OMAHA, Neb. (KMTV) — As the COVID vaccine is being administered, some people have fears over whether it’s safe and what the side effects could be. One Nebraska Medicine doctor took to Facebook to address those concerns.
In his post, Dr. Tom Marston addresses whether the vaccine could lead to infertility issues, mutations and more:
“Sorry for the long post but there is a lot to unpack about the new vaccine:
I have seen many posts recently spreading a lot of misinformation about the COVID-19 vaccine. There have been many false rumors about all sorts of vaccines over the years but the truth is that vaccines are some of the most scrutinized medications that we deliver. They have to be as we known that we are giving them to otherwise healthy individuals. I encourage all to ask questions of healthcare providers and those who have spent their lives trying to understand and advance science to help others but don’t substitute asking questions to those who are highly trained for a 10-minute google search or someone else’s Facebook post.
Pfizer’s vaccine is an mRNA vaccine. It is true that it will be the first approved vaccine using this technology but it is not a new technology. The technology has been studied for >30 years and multiple vaccines have been studied including for other viruses including Zika, Rabies and SARS-CoV1. These previous studies have given us a solid foundation of knowledge to help advance the research on this vaccine. mRNA vaccines are “smart” vaccines where a small piece of viral mRNA (genetic material) is injected into a patient. This mRNA is taken up by cells and your cellular components make small proteins. These proteins are presented to your immune system and you produce antibodies and memory cells to produce long term immunity. The mRNA naturally breaks apart fairly quickly as does all mRNA in the body. The proteins themselves are broken apart fairly quickly as are most proteins in our body. The pieces that are broken apart are naturally recycled as they are from the same building blocks that our body always uses for genetic RNA or proteins or are excreted as waste. The vaccine itself does not last long inside your body but the hope is to create enough immune response that the immune memory will. The specific protein targeted is called the spike protein and it is a protein uniquely found on the outside of SARS-CoV2 (COVID 19). mRNA vaccines actually have no preservatives in them which is why they need to be stored in extremely cold temperatures. I want to address a few misconceptions about the vaccine that I see being spread widely:
1. The vaccine has fetal parts or used stem cells: FALSE
No fetal parts or blood products are used in the manufacturing of the vaccine or are in the vaccine.
2. The vaccine can cause mutations in your body: FALSE
Your body does not have the cellular machinery to change mRNA to DNA so it cannot be incorporated into your DNA.
3. The vaccine causes infertility: FALSE
There is no evidence of any cross-reactivity with the spike protein and proteins in the placenta that cause infertility or loss of pregnancy. This false information comes from a belief that the spike protein and the human placental protein syncytin-1 are the same which is false. In fact, 13 people became pregnant during the study period and none of those who received the vaccine have had adverse reactions, though they will continue to be monitored through pregnancy.
4. The vaccine is not safe in pregnancy: Unknown- though likely false and should be a discussion between a pregnant woman and her doctor.
Pregnant patients were not recruited for the study (though 13 became pregnant during the study as mentioned above). This is common for almost any randomized controlled trial to not initially include pregnant patients or children. These are often studied later. We use many drugs in patients that have not been studied in pregnancy but the benefits outweigh any potential risks. Current animal model studies for pregnancy and lactation are being finished and the initial data appears that there are no significant adverse reactions. Further studies will be done on pregnant individuals. The vaccine does not contain live virus. The American College of Obstetrics and Gynecology currently recommends that pregnant and lactating women can get the vaccine but can also have a conversation with their doctor about the risks and benefits further.
5. The vaccine gets you sick from COVID: FALSE
There is no virus in the vaccine. It is common to have heat at the site of injection, feel fatigued, low-grade fevers and body aches for 24-48 hours. This is good. This is your immune responding and creating immunity.
6. The vaccine is not safe: FALSE
There were no statistically significant differences in severe adverse events including death, heart attacks, stroke, appendicitis, or other serious adverse events between the vaccine group and placebo. It is to be expected to have some people have these problems during a long study when studying large populations and is not related to the vaccine. There were no anaphylactic reactions. There have been 3 cases of bells palsy (out of 15,184 patients in the vaccine group) and 1 case of bells palsy in the placebo group (out of 15,165)- unclear relationship. There were 6 deaths in the vaccine group and 7 in the placebo group. There were 1% non-fatal adverse events in both groups. There were 2 reports of facial swelling in the vaccine group (out of 15,184). There was 1 case of rheumatoid arthritis (unclear if this is related) in the vaccine group. There was 1 case of severe nausea and vomiting in the vaccine group. Overall, the safety profile is good. There were not common serious adverse events or allergic reactions associated with the vaccine and occurred at such low levels that it is difficult to contribute to the vaccine.
What we do know is the vaccine is 94.5% effective at preventing COVID-19. This was authorized under an Emergency Use Authorization (EUA). Normal vaccines and medicines must have 6 months of data after the last dose was given in the study before getting fully authorized. In all vaccines 95% of adverse events happen within the first 6 weeks. The FDA made the decision that the vaccines would not be considered for EUA until at least 8 weeks after the last vaccine dose was given in the study. This does not mean that it is unsafe as EUAs still has to pass rigorous significant scientific studies to show efficacy and safety. The FDA has to conclude after looking at all the data that giving a healthy person a vaccine is of more benefit and less risk than not giving the vaccine at all. The EUA was applied for before waiting for 6 months of data because we have the equivalent of 7.5 Boeing 747s crashing every day (3000 deaths/day). If this was happening and we had the fix to this problem, we would all agree that it is unethical to not fix the problem and continue letting 7.5 Boeing 747s crash every day. The same is true for this vaccine. After looking at the efficacy and safety data it would be unethical to wait another 4 months allowing more people to die when we have a large 40,000 person randomized controlled trial (the gold standard of science) that shows good efficacy and a strong safety profile.
Finally, I will end with this. Doctors and scientist are some of the most skeptical people who scrutinize scientific data to the extreme. We have scrutinized the data and I for one will gladly be getting vaccinated. I ask all of you to use caution of where you get your information and help stop the spread of misinformation.”