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Pfizer released a first snapshot of its Phase 3 studies for its coronavirus vaccine on Monday and said the results look promising with data suggesting it is 90% effective at preventing the virus.
The company and its collaborator BioNTech may now be on track to file an emergency use application with U.S. regulators in late November, as stated earlier.
Read more:
Pfizer’s coronavirus vaccine may be 90% effective, early data suggest
However, the announcement doesn’t mean a vaccine is fast approaching, experts warn.
“We are not doing very well in the fight against COVID-19. The numbers continue to rise in Canada and around the world, ”said Kerry Bowman, professor of bioethics and global health at the University of Toronto.
“This is wonderful news to hear. … Psychologically we needed good news. However, we must be cautious enough, as the data is not complete and there are still some questions pending. “
This is because Pfizer only provided a glimpse of the data and warned that the initial protection rate could change after the study ends.
What does Phase 3 COVID-19 data say?
Monday’s interim analysis, by an independent data monitoring committee, looked at 94 confirmed cases of COVID-19 among volunteers who had received two doses of the vaccine or a placebo.
The Phase 3 clinical trial of the vaccine, named “BNT162b2”, began on July 27 and enrolled 43,538 participants – 38,955 of whom received a second dose of the candidate vaccine as of November 8.
“About 42 percent of global participants and 30 percent of US participants have racially and ethnically diverse backgrounds,” Pfizer said in its statement.
READ MORE: Pfizer may seek emergency approval of its OCIVD-19 vaccine in late November
According to the results, the study found that less than 10 percent of infections were in participants who were given the vaccine, a strong signal of effectiveness. More than 90% of the cases involved people who had been given a placebo.
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Pfizer said the vaccine provided protection seven days after the second dose and 28 days after the initial dose of the vaccine.
The company also said that – so far – no participant has become seriously ill.
What hasn’t been revealed?
“There are still some questions hanging in the air,” Bowman said. “How long does the vaccine work? We don’t know, but let’s hope it’s at least a year. “
Bowman said there is also a possibility that study participants may have contracted the virus but are showing no symptoms.
According to Pfizer, participants were only tested if they developed symptoms, leaving no response if vaccinated people could be infected but show no symptoms and unknowingly spread the virus.
Infection control epidemiologist Colin Furness, an assistant professor at the University of Toronto, said there is still a lot of data that needs to be examined. He said he would like to know what the experience was for the participants who received the COVID-19 vaccine and still have the virus.
“I would like to know whether or not it was a mild case of coronavirus,” he said. “All these data should be released, such as the demographics, who got sick and of course what the vaccine side effects are. Pfizer needs to be very transparent about it. “
The data has yet to be peer-reviewed or published in a medical journal. Pfizer said it will do so once it has the results of the entire process.
‘Cautiously Optimistic’
While the data is promising, Bowman said it is best for everyone to remain “cautiously optimistic” as there are still many unknowns.
“We have to be careful enough. We are looking into the public relations of a pharmaceutical company whose main focus is marketing and profit, “he said.” I’m not saying I don’t believe it, but you have to realize that the complete data has not been released. They are telling us. what the data says, so experts have yet to review it. “
But, he said, by the end of November, Pfizer could publish more results and then “we will be able to review the bigger picture.”
Read more:
A coronavirus vaccine is almost ready. But do you take it?
He also stressed the importance of not rushing a vaccine due to the “hesitation” surrounding inoculation.
Furness agreed.
As “political interference” could lead to speeding up a vaccine, Furness said, companies like Pfizer are aware that “public confidence may falter.”
“So they have to counter that by being very transparent, letting everyone know the data, releasing all the information,” he said. “Pharmaceutical companies usually want to protect their research. It’s the way to work … but transparency is very important in this case. “
What comes next?
Pfizer said it does not intend to stop its study until it registers 164 infections among all volunteers, a number the U.S. Food and Drug Administration (FDA) has agreed is enough to tell how well the vaccine is working. The agency made it clear that any vaccine must be at least 50% effective.
“The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had previous exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease,” he says. the company declaration.
The company expects its “safety data” following the second and final dose of the vaccine to be available by the third week of November.
“Based on current projections, we plan to globally produce up to 50 million doses of the vaccine in 2020 and up to 1.3 billion doses in 2021,” the company said (enough to vaccinate 650 million people as it is a double dose).
Canada signed an agreement with Pfizer in August to secure 20 million doses of the coronavirus vaccine in 2021.
Speaking at a press conference on Monday, Prime Minister Justin Trudeau said he hoped the vaccine would be introduced in early 2021.
Bowman said that because coronavirus rates are soaring in places like the United States and Canada, this means there’s a positive lining: more people can volunteer for trials. Remain optimistic that not only Pfizer is achieving positive results, but other companies as well.
READ MORE: Pfizer will include 12-year-old participants in COVID-19 vaccine studies
“This could be great news, and other vaccines could start working too, so we could have a situation where there is a combination of vaccines or you can ‘make your choice,'” he said.
However, he pointed out that despite Pfizer’s promising data, that doesn’t mean it’s over. It means we’re on an “up trend,” he said.
“We are not yet returning to normal life. It will take time and research, but boy, we needed this good news. “
– With Associated Press files
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© 2020 Global News, a division of Corus Entertainment Inc.
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