(Reuters) – Pfizer Inc’s PFE.N experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus 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 help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.
Pfizer and German partner BioNTech SE 22UAy.F said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance 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,” said Pfizer Chief Executive Albert Bourla.
“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,” he said.
Experts said they still wanted 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.
“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.
There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face covering set to remain for the foreseeable future.
Pfizer expects to seek U.S. emergency use authorization 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.
U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.