The European Medicines Agency recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union.
Following a closed-doors expert meeting Monday, the EU drug regulator said it was recommending the shot be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit followup data on their vaccine for the next year.
“This is really a historic scientific achievement,” said Emer Cooke, the head of the agency. “It is a significant step forward in our fight against the pandemic.”
The approval needs to be rubber-stamped by the EU’s executive branch on Monday evening.
European Commission President Ursula von der Leyen tweeted that the EMA’s approval was decisive moment.
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!<br><br>The <a href=”https://twitter.com/EMA_News?ref_src=twsrc%5Etfw”>@EMA_News</a> just issued a positive scientific opinion on the <a href=”https://twitter.com/hashtag/BioNTech?src=hash&ref_src=twsrc%5Etfw”>#BioNTech</a> / <a href=”https://twitter.com/pfizer?ref_src=twsrc%5Etfw”>@pfizer</a> vaccine.<br><br>Now we will act fast. I expect a <a href=”https://twitter.com/EU_Commission?ref_src=twsrc%5Etfw”>@EU_Commission</a> decision by this evening.
Authorities in Germany and several other European countries have said they hope to begin vaccinating people on Dec. 27.
“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the company’s chief executive and co-founder. “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”
“We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light,” Sahin said.
The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. EMA originally set Dec. 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved up the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.
The vaccine has already been given some form of regulatory authorization in at least 15 countries, including Canada.
Britain and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide to date, according to a tally by Johns Hopkins University.
Health Canada said its approval was made under an interim order that allowed it to “assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards.”
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” the health agency said in a Dec. 9 statement announcing the authorization of the Pfizer-BioTech vaccine.
In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the EMA stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.
“A vaccine’s benefits in protecting people against COVID-19 must be far greater than any side-effect or potential risks,” it said.
Scientists are still waiting for more long-term followup data to see how long immunity from the vaccines lasts and if there are any rare or serious side-effects. Final testing of the vaccine is still ongoing. More information on whether the shot works in children is needed, in addition to its effects in pregnant women.
The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it’s unclear if the reactions were caused by the immunization.
The U.S. Centers for Disease Control and Prevention said that as of Friday they had seen six cases of severe allergic reaction out of more than 250,000 shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.
BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive Commission chose to buy only 200 million doses, with an option for 100 million more.
The EMA plans to hold a meeting on Jan. 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.
The European Centre for Disease Prevention and Control, meanwhile, said “timely efforts” to prevent and control the spread of cases of COVID-19 involving the new coronavirus variant observed in Britain are needed, but infections have already been reported in at least three other countries in Europe.
The Stockholm-based agency said in a “threat assessment” Monday that while preliminary analysis in the U.K. suggests the new variant is “significantly more transmissible” there is no indication that infections are more severe.
ECDC said a few cases with the new variant have been reported already by Iceland, Denmark and the Netherlands. It also cited media reports of cases in Belgium and Italy.
What’s happening across Canada
As of 7:30 a.m. ET on Monday, Canada’s COVID-19 case count stood at 507,795 with 76,859 of those cases considered active. A CBC News tally of deaths based on provincial reports, regional health information and CBC’s reporting stood at 14,228.
Ontario Premier Doug Ford is set to address the public Monday afternoon after sources said the entire province will be sent into lockdown on Dec. 24. The province — which as of Sunday had 875 COVID-19 patients in hospital, including 261 in intensive care units — has seen six days straight with more than 2,000 daily cases of COVID-19.
What’s happening in the U.S.
U.S. congressional leaders reached agreement on Sunday on a $900 billion US package to provide the first new aid in months to an economy and individuals battered by the surging coronavirus pandemic, with votes likely on Monday.
The package would be the second-largest economic stimulus in U.S. history, following a $2.3 trillion aid bill passed in March. It comes as the pandemic accelerates, infecting more than 214,000 people in the country each day. More than 317,000 Americans have already died.
The package would give $600 direct payments to individuals and boost unemployment payments by $300 a week. It also includes billions for small businesses, food assistance, vaccine distribution, transit and health care. It extends a moratorium on foreclosures and provides $25 billion in rental aid.
WATCH | Millions in U.S. at risk of homelessness without support, eviction ban:
The United States is monitoring the new strain of COVID-19 emerging in Britain, multiple U.S. officials said, adding that it was unclear whether the mutated variant had made its way to the U.S.
What’s happening around the world
As of early Monday morning, more than 76.9 million cases of COVID-19 had been reported around the world with more than 43.3 million of those cases considered recovered or resolved, according to a coronavirus tracking tool maintained by Johns Hopkins University. The global death toll was approaching 1.7 million.
