Business
Pfizer files for emergency use of coronavirus vaccine in U.S. — what about in Canada? – Global News
Pfizer applied for emergency use authorization of its coronavirus vaccine with United States regulators Friday, days after the company said it finished its final round of human trials — with promising results.
Pfizer and its partner company, BioNTech, said the final data shows its vaccine is 95 per cent effective against the virus, with no serious safety concerns. But, the full results of its trial have not been released and must be peer-reviewed by independents scientists.
Even though the data is not available, the vaccine has been submitted to the U.S. Food and Drug Administration (FDA) for emergency use approval.
If it gets the green light, this does not mean the vaccine has full approval; the vaccine is only deemed “investigational” and can be given to people while studies are ongoing, according to the FDA.
This means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, the FDA said.
What about in Canada?
In Canada, Health Canada is in charge of reviewing and approving Pfizer’s coronavirus vaccine.
Pfizer applied to Health Canada for approval of the vaccine on Oct. 9, according to the department’s website.
Speaking at a media conference Friday, Minister of Health Patty Hajdu said Health Canada has a “rolling review” process for the vaccine. Meaning, Pfizer submits data to the department as it becomes available.
The rolling review process allows Health Canada to review the data right away as it continues to come in. This is in order to accelerate the process, according to the department.
[ Sign up for our Health IQ newsletter for the latest coronavirus updates ]
“The rolling review process is because the situation is urgent so that as soon as the data is available it can be quickly reviewed,” Kerry Bowman, a professor of bioethics and global health at the University of Toronto, said. “But there is no way they are cutting corners on this. They are looking at all the evidence section by section. I find it very encouraging.”
He said so far Health Canada is still reviewing Pfizer’s Phase 3 trials, but there is a chance more information about the data will come in December.
“They are balancing safety and trying to keep things going as quickly as possible,” he said.
Does Canada have an ’emergency authorization’?
Health Canada does not have an emergency use authorization like the FDA. However, it has a review process that is comparable.
It’s called the “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.” It was signed by the minister of health on Sept. 16, 2020.
The interim order allows “expedited authorization” for the importation, sale and advertising of drugs used in relation to coronavirus.
So, instead of a company, like Pfizer, providing substantial evidence of the safety and effectiveness of a new drug — as usually required by federal law — the interim order says an applicant can submit the information as it becomes available, allowing for the “rolling review” process.
This allows for a faster approval process during a health crisis.
“This new rolling review process under the IO (interim order) involves reviewing all the necessary data to support authorization in the context of the pandemic and urgent public health needs, and can shorten the time it takes for a new drug to be authorized once all of the necessary data are available,” Health Canada told Global News in an email.
Once a company submits new data, Health Canada said it starts the review “immediately.”
Under the interim order, a coronavirus drug is approved by Canada’s ministry of health once evidence shows the benefits outweigh the risks.
In order to be approved, the vaccine goes through a rigorous review process in Canada, despite the expedited timeline, Dr. Supriya Sharma, the federal department’s chief medical advisor, previously told Global News.
Under Canada’s system, three federal scientific teams review a vaccine prior to approving or rejecting it. Sharma explained that one team looks at pre-trial research on animals, a second team reviews human clinical trials, and a third team reviews the manufacturing process.
Sharma also said that the department’s review of potential COVID-19 vaccines will be “the same as with any other vaccine.” So if the department determines a vaccine candidate doesn’t meet the standards, Health Canada will not approve it, she said.
Following the authorization of any vaccine submission, Health Canada said it will also publish the evidence it reviewed in making its decision for transparency purposes.
How Canada’s vaccine approval differs from the U.S.
Health Canada said the requirements for vaccine approval under its interim order are similar to the FDA’s emergency use authorization — but there are some differences.
One important difference is that the FDA has been reviewing aspects of Pfizer’s data that Health Canada hasn’t seen yet.
Because Pfizer’s vaccine clinical trials took place in the U.S., Health Canada said U.S. regulators were able to review data such as the “quality” and “manufacturing” details, for several months.
“These trials were not carried out in Canada, therefore Health Canada will only have access to key data once they are filed under the IO,” the department said.
