The safety and interest of Indians is a top priority, the Indian Council of Medical Research (ICMR) said on Saturday that a memo from the agency began a backlash on 15 August to back out of both as the goal of developing the Coronav vaccine did. Medical Experts and Cons.
A letter sent earlier this week by the head of India’s top clinical research agency said that it “conceived” the launch of a novel coronavirus vaccine by Independence Day, prompting opposition to allege that the date was Prime Minister Narendra Determined to help in the political scores of Modi’s government. .
ICMR Director General Balram Bhargava’s letter asking doctors in 12 hospitals to give “fast track” clinical trials, also shocked some doctors and researchers who said the six-week deadline for testing the candidate’s safety and efficacy Determining was unrealistic. They have not even started.
Defending its message, the ICMR said on Saturday, “The letter by DG-ICMR to investigators at clinical trial sites meant cutting unnecessary red tape, bypassing any necessary procedures and accelerating recruitment of participants bring.”
“Just as red tape was not allowed to impede the fast-track approval of new indigenous test kits or introduce potential COVID-19 related drugs to the Indian market, the demand to make the indigenous vaccine development process even slower is untouched Has been done. File movement. The objective is to complete these steps as soon as possible, so that population-based tests for efficacy can be started without delay.
The agency said, “The ICMR’s process is to fast track the development of vaccines for potentially epidemic diseases in accordance with globally validated criteria, in which human and animal testing may continue in parallel.”
The vaccine will be tested following best practices and rigor, and will be reviewed as needed, the Data Protection Monitoring Board (DSMB), ICMR said.
“While issues raised by commentators from time to time in the public domain are welcome, as they are an important part of the feedback loop, India’s medical professionals and research scientists do not second-guess the best for their professionalism or adherence to the highest Must go. Scientific rigor. ICMR is committed to treating the safety and interest of the people of India as a top priority.
Dozens of vaccine candidates worldwide are in various stages of development to combat the coronovirus epidemic. India, the major manufacturer of vaccines and generic drugs, is expected to play an important role in this race.
At least seven vaccines are being researched in India and one is being developed from Bharat Biotech and with ICMR, and another drug manufacturer, Zydus Cadila, has been named in this week’s Phase I and Phase II clinical trials. Has been approved for.
Phase I and Phase II tests typically test the safety of a drug before entering Phase III trials that test its efficacy.
Each phase can last for months, if not years, and although regulators globally have conducted fast-tracking trials on drugs and vaccines to treat novel coronoviruses, the timeline given in the letter will be unprecedented.
Anant Bhan, a doctor and public health researcher, said on Twitter, “According to my information, such a rapid development route is not designed for any type of vaccine, even in other countries to be tried. is.”
“Even with accelerated deadlines, it seems really hasty, and therefore with insufficient attention to the process, with potential risks.”
Several other health experts and political parties also questioned the proposed launch date in the letter, which was widely shared on social media.
Stating that scientific progress cannot be made “to order”, Communist Party of India (Marxist) Secretary-General Sitaram Yechury on Saturday alleged that the ICMR is trying to hasten the vaccine so that Prime Minister Narendra Modi freedom To announce the day.
Congress leader Prithviraj Chavan also alleged on Saturday that the ICMR’s plan was only aimed at enabling the Prime Minister to make a big announcement from the Red Fort