Updated: January 8, 2022 12:34:03 pm
The Centre’s approval for Covaxin for 15 to 17 age group has resulted in a flurry of requests to vaccine-maker Bharat Biotech from private hospitals across the country. Sources close to the firm said that the government approval was sudden, adding lakhs of doses are being shipped to private hospitals on a daily basis now.
The Hyderabad-based firm’s Covaxin is the only available option in the 15-17 age group and more than one crore children have been administered with the first dose since January 3. “If it was known that the approval from the government was going to come so soon, prior arrangements would have been made,” a source said.
When contacted, a company spokesperson told The Indian Express: “In our country, the estimated number of beneficiaries in the 15-17 age group is 7.4 crore. We need two doses; so, for 15 crore doses, it is going to take a few months. This is not going to happen in a couple of weeks.”
The official added: “We have stated that our production capacity by the end of 2021 was in the 70-80 million doses range, translating roughly to a billion doses per year. There will be a few months’ delay between when the product is manufactured and when it hits the market,” the spokesperson said. “This is the final production run and there are no plans to increase this in the near future,” the spokesperson added.
Bharat Biotech said that there are various procedures and approvals required before a product hits the market. “It is a 120-day process from start to finish,” the spokesperson said. “Hence, from the time the drug substance is manufactured to the tune of a 70/80 million-dose level, converted into a product, again tested and sent to a government laboratory for approval, it takes two to three months for the product to hit the market,” the official added. The spokesperson said that there were enough vaccines available with the firm which is manufacturing Covaxin at its facilities in Hyderabad, Bengaluru and Ankleshwar.
WHO’s EUL for Covaxin for kids still awaited
Covaxin, the adjuvanted inactivated vaccine developed by Bharat Biotech, has been approved in India for the 15-17 group but is yet to receive WHO EUL (Emergency Use Listing) for this age indication.
When contacted, World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan told The Indian Express: “They (the firm) have to submit all the data yet. Countries, however, can make decisions based on their own regulatory agencies.”
WHO’s EUL procedure assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines. Sources close to Bharat Biotech International Limited have pointed out that usually the regulatory process is to get approval in one’s home country and then submit it to the WHO.
“The Government of India gave approval less than a week ago – This data is being presented to WHO and they will review it,” the source said.
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