The Free Press Journal

Govt explores option to import vax

Sputnik V, Pfizer, Moderna and Johnson and Johnson vaccines are under considerat­ion “

- SANJAY JOG sanjay.jog@fpj.co.in

The state government is keen to know whether Pfizer and Moderna have agreed to bridging or clinical trials and when they can be completed. - SENIOR BUREAUCRAT

Amidst the constraint­s in the procuremen­t of COVID19 vaccines from domestic producers, the Maharashtr­a government has been exploring the option of importing it to meet its requiremen­t. The government will soon initiate talks on the availabili­ty, price and the time schedule for the supply of vaccines from Sputnik, Johnson and Johnson, Pfizer and Moderna. It has, meanwhile, sought clarity from the central government on a couple of issues for the proposed import.

The state cabinet, chaired by Chief Minister Uddhav Thackeray, on Wednesday, extensivel­y discussed the option of importing vaccines from multiple suppliers. The Serum Institute of India (SII) and Bharat Biotech have indicated, due to their earlier commitment­s, they can not immediatel­y supply Covishield and Covaxin to vaccinate people in the age group of 18 to 44.

A senior bureaucrat, who was present at the cabinet meeting, told the Free Press Journal, “Russia's Sputnik V recently got an approval from the subject expert committee (SEC) for Emergency Use Authorisat­ion (EUA). Dr Reddy’s Laboratori­es and Russian Direct Investment Fund (RDIF) have initiated adaptive Phase II/III clinical trials for the Sputnik V vaccine in India. Dr Reddy’s Laboratori­es, that has the license to distribute the vaccine, on Tuesday, received India’s drugs controller’s approval for the import of the vaccine under restricted use in emergency situations. However, as per the present norms, if the vaccine is imported from Russia, then Dr Reddy’s Laboratori­es will have to make an equivalent supply back to Russia. The state government will like to know the procedure as to whether it will be treated as import or procuremen­t from the domestic market.’’

As far as the import of Pfizer and Moderna vaccines is concerned, the

Drug Controller General of India has insisted that each new vaccine that has completed the Phase 3 vaccine study outside the country must undergo the so-called bridging trials in India.

“The state government is keen to know whether Pfizer and Moderna have agreed to bridging or clinical trials and when they can be completed. Besides, there is an issue of cold chains, as these vaccines need more than minus 20 degree temperatur­e, which may not be possible to maintain in remote areas,” said the bureaucrat.

However, a senior officer from the Public Health Department said there was an unanimous view in the cabinet that, from the epidemiolo­gical point of view, the government should go in for multiple vaccines, as it will help curb the mutation.

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