COVID AND THE VACCINE - TRUTH, LIES, AND MISCONCEPTIONS REVEALED, page-50575

Kulldorff tries too hard to sound reasonable. No, they are not safe. So say so.

• Are the Covid mRNA Vaccines Safe? (Kulldorff)

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. 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. 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. 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. 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. These results concern only the Pfizer and Moderna mRNA vaccines. Fraiman et al. did not analyze data on the adenovirus-vector vaccines marketed by Johnson & Johnson and Astra-Zeneca.

Benn et al. found that they reduced all-cause mortality (RR=0.37, 95% CI:0.19-0.70), but nobody has used trial data to analyze AESIs for these vaccines. Critically, the Fraiman and Benn studies had a follow-up of only a few months after the second dose because Pfizer and Moderna, unfortunately, terminated their randomized trials a few months after receiving emergency use authorization. Of course, a longer-term benefit can provide a basis to tolerate negative or neutral short-term risk-benefit differences. However, that is unlikely since we know from observational studies that mRNA vaccine efficacy deteriorates a few months after the second dose.

There may also be long-term adverse reactions to the vaccine regarding which we do not yet know. Since the randomized trials ended early, we must look at observational data to answer that question. The publicly available data from the Vaccine Adverse Event Reporting System is of low quality, with both under- and over-reporting. The best observational data is from CDCs Vaccine Safety Datalink (VSD) and FDA’s Biologics and Effectiveness Safety System (BEST), but there have only been limited reports from these systems. Fraiman and colleagues have produced the best evidence yet regarding the overall safety of the mRNA vaccines. The results are concerning. It is the responsibility of the manufacturers and FDA to ensure that benefits outweigh harms. They have failed to do so.

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