Pfizer Inc and BioNTech could get US and European emergency approval for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drug makers said on Wednesday.
The effectiveness of the vaccine was found to be consistent across different age groups and ethnic groups – a promising sign given the disease that has disproportionately hurt the elderly and certain groups, including black people.
The U.S. Food and Drug Administration could grant an emergency by mid-December, BioNTech’s chief executive Ugur Sahin told Reuters TV. The 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 could get approval in the second half of December and start deliveries before Christmas, but really only if everything goes well,” he said.
The success rate of the vaccine developed by the US drug manufacturer and German partner BioNTech was far higher than indicated by the regulatory authorities. 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 study of over 43,000 people, 162 had received a placebo and not the vaccine, which means the vaccine was 95% effective. Of the 10 people with severe COVID-19, one had received the vaccine.
“A first in human history: less than a year from the sequence of the virus to a large-scale clinical trial of a vaccine based on an entirely new technology,” said Enrico Bucci, biologist at Temple University in Philadelphia. “Today is a special day.”
BioNTech’s Sahin said the U.S. Emergency Use Approval (EUA) would be requested on Friday.
An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, said a source familiar with the situation, although the dates may change. The FDA did not respond to requests for comment.
COVID-19 RUNS IN RAMPANT
The final test analysis is done one week after initial results showed the vaccine was more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday showing 94.5% effectiveness.
“We now have two safe and highly effective vaccines that could be approved by the Food and Drug Administration and marketed within a few weeks,” said Alex Azar, US Secretary of Health.
The Moderna vaccine is expected to be approved within seven to ten days of Pfizer receiving the EUA, US officials said. States stand ready to begin distribution within 24 hours.
The better-than-expected results of the two vaccines, both developed using the new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and the economy and daily life has destroyed.
The Pfizer BioNTech shot was found to have 94% effectiveness in people over 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 researcher in the Department of Pharmacology at Liverpool University.
Global stocks rose as the trial results countered concerns about the rising infection rate. Pfizer stock was up 1.6%, while BioNTech in the US was up 3.8%. The Moderna share fell 3.6%.
Investors have viewed vaccine development as a race between companies, even though the global demand for vaccine is likely to be as much as can be made for the foreseeable future.
DISTRIBUTION OF SHOTS
Pfizer expects to deliver up to 50 million doses of vaccine this year, enough to protect 25 million people and produce up to 1.3 billion doses by 2021.
While some groups such as healthcare workers in the US and UK have priority for vaccination, it will be months before large-scale rollouts begin in both countries.
On Wednesday, Pfizer announced it had provided millions of doses to Brazil in the first half of 2021. Pfizer also has agreements with the European Union, Germany and Japan that sales could begin next year.
Mike Ryan, the World Health Organization’s leading emergency expert, said it would take at least 4 to 6 months for significant vaccinations to happen around the world.
Distribution of a Pfizer BioNTech shot is made difficult by the need to store it in ultra-cold temperatures of -70 degrees Celsius. However, it can be stored in a thermal shipping box in normal refrigeration for up to five days or up to 15 days.
Moderna’s vaccine can be stored at -20 ° C for up to six months, although it is expected to be stable for 30 days at normal refrigerator temperatures of 2 to 8 degrees Celsius.
TIRED AND HEADACHE
Pfizer said the vaccine was well tolerated and that side effects were mostly mild to moderate and resolved quickly. The only serious adverse events in volunteers were fatigue (3.8%) and headache (2%) after the second dose. Older adults tended to report fewer and milder adverse events.
“These are exceptional results and the safety data looks good,” said David Spiegelhalter, professor and expert in risk and evidence communication at the University of Cambridge.
Of the dozen of drug companies and research groups battling to develop COVID-19 vaccines, the next late-stage data is likely to come from AstraZeneca Plc with Oxford University in November or December. Johnson & Johnson said it is on track to deliver data this year.
It will take longer to approve vaccines for children. Only Pfizer has started vaccinating volunteers under the age of 18 and ages 12 and over. Moderna and J&J have announced that they hope to have the vaccine tested in younger people soon.
(This story was not edited by GossipMantri staff and is automatically generated from a syndicated feed.)