Pfizer Inc said Wednesday that a final analysis of clinical trial data showed that its Covid-19 vaccine was 95% effective, paving the way for the company to apply for the first U.S. regulatory clearance for a vaccine. against the coronavirus in a few days.
US drugmaker and partner BioNTech SE said its vaccine protected people of all ages and ethnicities, without significant safety concerns so far in a trial that included nearly 44,000 participants.
“The phase 3 study of our Covid-19 vaccine candidate has met all primary efficacy endpoints. The study reached 170 confirmed Covid-19 cases, and the BNT162b2 vaccine candidate demonstrated 95% efficacy at starting 28 days after the first dose, “said Pfizer. .
The companies plan to submit to the FDA for Emergency Use Authorization (US) within days and share data with other regulatory agencies around the world.
The companies expect to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses by the end of 2021.
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 approaching 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.
Pfizer shares were up 2.7% in premarket trading, and BioNTech American’s depository receipts were up 7.3%. European stocks extended their gains after the news, with the Stoxx Europe 600 rising 0.4%.
“The results of the study mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic,” said Albert Bourla, CEO of Pfizer, adding that the companies were sharing the data. with regulators across the country. world.
“The results of the study mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic,” said Albert Bourla, CEO of Pfizer, adding that the companies were sharing the data. with regulators across the country. world.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very quickly after the first 30 µg dose, underscoring the power of BNT162. to provide early protection. ” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
In global phase 3 trials, 170 were found to have contracted coronavirus, of which 162 had received a placebo, the companies said. Only eight of those who had received two injections of the BioNTech-Pfizer vaccine developed the disease and only one became seriously ill, while nine from the placebo group developed severe Covid-19.
The update is the latest in a series of promising developments on the vaccine front in recent days. Moderna Inc.’s rival coup appears equally effective, judging from data released earlier this week, and a third contender, from AstraZeneca Plc and the University of Oxford, is expected to release the test results in the coming days. .
The vaccine’s efficacy in people 65 and older was more than 94%, the companies said.
Most of the people who received the injection tolerated it well. Severe fatigue was seen in 3.7% of volunteers after the second dose in the two-injection regimen, but that was the only serious side effect that occurred in more than 2% of people, according to the analysis.
“Pfizer relies on its vast experience, expertise and existing cold chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed temperature controlled heat carriers that use dry ice to maintain temperature conditions of -70 ° C. ± 10 ° C. They can be used as temporary storage units for 15 days by filling them with dry ice. Each sender contains a thermal sensor with GPS to track the location and temperature of each vaccine shipment on its pre-established routes taking advantage of the wide distribution of Pfizer network, “the company said.
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.
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