Expert panel approves Serum Institute's Covid-19 vaccine for emergency use

An Indian regulatory expert panel on Friday recommended emergency use authorization of the AstraZeneca-Oxford vaccine against Covid-19 – manufactured by Serum Institute in India - clearing the decks for an unprecedented campaign aimed at vaccinating 30 crore people in the next few months.

Sources said the approval for the first Indian Covid-19 vaccine came from the Central Drug Standards and Control Organisation’s subject expert committee after lengthy presentation by the company officials and detailed deliberations on the data they shared with the experts.

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While the panel recommended granting of the emergency use authorisation license to the Oxford-AstraZeneca vaccine, the final decision would be taken by the Drugs Controller General of India on the basis of the SEC report, said a health ministry official.

Despite repeated requests, ministry officials did not share any details on the outcome of the SEC meeting.

“The green flag has been raised for vaccination against Covid-19 in India. It is a welcome development, as the vaccine can protect vulnerable persons, like the aged and those with comorbidities, from severe illness and shield persons providing essential services from becoming ill and being required to isolate themselves," K Srinath Reddy, president, Public Health Foundation of India told DH.

"It will help reduce deaths, ease pressure on hospitals and avoid disruption of essential services. While we now have to see how smoothly the rollout happens, adequate planning and preparations appear to have been made. Even as the programme rolls out, we need to ensure that public health measures and personal precautions must continue to prevent person to person spread and super spreader events.”

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The CDSCO panel also heard a presentation from Bharat Biotech, Hyderabad on the homegrown Covid-19 vaccine but didn’t take a decision.

It asked the Hyderabad-based company to expedite volunteer recruitment and recommended interim efficacy analysis for its vaccine. The Bharat Biotech phase-3 trial to demonstrate the vaccine’s efficacy is halfway through with the firm recruiting 13,000 volunteers out of 26,000 such persons it plans to recruit for the trial.

The Serum Institute, on the other hand, did a phase-2/3 clinical trial on 1,600 persons to prove the safety and immunogenicity. There was no need for an efficacy evaluation for which the data considered by the UK regulatory authority for the Oxford-Astra vaccine, was perused by the Indian experts.

But there is no clarity at the moment on what the gap between the two shots would be – whether the two shots will be administered four weeks apart as per the protocol or three months apart as decided by the UK government. There is also no clarity on the dosing schedule.

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The regulatory approval comes a day before a dry run of the vaccination process all over the country. Since the approval has been accorded only for emergency use, additional emphasis would be given to check adverse effects during the vaccination campaign.

Union Health Minister Harsh Vardhan on Friday chaired a high-level meeting to review the preparedness for the pan-India dry run. Senior officials of the health ministry apprised the minister on the improvements that have been made to make the exercise glitch-free.