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(Reuters) – Pfizer Inc said on Wednesday that the final results of the last stage of the trial of its COVID-19 vaccine show it was 95% effective, adding that it had the required two months of safety data and would request the US emergency clearance days.
The drug maker said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnic demographics, and there were no major side effects, a sign that immunization could be used widely across the world. world.
Efficacy in adults over 65, who are at particular risk from the virus, was greater than 94%.
The final analysis comes just one week after the initial trial results showed the vaccine to be more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing similar effectiveness.
Better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes of ending a resurgent pandemic that has killed more than 1.3 million people worldwide. and it has wreaked havoc on economies and daily life.
However, while some groups, such as healthcare workers, will have priority in the United States for vaccines this year, it will be months before large-scale deployments begin.
Pfizer said Wednesday there had been 170 cases of the disease in its trial out of more than 43,000 volunteers, of which 162 were seen in the placebo group and 8 in the vaccine group.
Ten people developed severe COVID-19, one of whom received the vaccine.
He also said that the vaccine was well tolerated and that the side effects were mostly mild to moderate and disappeared quickly.
The only serious adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer solicited and milder adverse events after vaccination.
The results come as the virus spreads rampant in the United States, Europe, and elsewhere, putting enormous pressure on healthcare systems with a record number of new cases and hospitalizations.
The arrival of winter in the Northern Hemisphere along with the Christmas season is expected to worsen the number of cases as people spend more time indoors and gather for family gatherings.
“With hundreds of thousands of people around the world infected every day, we urgently need to bring a safe and effective vaccine to the world,” Pfizer CEO Albert Bourla said in a statement.
Pfizer and BioNTech also said they plan to send the data to other regulatory agencies around the world and in the United States. They also plan to submit data from the study to a peer-reviewed scientific journal.
Pfizer reiterated that it expects to produce up to 50 million doses of vaccines this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of drug manufacturers and research groups competing to develop COVID-19 vaccines, 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 release data this year.
Information from Michael Erman in Maplewood, NJ, Additional information from Ankur Banerjee in Bengaluru; Editing by Bill Berkrot, Peter Henderson and Edwina Gibbs
