Pfizer says it is days away from applying for emergency use approval with the US Food and Drug Administration for its coronavirus vaccine.
The US-based pharmaceutical company has revealed its COVID-19 vaccine is 95 per cent effective and that two months’ worth of safety data showed there were no major side effects.
The company could secure emergency US and European authorisation for their vaccine next month.
The news raises hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally.
Australia has secured 10 million doses of the two-dose Pfizer vaccine, meaning five million people would be covered.
The final analysis from a late-stage trial shows the vaccine was more than 94 per cent effective in adults over 65 years who have an increased risk of dying from the virus.
Pfizer CEO Albert Bourla said it “urgently” needs to “get a safe and effective vaccine to the world” and would apply for emergency US authorisation within days.
Some groups will be prioritised but it will be months before large-scale rollouts begin.
The news comes just two days after Moderna revealed the effectiveness of its experimental vaccine rose to 94.5 per cent, and one week after Pfizer’s candidate was found to be more than 90 per cent effective.
Pfizer plans to submit its final data to other regulatory agencies around the world as well as the US after concluding Phase 3 of its study, which it said had met all primary efficacy endpoints.
Philadelphia-based biologist Enrico Bucci was quoted by the ABC as saying “today is a special day”.
“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,” he said.
On Wednesday night, Pfizer revealed there had been 170 cases of the disease in its trial of more 43,000 volunteers of which 162 were observed in the placebo arm and eight were in the vaccine group.
Ten people developed severe COVID-19, one of whom received the vaccine.
It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.
The only severe adverse event that affected more than 2 per cent of those vaccinated was fatigue, which affected 3.7 per cent of recipients after the second dose.
Older adults tended to report fewer and milder solicited adverse events following vaccination.
Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
It hopes to submit data from the study to a peer-reviewed scientific journal.
Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.