Dear Colleagues!  This is Asrar Qureshi’s Blog Post #752 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to for publishing your contributions here.

When COVID19 started from Wuhan, China and rapidly gripped the world, the talk of vaccine started immediately. Pfizer-BioNTech vaccine took the lead in introducing its mRNA-based vaccine. It was closely followed by Moderna, and Johnson & Johnson. China and Russia also delivered their conventional vaccines. The vaccines were administered worldwide, despite the initial inequality when the developed nations kept most of the stock for their own population.

Some statistics are staggering.

  • 13.15 billion doses have been administered worldwide till 23 January 2023.
  • This translates into 162 doses for every 100 people worldwide
  • Cuba led the world with 369 doses administered to 100 people
  • The latest rate of administration was 7.07 million doses a day
  • In the US, 613 million doses were given, out of which over 369 million were Pfizer-BioNTech vaccine
  • The least wealthy 20.6% of the world population got only 9.5% of vaccines
  • Pfizer sold over $65 billion worth of Covid vaccine. It has the capacity to produce 4 billion doses in a year.
  • Pfizer also believes that the Covid vaccine sales shall continue beyond 2022
  • Moderna sold their vaccine for $18.4 billion in 2022
  • J&J sold their vaccine for $5 billion
  • China sold 1.26 billion doses to outside world, while they administered 2.2 billion doses to their own population. China has developed 35 Covid vaccines which are under trials in various centers
  • 753 million cases of Covid cases have been reported till January 30, 2023; 6.8 million deaths have occurred.
  • 573 new billionaires were created during the pandemic at the rate of one every 30 hours.
  • During 2022 alone, 263 million people were pushed into extreme poverty, at the rate of one every 33 hours.
  • Billionaires’ wealth rose more in the first 24 months of Covid 19 than in the 23 years combined. The total wealth of the world’s billionaires is now equivalent to 13.9 percent of global GDP. This is three-fold increase, up from 4.4 percent, in 2000.

Covid pandemic brought many changes in the world, most of which were undesirable. Conspiracy theories besides, the whole affair of pandemic is fraught with questions.

In these posts, we shall look at the case of Pfizer-BioNTech Covid vaccine, how it emerged, how it was approved, and the matter of undisclosed side effects.

Pfizer-BioNTech Covid-19 vaccine was the first to get Emergency Use Approval from the USFDA on December 11, 2020, for use in individuals 16 years and older. The authorization was expanded to include those 12 through 15 years of age om May 10, 2021.

On August 23, 2021, USFDA announced the first full approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older. (Later, the use was expanded to 5 years and older. Presently, it is being tried in 2 years and up).

Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

On September 16, 2021, a complaint was filed in a Texas court, by a group called PHMPT – Public Health and Medical Professionals for Transparency. PHMTP claims that it “exists for the sole purpose of disseminating to the public the date 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 read.

There are an estimated 450,000 pages of material about the vaccine. USFDA took the position that its department which handles FOIA related cases has only 10 employees and that they were already working on several such requests. Moreover, it had to redact personal information from thousands of pages. USFDA told the court that it could release 500 pages a month. At this rate, it would take 900 months, or 75 years, to release all documents. The FDA’s production schedule clashed with its promise of transparency.

The purpose of FOIA is government transparency. In the case of Pfizer-BioNTech vaccine, it is all the more necessary because Americans are required to receive a Covid-19 vaccine under the penalty of losing their job, or even more. Even more problematic is that, if injured, the people cannot sue Pfizer. There is virtually no other product where a consumer is prohibited from suing the company that manufactures, markets, and profits from the product.

“Decoupling a company’s profit interest from its interest in safety creates a moral hazard and departs from centuries of product liability doctrine. Thus, it is extraordinary that Americans must take this product under penalty of expulsion from work, school, the military and civil life, but they cannot sue Pfizer for any resulting injuries.

The federal government created this unprecedented situation. It granted the immunity, licensed the product, and aggressively sought mandates. This situation therefore warrants unprecedented transparency.” Bloomberg Law reported.

U.S. District Judge Mark T. Pittman, Northern District of Texas, did not agree with the 500-pages per month proposal of USFDA. He ordered the USFDA to produce at least 55,000 pages per month and make these available to scientific community for review. In his ruling, the judge recognized that the release of this data was of paramount public importance and should be one of the FDA’s highest priorities.


Disclaimer: Most pictures in these blogs are taken from Google Images and Pexels. Credit is given where known; some do not show copyright ownership. However, if a claim is lodged at any stage, we shall either mention the ownership clearly, or remove the picture with suitable regrets.

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