Iran Press/ America: US institution Pfizer and its German partner BioNTech SE are the first drugmakers to release successful data from a large-scale clinical trial of a coronavirus vaccine.
The companies said they have so far found no serious safety concerns and expect to seek U.S. authorization this month for emergency use of the vaccine.
If authorized, the number of doses will initially be limited and many questions remain, including how long the vaccine will provide protection.
However, the news provides hope that other COVID-19 vaccines in development may also prove effective, Reuters reported.
“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.”
BioNTech Chief Executive Ugur Sahin told Reuters he was optimistic the immunization effect of the vaccine would last for a year although that was not certain yet.
“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.”
The prospect of a vaccine electrified world markets with S&P 500 futures hitting a record high and tourism and travel shares surging. Stocks in European airlines such as ICAG, Lufthansa, and AirFrance KLM jumped a third.
Shares of other COVID-19 vaccine developers in the final stage of testing also rose with Johnson & Johnson up 3.3% in pre-market trading and Moderna 4.1% stronger. Britain’s AstraZeneca, however, was down 2.1% after earlier rising 0.5% on the news.
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 late this month.
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.
To save time, the companies began manufacturing the vaccine before they knew whether it would be effective. They now expect to produce up to 50 million doses, or enough to protect 25 million people this year.
Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.
The US pharmaceutical giant 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 placebo.
The efficacy rate is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.
To confirm the efficacy rate, Pfizer said it would continue the trial until there are 164 COVID-19 cases among participants. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.
Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million infections since the new coronavirus first emerged late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks and produced at scale more rapidly than conventional vaccines.
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