Following news that the United Kingdom has authorized a COVID-19 vaccine for use, questions are emerging about what the new approval could mean for other countries looking to secure a vaccine candidate in the race against the novel coronavirus.
Britain gave the green light to the COVID-19 vaccine candidate from American drugmaker Pfizer and Germany’s BioNTech on Wednesday and expects to start its first vaccinations in the country within days.
Canada’s Minister of Health Patty Hajdu took to Twitter on Wednesday to say that the U.K.’s approval of the Pfizer vaccine is “encouraging” and that Health Canada will complete its review of the candidate “soon.” She did not provide further details.
“Making sure a COVID-19 vaccine is safe before approving it is Health Canada’s priority, and when a vaccine is ready, Canada will be ready,” Hajdu tweeted.
Chief medical advisor at Health Canada Dr. Supriya Sharma said at a public briefing on Nov. 26 that Canada plans to make a decision on the Pfizer vaccine around the same time that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency do.
Those decisions are expected to be made sometime in December, with FDA having set a meeting on Dec. 10 during which they will make a final call on the vaccine.
However, Health Canada has its own approval processes, designed to ensure vaccines are safe and effective.
Sharma said Canada’s review of Pfizer’s vaccine, which began on Oct.3, is the most advanced out of the current candidates, but still ongoing.
“While significant time and resources are being devoted to expediting the scientific review of COVID-19 vaccines, the decision on whether they will be authorized will ultimately depend on assessment of the data, including the complete information from clinical trials, which is still coming in,” Sharma said.
Sharma said Canada “will only authorize a vaccine if its benefits clearly outweigh its risks.”
“While we are working hard to give Canadians access to COVID-19 vaccines as quickly as possible, we will not compromise our safety, efficacy and quality standards. Protecting the health and safety of Canadians is our top priority,” Sharma said.
While Pfizer’s vaccine may be furthest ahead in Canada’s review process, AstraZeneca, Moderna and Janssen’s vaccine candidates have also been submitted to Health Canada for approval.
Pfizer announced in November that results of clinical trials that showed its COVID-19 vaccine was 95 per cent effective and offered “significant protection” for older people. However, the candidate needs to be kept at -70 C during transportation and storage to remain effective, posing logistical problems.
Infectious disease specialist Dr. Abdu Sharkawy told CTV’s Your Morning on Wednesday that news of Britain’s approving the Pfizer COVID-19 vaccine is “exciting.” He expects other vaccine candidates to be approved in Western countries in the coming weeks.
Sharkawy said the approval adds to the “sense of optimism” around a successful coronavirus vaccine.
“If the data has been looked at very carefully by one regulatory body, like the MHRA in the U.K., then certainly the FDA and Health Canada should be able to do the same thing,” Sharkawy said
“I would be surprised if Health Canada did not follow suit with approval very, very soon,” he added.
However, in a statement to CTV News, Pfizer Canada said on Wednesday that “an approval in one jurisdiction does not equate to an approval in another.”
Despite being approved in the U.K., infectious disease specialist Dr. Isaac Bogoch says Pfizer’s vaccine candidate won’t land on Canadian soil anytime sooner.
Bogoch told CTV News Channel on Wednesday that regulatory bodies are “working at different paces” and said the U.K.’s approval does not mean that Health Canada should rush its own decision.
“I really hope that they do their job in a very fair manner without any external pressure, and I really hope that it doesn’t push them to do their job faster,” Bogoch said. “If it’s a day, a week, a couple of weeks longer, [that’s] fine, as long as they do a thorough job and ensure that Canadians get access to safe vaccines that are effective.”
Bogoch explained that Health Canada not only has to look at the data from a vaccine’s clinical trials, but the agency also has to consider the manufacturing process of that vaccine.
Bogoch said it is likely that Health Canada will approve the Pfizer vaccine in the “coming weeks.” However, once the vaccine arrives in Canada, Bogoch said the country needs to have programs already in place to ensure the shots are immediately rolled out.
“It’s not quite clear when the vaccine will land on our doorstep but when it does, we better work really, really hard right now to sort out how we’re going to ship this,” Bogoch said, adding that Pfizer’s temperature requirements do pose a challenge.
“This is that one where it requires [-70 C] freezing, so the logistics of getting this around the country are hard. I hope that process is underway because we might get access to this sooner than we think,” he said.
Canada has secured access to a total of 414 million doses of COVID-19 vaccines from different sources including 76 million from Pfizer, but just four million of those are expected to land in the country by the end of March.
Deputy Chief Public Health Officer Dr. Howard Njoo said on Nov. 26 that while there will be early prioritization of who gets vaccinated based on the limited initial supply, Canada will have enough doses to “provide access to every Canadian who wants one in 2021.”
However, Kerry Bowman, a bioethicist and assistant professor at the University of Toronto’s faculty of medicine, says he is concerned that vaccine access may be limited throughout the next year if a proper rollout plan is not in place.
Bowman told CTV News Channel on Wednesday that there is “a lot of confusion and ambiguity” as to when provincial health authorities will have a COVID-19 vaccine so inoculations can begin.
Bowman’s remarks come on the heels of weeks of moving targets and changes in messaging from federal and provincial officials about Canada’s vaccine standing and timelines.
“So many of the people in Canada and the provinces, if they’re going to be prepared for this they do need dates and they do need numbers. How do you prepare without that?” Bowman said.
While he acknowledges that administering a vaccine nationally “isn’t easy,” he said there needs to be more transparency from government officials about current rollout plans to ensure that Canadians aren’t hesitant to get vaccinated once they can.
“We really, really need to build trust with Canadians right now so that when the vaccine is available that people are trusting of that,” Bowman said.
Speaking virtually at the Canadian Immunization Conference, Chief Public Health Officer Dr. Theresa Tam said Canada’s vaccine rollout requires a “complex response” since the country has invested in a range of vaccine candidates that all have their own needs.
Tam said on Wednesday that Canada has ordered 126 freezers with various temperature capabilities for the vaccine, many of which she says have already been delivered.
She acknowledged that it is “very important” to be transparent with Canadians about the status of vaccine candidates and their subsequential rollout.
“It is important for all of us to get knowledgeable about the process of development and that the regulatory process is rigorous and that we would only provide vaccines that have gone through safety evaluations and efficacy evaluations,” Tam said.
Tam said the federal government will be using “behavioural insights” and other strategies such as sharing testimonials and using social media influencers to help address misinformation and “boost vaccine confidence among the population.”
However, Tam maintained that Canada will only approve a COVID-19 vaccine after thorough reviews are completed.
“We still have to look at the clinical trial results in depth. These initial vaccine candidates have reported good efficacy and provide hope for a new way forward in not just this pandemic, but for future,” Tam said.
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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