Pfizer says an early peek at its vaccine data suggests the shots may be 90 per cent effective at preventing COVID-19, indicating the company is on track later this month to file an emergency use application with U.S. regulators. The vaccine is among seven that Canada has pre-ordered.
Monday’s announcement doesn’t mean a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.
Pfizer Inc. did not provide any more details about those cases, and cautioned the initial protection rate might change by the time the study ends. Even revealing such early data is highly unusual.
“We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice-president of clinical development, told The Associated Press. “We’re very encouraged.”
Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and limited initial supplies will be rationed.
Both U.S. President Donald Trump and president-elect Joe Biden commented on the news from Pfizer early Monday.
Biden greeted the early results with enthusiasm, but warned that widespread vaccination remains months away and Americans need to continue wearing masks and maintain physical distancing.
“Today’s news is great news, but it doesn’t change that fact,” Biden said in a statement. “Today’s announcement promises the chance to change that next year, but the tasks before us now remain the same.”
Trump hailed the development on Twitter.
STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!
Prime Minister Justin Trudeau said the announcement was “very encouraging.”
“We hope a vaccine is coming early next year. We’re seeing a light at the end of the tunnel,” he told a news conference. Canada has a deal with Pfizer for a minimum of 20 million doses of the vaccine.
No serious safety concerns reported
The shots made by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in late-stage testing around the world — four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., also has said it hopes to be able to file an application with the Food and Drug Administration later this month.
Volunteers in the final-stage studies, and the researchers, don’t know who received the real vaccine or a dummy shot. But a week after their second required dose, Pfizer’s study began counting the number who developed COVID-19 symptoms and were confirmed to have the coronavirus.
Because the study hasn’t ended, Gruber couldn’t say how many in each group had infections.
Pfizer did not break down exactly how many of those who fell ill received the vaccine. The 90 per cent effectiveness implies that no more than eight of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.
Pfizer doesn’t plan to stop its study until it records 164 infections among all the volunteers, a number that the FDA has agreed is enough to tell how well the vaccine is working. The agency has made clear that any vaccine must be at least 50 per cent effective.
The results have not been peer-reviewed by outside experts or published in a medical journal. The vaccine developers have not publicly shared details about how the vaccine performed according to independent monitors overseeing the study.
Pfizer said its data would be peer reviewed once it has results from the entire trial.
WATCH | Early data on vaccine effectiveness
Pfizer says an early peek at its vaccine data suggests the shots may be 90 per cent effective at preventing COVID-19, but the announcement doesn’t mean a vaccine is imminent. 3:55
Montreal epidemiologist cardiologist Dr. Christopher Labos said the results so far are “encouraging.”
“Now the one question, the one caveat that we’re going to have with this vaccine is how long does the immunity last?” he said.
No participant so far has become severely ill, Gruber said. He could not provide a breakdown of how many of the infections had occurred in older people, who are at highest risk from COVID-19.
Paul Hunter, a professor of medicine at the University of East Anglia, said the company’s press release suggests the vaccine’s effectiveness seven days after the second dose at preventing infection.
“If this remains the case after the final analysis and the paper passes peer review, then this is a remarkable result,” Hunter said. “The press release suggests that the 90 per cent effectiveness is at preventing infection and not just serious illness. A vaccine that prevents infection would also dramatically reduce transmission of the virus providing that immunity lasts for at least a year or more.”
U.S. vaccines must be studied in at least 30,000 people
Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus.
The FDA has required that U.S. vaccine candidates be studied in at least 30,000 people. In addition to adequate numbers of older adults, those studies must also include other groups at high risk, including minorities and people with chronic health problems.
And it told companies they must track half their participants for side effects for at least two months, the time period when problems typically crop up. Pfizer expects to reach that milestone later this month, but said Monday no serious safety concerns have been reported.
Because the pandemic is still raging, manufacturers hope to seek permission from governments around the world for emergency use of their vaccines while additional testing continues — allowing them to get to market faster than normal but raising concerns about how much scientists will know about the shots.
The FDA’s scientific advisers last month said they worry that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. Those advisers said it’s critical these massive studies are allowed to run to completion.
Canada announced on Aug. 5 that it had preordered the Pfizer/BioNTech vaccine. It later specified that it had reserved 20 million doses, with the option to purchase more. Given that the vaccine is administered as two doses, 28 days apart, Canada would initially have enough to vaccinate 10 million people if it is approved.
Distributing the Pfizer/BioNTech vaccine could be logistically challenging. BioNTech said the genetic component of the messenger RNA vaccine would have to be shipped and centrally stored at minus 70 degrees C.
