Misinformation for thee, not me? FDA had similar concerns as COVID vaccine skeptics, docs suggest

If an outsider raises questions about contamination of COVID-19 vaccines or how closely the Food and Drug Administration monitors for severe adverse events, the agency considers it a boon to misinformation that lowers vaccine uptake and hence kills people.

If the FDA itself raises these issues, that's a different story.

The agency turned over nearly 52,000 pages of documents from the "biologic product file of Pfizer’s COVID-19 vaccine for ages 16 and up" earlier this month, in the purportedly final batch required by court order in a Freedom of Information Act lawsuit by the Informed Consent Action Network.

ICAN also put the CDC on the defensive this week with its FOIA production that acknowledged the agency had no scientific research to back its public claim in January that people can safely get their COVID, flu and monkeypox vaccines "at the same time."

The FDA documents, some heavily redacted under the FOIA exemption for trade secrets, show less daylight than may be thought between the agency and critics of federal COVID policy such as Florida Surgeon General Joseph Ladapo. ICAN highlighted several individually.

Peter Marks, director of the agency's Center for Biologics Evaluation and Research, didn't just tell Ladapo last week his concerns about DNA contamination were "quite implausible" but also shamed him for feeding what he considered misinformation that will cause preventable deaths

Yet an Aug. 6, 2021 email to Pfizer from CBER Senior Regulatory Review Officer Mike Smith about "endotoxins" – potential contaminants introduced in pharmaceutical manufacturing – shows the feds had similar concerns as they considered full approval for Pfizer's Comirnaty.

"Your procedure for measuring endotoxin in Drug Product (DP) includes a [redacted]' step," Smith wrote, copying FDA colleagues Ramachandra Naik and Laura Gottschalk.

"While you provide data demonstrating the [redacted] does not impact the activity of endotoxin that is [redacted], you have not provided data to evaluate the potential endotoxin-like activity of the [redacted]."

The next data request is too redacted to be intelligible, but the following asks Pfizer to use the resulting information to "establish the endotoxin limit and establish a specification for DP endotoxin activity levels for samples that are [redacted]."

A month before then-acting FDA Commissioner Janet Woodcock told the media that post-vaccination heart inflammation "appears to be very low," a CBER "surveillance" scientist made clear that the leader was not relying on the agency's own data.

Joyce Obidi reviewed how well CBER's Sentinel Program, created under a 2007 law to monitor drug safety through electronic healthcare data, could "evaluate the serious risk for myocarditis and pericarditis" following Pfizer COVID vaccination in recipients 16 and older, the first population authorized for emergency use.

"Post-authorization safety data identified serious risks for myocarditis and pericarditis after COMIRNATY, with increased risk in males under 30 years of age," Obidi wrote in the May 18, 2021, memo, which is also buried in the agency's 246-document public folder on materials related to Comirnaty's approval.

"Available data sources in the CBER Sentinel Program are NOT sufficient to identify the outcomes of myocarditis and pericarditis" and not "sufficiently powered to assess the magnitude of risk" for ages 12-30, she wrote. 

The program would need a minimum of 3-6 months followup data to check for "long-term sequelae," and it cannot study subclinical myocarditis "because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities," according to Obidi.

Sentinel's data sources at full approval of Comirnaty did not have "sufficient power to assess the magnitude of risk in patients 12-30 years of age" and hence cannot assess the "serious risks of myocarditis and pericarditis, and subclinical myocarditis" associated with the vaccine, she said.

The Aug. 21, 2021, approval letter for Comirnaty simply says the agency's "pharmacovigilance system" cannot assess the "known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis."

In another May 18, 2021, memo reviewing Pfizer's proposed pharmacovigilance plan for its vaccine, Analytic Epidemiology Branch Medical Officer Deborah Thompson evaluated the company's claim that "vaccine-associated enhanced disease" is just a "theoretical risk."

She cited Vaccine Adverse Events Reporting System reports of deaths in "fully vaccinated" patients at that early stage of vaccination.

"Severe manifestations and death from COVID-19 raise the possibility" of VAED because it has "overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe" infection in VAERS reports.

In a Form 483 to Pfizer following inspections that uncovered possible or actual product adulteration, FDA investigators made 13 observations about procedures at Pfizer's Andover, Massachusetts, manufacturing facility.

They include "insufficient data to support product quality prior to the release" of vaccine batch FA8057. The observation says "a deviation [redacted] was initiated due to the multiple control limit excursions during [redacted]" and the "affected batch was manufactured with a process that deviated from the validated process parameters" and was "not put on stability until July 22, 2021." It was released on a redacted date.

An observation on "inadequate quality oversight" implies that Pfizer was late in adding a notation to a batch record that        "[redacted] exceeded the allowable [redacted]." The company's quality assurance does not review "electronic data/reports" from a redacted manufacturing process "during batch record review or prior to batch release."

Several concern the adequacy of cleaning procedures, with one observation saying a particular building "demonstrates a lack of [cleaning] efficacy on all surfaces [redacted] except [redacted]." Another says redacted substances were observed "on multiple walls" and a hallway, and "dust and debris" and "streaking/raised residue" on redacted locations.

Pfizer released products to U.S. and international markets whose batches were processed in a room while its HVAC system was shut down, which caused the "pressure differential" to drop "relative to the outside non-controlled non-classified corridor." 

An operator did something redacted to "material from a full and previously opened container" whose lid "was not fully closed […] and there was no documentation as to when the container had been initially opened."

Just the News asked the FDA on Saturday night for its characterization of the documents in light of Marks' comments to Ladapo about feeding misinformation.

A spokesperson responded Monday night, saying the agency was working to provide an answer, which had not arrived by Thursday evening.