EXCLUSIVE: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses
U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.
The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.
According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).
In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.
The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”
The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”
It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.
Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said the agency’s refusal to provide the analyses was not acceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak, who sits on one of the FDA’s outside advisory panels, told The Epoch Times.
“What’s the point of having VAERS if you’re not releasing it to the public?” she added.
Witczak said her concerns about vaccine safety were heightened by a recent paper from Dr. Joseph Fraiman and others that found a higher incidence of serious adverse events in vaccinated participants in the original Pfizer and Moderna vaccine trials than in placebo recipients. She noted that the FDA’s 2004 warning for antidepressants that the drugs could increase the risk of suicidal thoughts and behavior came over 10 years after the trials on which it was based.
“If this data is available, shame on you for not making it known to the public,” Witczak said. “It’s as if they don’t trust the people to make their own best decision for what’s good for them and their families.”
The Centers for Disease Control and Prevention (CDC), according to the documents outlining operating procedures, was going to perform a different type of data mining analyses, called Proportional Reporting Ratio (PRR) mining.
The CDC has also refused, so far, to provide the results for those analyses.
It has also twice provided false information when responding to questions.
The agency initially said that no PRR analyses were done and that data mining is “outside of th[e] agency’s purview.” The agency then said that it did perform PRRs, starting in February 2021.
Later, the agency acknowledged that wasn’t true. The agency did not begin performing PRRs until March 2022, a spokesperson told The Epoch Times.
Roger Andoh, a records officer, gave the initial response, citing the CDC’s Immunization and Safety Office. Dr. John Su, a CDC official, gave the second response. It remains unclear with whom the information originated.
The Epoch Times has submitted Freedom of Information Act requests for internal emails that may provide answers.
Data Mining Reports
The Empirical Bayesian (EB) is focused on identifying disproportional numbers of adverse events, CDC scientist Dr. Tom Shimabukuro said in January 2021. It identifies “with a high degree of confidence, adverse event-vaccine pairs reported at least twice as frequently as expected for a COVID-19 vaccine compared to the VAERS database,” he said, or a comparison between the incidence of a specific event such as kidney disease after COVID-19 vaccine compared to the incidence of the same event after all other U.S.-licensed vaccines.
The FDA and CDC have provided periodic updates on the EB data mining effort.
“Importantly, there were no Empirical Bayesian data mining alerts detected for any adverse event COVID-19 vaccine pairs as of the last data mining run that the FDA performed on February 18th,” Shimabukuro told members of the FDA’s vaccine advisory panel on Feb. 26, 2021.
In a review memorandum (pdf) for an expansion of the emergency authorization granted to Pfizer’s vaccine, FDA researchers said that data through April 16, 2021, showed only a possible signal for body temperature.
In the journal Vaccine in June 2021, FDA researchers said an analysis of cases of blood clotting after the Pfizer and Moderna vaccines did not suggest a safety concern. The FDA and CDC paused the Johnson & Johnson vaccine in April 2021 over cases of blood clotting, some fatal, but lifted the pause just 10 days afterward. The FDA later restricted use of the Johnson & Johnson shot.
In a paper in the CDC’s quasi-journal in August 2021, FDA and CDC researchers said that the FDA used EB mining to monitor events in children aged 12 to 17 after vaccination. The results indicated a lack of a safety signal for post-vaccination heart inflammation, or myocarditis, though other surveillance systems had detected the issue as an adverse event.
And in a preprint in May 2022, scientists, including Su, said that EB mining analyzing data through Nov. 12, 2021, revealed only one signal for VAERS death reports, for “vaccination failure” after receipt of the AstraZeneca vaccine, which is not authorized in the United States.
More Reports of COVID Vaccine-Linked Heart Inflammation in Young Males Submitted to CDC
Reports submitted to the U.S. Centers for Disease Control and Prevention (CDC)’s vaccine surveillance system suggest that cases of post-COVID-19 vaccine-linked heart inflammation among young males have risen.
Recent figures published in the CDC’s Vaccine Safety Datalink surveillance system show that within a week of getting the two-dose Pfizer-BioNTech vaccine, there were 14 cases of myocarditis or pericarditis among 102,091 males between the ages of 16 and 17. And of the 206,000 12- to 15-year-old males who got the same two-dose vaccine series, there were 31 cases within a week, according to the CDC (pdf).
Those reports were presented to the CDC’s Advisory Committee on Immunization Practices on Sept. 1 show that the incident rate for the 12- to 15-year-old group is 150.5 per million—or about 1 in 6,600—and 137.1 per million for the 16- to the 17-year-old group—or about 1 in 7,262.
Following the first booster dose, CDC-presented figures show that it jumps to 188 per million among the 16- to 17-year-old group. But for the 12- to 15-year-old males, 61.3 per million developed heart inflammation after the booster dose, according to the figures.
In August 2021, the figures submitted to the CDC system (pdf) show that of 42.6 myocarditis and pericarditis cases per million and 71.5 per million for 12- to 15-year-old males and 16- to 17-year-old males, respectively. That breaks down to about one in 23,500 for the younger group and around one in 14,000 for the older group.
The agency noted that “myocarditis is a rare event following mRNA COVID-19 booster vaccination” and that it has “verified 131 myocarditis case reports to VAERS in people ages [5 years and older] after 123,362,627 million mRNA COVID-19 booster vaccinations.”
In analyses of the data, “myocarditis [and] pericarditis incidence following first booster dose and dose 2 of the primary series are similar, though case counts are small and confidence intervals around point estimates are wide,” said the CDC.
The Vaccine Safety Datalink is described by the agency as “a collaborative project between CDC’s Immunization Safety Office and nine health care organizations” and is designed to “monitor [the] safety of vaccines and conduct studies about rare and serious adverse events following immunization.”
In May, the CDC said reports of heart inflammation linked to the Pfizer vaccine were much lower in 5- to 11-year-old boys than in adolescents and young males. Among that group, the rate of heart inflammation stood at 2.7 cases per million.
After the figures were presented, the Advisory Committee on Immunization Practices recommended updated boosters, which was, in turn, endorsed by CDC Director Rochelle Walensky, the CDC’s director.
Walensky said that “updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” adding, “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants.”
“This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it,” she added on Sept. 1.
A study that was led by Dr. Tracy Hoeg, with the Florida Department of Health, and released in mid-2021 showed figures similar to the ones submitted to the CDC’s advisory committee on Sept. 1.
Hoeg said she and others published a preprint study last year showing a rate of 94 instances of myocarditis per million in 16- to 17-year-old males—or 1 in 10,6000—and 162 per one million in 12- to 15-year-old males—or 1 in 6,200—she wrote on Sept. 1.
The CDC “is now finally catching up & reporting similar,” Hoeg wrote on Twitter earlier this month.
“If we hadn’t been villified as ‘anti-vaxxers’ spreading ‘mis’ & ‘disinformation,’ how would the conversation around minimizing the chance of this adverse event have changed & how many cases of myo/pericarditis in young males would have been prevented over the last year?” she asked.
Hoeg also questioned recent statements made by CDC officials in recommending boosters to anyone aged 12 and older.
“Now today the CDC is recommending with no human data on benefits or risks that everyone 12 and up get a bivalent booster. ‘There is no bad time to get your COVID-19 booster.’ Really?” she asked. “Why are nuance & individualized recs so difficult for @CDCgov?”