A remarkable aspect of the Covid-19 pandemic has been the frequency with which unpopular scientific ideas, from the theory of laboratory leaks to the effectiveness of masks, were initially dismissed, if not ridiculed, only to resurface later in the world. dominant thought. Differences of opinion have at times been rooted in disagreements over the underlying science. But the most common motivation has been political.
Another thought reversal may be imminent. Some scientists worry that the safety risks of Covid-19 vaccines have been underestimated. But vaccination policy has relegated their concerns to the periphery of scientific thought – for now.
Historically, the safety of drugs, including vaccines, is often not fully understood until they are deployed in large populations. Examples include rofecoxib (Vioxx), a pain reliever that increases the risk of heart attack and stroke; antidepressants which appeared to increase suicide attempts in young adults; and an influenza vaccine used in the 2009-2010 swine flu epidemic, suspected of causing febrile seizures and narcolepsy in children. Real-world evidence is valuable because clinical trials often recruit patients who are not representative of the general population. We learn more about drug safety from real evidence and can adjust clinical recommendations to balance risks and benefits.
The Vaccine Adverse Event Reporting System, or Vaers, which is administered by the Centers for Disease Control and Prevention and the Food and Drug Administration, is a database that allows Americans to document adverse events that occur after receiving a vaccine. . The FDA and CDC say the database is not designed to determine whether events were caused by a vaccine. That is true. But the data can nonetheless be evaluated, taking into account their strengths and weaknesses, and that’s what the CDC and the FDA say.
Vaers data for Covid-19 vaccines shows an interesting pattern. Among the 310 million Covid-19 vaccines administered, several adverse events are reported at high rates in the days immediately following vaccination, then drop sharply thereafter. Some of these adverse events could have happened anyway. This trend may be in part due to the tendency to report more events that occur soon after vaccination.
The database cannot tell what would have happened in the absence of vaccination. Nonetheless, the large clustering of some adverse events immediately after vaccination is concerning, and the silence around these potential signals of harm reflects the policy surrounding Covid-19 vaccines. The stigma of such concerns is bad for scientific integrity and could harm patients.
Four serious adverse events follow this arc, according to data directly from Vaers: low platelet count (thrombocytopenia); non-infectious myocarditis or inflammation of the heart, especially in those under 30; deep vein thrombosis; And the dead. Vaers records 321 cases of myocarditis within five days of vaccination, dropping to almost zero in 10 days. Previous research has shown that only a fraction of adverse events are reported, so the actual number of cases is almost certainly higher. This tendency to underreport is consistent with our clinical experience.
Analyzes to confirm or refute these results should be done using large datasets from health insurance companies and healthcare organizations. The CDC and the FDA are surely aware of these data patterns, but neither agency has recognized the trend.
The implication is that the risks of a Covid-19 vaccine may outweigh the benefits for some low-risk populations, such as children, young adults, and people who have recovered from Covid-19. This is especially true in areas where community spread is low, as the likelihood of disease depends on the risk of exposure.
And while you would never know from listening to public health officials, no published study has shown that patients who have been infected previously benefit from the Covid-19 vaccination. That this is not easily recognized by the CDC or Anthony Fauci is an indication of how deep the entanglement of pandemic politics is in science.
There are however signs of life for scientific honesty. In May, the Norwegian Medicines Agency reviewed records of the first 100 reported deaths of nursing home residents who received the Pfizer vaccine. The agency concluded that the vaccine “probably” contributed to the deaths of 10 of those residents through side effects such as fever and diarrhea, and “possibly” contributed to the deaths of 26 others. But this type of honesty is rare. And it is rare for any vaccine to be linked to deaths, so this unusual development for mRNA vaccines warrants further investigation.
The battle to regain scientific honesty will be difficult in US anti-Trump policy in the spring of 2020, which has turned into social media censorship. Reports often lacked intellectual curiosity about the relevance of public health guidelines or why a minority of scientists strongly disagreed with dominant views. Scientists have argued for or against Covid-19 therapies while maintaining financial relationships with product makers and their foundation benefactors.
Public health authorities are making a mistake and endangering public confidence by failing to report the possibility of harm from certain side effects of vaccines. There will be lasting consequences of mixing political partisanship and science when dealing with a public health crisis.
Dr Ladapo is Associate Professor of Medicine at the David Geffen School of Medicine at UCLA. Dr Risch is Professor of Epidemiology at the Yale School of Public Health.
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