India Seeks Pfizer, J&J Vaccines With Fast-Tracked Approvals
Government will grant emergency use approval to vaccines approved by regulators in the U.S., U.K., EU, Japan or listed by the WHO.
(Bloomberg) -- India will fast-track approvals for Covid-19 vaccines approved by governments overseas in order to have a wider pool of shots as it struggles to control its soaring second wave of infections, effectively opening the door to shots made by Pfizer Inc. and Moderna Inc.
A government panel has recommended that inoculations approved by drug regulators in the U.S., U.K., European Union, Japan or which are listed in the World Health Organization, may be granted emergency use approval in the South Asian nation, according to a statement from the federal Health Ministry Tuesday.
India is inviting Pfizer, Moderna, Johnson & Johnson and others to seek emergency use approval of their vaccines as early as possible, V.K. Paul, who heads a panel advising Prime Minister Narendra Modi on the country’s inoculation efforts, said at a press briefing Tuesday.
The decision comes a day after India reported another record surge in new Covid infections and granted emergency use approval for Russia’s Sputnik V vaccine on Monday, making it the third shot approved by the nation as it races to control its pandemic. The country rolled out its vaccination drive on Jan. 16 with shots made by Astrazeneca Plc’s local partner, Serum Institute of India Ltd., and Hyderabad-based Bharat Biotech International Ltd.
India is now the world’s second worst-hit nation, having overtaken Brazil once again Monday with a sharp jump in daily new infections over the last 10 days pushing its total tally to nearly 13.7 million cases. On Tuesday the country reported 161,736 new cases and 879 deaths -- more than four times the daily average in January.
Shares of Pfizer Ltd. surged as much as 7.8% to a 5-month high on the news from the Health Ministry.
“India clearly needs more vaccines to tackle the Covid surge,” said Rohit Bhat, head of research at Mumbai-based B&K Securities. “The decision will help in this.”
The country is facing an escalating health crisis as a deadlier second wave begins to overwhelm hospitals and crematoriums, forcing some states to impose partial lockdowns. Some parts of the country, including Maharashtra where financial hub Mumbai is based, are also facing vaccine shortages.
An expedited process for foreign-made vaccines, waiving the need for local bridging trials ahead of approvals, will hopefully ease the shortfall. Pfizer’s attempts to get emergency authorization in India without running clinical tests in the South Asian nation were initially rebuffed.The bridging trials can now follow after the vaccines are cleared for use.
But it’s not immediately clear how quickly new vaccines will arrive in India.
While the new rules allow shots to be imported into the country “that all depends on the international demand and where those companies have made commitments,” said K. Srinath Reddy, adjunct professor of epidemiology at the T.H. Chan School of Public Health at Harvard University and president of the New Delhi-based health think-tank Public Health Foundation of India. “The next one or two months is going to be a bit of an uncertain situation in terms of the total amount of vaccines that will be available.”
As infections numbers soar public health experts and business leaders have also said the country needs to widen the pool of people it’s inoculating and give a larger role to the private sector. Currently only those above 45 are eligible, while the government controls vaccine purchases.
“I think what the government can really do to open up and increase vaccination is give the corporate sector the ability to buy the vaccine,” according to Suneeta Reddy, managing director of Apollo Hospitals Enterprise Ltd., the country’s largest private health care network. “I think the minute they do that they reduce their burden of having to vaccinate all of India.”
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