Pfizer said Monday that early results from its coronavirus vaccine suggest the shots may be a surprisingly robust 90 per cent effective at preventing COVID-19, putting the company on track to apply later this month for emergency-use approval from the Food and Drug Administration.
The announcement, less than a week after an election seen as a referendum on President Donald Trump’s handling of the crisis, was a rare and major piece of encouraging news lately in the battle against the scourge that has killed more than 1.2 million people worldwide, including almost a quarter-million in the United States alone.
“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.”
Dr. Anthony Fauci, the U.S. government’s top-infectious disease expert, said the results suggesting 90% effectiveness are “just extraordinary,” adding: “Not very many people expected it would be as high as that.”
“It’s going to have a major impact on everything we do with respect to COVID,” Fauci said as Pfizer appeared to take the lead in the all-out global race by pharmaceutical companies and various countries to develop a well-tested vaccine against the virus.
Dr. Bruce Aylward, the World Health Organization’s senior adviser, said that Pfizer’s vaccine could “fundamentally change the direction of this crisis” by March, when the U.N. agency hopes to start vaccinating high-risk groups.
Still, Monday’s announcement doesn’t mean for certain that 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. Some participants got the vaccine, while others got dummy shots.
Pfizer Inc. cautioned that the protection rate might change by the time the study ends. Even revealing such early data is highly unusual.
Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, called the partial results “extremely promising” but ticked off many questions still to be answered, including how long the vaccine’s effects last and whether it protects older people as well as younger ones.
Also, whenever a vaccine does arrive, initial supplies will be scarce and rationed, with priority likely to be given to health care workers and others on the front lines. Pfizer has estimated that 50 million doses of its two-shot vaccine could be available globally by the end of 2020, which could cover 25 million people.
Global markets, already buoyed by the victory of President-elect Joe Biden, exploded on the news from Pfizer. The S%P 500 surged 3.7% after the opening bell, and the Dow Jones Industrial Average was up more than 1,300 points. Pfizer jumped more than 9%. Other vaccine stocks were up as well.
Trump, who had suggested repeatedly during the presidential campaign that a vaccine could be ready by Election Day, tweeted: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”
Biden, for his part, welcomed the news but cautioned that it could be many months before vaccinations become widespread in the U.S., and he warned Americans to rely on masks and social distancing in the meantime.
News of the possible breakthrough came ahead of what could be a terrible winter in the U.S., with tens of thousands more coronavirus deaths feared in the coming months. Confirmed infections in the United States were expected to eclipse 10 million on Monday, the highest in the world. Cases are running at all-time highs of more than 100,000 per day.
The timing of Pfizer’s announcement is likely to feed unsubstantiated suspicions from Trump supporters that the pharmaceutical industry was withholding the news until after the election. Donald Trump Jr. tweeted: “The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?”
Pfizer Chairman and CEO Albert Bourla said on CNBC that the election was always an artificial deadline and that the data was going to be ready when it was ready. The independent data monitors met on Sunday, analyzing the COVID-19 test results so far and notifying Pfizer.
“I am very happy,” Bourla said, “but at the same time, sometimes I have tears in my eyes when I realize that this is the end of nine months, day-and-night work of so many people and how many people, billions, invested hopes on this.”
He added: “I never thought it would be 90%.”
Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50% effective and require yearly immunizations. Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.
Pfizer opted not to join the Trump administration’s Operation Warp Speed, which helped a half-dozen drugmakers accelerate their vaccine testing and helped fund the work. Instead, Pfizer funded all its testing and manufacturing costs itself. The company said it has invested billions of dollars.
The president’s boasts that a vaccine could be ready before Election Day raised fears that the Trump administration might pressure regulators and scientists to cut corners for political gain. After the first presidential debate, Bourla told his employees he was disappointed their work was being dragged into political debates and pledged the company was “moving at the speed of science.”
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 hopes to file an application with the FDA 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 dose, Pfizer’s study began counting the number who developed COVID-19 symptoms and were confirmed to have the coronavirus.
Because the Pfizer study hasn’t ended, Gruber couldn’t say how many in each group had infections. But the math suggests that almost all the infections counted so far had to have occurred in people who got the dummy shots.
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% effective.
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.
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.
