Govt Approves Foreign Vaccines: On What Conditions? Why the Delay?

The Centre has invited vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others, amid a COVID surge.

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Amid rising number of COVID-19 cases in India, the Centre said on Tuesday, 13 April, said that it was fast-tracking Emergency Use Approvals (EUA) for foreign-produced COVID-19 vaccines that have been granted EUA in other countries. This is being done in order to expand the collection of vaccines available for the vaccination drive in the country.

The move comes amid a surge in COVID-19 cases in India, as well as reports of shortage of vaccines from various states.

WHICH VACCINES WILL BE APPROVED WITH THIS MOVE?

All the vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and those that have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or the ones are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India.

ON WHAT CONDITIONS WILL THE VACCINES BE APPROVED?

While giving approval, the government has mandated the requirement of post-approval ‘parallel bridging clinical trial’ rather than a ‘local clinical trial’ as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.

A bridging clinical trial refers to a trial on a smaller local population, of a product manufactured and tested in a foreign country and its population.

With the new notification, the government has mandated a ‘parallel’ bridging trial in which the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.

WHAT WERE THE HURDLES IN APPROVING FOREIGN VACCINES BEFORE?

The Subject Experts Committee (SEC) advises the apex drug regulator, Drug Controller General of India (DCGI), on applications seeking approvals for new drugs, vaccines and clinical trials. The DCGI heads the Central Drugs Standard Control Organisation (CDSCO), the health ministry body that regulates the quality of drugs and vaccines in India.

The DGCI had so far refused to give approvals to any foreign vaccines without conducting bridging clinical trials.

The body in February had rejected the application for emergency use by Pfizer, as the company was not keen on conducting bridging trials in India. Pfizer had then withdrawn its application.

For the same reason, the regulatory body had also turned down Dr Reddy Laboratory’s request for approving Olokizumab, which is manufactured by Russian drugmaker R-Pharm to treat rheumatoid arthritis drug and, which the company is now trying to repurpose for COVID-19.

A request by Natco Pharma, which sought emergency use of Baricitinib tablets for COVID-19, was also rejected by the government.

WHEN AND WHY WAS THE DECISION TAKEN?

The decision to expand the vaccines’ availability in India was taken by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), which met on 11 April.

Addressing a press conference on Tuesday, VK Paul, chairman of the National Expert Committee on Vaccine Administration, said:

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson and Johnson and others... to be ready to come to India as early as possible.”

Vaccination is one of the critical pillars of COVID control and management strategy adopted by the Centre, a press release by the central government said.

The development was announced the same day as the news that the Drugs Controller General of India (DCGI) had approved the Russian COVID-19 vaccine Sputnik V for emergency use in India.

Cleared for roll-out in India, Sputnik V, thus, becomes the third vaccine for use in the country’s mass vaccination programme.

Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin are the other two vaccines in use in India.

Earlier, reports had suggested that in addition to Covishield and Covaxin, India could have five more vaccines by the end of the third quarter of 2021.

Apart from Sputnik V, these are the Johnson & Johnson vaccine (in collaboration with Biological E), the Novavax vaccine (in collaboration with Serum India), Zydus Cadila's vaccine, and Bharat Biotech's Intranasal Vaccine, a source had told news agency ANI.

(With inputs from ANI.)