'Data is power': Experts weigh-in on court-ordered release of Pfizer vaccine documents

Published March 11, 2022 4:57 p.m. ET
Updated March 11, 2022 7:19 p.m. ET

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The Food and Drug Administration (FDA) has lost a court battle, to protect the documents they used to approve the company’s COVID-19 vaccine.

On Sept. 16, 2021, a complaint was filed in a Texas court, by a group called Public Health and Medical Professionals for Transparency (PHMPT).

It reads in part “PHMPT exists for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID-19 vaccines.”

The complaint was issued pursuant to the Freedom of Information Act (FOIA), demanding all the data and information the FDA relied upon to grant Pfizer a licence to sell their COVID-19 vaccine.

“The medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of the Pfizer Vaccine,” the document reads.

“Given the speed at which this came on the market, going to the mandate stage was going a step too far,” says Dr. David Healy, a member of PHMP and a psychiatrist practicing in Hamilton, Ont.

“I don’t have an issue with this vaccine or any vaccine, ok? I’m quite pro vaccines,” Dr. Healy told CTV News in a zoom interview. “My issue is actually with the science. Now in this case it's access to the data.”

He likens Pfizer’s protection of their data, akin to creating his own vaccine at home, promising it works, but then not showing the evidence to support the claim.

“Pfizer on the other hand are able to say ‘well no you’re not going to see the evidence, we’re not going to let you see it,” says Dr. Healy. “That’s not science.”

During the court process, the FDA argued it would take them 75 years to redact all the personal information contained in the thousands of documents they have on file, related to the Pfizer vaccine.

On Jan. 6, 2022, Justice Mark Pittman ruled, “the court concludes that this FOIA request is of paramount public importance.”

In his reasons, Justice Pittman wrote, “John McCain (correctly) noted that ‘excessive administrative secrecy feeds conspiracy theories and reduces the public’s confidence in the government.’”

Read the orders here.

It concludes:

  • The FDA shall produce the “more than 12,000 pages" articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.
  • The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.
  • To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.
  • The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.

Dr. Healy says it’s a win for anyone who wants to have all the facts in front of them, “before they put their lives on the line.”

However, Dr. Healy anticipates it will take some time before all of the documents are released to the public.

“It’ll all be out there in next two or three years,” says Dr. Healy. “So it’s not going to be 75 years, but it’s not going to be tomorrow.”

As a psychiatrist, Dr. Healy says it's vital for him to understand the possible side effects of a drug or vaccine when dealing with his patients.

“Let’s say you’ve had the vaccine. Something has gone wrong. You don’t know if it's linked to the vaccine, or not. It’s useful, for me, as part of the effort to try to work out, ‘well could it have been linked to the vaccine?’ So that I don’t try to treat you for a completely different problem.”

However, Dr. Healy has yet to see the documents he’s most interested to pour over, specifically the details of clinical trials, including how many people were in them, what happened to them and how their involvement changed the outcome of the studies.

He notes even though there are thousands upon thousands of documents to pour over, interested people need only to look through most of them to find what he calls “patterns.”

He would tackle it this way: “I’ve seen that word crop up before. Let’s see what the other document that I’m now looking at says about is actually going on here, and trying to see if there’s a level of consistency there.”

One of the documents is specifically about adverse events.

The 38-page report details the adverse events reported to Pfizer between Dec. 1, 2020, and Feb. 28, 2021.

The total number of doses shipped around the world in that time period is redacted.

However, a graph appears to indicate in that same time frame 42,086 adverse events were reported.

Of them, 1,223 are listed as fatal with another 9,400 listed as unknown adverse effects.

“The events themselves are not necessarily related to the vaccine,” says infectious disease expert, Dr. Dale Kalina. “It’s just part of the reporting process. And it is a requirement.”

Dr. Kalina says it's “disingenuous” for people against COVID vaccines to imply the list of events is proof the vaccine isn’t safe.

“This is an affront to the reality that we know which is that after the billions of people that have received COVID vaccines, they are safe, they are effective. Yes, there are of course some side effects related to it,” says Dr. Kalina.

He notes each event doesn’t mean the vaccine caused that reaction, rather he says it was reported to Pfizer in the “days and weeks” after the vaccine was administered.

For instance, one of the adverse effects included in a report is about a child who swallowed a penny after getting the shot.

“Swallowing a penny is something that five-year-olds do, on occasion, unfortunately,” says Dr. Kalina. “But I think we can plainly see that that wasn't related to administration of the vaccine itself, but it’s a good example of the fact that all adverse events are required to be documented.”

Dr. Gerald Evans, chair of the Division of Infectious Diseases at Queen’s University, says it's “patently false” for people against COVID vaccines to use one graph in one document, as proof positive, the vaccine isn’t safe.

“The 1,223 deaths were actually amongst approximately 10,000,000 vaccine recipients giving an overall mortality rate of 0.01 per cent or 1 in 10,000 persons,” Dr. Evans wrote to CTV News in an email.

“Most were deaths from other causes occurring in persons who happened to have been vaccinated and were not caused by the vaccine itself,” says Dr. Evans.

“Data is power,” says Essex County pharmacist Tim Brady, but only when it’s taken with a grain of salt.

“Twelve hundred doesn’t mean they’re 12 hundred deaths related to the vaccine. It means that there was 12 hundred people that died over these millions of people that had the shot, that had the vaccine, that we have to consider, could it be a possibility (the vaccine caused their death)?” says Brady.

The report includes an appendix that lists all the adverse events, detailed in medical jargon over nine pages.

“The fact is, I find it reassuring that they have nine pages, that they’re documenting every possible side effect which is what we need to do,” says Brady.

He also notes the adverse effects included everything from fatigue to fibromyalgia.

“Any adverse effect from a vaccine is not something we want to see,” says Brady. “I’m highly confident that the vaccine saved more lives.”

Here’s more about adverse events, specifically.


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