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Covovax booster request may come up next week
On December 28, 2021, the Drugs Controller General of India approved Covovax for emergency use in adults. It approved the vaccine for emergency use among those aged 12 years and above in March last year, making it the fourth Covid-19 vaccine approved for emergency use in children in this age group.
An expert panel of India’s drugs regulator may next week consider approving Covovax, the second Covid-19 vaccine developed by the Serum Institute of India, to be used as a booster dose, according to people familiar with the matter.
“Covovax is already approved for restricted use and its use as booster should be discussed in the upcoming meeting that may take place next week,” a central government official said, requesting anonymity.
Serum Institute expects the approval to come in soon, chief executive Adar Poonawalla said at an event in Pune on Sunday. “Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield,” he said at Bharti Vidyapeeth University.
On December 28, 2021, the Drugs Controller General of India approved Covovax for emergency use in adults. It approved the vaccine for emergency use among those aged 12 years and above in March last year, making it the fourth Covid-19 vaccine approved for emergency use in children in this age group.
In August 2020, American pharma company Novavax had announced a licence agreement with Serun Institute for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low- and middle-income countries.
The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-Cov-2 to train immunity. It is the only vaccine apart from mRNA platform doses that demonstrates an efficacy of more than 90% against the original Sars-Cov-2 virus, according to the company statement.
A clinical trial among 460 Indian adolescents aged 12-18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well tolerated with a reassuring safety profile. The data indicated Covovax was immunogenic in adolescents.
The central government has a large inventory of Covishield and his company has stopped its production, Poonawalla said. “The central government has a lot of stock of Covisheild they can give it to the states,” he said. “As of now, production of Covisheild is at a halt. We can start it if needed.”
The company recently offered about 20 million Covishield doses to the government for free. Serum Institute has so far provided at least 1.7 billion doses of Covishield to the government to be used in the national Covid-19 immunisation programme, making it the vaccine most widely used in the country.
On January 3, HT reported that the Indian government had 8.1 million doses of Covishield in the supply pipeline, and about 7.5 million doses of Bharat Biotech’s Covaxin was with the states. Only about 28% of the eligible population has taken the third dose of the vaccine so far.
“There is no shortage of vaccine supplies in the country,” said the official cited earlier. “If it is required, the government can always procure more doses, but that will be based on the consumption pattern of the states and Union Territories.”
