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 provide local clinical trial data, as well as a proposal and justification for the approval.
According to officials familiar with the development, cited by the PTI news agency, the subject expert committee (SEC) on Covid-19 at the Central Drugs Standard Control Organisation (CDSCO) reviewed SII’s application for Covishield as booster dose and after “detailed deliberation”, recommended the company must submit local clinical trial data and the justification for additional jabs.
The Pune-based SII on December 1 requested the Drugs Controller General of India (DCGI) to authorise Covishield as a booster dose, citing the emergence of new coronavirus variants in the country and an adequate stock of vaccines to tackle that growing concern.
Prakash Kumar Singh, the director of government and regulatory affairs at SII, also referred to the UK’s medicines and healthcare products regulatory agency giving a go-ahead to the booster doses of the AstraZeneca ChAdOx1 nCoV-19 vaccine.
Developed in the United Kingdom by the University of Oxford and British-Swedish company AstraZeneca, the ChAdOx1 nCoV-19 is sold here by the Serum Institute under the brand name Covishield.
The SII official, while submitting his plea to the central authority, is said to have cited the fact that many countries have already started administering booster doses of Covid-19 vaccines, indicating that maybe it is time India, too, did the same.
“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 as saying.
Notably, it is not just the SII that is pushing for the approval of a booster dose of the Covid-19 vaccine. States like Kerala, Maharashtra, Rajasthan, Karnataka and Chhattisgarh have also recently urged the central government to decide on allowing the said booster doses amid growing concerns over Omicron.
The Centre, for its part, informed Parliament on Friday the National Technical Advisory Group on Immunisation and the National Expert Group on Vaccine Administration for Covid-19 are presently deliberating and considering scientific evidence for the need and justification for a booster dose against Covid-19.
According to the information available on www.ourworldindata.org, more than 60 countries across the world have already authorised booster doses of the Covid-19 vaccine, minister of state for health Bharati Pravin Pawar said in a written reply.
