AIIMS-Delhi Director Dr Randeep Guleria said that human trials of the Indias Covid vaccine, COVAXIN, had started today.
Trials on humans of the locally developed coronavirus vaccine, COVAXIN, began today, said AIIMS-Delhi director Dr Randeep Guleria, adding that it would take researchers at least three months to get to the first dataset.
Phase 1 of the three-phase human trial began when the coronavirus cases in India crossed the 11 lakh mark with 40,000 new cases of COVID-19.
“It (starting the trials) is encouraging because it is a native vaccine; making a new vaccine is a success. Even if a vaccine is first developed elsewhere in the world, India will mass produce it. We are good in this area, “he added. said.
Some 1,125 healthy volunteers will receive an injection of inactivated Sars-CoV-2 so that their bodies can produce anti-Covid antibodies.
Phase 1 includes 375 volunteers aged 18 to 55 without comorbidity; phase 2 will count 750 individuals in the 12-65 age group and phase 3 will be done with a larger population.
“Men and women will be recruited, but female volunteers cannot be pregnant,” said Dr Sanjay Rai, chief of community medicine, who will ignore the trial operations.
Our priority is to ensure safety, he said, adding that how long a vaccine can stay effective will depend on how the virus mutates. “The flu requires several vaccinations because the virus continues to mutate. We have not seen such mutations with COVID-19,” he said.
Dr Rai said that the distribution of such a vaccine should be prioritized for vulnerable groups, depending on the dosage available. “Health care workers will be on the priority list,” he said.
Medical experts, however, said it was difficult to predict when exactly the vaccine would be ready. “We are learning more about the virus every day,” said Dr. Guleria.
He added that the new coronavirus not only causes viral pneumonia, it affects several organs, causes inflammation of the blood vessels and discoloration of the skin. “It is a multi-system disease that causes an immune response in children. We call it multi-system inflammatory syndrome,” he said.
Dropping discussions of community transmission across the country, Dr. Guleria said local transmission is at stake in places with high caseloads.
He also urged not to drop guard after the transmission is over. “It is important to keep the cases down. We have not yet seen a relapse, but it is important to follow the patients,” he said.