Fauci said that the Pfizer vaccine and virtually all others in testing target the spike protein the coronavirus uses to infect cells, so the latest results validate that approach.
Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data “bad science” and said that any enthusiasm over the results “must be tempered” until they are reviewed by the FDA and its independent experts.
“Crucial information absent from the companies’ announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease,” the organization said.
FDA has told companies they must track half their participants for side effects for at least two months, the period when problems typically crop up. Pfizer expects to reach that milestone later this month.
Because the pandemic is still raging, manufacturers hope to get permission from governments around the world for emergency use of their vaccines while additional testing continues. That would allow them to get their vaccines to market faster, but it also raises safety concerns.
AP writers Marilynn Marchione, Frank Jordans and Charles Sheehan contributed to this report.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content
Ford government to release guidelines on holiday gatherings this afternoon – CP24 Toronto's Breaking News
Premier Doug Ford is expected to release guidelines this afternoon about what type of gatherings Ontarians will be permitted to have over the holidays.
Toronto and Peel Region are currently in a 28-day lockdown period, which is set to expire just days before Christmas.
Under the current restrictions, restaurants can only offer takeout and delivery and non-essential businesses have been forced to close stores to in-person shopping.
In the lockdown category of the province’s colour-coded reopening framework, residents must only gather with members of their own household and people have been told to only go outside for essential purposes, including picking up groceries, going to medical appointments, and getting exercise.
Mayor John Tory says he does not believe the province’s advice for holiday gatherings in Toronto will stray far from the restrictions that are currently in place.
“There are restrictions right now that say that you are not supposed to spend time with people outside your own home, with exceptions for people who live alone. And so I think you will see something more along that line,” Tory told CP24 on Wednesday morning.
Ontario’s daily case count of new COVID-19 infections has not dipped below 1,000 since Nov. 5, reaching a record high of 1,588 on Nov. 21.
Toronto and Peel Region continue to see the highest number of new COVID-19 infections in the province each day.
The rolling seven-day average of new cases in now 413 in Toronto and 421 in Peel.
Tory said in order to bring the virus under control, there will need to be strict limits on gathering in private homes over the holidays.
“There are going to be strong recommendations, if not restrictions, that are placed on the kinds of activities that people can engage in,” he said.
“Even if the 28-day period has come to an end and we’ve seen some improvement, the last thing everybody wants to see… is to be sliding back into some kind of another shutdown or series of restrictions in the New Year because we didn’t pay attention to our behaviour at Christmas.”
In Quebec, where the rolling seven-day average of new infections is now 1,182, Premier François Legault has eased restrictions for a four-day period, allowing residents in the province to attend two gatherings of up to 10 people between Dec. 24 and Dec. 27.
On Monday, Manitoba Premier Brian Pallister asked residents only to gather with those in their immediate households over the holidays due to a surge in new cases in that province.
Dr. Isaac Bogoch, an infectious diseases expert, told CP24 on Wednesday morning that recommendations given to Ontarians will likely be similar to the ones in Manitoba.
“I think we’re going to have a significantly modified holiday season, it’s pretty clear. Especially given how we’re doing in these hot spots. I never know what they’re going to say but I imagine it’s going to be akin to our Thanksgiving messaging which was if you don’t live under that roof, don’t go into that house,” he said.
“We know that indoor spaces, crowded spaces, confined spaces where people aren’t wearing masks in indoor spaces, we know that that’s how this is transmitted so we should be avoiding that at all costs. Connect virtually, connect outdoors, connect safely but let’s not have large family gatherings.”
Ford, Health Minister Christine Elliott, and Dr. David Williams, Ontario’s chief medical officer of health, will be releasing the province’s holiday gathering guidelines at a news conference at Queen’s Park at 1 p.m.
The announcement will be streamed live on CP24.com.
Ontario government to spell out whether people can have winter holiday gatherings – CP24 Toronto's Breaking News
The Ontario government is expected to spell out its guidelines today for celebrating the upcoming winter holidays as the COVID-19 pandemic continues.
Toronto and Peel Region are currently under the grey or lockdown level in the province’s tiered COVID-19 alert system, with those restrictions to stay in place at least until the week of Christmas.
Public health measures under the lockdown level include a ban on indoor gatherings except with those in the same household, as well as closing down restaurants for all but takeout and delivery.
