US drugmaker and partner BioNTech SE reported that no safety problems have been witnessed so far in a trial that involved as many as 44,000 participants and that their vaccine can protect people of all age groups and ethnicities.
"We are proud to announce, along with BioNTech, that the Phase 3 study of our Covid-19 vaccine candidate has met all primary efficacy endpoints," Pfizer said.
Within days, it plans to submit the vaccine to the FDA for Emergency Use Authorization (EUA). The company will also share data with other regulatory authorities around the globe.
The production is expected to be of a global scale with 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
Pfizer's shares have gone up by 2.7% in premarket trading, with BioNTech American depositary receipts up 7.3%.
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In the phase 3 trials conducted globally, 170 candidates having coronavirus were observed. 162 were given a placebo and only eight received two shots of the BioNTech-Pfizer vaccine and developed the disease - one became seriously ill, while nine in the placebo group had severe Covid-19.
Several promising developments are being reported in the vaccine candidates. Moderna Inc.’s vaccine is stated to be as effective, while the third rival from AstraZeneca Plc and the University of Oxford is also expected to release trial results in the coming days.
In people older than 65, the vaccine's efficacy is reported to be more than 94%.
In people who underwent trials, severe fatigue was seen in 3.7% of volunteers after the second dose in the two-shot routine. That, however, is the only severe side effect to occur in over 2% of people, the analysis shows.