J&J had initiated talks with India to start clinical trials here. The company could not be reached for comment. The WHO list does not mention the Chinese vaccine from Sinovac.
Addressing the media, Niti Aayog
member and chairman of the vaccine expert group V K Paul said, “We hope and invite vaccine makers such as Pfizer, Moderna and Johnson & Johnson
and others to be ready to come to India as early as possible.’’
Preparing for the next stage of the inoculation drive, Pune-based Serum Institute has started stock-piling the Novavax vaccine, which is awaiting USFDA’s nod. In about a month’s time, Serum will have a stockpile of close to 20 million doses of the Novavax vaccine candidate. Adar Poonawalla, CEO of Serum Institute, said the company could manufacture only half of what was planned due to shortage of raw materials from the US. SII has also started clinical trials in India.
As for US major Pfizer, the company had applied earlier and withdrawn the application after India’s drug regulator insisted on the need for local clinical trials as a pre-condition to enter the market. A Pfizer
spokesperson said, “We have noted the recent announcement with regard to the regulatory pathway for global vaccines. We remain committed to continuing our engagement with the government towards making the Pfizer
and BioNTech vaccine available for use in the government’s immunization programme in the country.” In the case of the other American player Moderna, Indian Immunologicals and Wockhardt were in partnership talks to bring the vaccine to the Indian market. These talks could revive now, according to industry sources.
Health secretary Rajesh Bhushan said, “With the streamlining and fast-tracking of the regulatory system by doing away with the precondition for local clinical trials, the availability of foreign vaccines becomes that much faster.” He also added that this would eventually open up imports of drug substances and finished vaccines, as well as lead to fill-and-finish opportunities in India.
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