In Africa, South Africa announced that a new variant of the COVID-19 virus is driving the country’s current resurgence of the disease, which is seeing higher numbers of confirmed cases, hospitalizations and deaths.
The new variant, known as 501.V2, is dominant among new confirmed infections in South Africa, according to health officials and scientists leading the country’s virus strategy.
“It is still very early but at this stage, the preliminary data suggests the virus that is now dominating in the second wave is spreading faster than the first wave,” Prof. Salim Abdool Karim, chair of the government’s ministerial advisory committee, said in a briefing to journalists.
South Africa may see “many more cases” in the new wave than it experienced in the first surge of the disease, said Abdool Karim.
South Africa currently has more than 8,500 people hospitalized with COVID-19, surpassing the previous high of 8,300 recorded in August.
“We are seeing a much earlier and much sharper rise in the second wave or resurgence than we anticipated,” Prof. Ian Sanne, a member of the advisory committee, told South Africa’s News24.
The new strain, different from the one in Britain, appears to be more infectious than the original virus. South African scientists are studying if the vaccines against COVID-19 will also offer protection against the new strain.
Some of the vaccines, including the one developed by Oxford University and AstraZeneca, are undergoing clinical tests in South Africa. The scientists studying the new variant emphasized that preventive measures like wearing masks and social distancing are vital.
In response to the resurgence of COVID-19, the South African government has introduced tougher lockdown restrictions which include limited days and hours for the trade of alcohol and the closure of beaches in areas identified as hotspots.
The country has recorded a total of 912,477 cases, including 24,539 deaths.
In the Asia-Pacific region, Hong Kong will ban flights from Britain after a more infectious variant of the coronavirus was found in the country, according to the city’s top health official.
Tokyo Gov. Yuriko Koike on Monday asked all residents to celebrate Christmas and New Year at home just with their families and asked organizers to have events close early in the night.
Japan’s daily coronavirus cases have been steadily on the rise and Tokyo hit its new high at 822 last Friday. On Monday, the Japanese capital city found 392 new cases for a prefectural total of 51,838.
Thailand’s total number of confirmed coronavirus cases surged past 5,000 on Monday as hundreds of migrant workers tested positive for the disease.
Thailand has been one of several Southeast Asian countries that had been relatively unscathed by the pandemic. But on Saturday, health officials reported a daily record of 548 new cases, almost all of them among migrant workers in the seafood industry in Samut Sakhon province, about 35 kilometres southwest of Bangkok, the capital.
Thai Prime Minister Prayuth Chan-ocha said his government would wait to see how the situation looked in a week’s time before deciding on any special restrictions for New Year’s celebrations.
In the Middle East, Saudi Arabia shut its land and sea borders late on Sunday and suspended international commercial flights temporarily over fears of a new coronavirus strain, but foreign flights already in the country can leave, the Interior Ministry said.
Fellow Gulf Arab state Oman will close its land, air and sea borders for one week starting Tuesday, state television reported on Monday.
In Kuwait, the civil aviation authority added the United Kingdom to its high-risk list of countries on Sunday, meaning all flights from it are banned.
The U.S. remained the hardest-hit country in the Americas, trailed by Brazil, which has seen more than 7.2 million reported cases of COVID-19 and more than 186,700 deaths.
Feds deny Ottawa Somali centre funding claiming it's not Black enough – CBC.ca
Leaders of a Somali organization in Ottawa say their relationship with Employment and Social Development Canada (ESDC) has been severely damaged after the department rejected its funding application by arguing it’s not Black enough.
“At this day and age, to come across something like that was very, very, very shock[ing] and somewhat uncalled for,” said Mohamoud Hagi-Aden, one of the founders of the Somali Centre for Family Services. The centre is among hundreds of organizations the government rejected, claiming they failed to meet its Black leadership criteria.
Hagi-Aden said he was in disbelief when he read the rejection letter, which claimed his organization was not sufficiently led by Black people. The centre’s founders, management and board are all of Somali background, according to the centre.
“The people who have been making these decisions [are] either from another planet, or they’re not from the [Black] community,” he said.
The letter recently sent by my department to unsuccessful applicants for funding was completely unacceptable.– Families, Children and Social Development Minister Ahmed Hussen
Executive director Abdirizak Karod applied last summer for the federal funding, called the Supporting Black Canadian Communities Initiative, after learning it was for Black groups looking to improve their work and community spaces. He said he wanted to use the funding to buy laptops for clients so they can access services and training remotely, as well as refurbishing the organization’s 28-year-old office building.
The funding guidelines say the groups must be focused on serving Black communities, and that at least two-thirds of the leadership and governance structure must be made up of people who self-identify as Black.
“I got an email saying our organization is not a Black-led organization,” Karod said. “I didn’t believe that what I [saw]. And believe me, I read it three times.”