For transport to and at the site of administration it can be kept for up to five days at fridge temperatures, CEO Ugur Sahin told Reuters, adding he was confident logistics would work very well.
Have a question?
Send your questions about this and other COVID-19 vaccine candidates to COVID@cbc.ca
Montreal Alouettes wide receiver Tyson Philpot has announced he will be out for the rest of the CFL season.
The Delta, B.C., native posted the news on his Instagram page Thursday.
“To Be Continued. Shoutout my team, the fans of the CFL and the whole city of Montreal! I can’t wait to be back healthy and write this next chapter in 2025,” the statement read.
Philpot, 24, injured his foot in a 33-23 win over the Hamilton Tiger-Cats on Aug. 10 and was placed on the six-game injured list the next week.
The six-foot-one, 195-pound receiver had 58 receptions, 779 yards and five touchdowns in nine games for the league-leading Alouettes in his third season.
Philpot scored the game-winning touchdown in Montreal’s Grey Cup win last season to punctuate a six-reception, 63-yard performance.
This report by The Canadian Press was first published Sept. 12, 2024.
MIAMI GARDENS, Fla. (AP) — Miami Dolphins quarterback Tua Tagovailoa sustained a concussion for the third time in his NFL career, leaving his team’s game Thursday night against Buffalo after running into defensive back Damar Hamlin and hitting the back of his head against the turf.
Tagovailoa remained down for about two minutes before getting to his feet and walking to the sideline after the play in the third quarter. He made his way to the tunnel not long afterward, looking into the stands before smiling and departing toward the locker room.
The Dolphins needed almost no time before announcing it was a concussion. The team said he had two during the 2022 season, and Tagovailoa was diagnosed with another concussion when he was a college player at Alabama.
Dolphins coach Mike McDaniel said Tagovailoa would get “proper procedural evaluation” and “appropriate care” on Friday.
“The furthest thing from my mind is, ‘What is the timeline?’ We just need to evaluate and just worry about my teammate, like the rest of the guys are,” McDaniel said. “We’ll get more information tomorrow and take it day by day from here.”
Some players saw Tagovailoa in the locker room after the game and said they were encouraged. Tagovailoa spoke with some players and then went home after the game, McDaniel said.
“I have a lot of love for Tua, built a great relationship with him,” said quarterback Skylar Thompson, who replaced Tagovailoa after the injury. “You care about the person more than the player and everybody in the organization would say the same thing. Just really praying for Tua and hopefully everything will come out all right.”
Tagovailoa signed a four-year, $212 million extension before this season — a deal that makes him one of the highest-paid players in the NFL — and was the NFL’s leading passer in Week 1 this season. Tagovailoa left with the Dolphins trailing 31-10, and that was the final score.
“If you know Tua outside of football, you can’t help but feel for him,” Bills quarterback Josh Allen said on Amazon following the game. “He’s a great football player but he’s an even greater human being. He’s one of the best humans on the planet. I’ve got a lot of love for him and I’m just praying for him and his family, hoping everything’s OK. But it’s tough, man. This game of football that we play, it’s got its highs and it’s got its lows — and this is one of the lows.”
Tagovailoa’s college years and first three NFL seasons were marred by injury, though he positioned himself for a big pay bump with an injury-free and productive 2023 as he led the Dolphins into the playoffs. He threw for 29 touchdowns and a league-best 4,624 yards last year.
When, or if, he can come back this season is anyone’s guess. Tagovailoa said in April 2023 that the concussions he had in the 2022 season left him contemplating his playing future. “I think I considered it for a time,” he said then, when asked if he considered stepping away from the game to protect himself.
McDaniel said it’s not his place to say if Tagovailoa should return to football. “He’ll be evaluated and we’ll have conversations and progress as appropriate,” McDaniel said.
Tagovailoa was hurt Thursday on a fourth-down keeper with about 4:30 left in the third. He went straight ahead into Hamlin and did not slide, leading with his right shoulder instead.
Hamlin was the player who suffered a cardiac arrest after making a tackle during a Monday night game in January 2023 at Cincinnati, causing the NFL to suspend a pivotal game that quickly lost significance in the aftermath of a scary scene that unfolded in front of a national television audience.
Tagovailoa wound up on his back, both his hands in the air and Bills players immediately pointed at him as if to suggest there was an injury. Dolphins center Aaron Brewer quickly did the same, waving to the sideline.
Tagovailoa appeared to be making a fist with his right hand as he lay on the ground. It was movement consistent with something that is referred to as the “fencing response,” which can be common after a traumatic brain injury.
