Are the Covid mRNA Vaccines Safe?
- Are the Covid mRNA Vaccines Safe?
by , https://brownstone.org/
Anew scientific study entitled “Serious adverse events of special interest following mRNA vaccination in randomized trials” provides the best evidence yet concerning the safety of the mRNA Covid vaccines. For most vaccines in common use, benefits far outweigh risks, but that may not be the case for the mRNA covid vaccines, according to this study by Joseph Fraiman and his colleagues. It depends on your age and medical history.
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The randomized controlled clinical trial is the gold standard of scientific evidence. When regulators approved the Pfizer and Moderna mRNA vaccines for emergency use in December 2020, two randomized trials showed that the vaccines reduced symptomatic covid infection by over 90% during the first few months after the second dose.
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Pfizer and Moderna did not design the trials to evaluate long-term efficacy or the more important outcomes of preventing hospitalization, death, or transmission.
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The randomized trials did collect adverse event data, including the presence of mild symptoms (such as fever) and more serious events requiring hospitalization or leading to death. Most vaccines generate some mild adverse reactions in some people, and there were considerably more adverse such reactions after the mRNA vaccines compared to the placebo.
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That is annoying but not a major issue. We care about severe health outcomes. The key question is whether the vaccine’s efficacy outweighs the risks of severe adverse reactions. The Fraiman study uses data from the same Pfizer and Moderna-sponsored randomized trials presented to the FDA for vaccine approval, but with two innovations that provide additional information.
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So, what are the results? There were 139 AESIs among the 33,986 people vaccinated, one for every 244 people. That may sound bad, but those numbers mean nothing without comparison against a control group. There were 97 AESIs among the 33,951 people who received a placebo. Combining these numbers implies 12.5 vaccine-induced AESIs for every 10,000 people vaccinated, with a 95% confidence interval of 2.1 to 22.9 per 10,000 people. To phrase it differently, there is one additional AESI for every 800 people vaccinated (95% CI: 437-4762).
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That is very high for a vaccine. No other vaccine on the market comes close.
The numbers for the Pfizer and Moderna vaccines are 10 and 15 additional events per 10,000 people, respectively, so both vaccines contributed to the finding. The numbers are similar enough that we cannot confidently say that one is safer than the other. Most excess AESIs were coagulation disorders. For the Pfizer vaccine, there was also an excess of cardiovascular AESIs.
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While these safety results are concerning, we must not forget the other side of the equation. Unfortunately, the study does not calculate composite estimates that also included the reduction in serious covid infections, but we have such estimates for mortality.
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Dr. Christine Benn and her colleagues calculated a combined estimate of the effect of vaccination on all-cause mortality using the same randomized trial data as Fraiman et al. They did not find a mortality reduction for the mRNA vaccines (relative risk 1.03, 95% CI: 0.63-1.71).
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1. Covid-recovered people have natural immunity that is stronger than vaccine-induced immunity. So, the benefit of vaccination is – at best – minimal. If the risk of adverse reactions is the same as in the randomized trials, there is a negative risk-benefit difference. Why are we mandating people in this group to be vaccinated? It is both unethical and damaging to public health.
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2. While everyone can get infected, children have a minuscule risk of covid mortality. There is very limited safety data from the trials on children. If the risk of adverse reactions is the same as for adults, the harms outweigh the risks. Children should not receive these vaccines.
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3. Older people above 70 have a much higher risk of covid mortality than the population in the Fraiman study. If their risk of adverse reaction is the same, then the benefits outweigh the harms. Hence, older people who have never had covid and are not yet vaccinated may benefit from these vaccines. However, we do not know if they are better than the Johnson & Johnson and Astra-Zeneca vaccines.
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4. It is unclear from the clinical trial data whether the benefits outweigh the risks for working-age adults who have not been vaccinated and who have not already had covid. This is true both historically, for the original covid variants, and currently for the newer ones.
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5. The Fraiman study analyzes data after the first and second doses. Both risks and benefits may differ for booster shots, but no randomized trial has properly evaluated the trade-off.
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