August 15 deadline for Covid-19 vaccine has dented ICMR’s credibility: Experts
Dr Balram Bhargava’s letter to the heads of 12 hospitals doing human trials for Covaxin vaccine asked them to secure necessary approvals for human trials by July 7 with a warning that “non-compliance will be viewed very seriously”.
Dr Balram Bhargava’s July 2 directive to lead researchers of several institutions chosen as test sites to complete clinical trials soon so as to have the world’s first Covid-19 vaccine ready on August 15 has dented the credibility of India’s apex medical research body that he heads, say top scientists, government officials, and public health experts, who are not buying the research’s agency argument that the letter was an effort to speed up vaccine trials.
“It is good to be ambitious and aspirational but it should not be done at the cost of due diligence for ensuring the safety and efficacy of the vaccine. I would Iike to believe that it is a typographical error of saying 2020, instead of 2021. If not, the implications are serious as the proposed vaccine can only be ready by August 15 by fudging data or incomplete documentation. There is no other way,” said K Sujatha Rao, former secretary, ministry of health and family welfare.
Dr Bhargava’s letter to the heads of 12 hospitals doing human trials for Covaxin vaccine asked them to secure necessary approvals for human trials by July 7 with a warning that “non-compliance will be viewed very seriously”.
Despite the statement from ICMR on July 4 that described the letter as an attempt to cut red tape, and which did not mention anything about a deadline, senior scientists in government say the incident has tarnished the credibility of an institute setting standards and guidelines for clinical research since 1911, and also of scientific research in India.
“It has lowered the credibility of ICMR, and along with that of India’s scientific community, regulatory system government, and the potential vaccine (itself)... its reputation is dented before it is even ready. It’s bad enough to have (Baba) Ramdev declaring a Covid-19 cure by press release, now we have ICMR appearing to ask investigators to bypass scientific protocols. ICMR should, like Caesar’s wife, not just be above reproach but should also be perceived as infallible. That reputation has taken a beating,” said Dr T Jacob John, virologist and former professor at Christian Medical College, Vellore, Tamil Nadu.
“Bharat Biotech will lose all the credibility it has earned all these years with hard work,” added Rao, referring to ICMR’s Hyderabad-based partner which is working on the vaccine.
The vaccine strain of Sars-CoV-2, the virus that causes Covid-19, was isolated in ICMR-National Institute of Virology (NIV), Pune, and transferred to Bharat Biotech on May 9. In a statement on Saturday, ICMR said the safety and interest of people of India was its topmost priority. “After intense characterisation and review of all data from BBIL (Bharat Biotech India Ltd), ICMR is supporting the clinical development as the vaccine candidate appears to be promising. Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trial,” it said.
The pre-clinical study has not been published.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine... ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” ICMR added in the statement.
“It’s obvious to everyone with a smattering of scientific knowledge that three phases of clinical trials cannot be done in 42 days. At best, you can get early data in a month on whether the vaccine is safe, well tolerated and can produce an immune response against the virus, which gives clues to whether it will work or not. You cannot have it ready for mass use simply by fixing a deadline,” said a senior scientist, who did not want to be named because he works in a government institute.
Interestingly, ICMR’s Saturday statement refers only to the first two phases of the trial for which it received regulatory approval from the Drug Controller General of India on June 30. “It (the July 2 letter) is an internal circular not meant to be shared. I suspect it was issued to impress upon his supervisors in the ‘topmost level of government’ that he was driving his team hard to meet the August 15 deadline. The prime minister announced Isro’s human spaceflight mission Gaganyaan on Independence Day in 2018, but Isro kept quiet. Political announcements should be left to the government, scientists should focus on science,” added a senior bureaucrat, requesting anonymity.
“The message is clear: all of us want a vaccine and we want a vaccine that is safe and effective. Pregnancy takes nine months; it is biology. Anything before that has risks,” tweeted Dr Chandrakant Lahariya, a Delhi-based vaccinologist and public health specialist.
Dr Bhargava did not respond to repeated calls and texts seeking comment.