FDA experts support COVID-19 vaccines, didn’t author unsupported allegations of vaccine-caused deaths

As of 22 September 2021, 54% of the U.S. population has been fully vaccinated against COVID-19. But discussions about the possible waning of vaccine-induced immunity over time and the spread of the Delta SARS-CoV-2 variant has prompted scientists to consider the use of a third dose (booster) aimed at strengthening the immune system.

The U.S. Food And Drug Administration (FDA) advisory committee for Vaccines and Related Biological Products met on 17 September 2021 to debate and vote on the authorization for booster shots. The committee rejected authorization of booster shots for everyone, but authorized them for people above 65 and those with a higher risk of developing severe COVID-19. Committee members cited the lack of data about the safety of a third dose and questions about the value of universal boosters in combating the pandemic as the reason for the vote against universal boosters.

Following this meeting, several websites made inaccurate claims that the vote by the FDA experts were driven by alleged dangers of COVID-19 vaccines. For instance, this article claimed that “FDA experts reveal the Covid-19 Vaccines are killing at least 2 people for every 1 life they save”. Another article claimed that “Doctors and experts testif[ied] government data demonstrates COVID shots are dangerous and may kill more than they save”.

In fact, neither the FDA nor the FDA Vaccines and Related Biological Products Advisory Committee made such claims. The claims in the aforementioned articles were made by Steve Kirsch during a public hearing session by the committee. Kirsch, who is not a doctor, is the CEO of a digital money platform who previously propagated health misinformation and doesn’t belong to the committee.

In a statement to Health Feedback, the FDA clarified:

“Steve Kirsch is not, and has never been, employed by the FDA and is not a member of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).“

Furthermore, Kirsch wasn’t testifying before the FDA, contrary to what this Gateway Pundit article claimed. The public hearing session held by the FDA was open to any individual wishing to speak. The FDA’s statement:

“As with all of the participants during the open public hearing portion of the meeting, Mr. Kirsch submitted a request to speak per the meeting announcement. The open public hearing portion of the meeting is open to anyone who is interested and signed up per the meeting announcement. FDA does not screen remarks from speakers during the open public hearing portion of the meeting in advance. Furthermore, the statements made by Mr. Kirsch during the open public hearing portion of the meeting were not based in science and go against FDA’s public health mission.“

In other words, the FDA neither sought nor endorsed Kirsch’s statement. In fact, the FDA disagreed with Kirsch’s views due to the lack of scientific evidence supporting his allegations, as we will show below.

First, Kirsch alleged that COVID-19 vaccines killed two people for every person they saved and that “four experts” showed that vaccines killed 411 persons per million doses. However, Kirsch didn’t present any evidence for this claim.

In addition to being unsupported, his numbers are inconsistent with available epidemiological data. The U.S. Centers for Disease Control and Prevention (CDC) estimated that over a period of two months following the shot, vaccination prevented 7,081 deaths per million fully vaccinated people^[1]. Given the 182,387,840 fully vaccinated individuals as of 22 September, that would mean 1,291,488 prevented deaths. If Kirsch’s number were true, that would also mean that we would have witnessed an excess of 2,582,976 deaths due to vaccines, whereas the observed number of excess deaths in the US was 788,900 for the May 2020 – September 2021 period.

Second, Kirsch claimed that nearly 150,000 people have died from COVID-19 vaccines. However, this isn’t supported by mortality data available from the CDC. Figure 1 shows the weekly number of deaths in the U.S., with one column for each week. The orange curve is the expected number of deaths for each week based on historical records and statistical predictions. Therefore, excess mortality occurred during weeks where the number of deaths rises above that orange curve; these weeks are marked by a red cross above the column.

Figure 1. Weekly number of deaths in the U.S. Each column represents a week. Green column: number of deaths not due to COVID-19. Blue bars: number of deaths due to COVID-19. Orange curve: expected weekly number of deaths based on statistical analysis. Red cross: weeks where the number of observed deaths was higher than the expected number of death, indicating an excess mortality.

