New Delhi: The Modi government has given the go-ahead to vaccine producer Serum Institute of India (SII) to manufacture and stockpile Covovax vaccine, ThePrint has learnt.
SII has already begun the production of the vaccine that is being developed in partnership with the US vaccine maker, Novavax.
SII has a tie-up with Novavax to manufacture and supply the vaccine in India and in low- and middle-income countries as part of the COVAX vaccine alliance countries.
“The government has given the nod to SII to start manufacturing Covovax. It will be buying the entire quantity that SII has started stockpiling,” an industry source privy to the developments told ThePrint.
The move is triggered by the severe shortage of vaccines that has put on halt the vaccination drive in several states in India. The Modi government is scrambling to find more options that could help in accelerating the country’s inoculation drive.
Three vaccines which are currently approved for use by the drug regulator, the Drug Controller General of India (DCGI) are Covishield, Covaxin, and Russia’s Sputnik V. The central government is also in talks with US pharma companies Pfizer and Moderna.
ThePrint reached the official spokesperson of SII and Rajesh Bhushan, secretary, Ministry of Health and Family Welfare, via text messages, for an official comment but did not receive any response till the time of publishing.
Covovax could hit markets by September
On 27 March, Adar Poonawalla, chief executive officer, SII had said he hopes to launch the Covovax vaccine by September.
“Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and SerumInstIndia. It has been tested against African and UK variants of COVID19 and has an overall efficacy of 89%. Hope to launch by September 2021!,” he had tweeted.
Covovax trials finally begin in India; the vaccine is made through a partnership with @Novavax and @SerumInstIndia. It has been tested against African and UK variants of #COVID19 and has an overall efficacy of 89%. Hope to launch by September 2021! https://t.co/GyV6AQZWdV
— Adar Poonawalla (@adarpoonawalla) March 27, 2021
Last Month, Poonawalla had also said that SII is considering applying for an expedited emergency licence for Covovax under the government’s revised norms if the vaccine’s developer Novavax secures authorisation from the US regulator.
“Once Novavax receives all the necessary global regulatory approvals, we can look at launching it (Covovax). That said, we would still want to continue with trials in India to ensure its immunogenicity and efficacy,” he was quoted as saying.
Once the American drug regulator, USFDA gives authorisation to Novavax, SII can immediately apply for the emergency use authorisation (EUA) in India.
According to the latest norms by the central government, a foreign vaccine with authorisation from USFDA or other other top regulators would be eligible for expedited authorisation in India.
However, reportedly, Novavax is facing delays in the filings. The company has announced that “it will not submit its COVID-19 vaccine to regulators in the US, UK and Europe until the third quarter of 2021, following issues with the manufacturing of certain components of the jab.”
The trials of the vaccine are on in India. The Serum Insititute of india, in partnership with the Indian Council of Medical Research (ICMR), had launched phase 2/3 bridging clinical trials of the vaccine in March-end.