from the vaccine took hold or because 95% effectiveness still isn’t going to be 100%. The reason we have the studies that compare a vaccine against a placebo is to try to determine what the vaccine actually causes, rather than what medical conditions happened by chance near the time a vaccine was given.

My takeaway from all of this is as follows: life (and medicine) are full of risk vs benefit decisions that we don’t know the precise outcome of, but must use the best information we have available. If the FDA gives emergency authorization to a COVID-19 vaccine, I have enough confidence that the benefits will outweigh the risks of vaccination that I will personally receive it even as a relatively young and healthy adult. For older adults, it will be an even easier decision. The major groups that I would not recommend be vaccinated as soon as possible are pregnant women and children under 18, because the vaccine has not yet been adequately tested in these populations. For those who have already had COVID or have other unique health situations, it may be more complicated and would be best to ask your own provider.

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