How Pfizer COVID Vaccines Failed To Meet India’s Safety Standards

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In Brief

  • The Facts:
    • Pfizer has withdrawn its application for emergency-use authorization of its COVID-19 vaccine in India.

    • This comes after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.

    • India also raised concerns about vaccine injuries that are currently under investigation in other countries.

  • Reflect On:
    • When there are countries saying no to the Pfizer COVID vaccine why have we been made to believe that the science is clear and no debate is needed on how safe and effective they are?

    • Why have we been made to believe that COVID vaccines are completely necessary? Why has discussion and evidence that calls this belief into question been censored?

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Last year, Pfizer has withdrew its application for emergency-use authorisation of its COVID-19 vaccine in India. The company failed to meet India’s demand for a local safety and immunogenicity study. Furthermore, India’s Central Drugs Standard Control Organisation has stated concerns of side effects resulting from the vaccine abroad.

As of today, vaccine injury reports have been a common theme throughout this pandemic. By Oct 15, 2021, adverse events reported worldwide passed 2,344,240 for COVID vaccines in the World Health Organization (WHO) reporting system VigiAccess. These include serious adverse reactions like deaths, permanent disabilities, hospitalizations and emergency room visits to very mild reactions as well. Approximately 50 percent of vaccine injuries reported to VAERS in the last 30 years are all from COVID vaccines. Documents released in November show Pfizer was aware of over 50K serious COVID vaccine reactions within months of distribution.

India’s decision meant that the shot would not be available for sale in one of the most populous countries. India is running their immunisation campaign using other products. The studies used to approve the Pfizer shot in other countries, like the United States and Germany for example, were not enough for India’s drug regulatory agency.

Pfizer said in a statement to Reuters approximately one year ago.

Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time.

The Indian Government declined to meet Pfizer and Moderna’s requests for legal protection over any side-effects from the use of their shots. Pfizer and Moderna trying to gain freedom from legal liability in India was no surprise. What is surprising is that the Indian government denied this request when vaccine manufacturers are already liability free in multiple countries like the US & Canada.

Indemnifying vaccine makers from liability has been a common theme throughout this pandemic. It allows manufacturers to get their products on the market faster, but it’s also a troublesome thought that there is no legal incentive for these companies to create safe vaccines and really vet their products.

In 1986 The National Childhood Vaccine Injury Act was created in the United States.

The VICP was established after lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates.

Health Resources & Services Administration

This act, like the one recently established in Canada, also protects manufacturers from liability regarding adverse reactions and serious adverse reactions like death. It also uses taxpayer money to pay victims.

The VICP has paid out more than $4 billion dollars due to vaccine injuries. Since 2015, the program has paid out an average total of $216 million divided by around 615 claimants each year.

Those injured by COVID vaccines, however, are not eligible to go through the VICP because the shots are being rolled out under emergency use authorization. As long as vaccines are approved for emergency use in the United States, those injured by them have nowhere to turn.

Nobody can be held accountable, neither the pharmaceutical companies nor the government.

This does not mean that the vaccines being used in India are more safe and effective. The potential consequences and lack of effectiveness are, at least, clearly outlined by the Indian government. It’s called the Bharat Biotech COVID-19 Vaccine, and you can learn more about it here if interested. They also recently approved a single dose vaccine.

As far at those who remain unjabbed, they do so due to a variety of reasons. Vaccine injury concerns, their low chances of death and hospitalization from COVID, and if they don’t have multiple underlying health conditions (given the fact that an overwhelming majority of people who have died with COVID also have an average of four other causes listed on their death certificate). Another big one would be that they want to reap the benefits of natural immunity.

Furthermore, COVID innoculations have failed to stop the transmission of the virus itself.

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