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Pfizer seeking indemnity, fast track approval for its COVID-19 jab in India

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At a time when India is facing an acute shortage of vaccines amid the second wave of the pandemic, foreign vaccine makers are utilising the opportunity to make inroads in the Indian market while seeking significant regulatory relaxations, including indemnification. If the relaxation is provided, these companies will get protection from compensation claims in case of adverse events.

US-based pharma major Pfizer is one such company that is seeking such relaxations while claiming that its jab against COVID-19 is highly effective against the India-dominant variants of the virus. The vaccine major recently held meetings with government officials saying that its COVID-19 jab can be administered to anyone aged 12 and above, and can be stored for a month in cold storages at a temperature ranging between 2-8 degrees Celsius.

Fast track approval

Pfizer is also seeking fast track approval to roll out five crore doses between July and October, provided it receives the regulatory relaxations, including indemnity.

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A number of meetings have been held between the company and Indian authorities in the past few weeks to resolve issues. Pfizer has said India should “rely on the 44 authorisations, including WHO approval, facilitate an emergency use authorisation/restricted use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study”.

India’s COVID-19 vaccination drive

Despite the tall claims of the government, India’s vaccination drive is moving relatively slow if the country’s huge population is taken into consideration. India has so far approved three COVID-19 vaccines for emergency use— Covishield manufactured by AstraZeneca, Covaxin manufactured by Bharat Biotech and Sputnik V manufactured by Dr Reddy’s.

As these companies are unable to meet the domestic demand, many states have repeatedly requested the Centre to increase the supply of vaccines. However, due to a wide gap between the demand and the supply, many states have stopped vaccination for people in the 18-44 year age group so that people above 45, who have already taken their first dose, can be administered the second dose.

Meanwhile, the Union health ministry informed on Thursday that over 20.26 crore COVID-19 jabs have been administered so far. Of it, over 18.85 lakh people were vaccinated on Wednesday.

 

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