Tagovailoa eventually got to his feet. McDaniel grabbed the side of his quarterback’s head and gave him a kiss on the cheek as Tagovailoa departed. Thompson came into the game to take Tagovailoa’s spot.
“I love Tua on and off the football field,” Bills edge Von Miller said. “I’m a huge fan of him. I can empathize and sympathize with him because I’ve been there. I wish him the best.”
Tagovailoa’s history with concussions — and how he has since worked to avoid them — is a huge part of the story of his career, and now comes to the forefront once again.
He had at least two concussions during the 2022 season. He was hurt in a Week 3 game against Buffalo and cleared concussion protocol, though he appeared disoriented on that play but returned to the game.
The NFL later changed its concussion protocol to mandate that if a player shows possible concussion symptoms — including a lack of balance or stability — he must sit out the rest of the game.
Less than a week later, in a Thursday night game at Cincinnati, Tagovailoa was concussed on a scary hit that briefly knocked him unconscious and led to him being taken off the field on a stretcher.
His second known concussion of that season came in a December game against Green Bay, and he didn’t play for the rest of the 2022 season. After that, Tagovailoa began studying ways where he may be able to fall more safely and protect himself against further injury — including studying jiu-jitsu.
“I’m not worried about anything that’s out of my hands,” McDaniel said. “I’m just worried about the human being.”
NEW YORK (AP) — When her husband turns on the television to hear news about the upcoming presidential election, that’s often a signal for Lori Johnson Malveaux to leave the room.
It can get to be too much. Often, she’ll go to a TV in another room to watch a movie on the Hallmark Channel or BET. She craves something comforting and entertaining. And in that, she has company.
While about half of Americans say they are following political news “extremely” or “very” closely, about 6 in 10 say they need to limit how much information they consume about the government and politics to avoid feeling overloaded or fatigued, according to a new survey from the Associated Press-NORC Center for Public Affairs Research and USAFacts.
Make no mistake: Malveaux plans to vote. She always does. “I just get to the point where I don’t want to hear the rhetoric,” she said.
The 54-year-old Democrat said she’s most bothered when she hears people on the news telling her that something she saw with her own eyes — like the Jan. 6, 2021, attack on the U.S. Capitol — didn’t really happen.
“I feel like I’m being gaslit. That’s the way to put it,” she said.
Sometimes it feels like ‘a bombardment’
Caleb Pack, 23, a Republican from Ardmore, Oklahoma, who works in IT, tries to keep informed through the news feeds on his phone, which is stocked with a variety of sources, including CNN, Fox News, The Wall Street Journal and The Associated Press.
Yet sometimes, Pack says, it seems like a bombardment.
“It’s good to know what’s going on, but both sides are pulling a little bit extreme,” he said. “It just feels like it’s a conversation piece everywhere, and it’s hard to escape it.”
Media fatigue isn’t a new phenomenon. A Pew Research Center survey conducted in late 2019 found roughly two in three Americans felt worn out by the amount of news there is, about the same as in a poll taken in early 2018. During the 2016 presidential campaign, about 6 in 10 people felt overloaded by campaign news.
But it can be particularly acute with news related to politics. The AP-NORC/USAFacts poll found that half of Americans feel a need to limit their consumption of information related to crime or overseas conflicts, while only about 4 in 10 are limiting news about the economy and jobs.
It’s easy to understand, with television outlets like CNN, Fox News Channel and MSNBC full of political talk and a wide array of political news online, sometimes complicated by disinformation.
“There’s a glut of information,” said Richard Coffin, director of research and advocacy for USAFacts, “and people are having a hard time figuring out what is true or not.”
Women are more likely to feel they need to limit media
In the AP-NORC poll, about 6 in 10 men said they follow news about elections and politics at least “very” closely, compared to about half of women. For all types of news, not just politics, women are more likely than men to report the need to limit their media consumption, the survey found.
White adults are also more likely than Black or Hispanic adults to say they need to limit media consumption on politics, the poll found.
Kaleb Aravzo, 19, a Democrat, gets a baseline of news by listening to National Public Radio in the morning at home in Logan, Utah. Too much politics, particularly when he’s on social media sites like TikTok and Instagram, can trigger anxiety and depression.
“If it pops up on my page when I’m on social media,” he said, “I’ll just scroll past it.”
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Sanders reported from Washington. David Bauder writes about media for the AP. Follow him at http://x.com/dbauder.
The AP poll of 1,019 adults was conducted July 29-August 8, 2024, using a sample drawn from NORC’s probability-based AmeriSpeak Panel, which is designed to be representative of the U.S. population. The margin of sampling error for all respondents is plus or minus 4.0 percentage points.
