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demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk [which the government will assume], but not the product risk.” 2 Another key driver in the expedited timeline was the pandemic itself. With tens of millions of cases, obtaining the number of participants needed to test safety and efficacy in clinical trials was that much easier.
2. Skepticism regarding mRNA vaccines: The Pfizer and Moderna vaccines use messenger RNA (mRNA), which cannot replicate or become part of your genetic code, rather than injecting a weakened or inactivated version of the coronavirus into the body, as a traditional vaccine would do. While this is a novel method, it is not new.
According to the CDC, “Messenger RNA (mRNA) vaccines
The body recognizes that this protein is foreign and triggers an immune response, which results in the production of antibodies and protects the body if the real virus were to enter our system.4 Messenger RNA doesn’t interact with the body’s DNA, so it doesn’t end up as part of the body’s genetic code. Cells break down the mRNA as soon as the instructions for making the protein are complete, limiting the mRNA’s time in the system to hours
or days.
The benefits of using mRNA vaccines are many. Because the vaccine is not injecting the actual coronavirus into the body, you cannot develop the virus from the vaccine, nor are you contagious from the vaccine after being vaccinated. Messenger RNA vaccines are also much easier and faster to develop and produce than traditional vaccines. The results of early clinical trials have been impressive. “In the primary analysis [of the Pfizer vaccine], only 8 cases of Covid-19 were seen in the vaccine group [comprised of 21,720 participants], as compared with 162 in the placebo group [comprised of 21,728 participants], for an overall efficacy of 95% (with a 95% credible interval of 90.3 to 97.6%).”5 While this is incredibly promising, long-term data has yet to be collected. This is one of the reasons these vaccines are operating under emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), rather than full approval.
3. Fear of long-term health risks associated with the vaccine: Until the coronavirus vaccines are granted full FDA approval, you will inevitably have some employees who are fearful of unknown risks. This is to be expected. However, according to the FDA’s website6, it is also “expected that the data supporting the EUA, together with those that will be collected during use of vaccine
2 https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
3 https://horizon-magazine.eu/article/five-things-you-need-know-about-mrna-vaccine-safety.html 4 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
5 https://www.nejm.org/doi/full/10.1056/NEJMe2034717
6 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy- framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions
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Researchers have been studying and working with
mRNA vaccines for decades. The advances already made in mRNA research were another
contributing factor to the speed with which the current coronavirus vaccines were able to be
developed and tested. Although the coronavirus vaccines are the first mRNA vaccines to be
brought to market, human clinical trials have been run in the past with other mRNA vaccines
against the flu, Zika, rabies, and as a potential cancer treatment.3
give instructions for our cells to make a
harmless piece of what is called the ‘spike protein.’ The spike protein is found on the surface of
the virus that causes COVID-19.”