Pfizer COVID vaccine under harsh glare from FDA, foreign research on serious side effects
Lawyer in FOIA suit suggests CDC steered early vaccine recipients to surveys where it could control reported side effects better.
The Facts Inside Our Reporter’s Notebook
- CDC's omission of known severe "adverse events of special interest"
- STAT analysis
- Kentucky Lantern
- Elsevier journal Vaccine
- Vaccine study on severe AESIs in the mRNA vaccine trials
- Florida's new Public Health Integrity Committee
- FDA's October study of insurance databases
- questioned data integrity in Pfizer's vaccine trial
- European Journal of Pediatrics
- Freedom of Information Act litigation
- ICAN's lawyer Aaron Siri wrote
- One participant filed months of worsening reports
Research by the FDA and Taiwanese medical institutions is casting a pall over Pfizer's mRNA COVID-19 vaccine for both elderly and young populations, raising fresh questions about the CDC's omission of known severe "adverse events of special interest" (AESIs) from post-vaccination surveys.
Big Pharma has kept political scrutiny at bay by doling out campaign checks. A STAT analysis in 2021 showed two-thirds of federal lawmakers received payouts in 2020, with Pfizer alone funding 228 members.
Last month, Pfizer gave the Kentucky GOP $1 million for its building fund, an indirect boon to Senate Republican Leader Mitch McConnell, the namesake of the state party's headquarters. The Kentucky Lantern said it may be the biggest party donation in Kentucky history, more than three times larger than the next biggest donor last month.
The FDA research published in the Elsevier journal Vaccine, which was first submitted in May, is notable for focusing on the oldest Americans rather than young people, now widely understood to have greater post-vaccination risk for heart inflammation.
Researchers reviewed Centers for Medicare & Medicaid Services data covering more than 30 million elderly people, looking for 14 "outcomes of interest" following COVID vaccination.
Initial evaluation found Pfizer's vaccine alone "met the threshold for a statistical signal" on increased risk for pulmonary embolism (54%), acute myocardial infarction (42%), "disseminated intravascular coagulation," or full-body blood clots, (91%) and "immune thrombocytopenia," or plunging platelet levels, (44%), they wrote.
When the researchers used "background rates from the flu-vaccinated population as the historical comparator," AMI and PE still met the signal threshold (41% and 48%).
"After further evaluation, only the RR [relative risk] for PE still met the statistical threshold for a signal," they said. The RR for pulmonary embolism was more than twice as likely in the "inpatient setting."
The FDA researchers emphasized that "more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals." The agency "strongly believes the potential benefits" of vaccination outweigh the risks of infection.
"If FDA reported any other drug increased lung blood clots 50% can you imagine our media staying silent?" tweeted emergency room doctor Joseph Fraiman, who coauthored an earlier study in Vaccine on severe AESIs in the mRNA vaccine trials and sits on Florida's new Public Health Integrity Committee.
In a November listserv message, Fraiman explained that the FDA's October study of insurance databases did not corroborate his Vaccine study because the former ensured "no false positives occur at the expense of false negatives ... the opposite of how a surveillance analysis should be conducted."
The Vaccine study's corresponding author, University of Maryland pharmaceutical research professor Peter Doshi, has also spoken about it. He's also a senior editor at the British Medical Journal, which has questioned data integrity in Pfizer's vaccine trial.
A new study of nearly 5,000 predominantly male Taiwanese teenagers in Springer's European Journal of Pediatrics adds to the global evidence base that young men have an elevated risk of post-vaccination heart irregularities. The only dispute is what counts as "rare" and "mild."
The Taiwanese medical researchers found that after the second Pfizer dose in the primary series 17% "had at least one cardiac symptom," 1% had "abnormal" electrocardiograms, and 0.1% "significant arrhythmias and myocarditis." None needed hospitalization, "and all of these symptoms improved spontaneously."
They cited previous studies that found second-dose Pfizer myocarditis rates up to 1.51 per 10,000 in 16-19 year-old males in Israel and increased cardiac arrhythmia in ages 16 and up in the U.K. after second-dose Moderna, whose "safety profile" they called worse than Pfizer's.
The scope of post-vaccination heart problems might have surfaced earlier, had the CDC included its list of severe AESIs in check boxes for mobile app v-safe, which surveys users after vaccination. It drew 8.5 million participants between its start in December 2020 and April 2021, after which new enrollment slid.
Newly obtained documents in Freedom of Information Act litigation by the Informed Consent Action Network show that the CDC's "prespecified medical conditions" chart — including heart attacks, myocarditis, stroke and spinal-cord inflammation — appeared in the first version of the v-safe protocol Nov. 19, 2021, predating the launch, ICAN's lawyer Aaron Siri wrote.
The second version, dated January 28, 2021 but released first in legal discovery, has the same chart. "Despite the foregoing, v-safe was launched without, and was never updated, to include any check-the-box fields for these conditions," Siri wrote.
That meant v-safe users had to manually write unlisted adverse events in free-text fields, preventing the agency from "clearly calculat[ing] a rate for each harm," he said. ICAN is still litigating to obtain free-text field entries.
The CDC's actions raise the possibility it guided the earliest vaccine recipients to v-safe, where it could highlight preferred side effects, so as to keep them from reporting serious AESIs in the publicly searchable Vaccine Adverse Events Reporting System, Siri said.
He noted the CDC told v-safe users to consider VAERS as a backup and also changed its v-safe protocol between January and May 2021 to only call back users who reported a "significant, medically attended health impact," at which point the agency would decide whether to make a VAERS report. Siri deemed this a "shell game."
Even when it followed up with v-safe users, the agency could take months to respond, he wrote. One participant filed months of worsening reports, including brain swelling, abnormal heart rhythm, chest pain and nausea, only getting a CDC response more than 200 days later.
"It was clear the CDC representative had not even read her v-safe reports" because the staffer asked when she had recovered, despite her reports indicating she was still on disability, Siri said.
The CDC told Just the News it couldn't respond to Siri's characterization of the v-safe decisions "due to ongoing litigation involving this individual and related to this subject matter."
Pfizer and McConnell's office did not respond to queries.