A letter to the centre dated Jan. 12 states that “information provided did not meet this eligibility criteria or was insufficient to clearly demonstrate that the organization is led and governed by people who self-identify as Black.”
A second letter was sent the next day to correct the first letter. It said the group was rejected because “ESDC did not receive the information required to move forward with your application.”
“They never tell us why we got rejected. They never tell us anything,” Karod said, explaining how he answered all the questions on the application.
“How we can trust this department again?” he asked. “I can’t trust them…. It was not an honest mistake.”
Letter ‘completely unacceptable’: Minister
ESDC declined an interview with CBC News, pointing instead to the minister’s Twitter thread.
“The letter recently sent by my department to unsuccessful applicants for funding was completely unacceptable,” Families, Children and Social Development Minister Ahmed Hussen tweeted. “As soon as it was presented to me, I quickly demanded a retraction and met with my officials to discuss how such a mistake could have happened in the first place.”
Hussen, who was born in Somalia, said he will “make sure it never happens again,” and vowed to work with Black-led organizations to improve.
I have implemented new measures to make sure it never happens again.<br><br>In addition, I will continue to work with Black Canadian organizations to improve our systems.
But the statement isn’t good enough, according to Hagi-Aden.
“How will [ESDC] repair the damage they’ve done to the Black community? We have so many barriers and so many difficulties,” he said. “The trust that we had in the system has been so severely damaged.”
Feds on defensive as no Pfizer vaccine shipment arriving next week – CTV News
Canada will not be receiving any shipments of Pfizer-BioNTech COVID-19 vaccine doses next week, which the federal government says will be the hardest hit the country gets during a month-long shortage in deliveries from the drug giant.
The news Canada will be experiencing a “temporary” delay in shipments resulting in an average weekly reduction of 50 per cent of coming doses due to the pharmaceutical company’s expansion plans at its European manufacturing facility came on Friday.
On Tuesday, Maj.-Gen. Dany Fortin who is leading Canada’s logistical rollout revealed that in reality, while this week’s shipment includes 82 per cent of what was originally planned, next week no new deliveries of doses will be coming to this country.
That means over the next two weeks Canada is set to receive just over 171,000 vaccine doses instead of the more than 417,000 planned before Pfizer announced its delay.
“Next week’s deliveries have been deferred by Pfizer in their entirety,” Fortin said, adding that the company just confirmed the amounts Tuesday morning. He said deliveries will start back up in the first two weeks of February.
“But those numbers remain to be confirmed by Pfizer Canada,” Fortin said, adding that because the shipments come in trays with 975 doses, some provinces will feel the impact more than others, but the federal government will strive to keep the future allotments as proportional per capita as possible.
Procurement Minister Anita Anand said in an interview on CTV’s Power Play that Canada is still waiting for the future delivery schedule from Pfizer.
The shipment shortage has strained provincial rollout campaigns— plans are being made to hold off on giving first doses to more people and to delay the administration of second doses for some—and has put the federal government on the defensive.
In his Rideau Cottage address on Tuesday, Prime Minister Justin Trudeau sought to reassure people about having access to considerably fewer Pfizer shots over the next few weeks, saying that “doses are coming,” and vaccinations for long-term care home residents and health-care workers continue.
Trudeau said he knows there is “a lot of work still to do,” but the overall goal of vaccinating six million prioritized people by March, and then everyone who wants to be by the end of September 2021, remains on track despite this “roadblock.”
Asked why he hasn’t tried to put more direct political pressure himself on Pfizer to rectify Canada’s complete absence of doses next week, Trudeau said the company remains contractually obligated to provide Canada with the doses purchased.
The federal government also faced questions about why it appears Pfizer is not treating all countries equally as promised when it comes to scaling back the size of shipments, with some European countries reporting their deliveries will not be as severely impacted as Canada’s.
Neither Trudeau or Anand could offer an explanation, with the prime minister stating that in his weekend call with German Chancellor Angela Merkel she too raised that she was being criticized for her country’s rollout.
“She sort of complained to me that every day she gets it from the German media that they’re not doing as well as Canada. I think a lot of people are comparing stories from country to country, and trying to figure out how we can all move quicker,” Trudeau said.
According to CTV News’ vaccine tracker, Canada is immunizing people faster than Germany by a small margin.
Anand said the situation with Pfizer’s delay is “very disappointing,” and she “spent the weekend on the phone with Pfizer executives,” pushing for Canada to return to the regular delivery schedule as soon as possible.
She said Canada “insisted” on equitable treatment, which she said Pfizer assured her Canada is receiving.
Ontario Premier Doug Ford said Tuesday he was “very angry” about the situation and if it was up to him, he’d be “on that phone call every single day,” with Pfizer. He then floated that in the interim, President-Elect Joe Biden should send Canada one million doses from the U.S.-based Pfizer facility, which is not experiencing delays.
