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Canada has contracts for up to four COVID-19 vaccines but they won't be mandatory – Yahoo News Canada

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Canada has contracts for up to four COVID-19 vaccines but they won't be mandatory

OTTAWA — Canada is near the front of the line to get millions of doses of four of the most promising COVID-19 vaccines in development, but the federal government does not plan to make getting a vaccine mandatory, federal cabinet ministers said Monday.

Procurement Minister Anita Anand announced new deals with Maryland-based biotech company Novavax for Canada to buy as many as 76 million doses of its experimental vaccine candidate, and up to 38 million doses of the vaccine in development by Johnson & Johnson’s pharmaceutical company Janssen Inc.

Earlier this month similar deals were signed with U.S. companies Pfizer and Moderna but Anand only revealed Monday that those deals would see Canada access up to 20 million doses of Pfizer’s candidate and up to 56 million doses of Moderna’s version.

A fifth deal with AstraZeneca is almost complete, Anand said, and deals with other companies could also follow. All are racing to research, test and produce vaccines against SARS-CoV-2, the virus that causes COVID-19.

“In short, when a vaccine is ready, Canada will be ready,” said Anand.

All four of the vaccines Canada has contracts for, as well as the AstraZeneca candidate, are also part of the United States Operation Warp Speed program, which aims to have a vaccine ready for use by the end of the year.

Health Canada’s approval process for any vaccine must still be followed, which will require proof a vaccine is both safe for use and effective at either preventing COVID-19 or reducing the severity of disease.

But Anand said the arrangements put in place with these companies mean if and when one of these vaccines is approved, Canadians will be among the first in line to get it.

“We are prepared to protect Canadians who choose to be vaccinated.”

The key word there is “choose,” with Health Minister Patty Hajdu ending speculation Monday Canada might force Canadians to get a COVID-19 vaccine.

“We believe that people have a choice in Canada about whether or not to be vaccinated,” Hajdu said. “But we also believe we have an important responsibility as Canadians to take vaccinations to protect our communities.”

Ontario, New Brunswick and Manitoba all have some mandatory vaccines kids must have to attend school, but beyond that public health officials rely on educating people about the safety and value of immunization programs. Hajdu acknowledged that the more people who get vaccinated the better, though she did not say what percentage of Canadians she believes would need to get vaccinated to create so-called herd immunity.

That is where enough people are immune to a disease that it cannot spread easily, so even people without immunity have low odds of catching it.

Hajdu added that Canada does not have the same level of skepticism towards vaccinations as is seen in some other places. Still, Canada’s vaccination rates fall below the stated national goals. The aim is for 80 per cent of seniors and high-risk adults to get the influenza vaccine each year. In 2018-19, 70 per cent of seniors and 43 per cent of high-risk adults between 18 and 64 were immunized against the flu.

In 2009, during the H1N1 flu pandemic, about two in five Canadians got vaccinated.

There are more than 160 COVID-19 vaccines in development around the world but only about two dozen are being tested on humans so far, including the four Canada is now in line to buy. Various vaccines use different technologies to try to train human immune systems to detect and fight off the novel coronavirus that causes COVID-19.

Anand said signing contracts for a number of different types of potential vaccines is critical because nobody knows which vaccine or vaccines will end up being approved. Pfizer and Moderna have started Phase 3 trials — most of the time there are only three phases of clinical testing, with the third phase being the biggest. Johnson & Johnson and Novavax are both in Phase 2 trials, which are conducted on smaller numbers of volunteers.

Monday’s announcement came just days after a collaboration between the National Research Council and Chinese vaccine-maker CanSino finally collapsed, taking that possible vaccine out of likely contention for use here.

Prime Minister Justin Trudeau was at the National Research Council’s Human Health Therapeutics Research Centre in Montreal Monday morning, which earlier this year was given $44 million to upgrade its facilities in part so it could produce the CanSino vaccine for Canadians if clinical trials proved it safe and effective.

The NRC had given CanSino a license to use a Canadian biological product as part of the COVID-19 vaccine and CanSino was going to provide samples of the vaccine for clinical trials at the Canadian Centre for Vaccinology at Dalhousie University. Trudeau announced that partnership in May, but China never approved shipments of the vaccine to be exported to Canada and the NRC killed the deal last week.

