New Delhi:

A vaccine for the coronavirus will likely be ready by early 2021 but rolling it out safely across India’s 1.3 billion people will be the country’s biggest challenge in fighting its surging epidemic, a leading vaccine scientist told Bloomberg.

India, which is host to some of the front-runner vaccine clinical trials, currently has no local infrastructure in place to go beyond immunizing babies and pregnant women, said Gagandeep Kang, professor of microbiology at the Vellore-based Christian Medical College and a member of the WHO’s Global Advisory Committee on Vaccine Safety.

The timing of the vaccine is a contentious subject around the world. In the U.S., President Donald Trump has contradicted a top administration health expert by saying a vaccine would be available by October.

In India, Prime Minister Narendra Modi’s government had promised an indigenous vaccine as early as mid-August, a claim the government and its apex medical research body has since walked back.

For a country of its size, and with a virus curve that shows no sign of flattening, a safe and quick vaccine is a top priority for the Modi administration.

The country’s broken health-care system, already struggling to deliver adequate care before the outbreak, cannot cope with the strain of a prolonged pandemic. A strict lockdown implemented in late March led to the biggest contraction among major economies with gross domestic product shrinking 23.9% in the three months to June from a year earlier.

“By year-end we will have data that will tell us which vaccines are working and which ones are not going to do so well,” said Kang, who until July was heading the Indian government committee looking into prospective indigenous vaccine candidates. “If we get good results by year-end then we are looking at vaccines being potentially available in tiny numbers in first half of 2021 and larger numbers in the latter part.”

Kang said that any vaccine currently in phase three trials, whether locally made or being tested by major western pharmaceutical companies, had a 50% chance of success.

Covid vaccine expected in early 2021: Govt

Meanwhile, Union Health Minister Harsh Vardhan assured the Lok Sabha that the Central government is not just waiting for "act of God" in fight against Covid-19 but also working round-the-clock in the direction to get solution and a vaccine will be available in the beginning of the next year anytime.

The Minister's assurance came on Monday when he was speaking in the lower House in a late night discussion of the passage of the Epidemic Diseases (Amendment) Bill, 2020 which seeks amendment to the Epidemic Diseases Act, 1897 and will replace the Epidemic Diseases (Amendment) ordinance, 2020 which was promulgated by the President on April 22.

Harsh Vardhan's response came in a reply to a Member of Parliament who alleged that the government is waiting for the act of God in fight against the disease which on Monday inched closer to 55 lakh-mark in India with a total of 54,87,580 cases in 235 days since the first case was reported on January 30.


Vaccacine approval inly if at least 50 percent of those administered with the vaccine are protected from the virus

For the development of COVID-19 vaccines, a vaccine developed in India should prove that at least 50 percent of those administered with the vaccine are protected from the virus to get an approval, said the the draft guidelines released by Central Drugs Standard Control Organisation (CDSCO) on September 21..

The document  has several safety protocols that companies have to follow while developing and manufacturing the vaccine.

For vaccines that are being developed outside India, the authorisation will be provided on the basis of clinical trial data once they pass evaluation for the overall safety and effectiveness of the vaccine.

However, an additional clinical trial may be required in the local population to confirm the safety and effectiveness in Indian population. The extent of local clinical trial requirements will be decided on a case by case basis," said  the 40-page document titled 'Draft Regulatory Guidelines For Development of Vaccines With Special Consideration For COVID-19 Vaccine ,