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Pfizer applies for US emergency approval of coronavirus vaccine

  • ‘We literally could be weeks away from the authorisation’ if the data is solid, says US Health Secretary Alex Azar
  • The Food and Drug Administration is tentatively planning advisory meetings for three days from December 8 to discuss vaccines
Pfizer and BioNTech recently reported comprehensive trial results that showed a 95 per cent effectiveness in preventing Covid-19. Photo: AFP/Getty Images/TNS

Pfizer said on Friday it has applied to US health regulators for emergency approval of its Covid-19 vaccine, in a major milestone to inoculate the population against the virus that has claimed lives and disrupted the economy.

The Food and Drug Administration (FDA) is tentatively planning advisory meetings for three days from December 8 to discuss vaccines ahead the potential approval of the Pfizer candidate, developed with German partner BioNTech.

“We literally could be weeks away from the authorisation of a 95 per cent effective vaccine,” if the data is solid, US Health Secretary Alex Azar said on CBS This Morning, referring to the Pfizer candidate.

If approved, the vaccine, which uses a new method known as messenger RNA (mRNA), will become the first to clear the US regulatory threshold since the pandemic began early this year.

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The production of the vaccine is ongoing with 50 million doses expected by the end of the year, the New York-based pharmaceutical company said. It will likely to be rolled out in phases, first going to health care workers, the elderly and people with underlying health conditions.

The application comes after Pfizer and BioNTech reported the comprehensive trial results that showed a 95 per cent effectiveness in preventing Covid-19 with no major safety concerns just two days ago. The FDA had set the minimum bar for efficacy at 50 per cent.

The final analysis evaluated 170 confirmed Covid infections among 43,000 participants in the late-stage trial. The companies said 162 cases were observed in the placebo group, while only eight cases were observed in the group that received its two-dose vaccine.

Pfizer said nearly 42 per cent of global participants and 30 per cent of US participants in the Phase 3 study have racially and ethnically diverse backgrounds.

Vaccines developed with the mRNA technology had a head start because it required just the sequencing of the virus, which was made available as early as January by Chinese scientists, to develop the candidates.

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“You can very quickly get development candidates out,” said Jacob Becraft, founder of Strand Therapeutics, a Cambridge, Massachusetts-based biotech firm using mRNA technology to develop treatments.

The method is designed to trigger the immune system to generate antibodies to fight the virus.

But Becraft said the “manufacturing and distribution are going to be challenging”.

“The mRNA industry is very young and the supply chains are not super well thought out. The reagents are very limited,” said Becraft.

Pfizer said earlier this month the company is on track to produce up to 50 million doses this year and up to 1.3 billion doses in 2021, which could inoculate up to 650 million people.

The companies said they can begin shipping doses almost immediately after the approval.

Pfizer said that the US agreed to buy 100 million doses for up to US$1.95 billion, with an option to buy an additional 500 million doses.

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“Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Pfizer CEO Albert Bourla said in a Friday statement.

Another biotech firm Moderna, based in Cambridge, Massachusetts, announced the trial results of its Covid-19 vaccine four days ago, saying it was 94.5 per cent effective. The study analysed 30,000 participants.

The Moderna candidate also uses the mRNA technology. The company said it intended to file “in the coming weeks” with the FDA for authorisation for emergency use.

The coronavirus continued to sweep across the US, infecting more than 11.7 million and killing more than 253,000 as of Friday, according to Johns Hopkins University.