Will India allow COVID-19 booster shots? Experts discuss

An expert panel of India’s central drug authority told the Serum Institute of India (SII) on Friday that before a potential booster dose of the Covishield vaccine can be approved, the Pune-based firm must submit local clinical trial data, as well as a proposal and justification for the approval. 

According to officials familiar with the situation, the Central Drugs Standard Control Organisation’s (CDSCO) subject expert committee on COVID-19 reviewed SII’s application for Covishield as a booster dose and recommended that the firm submit local clinical trial data and the justification for supplemental jabs after “detailed deliberation”.

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The UK’s medicines and healthcare products regulatory agency has given the go-ahead to the booster doses of the AstraZeneca ChAdOx1 nCoV-19 vaccine, according to Prakash Kumar Singh, SII’s director of government and regulatory affairs. 

The ChAdOx1 nCoV-19, developed by the University of Oxford and the British-Swedish company AstraZeneca in the United Kingdom, is sold in the United States by the Serum Institute under the brand name Covishield. 

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The SII official is said to have cited the fact that many countries have already begun injecting booster doses of COVID-19 vaccines in his submission to the central authority, implying that it may be time for India to follow suit.

“You are aware that now there is no shortage of Covishield in our country and the demand for a booster dose is increasing day by day from the people who have already taken two doses in view of the ongoing Covid-19 pandemic and emergence of new strains,” Singh was quoted by Hindustan Times as saying.

Notably, the SII is not the only organisation advocating for the approval of a COVID-19 vaccine booster dose. Several states, including Kerala, Maharashtra, Rajasthan, Karnataka, and Chhattisgarh, have recently urged the central government for allowing the booster doses, citing growing Omicron concerns. 

On Friday, the Centre informed Parliament that the National Technical Advisory Group on Immunisation and the National Expert Group on Vaccine Administration for COVID-19 are debating and considering scientific evidence for the need and justification for a booster dose against COVID-19. 

Over 60 countries around the world have already approved booster doses of the COVID-19 vaccine, according to information available on www.ourworldindata.org, said minister of state for health Bharati Pravin Pawar in a written response.