In human trials, the Pfizer vaccine was compared to a placebo in 43,448 people. During the study, 170 participants developed COVID-19. When the study blind was broken, it was revealed that 162 of these people had received the placebo. Only eight were in the vaccine group. Of 10 severe COVID-19 cases, nine were in the placebo group, and one had received the vaccine. (Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. doi: 10.1056/NEJMoa2034577). The Pfizer vaccine is fragile. It must be shipped and stored between −80 and −60 °C. When vaccines are not stored properly, they can lose their effectiveness.
In human trials, the Moderna vaccine was found equally effective. In 28,207 participants, there were 185 cases of COVID-19 in the placebo group and 11 cases in the vaccine group. Of 30 severe cases, all were in the placebo group. (U.S. Food and Drug Administration. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. Accessed March 31, 2021. www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid.). These figures showed an effectiveness of over 90% for the Moderna vaccine. The Moderna vaccine can be kept at more moderate temperatures but must still be shipped and stored correctly in order to work.
The one-shot Janssen vaccine, released by Johnson & Johnson, was reported to have an overall efficacy of 66%, although its ability to prevent severe cases appears to be much higher (Centers for Disease Control and Prevention. Information About Johnson & Johnson’s Janssen COVID-19 Vaccine. Updated March 30, 2021. Accessed March 31, 2021. www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html). Some have speculated that the lower apparent efficacy of the Janssen vaccine may be due to the arrival of variant coronaviruses that pose challenges for all current vaccines. The Janssen vaccine is stored with normal refrigeration.
The largest question with the current vaccines is how long immunity may last, particularly in the face of a mutating virus. We do not yet know whether the coronavirus vaccines will provide long-lasting protection like the Salk polio vaccine or will lose its efficacy in a matter of months, like influenza vaccines. So far evidence suggests sustained immunity, but only time will tell, in the initial vaccine groups, we are still only six months out from initial immunization; thus it is premature to draw any firm conclusions.
Short-term side effects of the Pfizer, Moderna, and Janssen vaccines have been minimal; primarily reported have been fatigue, headache, and muscle aches. Very rarely allergies have occurred, typically in people with multiple previous allergies; this rate of allergic reaction appears identical to other pharmaceutical trials over the past decade.
Pharmaceuticals do portend some level of risk, and close monitoring continues. While the Salk polio vaccination has been shown to be extremely safe, the live attenuated (Sabin) vaccine can actually cause paralytic polio, with approximately three cases of polio per million people vaccinated. The issue with live virus used in a vaccine can revert back to a disease-causing state, leading to polio, not in vaccinated individuals but in others to whom they pass the virus. In 1976, the swine flu vaccine caused cases of Guillain-Barré syndrome, a condition of weakness caused by an autoimmune reaction to the vaccine. The syndrome is fatal in about 5% of cases and disabling in others. There were 362 cases during the first six weeks of the vaccination program, leading to its discontinuation. Concerns about COVID-19 vaccines have been fueled by the rush to create a workable vaccine, but the level of actual risk has remained quite low in comparison to other vaccine trials in the past 100 years.
There have been a number of comments surrounding the vaccine ingredients, most of which have been erroneous. If you have questions related to vaccine ingredients, please access the CDC COVID Information website to clarify those concerns (www.cdc.gov/vaccines/parents/ingredients.html).
The COVID-19 vaccines use methods that are far different from those used for polio or swine flu, and evidence so far suggests that serious long-term side effects are extremely unlikely. Even so, many consumers are taking a “wait and see” attitude, deferring vaccination until more data are in, which is an unfortunate issue for public health moving forward.
AT the Resuscitation Group, we strongly urge all people to obtain their vaccination.