Pfizer Inc and BioNTech could get an emergency authorization in the US and Europe for their Covid-19 vaccine next month after final trial results showed it had a 95% success rate and no side effects. serious, drug companies said Wednesday.
The efficacy of the vaccine was found to be consistent across ages and ethnicities, a promising sign given that the disease has disproportionately harmed the elderly and certain groups, including blacks.
The US Food and Drug Administration could grant emergency use in mid-December, BioNTech CEO Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.
“If all goes well, you could imagine we get approval in the second half of December and start deliveries before Christmas, but really only if all goes well,” he said.
The success rate of the vaccine developed by American drugmaker and German partner BioNTech was much 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 the Pfizer trial that involved more than 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 human history: less than a year from virus sequencing to large-scale clinical trial of a vaccine, as well as being based on an entirely new technique,” said Enrico Bucci, a biologist at Temple University. in Philadelphia. . “Today is a special day.”
BioNTech’s Sahin said the US (USA) emergency use authorization would be applied for on Friday.
An FDA advisory committee tentatively plans to meet Dec. 8-10 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.
Covid-19 runs rampant
The final analysis of the trial comes one week after initial results showed the vaccine to be more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday showing an effectiveness of 94.5%.
“We now have two safe and highly effective vaccines that could be cleared by the Food and Drug Administration and ready to ship in a few weeks,” said US Secretary of Health and Human Services Alex Azar.
The Moderna vaccine is likely to be licensed within seven to 10 days of Pfizer’s receipt of the US, US officials said, and states will be ready to begin distribution within 24 hours.
The better-than-expected results of the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes of ending a pandemic that has killed more than 1.3 million people and wreaked havoc on the economies and daily life.
The news was especially welcome, as the virus once again spread across the world, setting records for new infections and hospitalizations almost daily.
The Pfizer-BioNTech injection was found to be 94% effective in people over 65, a particularly high-risk group.
“This is the evidence we needed to make sure the most vulnerable people are protected,” said Andrew Hill, senior visiting researcher in the department of pharmacology at the University of Liverpool.
Global stocks rose as trial results offset concerns about the rising infection rate. Pfizer shares rose 1.6% while BioNTech rose 3.8% in the United States. Moderna’s shares fell 3.6%.
Investors have treated vaccine development as a race between companies, although there is likely to be a global demand for as much vaccine as can be produced for the foreseeable future.
Distribute shots
Pfizer said it expects to produce up to 50 million doses of vaccines this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
While some groups, such as healthcare workers, will have priority in the United States and Britain for vaccines, it will be months before large-scale deployments 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 leading emergency expert, said it would be at least 4-6 months before significant levels of vaccination occurred around the world.
The dispensing of a Pfizer-BioNTech injection is complicated by the need to store it at extremely cold temperatures of -70 degrees Celsius. However, it can 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 -20 ° C, although it is expected to be stable for 30 days at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 ° -46 ° F).
Fatigue and headaches
Pfizer said the vaccine was well tolerated and the side effects were mostly mild to moderate and disappeared quickly. The only serious adverse effects experienced by the 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 looks good,” said David Spiegelhalter, professor and expert in risk communication and testing at the University of Cambridge.
Of the dozens of drug manufacturers and research groups vying to develop Covid-19 vaccines, the next late-stage data is likely to come from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson said it is on track to release data this year.
Authorizing vaccines for children will take longer. Only Pfizer has begun vaccinating volunteers under the age of 18 and 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.
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