India
oi-Deepika S
New Delhi, Sep 22: A COVID-19 vaccine candidate should show at least 50 per cent efficacy during phase III of clinical trials for it to be widely deployed, according to a draft guidance document for vaccine developers issued by the central drug authority.
However, adequate data informing about the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) will need to be generated, the Central Drugs Standard Control Organisation (CDSCO) said in its draft ”Regulatory Guidelines for Development of Vaccines with Special Consideration for COVID-19 Vaccine”.
It said people with a history or laboratory evidence of prior novel coronavirus infection should be allowed to participate in trials if they did not have acute COVID-19 or other acute infectious…
