Pfizer bails out of India after country demands safety testing for COVID vaccine
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INDIA, February 10, 2021 (LifeSiteNews) – US-based COVID-19 vaccine maker Pfizer has withdrawn its application for emergency-use authorization of its product in India after the country’s health authorities demanded local safety testing.
India’s drug regulator last weekdeclined Pfizer’s request that its experimental COVID-19 mRNA vaccine “BioNTech” (BNT162b) be approved without a local trial of the product’s safety on the country’s population.
The country’s Central Drugs Standard Control Organisation formed a Subject Expert Committee that met on Feb. 3 to discuss Pfizer’s proposal for the emergency use authorization of its COVID-19 experimental vaccine.
“The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated,” the committee reported.
“Further, the firm [Pfizer] has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” the committee added.
Pfizer in turn withdrew its application.
“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 company stated, as reported by Reuters.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”
India’s concerns about the safety of Pfizer’s mRNA gene-altering technology are not misplaced.
Data from the US-based National Vaccine Information Center shows that as of Jan. 29, there have been 501 deaths — a subset of 11,249 total adverse events — following COVID-19 vaccinations. Pfizer’s vaccine was taken by 59 percent of those who died while Moderna’s vaccine was taken by 41 percent.
The Norwegian Medicines Agency reported on Jan. 14 that twenty-three people died within days of receiving the first dose of Pfizer’s product.
California officials are investigating the Jan. 7 death of a 60-year-old healthcare worker who died four days after receiving his second injection of Pfizer’s product. A reportedly “perfectly healthy” 56-year-old Miami obstetrician died 16 days after receiving the Pfizer shot. State along with federal officials are investigating the Jan. 30 death of a 58-year-old Virginia woman who died hours after receiving the first dose of Pfizer’s vaccine.
America’s Frontline Doctors are urging the Biden administration to take note of India’s decision to deny Pfizer’s application based on a lack of safety.
“President Biden and his COVID-19 task force need to immediately and clearly explain to the American people why the Pfizer-BioNTech experimental vaccine is safe for Americans despite Indian drug regulators denying its emergency use based on concerns about potential side effects, immunogenicity, and other data,” the doctors’ group stated.
“The burden of proof should fall on the Biden White House to provide Americans with greater transparency and information so that they can make informed decisions about their own healthcare. Science should guide this administration’s COVID response plan not public relations, polls, and politics.”
While India has rejected Pfizer’s vaccine, it has approved the use of Oxford University’s AstraZeneca vaccine and another one developed on home soil by Bharat Biotech with the Indian Council of Medical Research, reports Reuters.
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