In a letter to Bharat Biotech dated July 2, 2020 (D.0.No.ECD/COVID19/Misc./2020), ICMR Director General Dr Balram Bhargava said “It is envisaged to launch the vaccine for public health use latest by 15"August2020 after completion of all clinical trials.”
MUMBAI, Aug 15, 2020: Mumbai-based newspaper Mid-day was the first to declare that it was just impossible to come up with a COVID vaccine by the Independence Day, as mandated by the ICMR.
In a letter dated July 2, 2020 (D.0.No.ECD/COVID19/Misc./2020), ICMR Director General Dr Balram Bhargava said “It is envisaged to launch the vaccine for public health use latest by 15"August2020 after completion of all clinical trials.” BNC has reviewed a copy of the ICMR letter.
Quoting celebrated virologist T Jacob John, Mid-day wrote on July 27 that “A Phase 1 vaccine trial has just started for one vaccine, and even that trial will not be completed by August 15. What the Government of India can declare on 15 August, if it desires to announce some good news, is a firm policy and plan of action to utilise one or more vaccines in the country as soon as available. But that will not be as 'ear-catching' as a vaccine launch.”
Those who were expecting a big announcement on the COVID vaccine today were in for a bigger surprise as the PM did not provide any big headline on the subject.
In his Independence Day address to the nation, the Prime Minister mentioned about India’s strategy for development of the Corona Vaccine and said scientists are working on this mission with strong determination. Presently, three vaccines are in different stages of testing. As soon as the scientists give a nod, mass production shall commence. A blueprint for the production and distribution of the vaccine is also ready, he added.
ICMR has partnered with Bharat Biotech International Limited (BBIL) to fast-traCk Clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID Vaccine).
Dr Bhargava said in his letter: “BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project.”
Dr Bhargava, who is also the Secretary to the Government of India, Department of Health Research, Ministry of Health & Family Welfare, addressed the letter to 13 institutions involved in the vaccine trial.
He said: “You have been chosen as a clinical trial site of the BBV152 COVID Vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated no later than 7" July 2020.
He then cautioned the institutions: “Kindly note that non-compliance will be viewed very seriously.” “Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse,” he said.
The ICMR letter drew lot of criticism for trying to hurry BBIL and others into finishing the trials.