US FDA approves emergency use of Pfizer-BioNTech COVID-19 vaccine, Trump says rollout in next 24 hours

File image: Pfizer's COVID-19 vaccine

The US Food and Drug Administration (FDA) on December 11 approved the Pfizer-BioNTech COVID-19 vaccine for emergency use, and President Donald Trump said the rollout could begin "in less than 24 hours".

This is the first COVID-19 vaccine candidate that has been granted emergency use authorisation (EUA) in the Unites States, the country most affected by the pandemic.

The US has so far recorded nearly 16 million (1.6 crore) cases of the novel coronavirus and nearly 300,000 (3 lakh) deaths.

In a video statement released on Twitter, Trump said the US will start administering the Pfizer-BioNTech COVID-19 vaccine "in less than 24 hours" and will be "free for all Americans".

Also read: Serum Institute 'hopeful' of EUA by December-end, India vaccination drive could begin from January, says Adar Poonawalla

"Through our partnership with FedEx and UPS, we have already begun shipping the vaccine to every state and zip code in the country," he said, adding that governors would decide who would receive the shots first in their states.

US pharmaceutical giant Pfizer developed the vaccine against COVID-19 along with German company BioNTech. The mRNA vaccine candidate, administered in two doses, has been found to be 95 percent effective in preventing the disease.

"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," FDA Commissioner Stephen M Hahn said in a statement on December 11.

"We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year," Pfizer Chairman and CEO Dr Albert Bourla said in a statement.

Also read: Explainer | Where are we in the COVID-19 vaccine race?

About 3 million doses of the vaccine are expected in the first shipments around the US, officials with Operation Warp Speed told Associated Press. Operation Warp Speed is the Trump administration's COVID-19 Vaccine development programme.

The vaccine candidate from Moderna is the second application being considered by the US FDA for emergency approval.

BioNTech CEO Ugur Sahin told Reuters that the biggest challenge now is scaling manufacturing to meet the massive demand.

UK residents began receiving doses of the Pfizer-BioNTech vaccine on December 8, after the jab received emergency use authorisation in the country. Canada, Mexico, Saudi Arabia and Bahrain have also approved the vaccine candidate for emergency use.

Pfizer has also sought EUA for the jab in India, and has submitted an application to the Drugs Controller General of India (DCGI).

Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech have also applied for EUA in India. SII has partnered with British-Swedish drugmaker AstraZeneca and the University of Oxford to conduct trials and manufacture their COVID-19 vaccine in India.