Pfizer says its vaccine effective on COVID mutant, suitable for 12+

American pharma major Pfizer has told the Centre that its COVID-19 vaccine has shown “high effectiveness” against the variant which is supposed to have triggered a second wave of infections in the country.

Pfizer has said that it would roll out five crore doses of the vaccine by the year-end, informing that the shots are suitable for everyone over 12 years and can be stored for a month between two and eight degrees Celsius.

The company has requested for indemnification from the Centre to enable supply of the vaccine to India. A series of meetings have been held in this regard over the past week.

The vaccinemaker has also sought regulatory relaxations including relaxation in the requirement of post-approval bridging trials while also doing away with the mandate of testing the vaccine in the Central Drugs Laboratory.

“The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too,” PTI quoted the company as saying to the government.

Pfizer, according to sources, has also told the Centre that it should rely on 44 authorisations including WHO approval to give a nod to the vaccine instead of seeking a Post Approval Commitment study.

The company, however, is willing to consider the safety surveillance of the first 100 subjects after understanding the process to be followed. These discussions which were also attended by Pfizer Chairman and CEO Albert Bourla, had three key issues – procurement through a central government pathway, indemnity and liability, and the regulatory requirement for post-approval bridging studies.

India is currently using three vaccines – Covishield, manufactured by Serum Institute of India and Bharat Biotech’s Covaxin and Russian jab Sputnik. So far, a cumulative number of 20.25 crore vaccine doses have been administered across the country, the Union health ministry said on Wednesday.

It said 8,31,500 beneficiaries in the 18-44 age group received the first dose of COVID vaccine on Wednesday and cumulatively 1,38,62,428 people across 37 states and union territories have received it since the start of Phase-3 of the vaccination drive on May 1.

(With inputs from agencies)