Human trials of the indigenously developed coronavirus vaccine, COVAXIN, began today, AIIMS-Delhi Director Dr Randeep Guleria said, adding that it would take at least three months for researchers to arrive at the first set of data.
Phase 1 of the three-phase human trials started as coronavirus cases in India crossed the 11 lakh-mark with 40,000 fresh cases of COVID-19.
“It (starting trials) is heartening because it’s an indigenous vaccine; making a new vaccine is an achievement. Even if a vaccine is first developed somewhere else in the world, India will be mass producing it. We are good at it,” he said.
Some 1,125 healthy volunteers will be injected with inactivated Sars-CoV-2 so their body can produce Covid-fighting antibodies.
Phase-1 includes 375 volunteers in the 18-55 age group with no co-morbidity; phase 2 will have 750 individuals in the 12-65 age group and Phase 3 will done with a larger population.
“Men and women will be recruited, but women volunteers can’t be pregnant,” said Dr Sanjay Rai, head of community medicine, who will be overlooking the trials operations.
Our priority is to ensure safety, he said, adding that the duration for which a vaccine may remain effective will depend on how the virus mutates. “Influenza requires multiple vaccinations because the virus keeps mutating. We have not seen such mutations with COVID-19,” he said.
Dr Rai said the distribution of such a vaccine would have to be prioritized for vulnerable groups, depending on dosage available. “Healthcare workers would be on the priority list,” he said.
The medical experts, however, said predicting when exactly would the vaccine be ready was difficult. “We are learning more about the virus every day,” Dr Guleria said.
He added that the novel coronavirus not only causes viral pneumonia, it affects multiple organs, causes inflammation of the blood vessels and skin discolouration. “It’s a multi-system disease and causes an immune reaction in kids. We are calling it Multi-System Inflammatory Syndrome,” he said.
Dismissing talks of country-wide community transmission, Dr Guleria said that local transmission was in play in places where the number of cases was high.
He also urged against letting your guard down once the transmission peaks out. “It is important to sustain the lessened cases. We have not seen any cases of relapse yet, but it is important to follow up with patients,” he said.