Coronavirus: Pfizer and BioNtech to seek emergency US approval ‘within days’ after better-than-expected test results

Josephine Ma
·4-min read

Pfizer and BioNtech announced on Wednesday that their Covid-19 vaccine had achieved 95 per cent efficacy in its final clinical trials.

The two companies said there was sufficient data to meet the requirements of the US drug regulator and they would submit an application for emergency use authorisation “within days”.

Last week the two companies said interim results from the phase three trials showed that its efficacy level was above 90 per cent, which scientists said was above expectations.

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Another US company using similar genetic technology, Moderna, also announced on Tuesday that its vaccine has an efficacy level of 94.5 per cent, raising hopes that other vaccines would also prove effective.

A Russian vaccine, Sputnik V vaccine has reported a 92 efficacy rate, but scientists say it is based on just 20 Covid-19 cases in trials – a number too small to reach any firm conclusion.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, chairman and chief executive of Pfizer said.

”We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Pfizer, an American company, and the German firm BioNTech were the first to release data from their large-scale clinical trials for the experimental vaccine, and said they expect to produce up to 50 million doses this year, which would cover 25 million people. By the end of next year, they expect to produce up to 1.3 billion doses.

Vaccines will be critical in easing the global pandemic, which has so far caused more than 55 million confirmed cases and more than 1.3 million deaths worldwide.

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The US has been particularly hard hit, with more than 1,000 coronavirus deaths reported each day. Millions have lost their jobs amid partial lockdowns aimed at containing the spread of the deadly virus.

The World Health Organization and regulators such as those in the US and China had originally called for vaccines to be at least 50 per cent effective, so the latest vaccine study findings have far exceeded expectations.

But concerns remain about vaccine safety and distribution, including access for developing countries. The global collaboration Covax has responded by raising more than US$2 billion from richer nations to purchase vaccines for poorer countries.

Pfizer said the candidate vaccine’s efficacy was consistent across different ages, genders and ethnic groups. Its efficacy among over-65s – the most vulnerable group – was 94 per cent.

Among the trial’s 43,000 volunteers, there were 170 confirmed cases, 162 of which came from the placebo group.

The team said there were 10 severe cases reported in the trials, with nine of them in the placebo group and one in the vaccinated group.

They said the study had raised no major safety concerns. In a subgroup of 8,000 participants where side effects were observed, the only serious ones were fatigue and headache.

The result puts the vaccine – which uses a genetic material known as mRNA to trigger an immune response – in pole position to win approval for emergency use from the US Food and Drug Administration.

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The Chinese government has already approved the emergency use of vaccines that are still undergoing phase three clinical trials.

While scientists are thrilled about the results from the Pfizer and Modena trials they say it is important to see how long the immune response lasts.

Pfizer stock rose by 2.86 per cent to US$36 in pre-market trading on Wednesday after the announcement.

The US government has already secured a US$1.95 billion agreement with Pfizer and BioNTech to provide 100 million doses at no cost to the American public, with an allowance to acquire an additional 500 million.

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