Wednesday, November 18th 2020, 11:15 am - The pharmaceutical giant expects to seek broad U.S. authorization for emergency use of the vaccine for people aged 16 to 85.
By Michael Erman and Julie Steenhuysen
(Reuters) - Pfizer Inc's <pfe.n> experimental COVID-19 vaccine was more than 90% effective based on initial trial results, the company said on Monday, a major victory in the fight against a pandemic that has killed over a million people and battered the world's economy.
Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could halt the pandemic though mass roll-outs of the shot, which needs regulatory approval, won't happen this year.
Pfizer and its German partner BioNTech SE <bntx.o> said they had so far found no serious safety concerns and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the possibility of a regulatory decision as soon as December.
If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
"Today is a great day for science and humanity," Albert Bourla, Pfizer's chairman and chief executive, said.
"We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."
Experts cautioned that they still needed to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging so far.
There are still many questions around the vaccine, such as how effective it is for vulnerable groups and how long it will provide immunity, and the "new normal" of social distancing and face masks looks set to remain for the foreseeable future.
BioNTech Chief Executive Ugur Sahin told Reuters he was optimistic the immunisation effect of the vaccine would last for a year though that was not yet certain.
"This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general," said Peter Horby, professor of emerging infectious diseases at the University of Oxford.
FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo
The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil majors and travel companies soared. Pfizer shares were 8.6% higher in New York at 1450 GMT, while BioNTech's stock was up 11%.
Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson <jnj.n> up 4.5% and Moderna <mrna.o> 5.5% stronger. Britain's AstraZeneca <azn.l> was down 3.5%.
"The efficacy data are really impressive. This is better than most of us anticipated," said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine, Nashville, Tennessee. "The study isn't completed yet, but nonetheless the data look very solid."
U.S. President Donald Trump welcomed the test results, and the market boost: "STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!" he said on Twitter.
STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!— Donald J. Trump (@realDonaldTrump) November 9, 2020
President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.
WATCH BELOW: WHEN A MASK GETS WET, CAN IT STILL PROTECT YOU?
1.3 BILLION DOSES
Pfizer expects to seek broad U.S. authorization for emergency use of the vaccine for people aged 16 to 85. To do so, it will need two months of safety data from about half the study's 44,000 participants, which is expected in the third week of November.
"I'm near ecstatic," Bill Gruber, one of Pfizer's top vaccine scientists, said in an interview. "This is a great day for public health and for the potential to get us all out of the circumstances we're now in."
To break the dynamic of the spread of the coronavirus, between 55% and 65% of the population will need to be vaccinated, Germany's health minister Jens Spahn told a news conference on Monday, adding that he doesn't expect a shot to be available before the first quarter of 2021.
Pfizer and BioNTech have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.
The U.S. drugmaker said the interim analysis was conducted after 94 participants in the trial developed COVID-19, examining how many of them had received the vaccine versus a placebo.
Pfizer did not break down exactly how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.
The efficacy rate is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.