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Pfizer Makes Changes to Q4 Earnings after Judge Orders FDA Submit Docs Used for Vaccine EUA Approval

There are some very interesting developments in Pfizer's Q4 earnings report compared to their Q3 earnings report. The timing is also interesting. Before breaking those down, here is a quick review of what potentially led to the drastic changes.

A Freedom of Information Act (FOIA) was filed in September in a US District Court in Texas requesting to get the data relied upon by the FDA to license COVID-19 vaccines. The group who filed the FOIA was Public Health and Medical Professionals for Transparency (PHMPT). They stated that they took "no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses."

This was met with immediate resistance from the FDA, who claimed there were over 329,000 pages of data and that it would take them 55 years to go through and redact sensitive information.They claimed they could get about 500 pages a month out. PHMPT rightfully fired back at this offer stating it was "dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harm, but yet refuse to let Americans see the data underlying its licensure." The FDA came back before the judge could even rule and tried to claim their estimates were off and the agency actually needed 75 years to hand over the information.US Judge Mark Pittman wasn't having this and said the data "is of paramount public importance". He ruled that the FDA would have 108 days to hand the data over. That is the same amount of time it took them to go through it and approve the emergency use authorization of the vaccine. The FDA was not happy. They wanted 75 years and got 8 months. The first 55,000 documents are due to be handed over on March 1 and they are to turn over an additional 55,000 every month until October when it should be completed.

Pfizer also tried to make claims for why the data documents shouldn't be handed over as ruled upon. On January 26, lawyers for the Big Pharmaceutical Company claimed they wanted to intervene in the case. They claimed that while they support disclosing the data to the public, they wanted to make sure their "trade secrets" were not disclosed for the FOIA request.PHMPT didn't like this and said "Pfizer can render assistance without intervening." Basically they argued that Pfizer could help get the documents out without joining the case and trying to delay the release.

Fast forward to February 8 and Pfizer has made some important changes to their fourth quarter earnings release. When looking at the section regarding their business risk disclosures, there is significant change. One of the new risks that was added in this quarter was "further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection". This was not in the Q3 earnings release which came out around the time the FDA believed they could take 55 to 75 years to release the documents. It was added in the Q4 earnings release when they were ordered to get the documents out in eight months.After the ruling, Pfizer not only tried to get involved in the case but they told their investors there could be a potential risk in regards to further information about the quality of their data.

The above picture shows another difference in the earning reports. Everything in black remained the same as Q3 but the information in red was changed in Q4. Part of what was changed after the ruling was "challenges related to public confidence or awareness of our covid-19 Vaccine or Paxlovid, including challenges driven by misinformation, access, concerns about clinical data integrity and prescriber and pharmacy education". This is interesting that after they realized the data is going to come out they listed challenges like concerns about clinical data integrity to the list.

Another potentially significant admission to come out of the earnings report was a look into what Companies like Pfizer think and how they view things. One of the risks listed was "the risk that demand for any products may be reduced or no longer exist; the possibility that Covid-19 will diminish in severity or prevalence, or disappear entirely".This clearly states that an end to Covid is bad for Pfizer when that is what the rest of the world wants. In reality, people are waking up daily and understanding that Covid has been massively overblown and as the variants get less deadly and people start taking the proper PCR tests which don't produce so many false positives, this "pandemic" will go away. The data documents the FDA and Pfizer are so hesitant to release will likely aid in this as well.

Written by guest writer Chris Turner


Q4 Pfizer earnings release -

Q3 Pfizer earnings release -

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