Centre waives 'bridging trials' to allow foreign vaccines for emergency use

Express News Service
NEW DELHI: The Centre has now decided to exempt foreign Covid vaccine makers from bridging trials in India completely, after announcing last month that the first 100 beneficiaries of foreign vaccines will be assessed for seven days for safety outcomes before the vaccine is incorporated in the immunization drive.

The development comes in the backdrop of negotiation between the government and Pfizer over the import of its Covid vaccine in India, which is likely to begin from July.  

VK Paul, member (health) Niti Aayog and chairman of the national expert group on vaccine administration for Covid said in a press conference on Wednesday that Pfizer has indicated the availability of its Covid vaccine for India while other terms of the agreement are under discussion.

The company, he said, had sought indemnification from cost of compensation about which a final decision is yet to be taken.

“Pfizer has indicated a certain volume of vaccine availability, possibly starting from July..looking at what their expectations are from us, and what we are our expectations from them,” said Paul in a press briefing by the Union health ministry on Covid status in India.

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“They have requested indemnity from all nations, it’s their condition. We are examining this request. There is no decision as of now,” he added.

A document released by Niti Aayog, in order to Prepa issue a detailed clarification on the narratives that that the government is not doing enough to ensure a ramped and quick supply of covid vaccines, meanwhile, said that the Centre has “proactively” eased entry of vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s emergency use listing into India in April. 

“These vaccines will not need to undergo prior bridging trials,” said the statement. “The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.”

On April 13, in a statement on fast tracking emergency approvals for foreign produced vaccines, the government had on the other hand said that the permissions would be granted, “mandating the requirement of post-approval parallel bridging clinical trials in place of conduct of local clinical trials.”

“Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country,” it had said.

Officials in the health ministry said that in December, 2020 when Pfizer had first applied for the emergency approval, it had insisted on doing away with the bridging trial completely—a demand that had been turned down completely.

“As of now, however this vaccine has been used in several countries and there is real world data on its safety and efficacy, therefore we are okay to immediately launch the vaccine in the country’s Covid vaccination drive upon import,” said a top official.