India gives more waivers to foreign vaccine companies

This new waiver can open the doors to the Chinese Sinovac Covid-19 vaccine

Saddled with a Covid-19 vaccine shortage, the Centre has waived the legal requirement of “post-approval bridging trials” and “batch testing” for foreign vaccine manufacturers like Pfizer and Moderna if the vaccine batches have been certified by the National Control Laboratory of the Country of Origin.

The Central Drug Standards Control Organisation (CDSCO) on Tuesday issued a notice waiving such regulatory requirements for the vaccines that have been approved for restricted use by the regulatory authorities of the USA, UK, European Union and Japan as well as by the World Health Organisation.

Read | Covid-19 vaccines: Pfizer, Moderna closer to indemnity

This is one of the two key demands of Pfizer, which is in talks with the Centre for the supply of 5 crore doses between July and October. The pharmaceutical giant has also sought a legal indemnity.

Asked for details about Pfizer’s proposal, a company spokesperson told DH: “Pfizer continues to remain engaged with the Government of India towards making its Covid-19 vaccine available for use in the government immunisation programme in the country. As these discussions are ongoing, we are unable to share any additional details at this time.”

Besides Pfizer, other vaccine manufacturers to be benefitting from the decision are Moderna and Johnson and Johnson.

Moreover, since the CDSCO waiver applies to the vaccines picked up by the WHO for its emergency use list, the waiver can open up the doors for the Chinese Sinovac Covid-19 vaccine that received the WHO approval on June 1.

The two-dose of the Chinese vaccine, recommended for use in the 18 years and older population, prevented symptomatic disease in 51% of those vaccinated and halted severe Covid-19 and hospitalisation in 100% of the studied population, the world health body said in a release.

The decision to grant the exemption was taken in light of the huge vaccination requirements in India in the wake of the recent surge of Covid-19 cases and the need for increased availability of imported vaccines to meet the national requirements, V G Somani, Drugs Controller General (India) wrote in the notice.

However, the safety assessment on the first 100 beneficiaries for seven days and scrutiny of the “summary lot protocol and certificate of analysis of batch” would be carried out before the foreign vaccines are rolled out in the Indian market, he said.