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Pfizer vaccine on the cusp of securing Indian approval, CEO says

The alleged involvement of Pfizer in the patent battle has led to scrutiny. Image credit: Roman Tiraspolsky / 123rf. Pfizer vaccine concept.
 Image credit: Roman Tiraspolsky / 123rf

The Pfizer vaccine against COVID-19 is on the verge of securing approval for use in India. This is according to the drugmaker’s chief executive officer Albert Bourla who, speaking at a virtual event, said they were in the “final stages” of receiving the nod and said “I hope very soon we will finalise an agreement with the government.”

Presently, three COVID-19 vaccines are approved for use in India. They are the indigenously-manufactured Covaxin, manufactured by Bharat Biotech; Covishield, the AstraZeneca vaccine which is manufactured in India by the Serum Institute of India; and Sputnik-V, developed by the Gamaleya Research Institute of Epidemiology and Microbiology based in Russia. 

The Pfizer vaccine, made in collaboration with the German firm BioNTech, boasts an efficacy rate of more than ninety percent. While there is to be a warning label attached to it by the US Food and Drug Administration over the possibility of heart inflammation among young adults, it is considered largely safe and uptake is encouraged. Other side effects include swelling of the skin, though such effects are rare. 

Pfizer world headquarters in New York City, USA. Pfizer is one of two COVID vaccine candidate manufacturers to request emergency use authorisation in India. Image credit: Jim.henderson, Public domain, via Wikimedia Commons.
Pfizer world headquarters in New York City, USA. Image credit: Jim.henderson, Public domain, via Wikimedia Commons

The Pfizer vaccine is one of two vaccines currently under consideration for approval in India according to Niti Aayog member Dr Vinod K. Paul, the other being the vaccine manufactured by Moderna. Pfizer has expressed willingness to provide five crore doses of its vaccine to India between July and October, whilst also seeking indemnification should any legal claims arise from adverse effects. No such indemnification has been granted to any other vaccine manufacturer by India.

The country recently hit a milestone of administering more than eight million COVID-19 vaccine doses in a single day, hailed by Prime Minister Narendra Modi as “gladdening.” However, concerns remain over the pace of the vaccine rollout. Reuters reported that “India’s vaccinations over the next few weeks could fall short of the blistering pace set on the first day of a federal campaign, unless it makes inroads in a vast hinterland and bridges a shortage of doses, experts said on Tuesday.” 

Clearing the way for Pfizer and other international drugmakers to enter the Indian market has been the decision of the Drug Controller General of India to waive the requirement for specific clinical trials in-country for vaccines already approved by certain international regulators. These include the US Food and Drug Administration, the European Medicines Agency, the United Kingdom Medicines and Healthcare products Regulatory Agency, and Japan’s Pharmaceuticals and Medical Devices Agency, as well as vaccines listed for emergency use by the World Health Organization. 

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