ICMR's haste in launching a COVID vaccine COVID vaccine as shown by its claim, "we envisage to launch it for public health use latest by August" has been met with fear and criticism from various quarters of the scientific fraternity. Many opine that this could lead to compromises in the quality, safety and efficacy of the drug.
ICMR's haste in launching a COVID vaccine COVID vaccine as shown by its claim, "we envisage to launch it for public health use latest by August" has been met with fear and criticism from various quarters of the scientific fraternity. Many opine that this could lead to compromises in the quality, safety and efficacy of the drug.
ICMR proposed an accelerated development pathway for BBV152 COVID vaccine. "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project," read a letter from Balram Bhargava, Director of ICMR. The country’s apex medical body selected 12 institutes for the clinical trial of the country’s first indigenous COVID-19 vaccine.
While Phase I and Phase II trials test the safety of a drug before it can enter Phase III where its efficacy is tested. According to many scientists and pharmaceutical experts, each phase can last months and even years, but regulatory bodies around the world have been fast-tracking trials on medicines and vaccines aimed at tackling the coronavirus, which has infected more than 10.9 million people globally and killed more than 520,000.
Even AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, seemed shell shocked with this announcement. “It will be a very challenging and difficult task, considering that we have to look at both the efficacy and safety of any vaccine that is introduced. Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” said Guleria in an interview to the media.
What kind of language is “Kindly note that non-compliance will be viewed very seriously?” questioned Shaheed Jammel, a virologist of acclaim who also called the timeline "ridiculous. “I fear the global scientific community would be laughing at us for this. It should not have happened. India is a serious player in science. Who is going to trust us if we behave like this? Who is going to believe us even if we indeed come up with a good vaccine tomorrow? And I am appalled at the kind of language used in the letter. It is not a letter, it reads like a threat,” lambasted Jameel.
One of the top clinicians who works closely with the government raised concerns over ICMR's haste in launching the vaccine. On the condition of anonymity, he spoke to a national daily and said, "“It is impossible and too dangerous a task. The vaccine trial has not even taken off. In Phase 1, the enrollment itself takes a few months. This takes time because you have to examine if the vaccine is able to produce enough neutralising antibodies to fight the virus. Second, if the vaccine produces antibodies, we need to examine if they sustain for some time. The antibodies may last only for a few weeks. You can’t have a vaccine that has to be given every few weeks.”
Anant Bhan, a public health researcher, questioned the haste. He tweeted, "To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries."
Several other doctors, scientists and health experts also have questioned the proposed launch date of the vaccine and criticised the haste the matter is being dealt with.