Pfizer seeks emergency approval from US regulators for vaccine

WASHINGTON: Pfizer said on Friday it is asking US regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until ater a long, hard winter.

The action comes days ater Pfizer Inc. and its German partner Biontech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

Unless some nasty surprises turn up, Pfizer’s action on Friday could be the first step towards vaccinating the most vulnerable Americans by December end.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorisation, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the UK and intend to submit similar information soon.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

With the coronavirus surging around the US and the world, the pressure is on for regulators to make a speedy decision.

“Help is on the way,” Dr Anthony Fauci, the top US infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”

Britain has also formally asked its medical regulator, the MHRA, to assess the vaccine being produced by Pfizer Inc and its German partner Biontech, Health Minister Mat Hancock said on Friday.

Meanwhile, the UAE Ministry of Health and Prevention (MOHAP) on Friday announced 1,269 new coronavirus cases, taking the overall tally in the country to 156,523.

The UAE Health Ministry also announced three deaths due to COVID-19 complications, bringing the total number of fatalities in the country to 547.

The MOHAP also noted an additional 840 individuals had fully recovered from COVID-19, bringing the total number of recoveries to 147,309.

India’s coronavirus caseload passed nine million on Friday, as hospitals in the capital New Delhi came under increasing pressure and graveyards began to fill up.

The head of an Indian company contracted to make Astrazeneca Plc’s COVID vaccine said it could deliver it to health care workers and elderly Indians by January as the country’s caseload of infections crossed nine million on Friday.

The Serum Institute of India, the world’s largest vaccine manufacturer, has already manufactured millions of doses of the vaccine that is being developed in collaboration with Oxford University while results from late-stage trials are awaited.

The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said.

“The companies will be ready to distribute the vaccine candidate within hours ater authorisation,” their statement said.

The Food and Drug Administration has not said how long it will take to study the vaccine data, but the government expects to give the green light for the vaccine in the first two weeks of December.

Pfizer and another US company, Moderna, have broken all vaccine development speed records in their race for a cure over the last nine months.

US regulators are standing by for the approval process while coronavirus cases are surging to record levels across all the 50 states.

Pfizer’s submission also includes safety data on approximately 100 children aged 12-15 years.

The US government says it plans to vaccinate more than 20 million people in December, and then another 25-30 million per month.

Adding to the encouraging 95 per cent efficiency data for the Pfizer product is the fact that efficacy was found to be consistent across all age-groups — a primary concern for a disease that hits the elderly the hardest — as well as genders and ethnicities.

In a separate development, researchers at the University of Oxford said on Friday that individuals infected with coronavirus are unlikely to catch the illness again for at least six months. The finding comes as part of a large-scale study into COVID-19 reinfection ater observations from healthcare professionals that the phenomenon was relatively rare.

Oxford University Professor David Eyre, one of the authors of the study, called the findings “really good news.”

“We can be confident that, at least in the short term, most people who get COVID-19 won’t get it again,” he said.

The World Health Organisation ( WHO) welcomed the study saying the findings extended its understanding of coronavirus protection.