Pfizer announced that the ongoing Phase 3 study for its coronavirus disease (COVID-19) vaccine candidate has successfully met all of its primary efficacy endpoints on Wednesday, November 18.
In a completed analysis of their experimental BNT162b2, an mRNA-based COVID-19 vaccine, they found out that it has protected 95% of people against the disease. They also announced that they will be applying for the US emergency approval “within days.”
The US pharmaceutical company and its German partner, BioNTech, brought further hope to a world upended by the coronavirus pandemic with the announcement, which follows a week after they said a preliminary analysis showed the product was 90% effective.
Consistent across all age-group
Adding to the encouraging data was that the efficacy was found to be consistent across all age-groups – a primary concern for a disease that hits the elderly the hardest – as well as genders and ethnicities.
“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,” said Pfizer CEO Albert Bourla.
“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” he added.
Clinical trial update
Wednesday’s news came after 170 people fell sick in an ongoing clinical trial of almost 44,000 people – 162 of whom were in a placebo group, and 8 of whom received the two-dose medicine.
Out of the 170 patients who became sick, ten developed severe COVID-19 – 9 in the placebo group and one in the vaccine group.
The new data showed the vaccine was generally well tolerated, with most side-effects short-lived and either mild or moderate.
About 4% experienced severe fatigue, and 2% got severe headaches after their second dose.
Older patients had fewer and milder side-effects.
Pfizer vaccine to produce “50 million doses this year”
The preliminary analysis announced last week had been based on data from 94 sick people, and the companies say the additional patients have now given them a complete picture.
The ongoing late-stage trial is taking place at 150 global sites in the US, Germany, Turkey, South Africa, Brazil and Argentina.
The trial will continue for another two years to find out how long immunity lasts and whether there are longer-term safety issues.
The vaccine could start reaching the first Americans – frontline workers, the elderly and other high-risk people – in the first half of December if the FDA will issue an emergency use authorization.
The US has said it expects it to be available to the general population by April.
Pfizer and BioNTech said they expect to produce 50 million doses of its COVID-19 vaccine this year and 1.3 billion by the end of 2021.
- AGENCE FRANCE-PRESSE (AFP). 18 November 2020. Pfizer, BioNTech say results show COVID-19 vaccine 95% effective
- Pzifer News. 18 November 2020. Our COVID-19 Vaccine Study – What’s Next?