Anand said Tuesday in response to Ford’s suggestion that all the vaccines being made at the U.S. plant will be distributed within Canada but she will “continue to press all levers.”
In an interview on CTV’s Question Period that aired on Sunday, Anand said she’d heard concerns from some vaccine companies about lengthy delays between vaccine doses, as they go beyond what their clinical-trial-based recommendations are.
In an email, Pfizer said some provinces decision to delay the administration of their second doses was not a factor in the current delivery schedule for Canada, stating that the decision to scale-up at the Belgium plant is so that by the end of 2021 the pharmaceutical giant can deliver 2 billion doses worldwide.
“Pfizer is working closely with all Governments on allocation of doses. While the precise percentage allocation may fluctuate, we anticipate that it will balance out by the end of Q1 2021. Pfizer remains dedicated to helping each country meet the vaccination needs of its citizens without compromising our highest safety and quality standards,” said spokesperson Christina Antoniou.
Canada was planning on receiving between 124,800 and 366,600 Pfizer doses every week between now and the end of February, as part of the plan to have six million doses total from Pfizer and Moderna by the end of March when Phase 1 ends. Officials continue to state that once next week passes, deliveries will ramp-up and make up for the loss with larger batches arriving.
Fortin said Tuesday that Canada’s Moderna deliveries will continue as planned. These vaccines are delivered in a three week cycle, with the next shipment of 230,400 doses coming the first week of February.
Anand said come the spring Canadians will see a “dramatic increase in vaccine deliveries,” but cautioned about “additional supply challenges along the way.”
“This is precisely why we have multiple agreements in place with multiple manufacturers,” Anand said.
In a statement, Conservative Leader Erin O’Toole said he is “deeply frustrated by the government’s on-going failure to procure and deliver vaccines for Canadians.”
He is calling on the Liberals to deliver an “emergency plan,” and disclose Canada’s precedence in comparison to other countries’ vaccine delivery contracts.
“We cannot accept this kind of failure, not with so much at stake,” O’Toole said.
So far, more than 604,000 Canadians have received their first dose of one of the two approved COVID-19 vaccines, and nearly 37,200 have received both shots required in the two-dose regimen.
Alibaba’s Jack Ma makes first public appearance in three months
SHANGHAI (Reuters) – Alibaba Group founder Jack Ma made his first appearance since October on Wednesday when he spoke to a group of teachers by video, easing concern about his unusual absence from public life and sending shares in the e-commerce giant surging.
Speculation over Ma’s whereabouts has swirled in the wake of news this month that he was replaced in the final episode of a reality TV show he had been a judge on, and amid a regulatory clampdown by Beijing on his sprawling business empire.
The billionaire, who commands a cult-like reverence in China, had not appeared in public since Oct. 24, when he blasted China’s regulatory system in a speech at a Shanghai forum. That set him on a collision course with officials and led to the suspension of a blockbuster $37 billion IPO for Alibaba’s financial affiliate Ant Group.
Alibaba and his charitable foundation both confirmed he participated in an online ceremony for an annual event for rural teachers on Wednesday.
In the 50-second video, Ma, wearing a navy pullover, spoke from a room with grey walls, a large painting and floral arrangements. It was not clear where the room was.
Alibaba’s Hong Kong-listed shares jumped over 10% on the news, which was first reported by Tianmu News, a media outlet backed by the government of Zhejiang, the province where Alibaba’s headquarters are based.
“Jack Ma’s reappearance has given investors peace of mind after a lot of rumours, allowing them to pile into the stock which had been a laggard in the market,” said Steven Leung, sales director at brokerage UOB Kay Hian in Hong Kong.
The topic “Jack Ma makes his first public appearance” and his video address to the teachers soon began trending on China’s Twitter-like Weibo, triggering heavy discussion.
Although Ma has stepped down from corporate positions and earnings calls, he retains significant influence over Alibaba and Ant and promotes them globally at business and political events. He also continues to mentor management talent in the “Alibaba Partnership”, a 35-member group of company managers.
China has stepped up a regulatory crackdown on anticompetitive behaviour in the internet sector and Alibaba became the target of an antitrust investigation launched last month by Chinese authorities.
The company plans to raise at least $5 billion through the sale of a U.S. dollar-denominated bond this month.
(Reporting by Brenda Goh and Luoyan Liu in Shanghai, Kane Wu, Donny Kwok and Sumeet Chatterjee in Hong Kong, Yingzhi Yang, Cheng Leng and Zhang Yan in Beijing and the Shanghai Newsroom; Editing by Gerry Doyle and Edwina Gibbs)
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