Tuesday, November 2, 2021

DCGI may await UK nod for AstraZeneca’s Covid shot before approving SII vaccine


New Delhi | Mumbai: India’s drug regulatory body has started reviewing the application of Serum Institute of India (SII) seeking emergency use authorisation for its Covid jab but officials say it could wait for the UK regulator’s nod for the AstraZeneca vaccine before giving approval.

SII on Sunday had applied for emergency use approval of Covishield, its potential vaccine against Covid-19. The SII vaccine has been developed by using the master seed of the AstraZeneca vaccine and the Pune-based vaccine maker is using the UK company’s technology.

“We have started reviewing the application and the matter will soon be referred to the Subject Expert Committee (SEC) which consists of senior doctors and specialists of various government hospitals. The SEC will give its recommendations to the drug regulator based on which the decision will be taken,” said a senior government official.

Officials said both the Pfizer and the SII emergency use applications are being reviewed on an accelerated basis. But as the trials for Serum’s Covishield are still ongoing in India, the absence of approval from the UK regulator for the AstraZeneca shot might prove a hurdle.

“The approval from the UK regulator is of utmost importance. Once that happens only then there will be confidence. Otherwise there is no benchmark as of now. The trials in India are still ongoing,” said another official.

SII officials told ET that the company is confident that it will receive an EUA by the end of December. “The efficacy data looks promising for Covishield,” said one executive.

“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first made-in-India vaccine, COVISHIELD. This will save countless lives…,” said SII CEO Adar Poonawalla in a tweet on Monday.

Prime minister Narendra Modi had last Friday at an all-party meet said going by expert opinion, the first vaccine should be available in the country in a few weeks.

Last month, AstraZeneca and Oxford released interim data that showed their jab was 90% effective when given in a 30-day half dose followed by full dose regimen and 62% effective when given in a 30-day full dose followed by full dose course. The release of the data was followed by confusion and controversy about whether the half dose was administered by accident or design. The company has subsequently said it is doing another trial for the initial half dose followed by full dose course. A 50% efficacy is considered to be the threshold for a successful vaccine.

The UK government formally asked the country’s drug regulator to assess the safety of AstraZeneca shot in the last week of November.

SII’s ongoing phase 3 trials seek to look at a head-to-head comparison of Covishield with the Astra Zeneca vaccine and a placebo. The trial will determine if it is as effective as the AstraZeneca vaccine.

“Covishield is an identical vaccine to the Oxford-AstraZeneca vaccine,” said SII in a statement to ET.

The Pune-based company has already stockpiled 40 million jabs and has said it will be ready to roll out 100 million doses by December-end, with the capacity to ramp up production to 400 million doses by March-April. This vaccine can be stored in a normal fridge.

Pfizer had submitted its emergency use authorisation application last week. The company has got approval from the UK regulator for emergency use, but it has not conducted any clinical trials in India. The authorities will examine if it needs to undergo bridging studies in the Indian population. Keeping in view the emergency situation, the company stands a chance to get an approval without undertaking trials, an official had told ET.





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