Serum shot may get India nod before UK3 min read . Updated: 23 Dec 2020, 06:57 AM IST
- Regulator may approve vaccine if clinical data is satisfactory
The drug regulator may allow the emergency use of Serum Institute of India’s Covishield vaccine in the country without necessarily waiting for the vaccine’s approval in the UK where it was developed, said two senior government officials directly aware of the matter.
The Drug Controller General of India may clear the shot for use if clinical data furnished by Serum Institute is found to be satisfactory, the officials cited above said, seeking anonymity.
Also Read | How hunger came back to haunt India
“Serum Institute has submitted the additional data as sought by the subject expert committee in the last review (on 9 December) " said one of the officials.
Covishield is Serum Institute’s version of the vaccine being developed by Oxford University and British drugmaker AstraZeneca Plc. In the December meeting, the expert panel had asked Serum Institute to present the outcome of the assessment of the UK regulator for grant of emergency use licence.
This meant that the UK’s approval was thought to be key. The current request submitted by Serum Institute is based on clinical trials data from the UK and Brazil, but the firm is also conducting trials in India, the final results of which are expected to take some more time. “The review here is happening in parallel with the one in the UK. The same data that the UK regulator is reviewing we are also reviewing (along with Serum’s bridging study data)," said the person cited above.
Serum Institute submitted its revised data on the vaccine on Monday, and the expert panel will be considering the proposal, along with that from Pfizer, by the end of the month, the second official said. “We have to review the proposal to see if the evidence is satisfactory and then take a call," the second official said.
According to another person in the know, discussions between the government and Serum Institute are underway for procurement of Covishield doses, and that a decision on it could be formally announced as early as this week.
This would mark a major development as the expert panel’s last meeting on 9 December with Serum Institute in which it was asked for the outcome of the UK regulator’s assessment of Oxford-AstraZeneca’s application for an emergency licence.
A report in the Daily Telegraph on Friday said the UK is expected to authorize the vaccine by 28 or 29 December.
The expert committee also asked Serum Institute for updated safety data from its phase 2 and 3 bridging study of 1,600 participants in India, along with immunogenicity data from the clinical trials in the UK and India. This data was submitted to Drug Controller General of India V.G. Somani on Monday, the second official said.
US drugmaker Pfizer was also scheduled to make its presentation to the committee on 9 December for its vaccine, but sought more time as its officials were preparing for a meeting with the US Food and Drug Administration (FDA) the next day. The FDA panel approved Pfizer’s application that day, and the regulator granted the vaccine an emergency licence the following day.
In India, Pfizer has sought an emergency use licence for its messenger RNA vaccine through the accelerated approval process, along with permission for clinical trial waiver and import.
Serum Institute’s vaccine is crucial to the government’s immunization programme as it is expected to be available for as cheap as $3 per dose and can be stored at 2 to 8 degree Celsius, a refrigeration temperature used for most vaccines, unlike Pfizer’s that requires ultra-low temperatures for storage.
On Tuesday, government officials said the new covid strain found in the UK is unlikely to have an effect on vaccines that are in development. “As per our understanding today, it has no impact on the potential of the emerging vaccines that are being developed in our country and (those that) are available also in other countries," Niti Aayog member–health V.K. Paul said.
Never miss a story! Stay connected and informed with Mint. Download our App Now!!