India fast-tracks emergency use of foreign-made Covid-19 vaccines

No need for prior local clinical trials for vaccines cleared by regulators

In a significant move, the Union government on Tuesday allowed emergency use of foreign Covid-19 vaccines through a fast-track route, striking off the need for a prior local trial. In line with the recommendations of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), vaccines which have been developed and are being manufactured in foreign countries, with approval from health regulators in the US, UK, European Union and Japan, would now be permitted for emergency use in India. Those in the World Health Organisation (WHO) emergency use list will also be allowed.

Instead of prior local clinical trials, companies must do parallel clinical trials after vaccine enters the India market. Also, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before an expansion of the immunization programme, the health ministry said in a statement.

So far, Pfizer-BioNTech, Moderna and AstraZeneca’s vaccines have approvals from these agencies. In the case of Janssen, a Johnson and Johnson (J&J) arm, vaccine use was paused by the USFDA after incidents of blood clots were reported. 

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.’’    

On Tuesday, the Indian regulator also granted emergency use approval to Russia’s Sputnik V, a day after the expert panel gave its nod.

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As for US major Pfizer, the company had applied earlier and withdrawn the application after India’s drug regulator insisted on the need for local clinical trials as a pre-condition to enter the market.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.