Pfizer deliveries could start before Xmas

Michael Erman and Ludwig Burger
·3-min read

Pfizer Inc and BioNTech could secure emergency US and European authorisation for their COVID-19 vaccine next month after final trial results showed a 95 per cent success rate and no serious side effects.

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including black people.

The US Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin said on Wednesday.

Conditional approval in the European Union could be secured in the second half of December, he added.

"If all goes well I could imagine we gain approval in the second half of December and start deliveries before Christmas but really only if all goes positively," he said.

The success rate of the vaccine developed by the US drugmaker and German partner was far higher than what regulators had said would have been acceptable.

Experts said it was a significant achievement in the race to end the pandemic.

Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95 per cent effective.

Of the 10 people who had severe COVID-19, one had received the vaccine.

"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," said biologist Enrico Bucci at Philadelphia's Temple University.

"Today is a special day."

BioNTech's Sahin said US emergency use authorisation (EUA) would be applied for on Friday.

An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, a source familiar with the situation said.

The final trial analysis comes a week after initial results showing the vaccine more than 90 per cent effective.

Moderna Inc on Monday released preliminary data for its vaccine showing 94.5 per cent effectiveness.

"We now have two safe and highly effective vaccines that could be authorised by the Food and Drug Administration and ready to distribute within weeks," US Health and Human Services Secretary Alex Azar said.

The Moderna vaccine is likely to be authorised within seven to 10 days of Pfizer receiving its EUA, US officials said, with states ready to begin distribution within 24 hours.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The news was especially welcome with the virus running rampant around the world, setting records for new infections and hospitalisations almost daily.

The Pfizer-BioNTech shot was found to have 94 per cent efficacy in people over 65, a particularly high-risk group.

Pfizer said it expects to make up to 50 million vaccine doses this year, enough to protect 25 million people, and produce up to 1.3 billion doses in 2021.