But Health Canada said it has been in “continuous contact” with Pfizer on the progress of their studies and filing plans.
Both the FDA and Health Canada have set up systems that safely allow ways to dramatically speed up the process for COVID-19 vaccines. This is because the normal approval process of a new vaccine can take about a decade.
An exact timeline of vaccine approval is still unclear in Canada, but last week Prime Minister Justin Trudeau said he hopes to have the vaccine available in early 2021.
If the vaccine is approved, Canada has an advance-purchase agreement for 20 million doses. The vaccine requires two doses.
© 2020 Global News, a division of Corus Entertainment Inc.
Tesla has promised to start selling cheaper models next year, days after a Reuters report revealed that the company had shelved its plans for an all-new Tesla that would cost only $25,000.
The news that Tesla was scrapping the Model 2 came amid a drop in sales and profits, and a decision to slash a tenth of the company’s global workforce. Reuters also noted increased competition from Chinese EV makers.
Tesla’s deliveries slumped in the first quarter for the first annual drop since the start of the pandemic in 2020, missing analyst forecasts by a mile in a sign that even price cuts haven’t been able to stave off an increasingly heated competition on the EV market.
Profits dropped by 50%, disappointing investors and leading to a slump in the company’s share prices, which made any good news urgently needed. Tesla delivered: it said it would bring forward the date for the release of new, lower-cost models. These would be produced on its existing platform and rolled out in the second half of 2025, per the BBC.
Reuters cited the company as warning that this change of plans could “result in achieving less cost reduction than previously expected,” however. This suggests the price tag of the new models is unlikely to be as small as the $25,000 promised for the Model 2.
The decision is based on a substantially reduced risk appetite in Tesla’s management, likely affected by the recent financial results and the intensifying competition with Chinese EV makers. Shelving the Model 2 and opting instead for cars to be produced on existing manufacturing lines is the safer move in these “uncertain times”, per the company.
Tesla is also cutting prices, as many other EV makers are doing amid a palpable decline in sales in key markets such as Europe, where the phaseout of subsidies has hit demand for EVs seriously. The cut is of about $2,000 on all models that Tesla currently sells.
By Charles Kennedy for Oilprice.com
More Top Reads From Oilprice.com:
Article content
Divisions within the Bank of Canada over the timing of a much-anticipated cut to its key overnight interest rate stem from concerns of some members of the central bank’s governing council that progress on taming inflation could stall in the face of stronger domestic demand — or even pick up again in the event of “new surprises.”
“Some members emphasized that, with the economy performing well, the risk had diminished that restrictive monetary policy would slow the economy more than necessary to return inflation to target,” according to a summary of deliberations for the April 10 rate decision that were published Wednesday. “They felt more reassurance was needed to reduce the risk that the downward progress on core inflation would stall, and to avoid jeopardizing the progress made thus far.”
Article content
Others argued that there were additional risks from keeping monetary policy too tight in light of progress already made to tame inflation, which had come down “significantly” across most goods and services.
Some pointed out that the distribution of inflation rates across components of the consumer price index had approached normal, despite outsized price increases and decreases in certain components.
“Coupled with indicators that the economy was in excess supply and with a base case projection showing the output gap starting to close only next year, they felt there was a risk of keeping monetary policy more restrictive than needed.”
In the end, though, the central bankers agreed to hold the rate at five per cent because inflation remained too high and there were still upside risks to the outlook, albeit “less acute” than in the past couple of years.
Despite the “diversity of views” about when conditions will warrant cutting the interest rate, central bank officials agreed that monetary policy easing would probably be gradual, given risks to the outlook and the slow path for returning inflation to target, according to the summary of deliberations.
Article content
They considered a number of potential risks to the outlook for economic growth and inflation, including housing and immigration, according to summary of deliberations.
The central bankers discussed the risk that housing market activity could accelerate and further boost shelter prices and acknowledged that easing monetary policy could increase the likelihood of this risk materializing. They concluded that their focus on measures such as CPI-trim, which strips out extreme movements in price changes, allowed them to effectively look through mortgage interest costs while capturing other shelter prices such as rent that are more reflective of supply and demand in housing.
