ICMR ‘clarifies’ that August 15 was not a deadline for COVID-19 vaccine after experts called out how impossible it was

• ICMR, on Sunday (July 5) said that it has not set any deadline for the COVID-19 vaccine.
  
• The aim is to conduct clinical trials as quickly as possible, given the urgency and uncertainty of the global pandemic, it said.
  
• Experts believe that vaccine development takes a lot of time as it undergoes several phases and clinical trials — and it is nearly impossible to adhere to the deadline.
  
• This was after the DCGI approved to conduct human trials of Covaxin — developed jointly by Bharat Biotech, National Institute of Virology and the IndianCouncil of Medical Research (ICMR).

Much like the rest of the world, India too is waiting with bated breath for a COVID-19 vaccine. Drug Controller General of India’s (DCGI) approval to conduct human trials of Covaxin — developed jointly by Bharat Biotech, National Institute of Virology and the IndianCouncil of Medical Research (ICMR) ⁠— has sparked hopes but then a circular last week turned that hope into fear of rushed process.

The biomedical research body told the trial centres that it wanted to launch the vaccine by August 15, 2020. It was an audacious target and ICMR faced much flak from experts.


However, ICMR, on Sunday (July 5) said that it has not set any deadline for the vaccine. The idea is to conduct clinical trials as quickly as possible, given the urgency and uncertainty of the global pandemic, it said.

“Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials," Mint reported citing an ICMR official.

“Our trials will be done following the best practices and will be reviewed by a data safety monitoring board," ICMR added.

The path ahead for COVAXIN

On July 2, ICMR Director Balram Bhargava, in a letter, asked Bharat Biotech to accelerate the clinical trials of Covaxin. It also directed companies to grant approvals related to trials quickly.

According to reports, as many as 1,125 people will undergo Covaxin trials — and the recruitment of these candidates will begin from July 7.

Gillurkar Multispeciality Hospital in Nagpur, which is one of the selected 12 institutes to conduct the trials, said that they haven’t got the vaccine yet to start the process. Even the candidates for human trials have not been selected yet.

“We will start screening patients from Tuesday. Their samples will be sent to a Delhi laboratory and the report will come in three days. We will then recruit healthy volunteers,” said Dr Chandrasekhar Gillurkar of Gillurkar Multispeciality Hospital.

The human trails will happen in two phases. Gillurkar said that, after the first dosage is given, the waiting period will be around 14 days before the second dose can be given to those candidates. They will again be checked after 14 days to assess the immune system and if they have developed antibodies. So, the entire process will be completed in over 28 days.

According to the Union Science & Technology Ministry, six Indian pharma companies are working to develop a COVID vaccine. It also said that these vaccines may not be ready for use until 2021 — and later backtracked the mention of the deadline.

Globally, there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase, according to the World Health Organisation (WHO).

See also:
India wants a COVID-19 vaccine by August 15 at the risk of rushing trials and approvals

Oxford COVID-19 vaccine may hit the Indian market by the end of the year if successful, says CEO of world’s largest vaccine manufacturer

An Indian COVID-19 vaccine made by Bharat Biotech is set to enter human trials