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India’s Covid-19 vaccination campaign starting on January 16 with the AstraZeneca-Oxford vaccine and the homegrown Bharat Biotech jab will not offer beneficiaries the option to choose between the two, the Union health ministry has signalled.
But online discussions and free-wheeling exchanges in medical circles across the country, doctors say, appear to reflect expectations among many that they would receive the AstraZeneca-Oxford vaccine called Covishield in India instead of the homegrown Covaxin.
The health ministry said on Tuesday that 11 million doses of Covishield and 5.5 million doses of Covaxin ordered by the Centre to start the campaign would be received by all states and Union Territories by January 14, but did not explain which vaccine would go where.
India’s drug regulatory expert panel on Saturday recommended conditional and restricted emergency use of a home-grown vaccine against the coronavirus disease without direct evidence for its protective efficacy.
Earlier on Friday, the AstraZeneca-Oxford vaccine had been recommended. The recommendations from the Subject Expert Committee (SEC) to the Central Drugs Standard Control Organisation, the apex regulatory authority for drugs and vaccines, imply India could use two vaccines for its planned campaign to initially vaccinate around 300 million people.
The Union health ministry said on Saturday the SEC had granted the permissions under multiple conditions, but some medical experts said the committee appeared to have yielded to a desire to launch an Indian-made vaccine alongside a foreign one.
Serum Institute Fracas Exposes Loose Ends of India s Clinical Trial Machinery
Participants voices are missing from deliberations about how officials should address serious adverse events in clinical trials.
Representative photo: NCI/Unsplash.
Health11/Dec/2020
Bengaluru: In November, two leading Indian COVID-19 vaccine manufacturers, Bharat Biotech and Serum Institute of India (SII), found themselves embroiled in controversy. Media reports alleged that there had been a “serious adverse event” in phase 1 of Bharat Biotech’s clinical trials for Covaxin. Phase 1 tests the safety of a new drug or vaccine in human subjects for the first time.
Then, a 40-year-old man in Chennai, through a legal notice to SII, sought compensation of Rs 5 crore for an illness he alleged appeared after he participated in a clinical trial for Covishield, SII-made version of University of Oxford and AstraZeneca’s COVID-19 vaccine candidate.