New Delhi: Bharat Biotech Ltd has sought a time-frame of more than a year to launch Covaxin, India’s much-awaited coronavirus vaccine.
The Indian Council for Medical Research's (ICMR) claims that Covaxin will be available for the public by August 15 had triggered a row.
The Bharat Biotech had sought one year and three months to complete the human trials. This is clearly mentioned in the details submitted to the Clinical Trials Registry-India (CTRI).
It would take six months just for the further procedures, as per the trial protocol. Even when the government records include the time-frame, the ICMR made its ambitious claims, setting the August-15 deadline for the vaccine.
Authorities at the Bharat Biotech had told Malayala Manorama the other day that the clinical trials would take at least three months.
The vaccine is being developed by the Bharat Biotech in collaboration with the National Institute of Virology.
Current stage
* Registration of the volunteers is under way for the first phase of clinical trial
* The trial vaccine batch needs to get approval from the Drug Controller General of India
* Some of the institutions, partnering in the project, are yet to receive ethical clearance
* In the first phase, 375 people in the age group of 18 to 55 will be administered the vaccine. In the second phase, 750 people aged between 12 and 65 will be given the vaccine.
* The safety and immunity of the vaccine will be known 28 days after the first phase vaccination.
Tests will be done to ascertain if antibodies are being produced. After this, an interim report will be submitted to the DCGI and Standard Control Organisation
* In the second phase, random vaccinations will be done. Vaccine will be given to some people among the 750, while certain others would be left out. Studies on immunity will be conducted on the 14th day, 28th day and 194th day.
Yechury flays ICMR’s announcement
CPM general secretary Sitaram Yechury has criticised the ICMR's announcement that the vaccine will be developed by the Independence Day, without giving adequate time for trials.
"If the health safety protocols are by-passed and the vaccine is developed merely for the Prime Minister to make the announcement on Independence Day, it could cost several lives," Yechury said.
The Left leader also raised many questions on the procedures in the vaccine research on Twitter.
Fastest vaccine in 4 years
The mumps vaccine, which was rolled-out in 1967, is one of the fastest-developed vaccines. The vaccine was developed after four years of research. The Ebola vaccine was the fastest-developed vaccine in the recent past. The vaccine was given licence last year after five years of research.
ICMR says will not interfere in the trial procedures
The ICMR has clarified that priority would be always to protect the interests and safety of the Indians.
The ICMR said that it shot off a missive on the deadline to prevent the vaccine research, which has entered the human trial phase, from getting entangled in the red tape. Also, that it would not interfere in the essential procedures. The ICMR further said that it follows the global norms.
Remdesivir dosage revised
The Union Health Ministry has revised the dosage of Remdesivir, given for COVID-19 treatment, after liver-related issues were reported in the patients. The drug, which was prescribed for six days earlier, needs to be administered only for 5 days now.
An injection of 200mg needs to be administered on day one and shots of 100mg need to be given in the following four days. The medicine should be administered only in the critical stage. Several government and private hospitals in the country had reported liver-related ailments among the COVID-19 patients, who were administered Remdesivir.
