The Early Danger Signs of Pfizer’s COVID-19 Vaccine

After having been sued by the group Public Health and Medical Professionals for Transparency, we now have a complete picture of the adverse events connected to the early days of the rollout of Pfizer's BNT162b2 COVID-19 vaccine now known as Comirnaty.  This document was released under a Freedom of Information request against the Food and Drug Administration, the U.S. government body responsible for approving Pfizer's COVID-19 vaccine.

Let's open with this screen capture showing the first three pages of the civil action taken by Public Health and Medical Professionals for Transparency (PHMPT) which was filed on September 16, 2021:

 

As background, PHMPT is a non-profit organization headquartered in Fort Worth, Texas.  It consists of "…public health professionals, medical professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. The organization takes 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."

The suit was filed by PHMPT because the FDA originally denied PHMPT's Freedom of Information Act request for the documentation on the data behind the FDA's conclusion that the Pfizer vaccine was safe and effective because PHMPT did "not demonstrate a compelling need that involves an imminent threat to the life or physical safety of an individual” or “that there exists an urgency to inform the public concerning actual or alleged Federal Government activity".  We'll let the documents tell us whether that is actually true.

Now, let's look at one of the key documents, Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021 which looks at data from the first two and a half months after the vaccine received Emergency Use Authorization from the Food and Drug Administration.  

Here is the lead page of Pfizer's document which was submitted to the FDA as part of its approval process for BNT162b2:

 

The time period covered by this analysis includes data from the United States and foreign nations in the post-authorization period reported through to February 28, 2021, in other words, the very early days of the vaccine rollout which began around December 1, 2020.  The vast majority of adverse events were reported from the United States and most involved women (29,914 vs. 9,182 for men) and those between the ages of 31 and 50 years old.  

Let's look at some of the key sections noting that Pfizer states that the reports are submitted voluntarily and that the magnitude of underreporting is unknown (see page 5).  The report also notes the following with my bolds:

"Due to the large numbers of spontaneous adverse event reports received for the product, the MAH (marketing authorization holder – BioNTech) has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity. The increased volume of reports has not impacted case processing for serious reports, and compliance metrics continue to be monitored weekly with prompt action taken as needed to maintain compliance with expedited reporting obligations. Non-serious cases are entered into the safety database no later than 4 calendar days from receipt. Entrance into the database includes the coding of all adverse events; this allow for a manual review of events being received but may not include immediate case processing to completion. Non-serious cases are processed as soon as possible and no later than 90 days from receipt. Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues."

Even Pfizer is admitting that there were a large number of adverse events reported which meant that they had to prioritize the most serious cases with the less serious cases taking up to 90 days to be processed and added to the adverse event database.

Note that I have provided you with the page numbers from the report should you care to look the facts up for yourself.

1.) General Adverse Event Data (pages 6, 7 and 8): 

 

Here is Figure 1 as referred to above:

Here is a table showing the selected characteristics of all cases during the reporting interval:

Note that according to Pfizer's own data, there were already 1223 deaths attributed to the administration of their COVID-19 vaccine with 11,361 individuals having not recovered by the end of February 28, 2021 and 520 still experiencing adverse symptoms well after administration of the vaccine (sequelae).

2.) Anaphylaxis (page 10):

3.) Use in pregnancy and lactation  (page 12):

 

It is important to remember that the vaccine was not approved for pregnant or nursing women at that point in time.

4.) Vaccine Effectiveness (page 13 and 14):

a.) Defining Vaccine Failure and Drug Ineffectiveness:

 

b.) Drug ineffective cases noting that according to the RSI, individuals may not be fully protected until 7 days after their second dose of vaccine:

5.) Cardiovascular Adverse Events of Special Interest (page 16):

Of these events, 136 were fatal, 767 were resolved or resolving, 21 were resolved with sequelae and 140 were not resolved  (380 unknown).

6.) Facial Paralysis (page 19):

As an aside, throughout the document these sentences appear frequently as part of Pfizer's conclusions:

"This cumulative case review does not raise new safety issues. Surveillance will continue."

Apparently even the deaths of over 1200 "customers" associated with the administration of its vaccine isn't of any particular concern to Pfizer and most definitely should not be a reason to withdraw its COVID-19 vaccine from the market even though this has happened:

I believe that is enough information to digest.  If you wish to further investigate other adverse events, I would suggest that you peruse the document for yourself as found at this link.

Let's close with this summary from Pfizer's report:

"The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine."

In other words, nothing to see here FDA, just move along.  

Full speed ahead.  I guess that killing people is no longer sufficient grounds for removing a pharmaceutical from the marketplace which shows us just how corrupt the FDA's approval process has become.

There is one thing that we can be certain of in the post-truth COVID-19 era; Pfizer's vaccine is most assuredly providing a favourable benefit to Pfizer's and BioNTech's profitability, deaths and serious adverse events be damned.  

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