Home >News >World >Pfizer-BioNTech Covid vaccine shot proves 95% effective, ready for regulators
Syringes are seen in front of displayed BioNtech and Pfizer logos in this illustration (Reuters)
Syringes are seen in front of displayed BioNtech and Pfizer logos in this illustration (Reuters)

Pfizer-BioNTech Covid vaccine shot proves 95% effective, ready for regulators

  • The US drugmaker and partner BioNTech SE said their vaccine protected people of all ages
  • The companies plan to submit within days to the FDA for Emergency Use Authorization and share data with other regulatory agencies around the globe

Pfizer Inc on Wednesday said a final analysis of clinical-trial data showed its Covid-19 vaccine was 95% effective, paving the way for the company to apply for the first US regulatory authorization for a coronavirus shot within days.

The US drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that included almost 44,000 participants.

"The Phase 3 study of our Covid-19 vaccine candidate has met all primary efficacy endpoints. The study reached 170 confirmed cases of Covid-19, with the vaccine candidate BNT162b2 demonstrating 95% efficacy beginning 28 days after the first dose," Pfizer said.

The companies plan to submit within days to the FDA for Emergency Use Authorization (EUA) and share data with other regulatory agencies around the globe.

The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

The only severe 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 and milder solicited adverse events following vaccination.

The results come as the virus is running rampant in the United States, Europe and elsewhere, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.

The approach of winter in the northern hemisphere in tandem with the holiday season is expected to worsen case numbers as people spend more time indoors and get together for family gatherings.

Pfizer shares rose 2.7% in premarket trading, with BioNTech American depositary receipts up 7.3%. European stocks extended their gains after the news, with the Stoxx Europe 600 up 0.4%.

“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 Albert Bourla, Pfizer chief executive, adding that the companies were sharing the data with regulators around the world.

“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 Albert Bourla, Pfizer chief executive, adding that the companies were sharing the data with regulators around the 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 fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection," said Ugur Sahin, MD, CEO and Co-founder of BioNTech.

In global phase 3 trials, 170 were observed to have contracted coronavirus, out of which 162 had been given a placebo, the companies said. Just eight of those who had received two shots of the BioNTech-Pfizer vaccine developed the disease and only one became seriously ill, while nine of the placebo group developed severe Covid-19.

The update is the latest in a string of promising developments on the vaccine front in recent days. Moderna Inc.’s rival jab appears equally effective, judging from data published earlier this week, and a third contender, from AstraZeneca Plc and the University of Oxford, is expected to release trial results in coming days.

The vaccine’s efficacy in people older than 65 was more than 94%, the companies said.

Most people who received the shot tolerated it well. Severe fatigue was seen in 3.7% of volunteers after the second dose in the two-shot regimen, but that was the only severe side effect that occurred in more than 2% of people, according to the analysis.

"Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network," the company said.

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.


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