Medical experts around the world have been continuously saying that the launch of vaccine for corona virus will take at least 12-18 months. Recently, Indian Council of Medical Research (ICMR) sent letters to 12 principal investigators who are indulged in the work of launching the vaccine to speed up their trial process of Bharat Biotech’s COVID-19 vaccine and launch it by 15th August, 2020.
Scientists and medical experts showed their serious concern over this letter and hence as a clarification to them ICMR stated that the letter was only to cut unnecessary red tape and to speed up participant’s recruitments. Chief Scientist at WHO, Soumya Swaminathan, said that “A realistic (but very optimistic) timeline from the start of Phase-1 to the completion of Phase-3 could be about six to nine months (if all goes according to plan).”
Only Phase-1 and Phase-2 of trials have been approved to be conducted by Bharat Biotech. This means that launching of the vaccine before August 15 is only possible if the Phase-3 of the trial is skipped or rushed forward. Phase-3 trial tests the safety and efficacy of the vaccine on a large number of participants and is one of the most important Phases of the trial.
To address the question that whether Phase-3 can be skipped or not before making it available to the public at large, Dr. Soumya Swaminathan stated that “Any vaccine must demonstrate efficacy and safety in a sizable number of participants.” She also added that” it is possible to have protocols which flow seamlessly from Phase-2 to Phase-3 based on interim analysis of data. “