Covaxin was approved this week for Phase I and Phase II clinical trials.
Ministry of Science & Technology (MoST) initially said that a vaccine for COVID-19 is unlikely for public use before 2021. The letter also states that "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".
On July 2, the day that ICMR director-general Balram Bhargava wrote to doctors envisioning a mid-August launch, Francis Collins, a top American biomedical researcher testifying in a US Senate hearing, explained how even at high speed, a vaccine is expected only in early 2021.
The company had announced on June 29 that it had successfully developed Covaxin, India's first vaccine candidate for COVID-19, in collaboration with the ICMR and NIV.
Hyderabad's Nizam's Institute of Medical Sciences was one of the trial sites that received the Indian Council of Medical Research (ICMR)'s letter.
"Scientifically unreasonable demands and claims lower the hard-earned global renown of our biomedical research institutions and pharmaceutical industry", said Partha Majumder, president of the IASc. The duration of a phase III trial would depend on several factors, including the number of subjects enrolled and decisions by a data safety monitoring board, but would probably add at least another 6 months, Jacob John says.
Development of the other vaccine candidate has been done by Indian pharmaceutical company Zydus Cadila.
The research body said the Director's letter was meant to cut red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.
India is eagerly awaiting a COVID-19 vaccine.
The bid underscores India's urgent need for a way to halt the coronavirus, which has sickened more than 640 000 people and killed over 18 600 in the Asian nation - the world's fourth-largest outbreak.
"The vaccine is being derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune". After conducting various tests, the final list will be confirmed. "It's not about getting there first but to be able to do it well and it is good that India has been able to come up with candidate vaccines, which is not a small achievement".