The blue segment of the column indicates deaths caused by COVID-19 for that week. These are deaths of COVID-19 patients whose clinical course of events leading to death was consistent with what is known of the disease. The green segment represents deaths that aren’t due to COVID-19. Therefore, if the green segment of the column for a specific week rises above the orange curve of expected deaths, it means that that week registered an excess mortality not due to COVID-19.

Given that the number of vaccinated people has been constantly rising since December 2020, one would expect the number of excess deaths not due to COVID-19 to increase over time if Kirsch’s claim were accurate. But this isn’t what happened as Figure 1 shows, with no trace of the alleged 150,000 deaths, as claimed by Kirsch.

In its statement, the FDA also explained:

“Although under reporting is a limitation [of pharmacosurveillance databases] with regard to COVID-19 vaccine safety monitoring, there currently is not evidence to suggest it would underestimate the amount of COVID-19 associated related deaths to such a large degree.“

Third, Kirsch pointed out that “there are 4 times as many heart attacks in the treatment group in the Pfizer’s 6 months trial report”. Kirsch referred to a pre-publication — a pre-publication is a scientific report that hasn’t yet been peer reviewed — reporting the findings of a study that monitored the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine for six months after vaccination^[2]. This pre-publication listed the causes of death of 29 individuals who died during the course of the blinded trial; these 29 included both vaccinated and unvaccinated individuals.

There were indeed four cardiac arrests in the vaccine group and one in the unvaccinated placebo group. However, this alone doesn’t show that the Pfizer COVID-19 vaccine kills people. If vaccines were dangerous, we would expect a significantly higher proportion of deaths among vaccinated people compared to unvaccinated people, but this isn’t what the report says. Indeed, the proportions are very similar: there were 15 deaths in the vaccinated group (0.068%) and 14 in the unvaccinated, placebo group (0.063%).

While some causes of deaths are more represented in the vaccinated group, others are more common in the unvaccinated group. For instance, there were two reports of multiple organ dysfunction syndrome and one case of aortic rupture in the unvaccinated group and none in the vaccinated group. When comparing two similar groups of people, it is normal to observe such differences, even in the absence of any effect of the medical intervention under scrutiny. This is because death is partly random and unpredictable, so there always will be some discrepancies between groups.

Fourth, Kirsch justified his claim by the fact that “VAERS shows heart attacks happened 71 time more often following these vaccines compared to any other vaccines”. The Vaccine Adverse Events Reporting System (VAERS) database provides the general public and healthcare workers with an avenue to report adverse events occurring after vaccination.

VAERS data can’t show whether an adverse event is the consequence of a given medical intervention such as vaccination. This is due to several reasons. One of them is that anyone can submit a report to VAERS and the information in the report isn’t verified. VAERS clearly warns users of the database about this caveat: “Some reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they are subject to biases.”

Another reason is that simply because one event followed another doesn’t mean the two are causally linked, as discussed in this Health Feedback review. The FDA’s statement also highlighted these caveats of VAERS:

“FDA strongly disagrees with the analysis Mr. Kirsch put forth during the VRBPAC meeting, as we believe the data from VAERS that he referenced were not properly interpreted. This is due to the limitations of VAERS itself, as well as the limitations regarding certain private patient information that is not available to individuals outside of FDA and CDC.”

Furthermore, we cannot directly compare adverse event numbers between the COVID-19 vaccines and previous vaccines. VAERS explains that healthcare providers are required by law to report any major adverse events, such as death, for vaccines under EUA, which was the case for all COVID-19 vaccines in use in the U.S. Therefore, the death of someone who received a COVID-19 vaccine must be reported to VAERS, regardless of the cause of death. Consequently, there is an inherent reporting bias in VAERS towards increased reporting of deaths among people who received a COVID-19 vaccine compared to other vaccines.

In summary, it is inaccurate that the FDA and/or FDA experts claimed that COVID-19 killed more people than they saved. These allegations were in fact made by members of the public, and primarily originate from a presentation by Steve Kirsch, who isn’t a scientist. Kirsch didn’t present data to support his allegations that the COVID-19 vaccines are unsafe, and his claims are at odds with publicly available data on U.S. mortality.

