Serum Institute of India (SII) chairperson Cyrus Poonawalla on Friday said that there are some issues between the US Food and Drug Administration (USFDA) and Novavax are preventing Covovax, another Covid-19 vaccine being manufactured by his company in India, from getting launched before October.
“We can’t launch Novavax’s vaccine unless we get a license to launch it. The parent American company has some issues with the USFDA, which should be cleared by the end of October. We will get the license only when the company gets one from the FDA. We are trying to obtain the license ahead of the parent company, but it’s an uphill task,” the Serum chairman and MD was quoted as saying by news agency ANI.
Unless we get a license to launch Novavax, we can't launch it. The parent American company has some issues with the US Food and Drug Administration (FDA), those should be cleared by the end of Oct: Cyrus Poonawalla, Chairman & MD of Serum Institute of India pic.twitter.com/k3BeV5KSg6— ANI (@ANI) August 13, 2021
“Once they will get a license then we’ll get a license. There are efforts to get the license before the parent company but it’s an uphill task,” he added.
Last week, Cyrus Poonawalla’s son, SII CEO Adar Poonawalla had given a similar statement, saying he is hopeful that Covovax will be launched in October for adults and for children by the first quarter of 2022. He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand.
“By the first quarter of 2022, we will have a vaccine for kids", he had told media on August 6. The SII also applied for Emergency Use Authorization for Novavax to the Central Drug Standard Control Organisation on the same day.
Poonawalla had also said that there is no need to mix the vaccine doses, after an expert committee of the Central Drugs Standard Control Organisation had recommended granting permission for the same.
If anything misfires, he said, then “Serum will say that the other vaccine is not good and they (the other vaccine company) will blame us claiming there was an issue. I think it is very wrong to mix the vaccines and you can quote me," he was quoted as saying by Economic Times.
The Pune-based institute is set to start trials of Covovax on children this month. The trials would cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites.
Two Indian vaccine makers — Bharat Biotech (Covaxin) and Zydus Cadila (ZyCoV-D) — have already begun the pediatric trials.
Covovax is said to have an efficacy of close to 90 percent but is yet to be approved for use anywhere.
An expert panel of the Central Drug Authority had last month recommended granting permission to SII for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.