The grant of emergency approval to Covovax by the World Health Organization (WHO) has brightened the chances of the vaccine receiving approval from India’s drug regulator.
Covovax is being manufactured in India by the Serum Institute of India (SII). SII has been submitting trial data on a rolling basis and the final data will be submitted soon to the drug regulator, people in the know told ET.
Once data is submitted, the subject expert committee (SEC) under India’s drug regulator will review the jab, the same people said.
“Covovax should be licensed in December-January,” Adar Poonawalla, CEO, SII had earlier said.
Experts believe that Covovax can work better as a booster shot.
“Very welcome development as we search for the right booster combination. It is produced as Covovax in India by SII and contains spike proteins assembled on a lipid nanoparticle. It induces a strong immune response and has an excellent safety profile,” said Anurag Agrawal, chair, WHO’s technical advisory group on SARS-CoV-2 virus evolution, in a tweet on Saturday.
Covovax is the ninth vaccine listed by the world’s top health body for emergency use. Covaxin from Bharat Biotech and Covishield from SII are the two vaccines which are widely used in India.
Covovax is India’s version of US firm Novavax’s Covid-19 vaccine candidate.
SII has been conducting a bridging trial for the jab in India. The company had applied for emergency use authorisation to the Indian drug regulator in August. It had also submitted the international data then.
“As you know the vaccine has a 92% efficacy, and works very well against all variants. We have done a bridging trial in India and by end of December-January the drug regulator will have all the data to license it,” Poonawalla had earlier said.
The company has also manufactured the first batch of Covovax. Poonawalla had earlier said that the vaccine has the potential to protect those below 18.
In August, Poonawalla had said that Covovax will be launched for children during the “first quarter of 2022”.
Novavax has recently received approval for use in Indonesia and the Philippines and has sought a go-ahead from the Japanese regulator. The company said it is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter, as it has joined hands with SII, as well as a wholly owned manufacturing site in the Czech Republic, and sites (SK Bioscience) in South Korea and (Takeda in) Japan, among others.