India Crosses 10 Million Covid Cases as Vaccine Approval Pending

(Bloomberg) -- India’s coronavirus infections crossed the 10-million mark, despite a recent easing in the number of new cases as the country awaits several emergency vaccine approvals that may help tame the world’s second-worst outbreak.

Some 25,152 new cases were added, according to the latest data from the federal Health Ministry released on Saturday, much lower than a peak of over 97,000 daily infections in mid-September. The number of deaths stood at 145,136, up 347 from Friday

India has said it expects to start rolling out its Covid-19 immunization program as soon as a shot gets the green-light, but it has yet to approve a vaccine for early use authorization.

Senior government officials have said the delays in getting authorization will not impact their time-line for starting an inoculation campaign, adding that other preparations, including identifying the priority population, setting up cold chains and training vaccinators, are underway.

India is relying largely, at least in the initial phase, on two domestically produced vaccines manufactured by Bharat Biotech International Ltd. and the Serum Institute of India Ltd. Serum has partnered with AstraZeneca Plc to make at least one billion doses of its shot.

Both Bharat and Serum have applied to the Indian regulators for early use authorization, but have been asked to provide additional data on safety, efficacy and immunogenicity.

“We do not believe that this regulatory process will impact the time-line of the vaccines,” Rajesh Bhushan, secretary at the health ministry, said at a news briefing on Tuesday.

Pfizer Inc. has also applied for accelerated approvals of its own vaccine, though its requirements for ultra-cold storage make it an unlikely choice for widespread use across India, which has patchy health networks and infrastructure particularly in its rural hinterlands.

Millions of Doses

Serum, which is expected to produce India’s front-runner vaccine, has already produced millions of doses of AstraZenaca’s shot ahead of approval, but has come under the scrutiny recently after a manufacturing discrepancy cast doubts over the results from its final stage trials.

An expert Indian committee last week asked Serum to present additional safety data in its final stage human trials in the country, immunogenicity data from clinical trials in the U.K. and India and the assessment of the U.K. Medicines and Healthcare Products Regulatory Agency.

Even once a vaccine is approved, there are numerous obstacles to swiftly rolling it out across India’s population of about 1.3 billion, including the scaling up of the country’s inoculation network the government is relying on.

The existing universal immunization program currently only targets 26.7 million newborns and 29 million pregnant women every year, which public health experts say will need to be significantly ramped up to reach the country’s entire adult population.

Around 300 million Indians are expected to be vaccinated in the first stage -- starting with health workers, followed by police personnel and soldiers, followed by those with co-morbidities and people over the age of 50.

“Rolling out vaccines to India’s huge population will be challenging,” S&P Global Ratings said in a report on Tuesday. “However, the aim to inoculate 300 million people by August 2021, combined with an existing high infection rate in some parts of the country, could result in a pronounced decline in reported cases later next year.”

©2020 Bloomberg L.P.