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A man who promotes himself as an entrepreneur and technology expert made a COVID-19 claim that drew wide attention on Facebook and elsewhere: Pfizer vaccine kills more people than it saves. That’s not accurate. Steve Kirsch made the claim in a presentation he gave during the public comment period of a U.S. Food and Drug Administration committee meeting on Sept. 17; he had tweeted out a slide show of his presentation three days earlier. The meeting was held by FDA’s Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s application to give booster shots of its COVID-19 vaccine. Pfizer’s COVID-19 vaccine is the only one approved in the U.S. The Moderna and Johnson & Johnson vaccines continue to be used under an emergency use authorization. In non-binding votes , the committee recommended that the FDA not approve the booster for all adults, but approve it for people 65 and older and those at risk of serious disease. The claim about Pfizer Kirsch made many allegations in his presentation about the dangers of COVID-19 vaccines. Regarding the Pfizer vaccine, he claimed that a six-month study showed the Pfizer vaccine killed five people for each COVID-19 death it prevented. At the hearing, he said the statistic was not statistically significant but was still troubling. That’s not what the study he cited showed. The study was a non-peer-reviewed preprint posted July 28. It concluded that, with up to six months of follow-up and despite a gradually declining trend in vaccine efficacy, the Pfizer vaccine had a favorable safety profile and was highly efficacious in preventing COVID-19. In response to PolitiFact’s request for evidence to support his statement about the Pfizer vaccine, Kirsch said my statement about deaths was not based at all on the Pfizer study. He referred us to several other documents he produced, in which he said he used the Vaccine Adverse Event Reporting System, or VAERS, jointly run by the CDC and the FDA. Kirsch told us he used VAERS as one of eight methods to determine the number of excess deaths, and that we could only find that the vaccine was the only plausible cause of the excess deaths. Excess deaths is a statistic that takes the number of actual deaths in a given period and subtracts the expected number of deaths from all causes for that period, based on an average of recent years. VAERS and post-vaccine deaths Though the VAERS database is an important tool to help researchers detect trends in vaccine-related side-effects, the CDC makes very clear on the VAERS website that the data available through VAERS can’t be used to conclude that COVID-19 vaccines caused deaths. The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. What’s more, anyone can submit a report, and the reports are widely accessible, a fact that has made VAERS a popular breeding ground for misinformation . More than 386 million doses of COVID-19 vaccines were administered in the United States from mid December through Sept. 20. And in that period, VAERS received 7,899 reports of death (0.0020%) among people who received a COVID-19 vaccine. But, the CDC, which analyzes all reports to VAERS, has determined that a review of available clinical information, including death certificates, autopsy and medical records, has not established a causal link to COVID-19 vaccines. The CDC notes that recent reports indicate a plausible causal relationship between the Johnson & Johnson vaccine and TTS, a rare condition with blood clots with low platelets that has caused deaths. It’s also worth noting that the CDC requires users of its search engine for VAERS data to agree to a disclaimer that says in part that VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. However, the document Kirsch presented to the FDA committee cites an alternative portal that does not require agreeing to the disclaimer. That portal is offered by the National Vaccine Information Center, an anti-vaccine advocacy group. Vaccine effectiveness COVID-19 has killed nearly 675,000 people in the U.S., and more than 4.5 million worldwide. The vaccines authorized in the U.S. have been shown to significantly reduce the likelihood of severe illness, hospitalization and death from COVID-19. And no evidence has established that a COVID-19 vaccine authorized in the U.S. caused any deaths. The CDC analyzed vaccine effectiveness across 13 jurisdictions from April 4 to July 17 and matched that data to vaccine registries from those areas. It found that after delta became the most dominant variant of the coronavirus, unvaccinated people were five times more likely to be infected than fully vaccinated people, and more than 10 times more likely to be hospitalized or die. Across 13 U.S. jurisdictions, incidence rate ratios for hospitalization and death changed relatively little after the delta variant reached predominance, suggesting high, continued vaccine effectiveness against severe COVID-19, the Sept. 10 report said. Our ruling Kirsch’s presentation said: Pfizer vaccine kills more people than it saves. There is no evidence that the Pfizer COVID-19 vaccine has caused death. Available data indicate just the opposite: Vaccines are overwhelmingly effective at preventing death and serious illness from the virus that causes COVID-19. We rate the post Pants on Fire!
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