Bharat Biotech has sought permission from India’s drug regulator to conduct clinical trials for evaluating the efficacy of a third dose of its Covid-19 vaccine, Covaxin.
According to a top government official, the indigenous vaccine maker has proposed to conduct clinical trials for Covaxin’s booster shot on 5,000 healthy volunteers, keeping a gap of six months between the second and third dose. Additionally, the firm has also proposed to run trials on immunocompromised individuals, involving around 500 HIV-positive patients, the government official added.
This comes after Prime Minister Narendra Modi announced a precautionary dose or a third dose for healthcare, frontline as well as co-morbid senior citizens. The precautionary dose will be administered from January 10, 2022.
Recently, Adar Poonawalla’s Serum Institute of India also sought the approval of Drug Controller General of India (DCGI) to administer Covishield as a booster dose citing adequate stock and a demand for a booster shot, but the request was denied.
According to sources, the expert panel of the DCGI that reviewed Serum institute’s application asked the firm to submit local clinical trial data to justify the request for boosters. Moreover, SII had presented immunogenicity data of only 75 subjects from the Britain study.
Earlier this month, World Health Organization’s strategic advisory group of experts on immunisation had said people who are immunocompromised or those who have received an inactivated Covid-19 vaccine should receive booster shots for protection in wake of waning antibodies and rising Covid-19 cases fuelled by Omicron variant of the novel coronavirus.