Recommended from Editorial
They also agreed to keep a close eye on immigration in the coming quarters due to uncertainty around recent announcements by the federal government.
“The projection incorporated continued strong population growth in the first half of 2024 followed by much softer growth, in line with the federal government’s target for reducing the share of non-permanent residents,” the summary said. “But details of how these plans will be implemented had not been announced. Governing council recognized that there was some uncertainty about future population growth and agreed it would be important to update the population forecast each quarter.”
• Email: bshecter@nationalpost.com
Bookmark our website and support our journalism: Don’t miss the business news you need to know — add financialpost.com to your bookmarks and sign up for our newsletters here.
Share this article in your social network
Shares in US tech giant Meta have sunk in US after-hours trading despite better-than-expected earnings.
The Facebook and Instagram owner said expenses would be higher this year as it spends heavily on artificial intelligence (AI).
Its shares fell more than 15% after it said it expected to spend billions of dollars more than it had previously predicted in 2024.
Meta has been updating its ad-buying products with AI tools to boost earnings growth.
It has also been introducing more AI features on its social media platforms such as chat assistants.
The firm said it now expected to spend between $35bn and $40bn, (£28bn-32bn) in 2024, up from an earlier prediction of $30-$37bn.
Its shares fell despite it beating expectations on its earnings.
First quarter revenue rose 27% to $36.46bn, while analysts had expected earnings of $36.16bn.
Sophie Lund-Yates, lead equity analyst at Hargreaves Lansdown, said its spending plans were “aggressive”.
She said Meta’s “substantial investment” in AI has helped it get people to spend time on its platforms, so advertisers are willing to spend more money “in a time when digital advertising uncertainty remains rife”.
More than 50 countries are due to have elections this year, she said, “which hugely increases uncertainty” and can spook advertisers.
She added that Meta’s “fortunes are probably also being bolstered by TikTok’s uncertain future in the US”.
Meta’s rival has said it will fight an “unconstitutional” law that could result in TikTok being sold or banned in the US.
President Biden has signed into law a bill which gives the social media platform’s Chinese owner, ByteDance, nine months to sell off the app or it will be blocked in the US.
Ms Lund-Yates said that “looking further ahead, the biggest risk [for Meta] remains regulatory”.
Last year, Meta was fined €1.2bn (£1bn) by Ireland’s data authorities for mishandling people’s data when transferring it between Europe and the US.
And in February of this year, Meta chief executive Mark Zuckerberg faced blistering criticism from US lawmakers and was pushed to apologise to families of victims of child sexual exploitation.
Ms Lund-Yates added that the firm has “more than enough resources to throw at legal challenges, but that doesn’t rule out the risks of ups and downs in market sentiment”.
With capital gains change, the Liberals grasp the tax reform nettle again – CBC News
That offer to buy your time-share could be from a Mexican drug cartel – CBC.ca
Investment Statistics (10 Investment Statistics Investors Need To Know) – Forbes
Silver investment demand jumped 12% in 2019
12 Bizarre Things People Did Just To Make Social Media Content
Global Media Markets, 2015-2020, 2020-2025F, 2030F – TV and Radio Broadcasting, Film and Music, Information Services, Web Content, Search Portals And Social Media, Print Media, & Cable – GlobeNewswire
-
Politics20 hours agoOpinion: Fear the politicization of pensions, no matter the politician
-
Politics19 hours ago
Pecker’s Trump Trial Testimony Is a Lesson in Power Politics
-
Science20 hours ago
NASA Celebrates As 1977’s Voyager 1 Phones Home At Last
-
Media19 hours ago
B.C. puts online harms bill on hold after agreement with social media companies
-
Media13 hours ago
B.C. online harms bill on hold after deal with social media firms
-
Business19 hours ago
Oil Firms Doubtful Trans Mountain Pipeline Will Start Full Service by May 1st
-
Art21 hours ago
Turner Prize: Shortlisted artist showcases Scottish Sikh community
-
Investment21 hours ago
FLAGSHIP COMMUNITIES REAL ESTATE INVESTMENT TRUST ANNOUNCES CLOSING OF APPROXIMATELY US
