More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755

More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755

Dear Colleagues!  This is Asrar Qureshi’s Blog Post #755 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 asrar@asrarqureshi.com for publishing your contributions here.

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An excerpt from a study published on 5th January 2023 in BMC Infectious Diseases Journal. The study was conducted in the Palestinian territory. 

[Quote] Approximately one-third of participants reported no adverse effects after receiving the first, second, or third dose of the Pfizer vaccine, with 34%, 33.6%, and 32.5%, respectively. Participants who received more than one dose experienced more side effects. The most commonly reported adverse effects were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions following vaccination, such as allergic skin reactions (itching, burning, and rash), angioedema, shortness of breath, coughing, and significant swelling of the tongue or lips, were reported by 144 (12.7%) participants (Fig. 2). Rare and severe side effects that require medical attention were reported by eight participants, including one (0.1%) case of myocarditis and 7 (0.6%) cases of thrombocytopenia. [Unquote]

DISCUSSION

The list of side effects is long and serious. Having said that, there are arguments that COVID-19 vaccine safety profile still deserves serious consideration for use to protect against COVID infections.

First argument is about the extent of use. Pfizer-BioNTech, Moderna, AstraZeneca, and J&J vaccines which are based on mRNA technology have been administered in billions of doses, Pfizer leading by a wide margin. The sheer size of the population who have received it is staggering. Most of these patients are in the developed countries where adverse events system reporting is in place and working. The number of adverse events is comparatively small to the extent of use. As is said in the pharmaceutical terminology, which is used by Pfizer also, ‘This cumulative case review does not raise new safety issues. Surveillance will continue’ and ‘The risk-benefit ratio favors the use of vaccine’. 

Second argument is that all new drugs carry a very long list of side effects, many of which are very serious. This is a trend that is increasing. USFDA, EMA, and other leading regulatory agencies deal with it by putting on warnings on the label and pack. Extremely serious side effects get a ‘Blackbox’ warning on the pack It looks like that safety profile has taken backseat while efficacy is riding on the front seat. Even targeted therapies carry huge number of adverse events, though these were expected to target the diseased cells while sparing the other body organs and systems. Pfizer vaccine is no exception. 

COVID19 vaccines were developed in haste. It takes almost ten years for a product to reach the market commercially. COVID vaccines were launched between 6-12 months of the onset of COVID pandemic. It is a great achievement, and some compromises might have been made. However, vaccines did save lives against waves of original and variant viruses. ‘The risk-benefit ratio favors the use’. 

Third argument is that the causal relation between adverse events and covid vaccines is not established for most of the events. Some of the adverse events might have been caused by the COVID19 itself because it was also an unknown infection and not much was understood about it. Where a cause and effect relation was established, an appropriate warning was issued. For example, in case of AstraZeneca vaccine Vaxzevria, 28 cases of blood clotting were reported in Canada which pointed to a direct relationship with the drug. J&J vaccine has also been implicated with causing blood clotting. Both have been asked to put warning labels. Pfizer vaccine has so far not been associated with any such serious adverse event.

Fourth argument is about whether Pfizer deliberately concealed information about adverse events. Experts say that it will require a more nuanced look at the heap of documents released by USFDA to make an educated comment on it. It will take months, probably couple of years before a full understanding is developed. Meanwhile, it is business as usual for Pfizer. 

It is true that COVID19 has been the greatest windfall for Pfizer and other manufacturers of COVID vaccines. It is also true that these companies have used it to their fullest advantage. They have charged exorbitant prices, made shipments as per their schedule, and refused to supply to poorer countries. In Latin America, Pfizer asked for additional indemnity against civil lawsuits that citizens might file in relation to problems caused by their COVID vaccine. The most brazen act was that Pfizer asked governments in Argentina and Brazil to put up sovereign assets, including military bases and federal bank reserves, as collateral for potential future legal costs. It is pertinent to mention that the vaccine manufacturers already enjoy indemnity against lawsuits for injury caused by vaccines in the US and Europe.

Pfizer also demanded from Argentina, Brazil, and another Latin America country to provide liability protection not only against civil claims from citizens who suffer serious adverse events after being vaccinated, but also for cases brought due to Pfizer’s own negligence, fraud, or malice. As a result of these demands, neither Argentina nor Brazil signed vaccine supply deal with Pfizer. Brazil had the third highest number of COVID cases worldwide and the second largest number of deaths in the world. Access to safe and effective vaccines might have been a key factor in stemming the tide of the pandemic, but did not happen.

Pfizer said, “Globally, we have also allocated doses to low- and lower-middle income countries at a not-for-profit price… we are committed to supporting efforts aimed at providing developing countries with the same access to vaccines as the rest of the world.”

On the ground however, richer countries were criticized for inequitably hoarding available COVID vaccine doses at the expense of poorer developing countries. WHO Director General Dr. Tedros Adhanom Ghebreyesus declared the world to be on the brink of a catastrophic moral failure.

The world failed miserably on account of morality during COVID19 pandemic, and the fall continues unabated. Whatever semblance of sanity and decency had been there, has been lost to insatiable greed of the few.

Concluded.

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https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07974-3 

https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf 

https://www.ctvnews.ca/health/coronavirus/what-is-an-adverse-event-inside-the-recently-released-report-on-pfizer-s-covid-19-vaccine-1.5812411 

https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/