Canada’s largest city is going into lockdown for at least 28 days
From CNN’s Gisela Crespo
Toronto, Canada’s biggest city, is going into lockdown for at least 28 days to limit the spread of Covid-19, according to a news release from the Office of the Premier of Ontario published Friday.
The lockdown will go into effect Monday and it includes Peel Region, which is part of the Greater Toronto Area.
Ontario Premier Doug Ford said in the news release that Covid-19 numbers are “rising rapidly in certain regions,” adding the lockdown will protect “hospitals, long-term care and retirement homes, and every person in this province.”
“We cannot afford a province-wide lockdown, so we are taking preventative action today by moving Toronto and Peel into lockdown level restrictions … We need to take decisive action to stop the spread of this deadly virus,” Ford said.
These are the lockdown rules:
- Indoor social gatherings or events won’t be allowed except with members of the same household, and outdoor gatherings will be limited to no more than 10 people, according to the release.
- Wedding services, funerals, and religious ceremonies where physical distancing can be maintained indoors or outdoors will also be limited to no more than 10 people.
- Retail will be allowed to operate for curbside pick-up or delivery only. Certain businesses such as grocery stores and pharmacies will be allowed to open at 50% capacity.
- Schools and childcare will remain open, and post-secondary education will move to virtual learning except for training that can only be provided in person.
Other parts of the province will move to higher levels of restrictions starting Monday as well, according to the release.
FDA announces advisory committee to meet to discuss Pfizer’s vaccine application in December
From CNN’s Ben Tinker and Maggie Fox
The US Food and Drug Administration said Friday it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Dec. 10.
The companies submitted their application for an EUA earlier Friday. It’s the first application for an FDA regulatory OK for a coronavirus vaccine.
“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in Covid-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“The FDA has been preparing for the review of EUAs for Covid-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”
The FDA is supposed to post the VRBPAC meeting schedule in the Federal Register at least two weeks ahead of time. The agency has promised to fully consider input from the committee, which is made up of vaccine experts and others with no ties to the companies submitting vaccines for FDA approval or authorization.
“A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of Covid-19,” Hahn said.
The FDA said it will livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels and from the FDA website.
Donald Trump Jr. tests positive for coronavirus
From CNN’s Kaitlan Collins and Veronica Stracqualursi
Donald Trump Jr., President Donald Trump’s eldest son, has tested positive for the coronavirus, a personal spokesman told CNN on Friday.
“Don tested positive at the start of the week and has been quarantining out at his cabin since the result,” the spokesman said. “He’s been completely asymptomatic so far and is following all medically recommended COVID-19 guidelines.”
Bloomberg was first to report Trump Jr.’s positive result.
Trump Jr. becomes the latest figure close to the President to test positive for Covid-19. In addition to himself, first lady Melania Trump, his youngest son Barron, his chief of staff Mark Meadows and a number of other top aides both in his campaign and in the White House have tested positive in recent months.
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Pfizer and BioNTech apply for FDA emergency use authorization for coronavirus vaccine
From CNN’s Jamie Gumbrecht
Pfizer and BioNTech on Friday submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate.
This is the first coronavirus vaccine to seek regulatory clearance in the United States.
“It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA’s hands,” Pfizer CEO Albert Bourla said in a video shared on Friday. “This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day.
“We have operated at extraordinary speed in our clinical development program, from concept to regulatory filing, while always maintaining our focus on safety.”
The vaccine, known as BNT162b2, could potentially be available for use in high-risk populations in the United States by the middle to end of December, Pfizer and BioNTech said in a statement earlier Friday. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.
The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
The final analysis from the trial found the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and BioNTech said this week. The submission also includes safety data on about 100 children ages 12 to 15.
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