Furthermore, Kirsch misused the VAERS adverse event database and cherry-picked death reports from a 6-month follow-up report of the Pfizer-BioNTech COVID-19 vaccine.

The FDA refuted Kirsch’s claims and clarified that it “continues to find the three authorized and approved COVID-19 vaccinations meet the agency’s rigorous standards for safety, effectiveness, and manufacturing quality. These vaccines have proven to be an important tool for fighting the COVID-19 pandemic”.

Steve Kirsch is not, and has never been, employed by the FDA and is not a member of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). As with all of the participants during the open public hearing portion of the meeting, Mr. Kirsch submitted a request to speak per the meeting announcement. The open public hearing portion of the meeting is open to anyone who is interested and signed up per the meeting announcement. FDA does not screen remarks from speakers during the open public hearing portion of the meeting in advance. Furthermore, the statements made by Mr. Kirsch during the open public hearing portion of the meeting were not based in science and go against FDA’s public health mission.

FDA strongly disagrees with the analysis Mr. Kirsch put forth during the VRBPAC meeting, as we believe the data from VAERS that he referenced were not properly interpreted. This is due to the limitations of VAERS itself, as well as the limitations regarding certain private patient information that is not available to individuals outside of FDA and CDC.

Reports of death after COVID-19 vaccination are rare. More than 380 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through September 13, 2021. During this time, VAERS received 7,653 reports of death (0.0020%) among people who received a COVID-19 vaccine. 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. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths.

FDA continues to find the three authorized and approved COVID-19 vaccinations meet the agency’s rigorous standards for safety, effectiveness, and manufacturing quality. These vaccines have proven to be an important tool for fighting the COVID-19 pandemic.

Furthermore:

There is no evidence that deaths are underreported in VAERS by the factor claimed by Mr. Kirsch. Underreporting is a well-known limitation of all passive surveillance systems. This has been acknowledged multiple times by FDA and CDC at public meetings and on the VAERs website. It is why multiple systems in addition to VAERS are put in place to monitor vaccine safety. We are aware of two references that have been cited to support the contention that there is under-reporting of deaths in VAERS. However, neither reference addresses spontaneous adverse event reporting in the context of emergency use authorization (EUA). The first reference is a letter to the editor written by a retired pediatrician in 2010^[3]. It contrasts the reporting rate of Kawasaki disease in VAERS with its incidence in the pediatric population. Since a causal relationship between Kawasaki disease and vaccination has not been established, it is not surprising that there is a paucity of reports in VAERS. A likely scenario is that clinicians diagnosing or treating patients with Kawasaki disease did not feel it was related to the vaccine due to timing or other factors. The second reference is from a paper authored by CDC staff that evaluated the reporting sensitivity of VAERS for anaphylaxis and for Guillain-Barré syndrome^[4]. This study found VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%, sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%.

Of note, the study found the highest percent of adverse events captured in VAERS were after the 2009 H1N1 inactivated pandemic influenza vaccine. During this time, 76% of cases of anaphylaxis were captured in VAERS. This suggests that the degree of under reporting in VAERS may be mitigated in the setting of a pandemic where there is a heavy emphasis on vaccine safety. The COVID-19 vaccine program is unique as under the EUA conditions of use there are mandatory reporting requirements for vaccine administrators and manufacturers which likely would lead to increasing capture of death reports.

Although under reporting is a limitation in VAERS with regard to COVID-19 vaccine safety monitoring, there currently is not evidence to suggest it would underestimate the amount of COVID-19 associated related deaths to such a large degree.

 

REFERENCES

• 1 – Rosenblum et al. (2021) Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021. CDC Mortality and Morbidity Weekly report.
• 2 – Thomas et al. (2021) Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. MedRxiv (pre-publication).
• 3 – Collignon et al. (2010) Ramifications of adverse events in children in Australia. British Medical Journal.
• 4 – Miller et al. (2020) The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome. Vaccine.