India speeding up review of Pfizer, AstraZeneca COVID-19 vaccines

(Reuters) – India is accelerating its review of COVID-19 vaccines developed by Pfizer Inc and AstraZeneca to authorise for emergency use, a senior official said on Monday, as the world’s second-hardest hit country seeks to contain the virus outbreak.

The government is pinning its hopes for mass supply on the Serum Institute of India, the world’s largest vaccine producer by volume, which lodged the first formal application for emergency-use approval of AstraZeneca’s shot on Monday.

Pfizer had already applied for emergency-use approval for its vaccine in India over the weekend, the government official said, declining to be identified due to the confidential nature of the information.

“We are in the process of reviewing. It is an accelerated reviewing process, which is there for Serum too,” said the official. “It is the need of the hour. We have to review at the earliest.”

India’s Bharat Biotech also filed an application on Monday seeking emergency-use authorization for its COVID-19 vaccine, the official said.

The private pharmaceutical company based in the southern city of Hyderabad is developing a shot called Covaxin that it plans to launch by the second quarter of 2021.

The company could not immediately be reached for comment.

The country of over 1.3 billion people has 9.68 million infections, putting it second only to the United States for COVID-19 cases, while more than 140,000 people have died.

Lockdowns imposed to contain the spread of the virus have plunged the economy into one of its worst downturns in decades.

Serum Institute CEO Adar Poonawalla tweeted that the move to apply for emergency use “will save countless lives”, but did not give any other details.

The company declined to reply to Reuters’ follow-up questions about the process.

AstraZeneca, Pfizer and Moderna Inc are among the drugmakers seeking advanced approvals for their vaccines, which are increasingly being seen by governments as the only way to stop the pandemic.

AstraZeneca’s vaccine, called “Covishield” by Serum Institute, has less stringent storage requirements and is expected to be easier to distribute and faster to scale up in low-income countries.

But it is also facing queries from scientists over the robustness of some of its trial data, which showed a 1.5 dose regimen delivered more than 90% efficacy and a full two-dose regimen just 62%, both administered over two stages.

Britain and some other nations have pressed on with plans to roll out the AstraZeneca vaccine, while the Philippines and Thailand secured millions of doses, giving the shot a vote of confidence.

AstraZeneca said two weeks ago that it could launch an additional trial to evaluate the lower dose regimen, but Serum Institute has said it would continue to test only the two full doses as it would delay trials.

Poonawalla has said here the company will first focus on supplying the vaccine in India before distributing it to other countries, pricing it at 1,000 rupees per dose ($13.50) for private markets.

Serum Institute has also said an emergency-use approval could preface a full rollout by February or March.