Pfizer Inc. and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.
The vaccine's efficacy was found to be consistent across different ages and ethnicities — a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.
The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin said. Conditional approval in the European Union could be secured in the second half of December, he added.
"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said.
The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would be acceptable. Experts said it was a significant achievement in the race to end the pandemic.
Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.
"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," said Enrico Bucci, a biologist at Temple University in Philadelphia. "Today is a special day."
BioNTech's Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.
An FDA advisory committee tentatively plans to meet from Dec. 8 to 10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.
The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc. on Monday released preliminary data for its vaccine showing 94.5% effectiveness.
"We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks," U.S. Health and Human Services Secretary Alex Azar said.
The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.
The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.
The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.
The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.
"This is the evidence we needed to ensure that the most vulnerable people are protected," said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology.
Global shares rose as the trial results countered concerns around the soaring infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. Moderna shares fell 3.6%.
Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.
Pfizer said it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
While some groups such as health care workers will be prioritized in the United States and the U.K. for vaccinations, it will be months before large-scale rollouts begin in either country.
On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.
Mike Ryan, the World Health Organization's top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.
Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultracold temperatures of minus 70 degrees Celsius. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.
Moderna's vaccine can be stored for up to six months at minus 20 C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius.
Pfizer said the vaccine was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose. Older adults tended to report fewer and milder adverse events.
"These are extraordinary results, and the safety data look good," said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.
Of the dozens of drugmakers and research groups racing to develop COVID-19 vaccines, the next late-stage data will likely be from AstraZeneca PLC with the University of Oxford in November or December. Johnson & Johnson said it is on track to deliver data this year.
Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under age 18 and as young as 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.
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