The province’s top doctor said earlier this week it seemed unlikely the situation would improve in those regions enough over 28 days to warrant moving them to the red alert level, which is one level lower.
Five other regions — Hamilton, Durham, Halton, York and Waterloo — are currently classified as red zones, which caps social gatherings at five people indoors and 25 outdoors.
Ontario’s most recent modelling showed the province is on track to see up to 6,500 new daily cases of COVID-19 by mid-December, though those projections are expected to be updated Thursday.
1 in 3 Toronto schools, nearly half of Brampton schools, have active COVID-19 cases – 680 News
One in three Toronto public schools have an active case of COVID-19 – more than double the provincial average being touted by Ontario’s education minister as he promotes the government’s school safety strategy and the picture worsens at other boards in pandemic hot spots.
In Toronto’s public board, 35 per cent of schools, some 206 facilities, have at least one student or staff member who are reported as actively sick with COVID-19. Of Toronto’s Catholic schools, 40 per cent – or 79 institutions — have active cases. In Brampton, 48 per cent of all schools, both public and Catholic, have active cases.
Toronto and Peel are in lockdown so it’s no surprise they have more cases than the provincial average, but the premier has acknowledged it’s concerning.
“It is definitely setting off alarm bells,” Premier Doug Ford said at a press conference Tuesday.
The government has consistently said it is safer for students to be in school, and that the priority is to keep them open. It has never mentioned that cases in locked-down regions are significantly higher than the provincial average, which is 14.6 percent. Four schools are currently closed due to outbreaks.
Education Minister Stephen Lecce stood in the legislature Monday and insisted schools were safe.
“Parents want the facts. Here’s a fact that I think would instill a level of confidence: if they knew that 99.95% of students are COVID-19-free, that 99.92% of staff are COVID-19-free, that 99.7% of staff have never had COVID-19,” said Lecce. “Our leadership in public health and our school boards are working together to flatten this curve, to reduce the risk and to keep our kids safe, and that is a good thing we should celebrate in this province”
In Brampton, 61 public schools and 28 Catholic schools are reporting 122 and 89 cases, respectively. In the public board, 51 schools beyond Brampton are reporting a further 78 cases. Of those, 46 schools are in Mississauga, four schools are in Caledon, and one is in Bolton.
In the Dufferin-Peel Catholic board, 37 schools outside of Brampton are reporting a total of 61 cases. All but one of those schools is in Mississauga, with the lone other location in Caledon.
Brampton’s percentage of schools with active COVID-19 cases exceeds the proportion in its school boards in large.
The rate across Dufferin-Peel Catholic School Board, which includes Mississauga, Caledon, Bolton and Orangeville, is 43 per cent, with a total 65 of its 151 elementary and secondary schools reporting active cases. In Peel’s public board, which serves Brampton, Mississauga and Caledon, the rate is 44 per cent, or 112 of the boards 257 schools.
CityNews has used the latest information posted on all the boards’ own websites to compile this data.
The premier said today that he was not downplaying cases at schools: “numbers don’t lie, they are out there.”
Ontario’s Chief Medical Officer of Health has said several times it is important to keep schools open for children’s mental health, and while students and staff are bringing COVID-19 into schools, it’s not being spread inside them. Provincial Minister of Health Christine Elliott echoed that today, adding she would re-evaluate the situation if needed.
“If the circumstances change and there’s a huge increase in the number of cases in schools, we might have to take another look at it,” Elliott said.
Ontario has started deploying rapid testing in long-term care homes and rural communities. Ford called it a game-changer and suggested if schools needed testing, it could happen. University of Toronto epidemiologist Colin Furness says he doesn’t believe schools need to close, but he says those inside should be tested regularly.
“We should be doing surveillance testing broadly in the province, we should have been doing that since April. By surveillance testing, I mean you don’t test people who show up at hospital looking sick, that’s diagnostic testing. Surveillance testing means you go and test people at risk,” he explained.
“We should be testing teachers because they are also in high-risk positions, and if want to know what’s going on with COVID in schools, test teachers,” he added, “But Ontario has been very resolutely committed to not doing surveillance testing. We are not trying to control transmission with testing, we are controlling with lockdowns. I think that’s unfortunate.”
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