Trudeau said the NRC partnership with CanSino had been well established and did good work on a vaccine for Ebola and said he is “disappointed” it did not work out this time.

“Unfortunately China didn’t grant export permits for the vaccine to Canada so we are continuing to focus on many other paths that are very promising in terms of developing a vaccine,” he said.

The updated NRC lab in Montreal is to be able to produce up to 250,000 doses of vaccines a month as of November.

Trudeau announced additional funding to build a new facility at the Montreal lab over the next two years, to produce even more vaccines within Canada.

This report by The Canadian Press was first published Aug. 31, 2020.

Mia Rabson, The Canadian Press

Note to readers: This is a corrected story. A previous version misspelled the name of pharmaceutical company Novavax.

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Johnson & Johnson’s single-dose COVID-19 vaccine candidate begins phase 3 trial – Global News

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Johnson & Johnson is beginning a huge final study to try to prove if a single-dose COVID-19 vaccine can protect against the virus.

The study starting Wednesday will be one of the world’s largest coronavirus vaccine studies so far, testing the shot in 60,000 volunteers in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.

A handful of other vaccines in the U.S. — including shots made by Moderna Inc. and Pfizer Inc. — and others in other countries are already in final-stage testing. Hopes are high that answers about at least one candidate being tested in the U.S. could come by year’s end, maybe sooner.

U.S. health officials insist the race for a vaccine isn’t cutting corners.

Read more:
9 drugmaker executives testing coronavirus vaccines pledge safety, high standards

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“We want to do everything we can without sacrificing safety or efficacy — we’re not going to do that — to make sure that we end up with vaccines that are going to save lives,” Dr. Francis Collins, director of the National Institutes of Health, told reporters.

But many vaccine specialists question whether the Food and Drug Administration will stick to that goal under intense pressure from the Trump administration. President Donald Trump has consistently presented a faster timeline for a new vaccine than experts say is adequate to fully test the candidates.

Meanwhile, testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the U.S. as officials examine a safety question, even though studies have resumed in other countries.

Earlier this week, Vice-President Mike Pence urged state governors to “do your part to build public confidence that it will be a safe and effective vaccine.”






5:37
Coronavirus: Trump says his administration expects vaccines for every American by April


Coronavirus: Trump says his administration expects vaccines for every American by April

And Dr. Anthony Fauci, the top U.S. infectious disease expert, added in the call to governors that he is confident in “a tried and true process” that has checks and balances built in, including an independent board evaluating the progress of each vaccine trial, as well as “the integrity of the FDA.”

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A recording of the call was provided to The Associated Press.

Senators were scheduled to question FDA Commissioner Stephen Hahn, Fauci and other administration officials later Wednesday about the pandemic response.

Even if the FDA were to allow emergency use of a vaccine by year’s end, supplies would be limited and given first to vulnerable groups such as health workers. Most Americans aren’t likely to receive a vaccine until sometime next year.

Read more:
Canada to join global coronavirus vaccine procurement program

The Centers for Disease Control and Prevention wants states to get ready now to roll out vaccinations, which will present enormous logistical challenges. On Wednesday the CDC was set to announce distribution of $200 million in congressionally approved funds to help begin setting up operations.

Health and Human Services Secretary Alex Azar said the COVID-19 vaccine campaign will build on longstanding co-operation between the federal government and the states on immunizations.

J&J’s vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created. Unlike the other three vaccines that started late-stage testing in the U.S., it requires only one shot, not two. Despite a later start to testing than some of its competitors, Dr. Paul Stoffels, J&J’s chief scientific officer, told reporters that the study was large enough to yield answers possibly by early next year.

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Associated Press writers Lauran Neergaard and Ricardo Alonso-Zaldivar contributed to this report.

© 2020 The Canadian Press

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Johnson & Johnson begins giant trial testing one-dose COVID shot – BNN

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Johnson & Johnson has begun dosing up to 60,000 volunteers in a study of its COVID-19 vaccine, marking the first big U.S. trial of an inoculation that may work after just one shot.

J&J became the fourth vaccine maker to move its candidate into late-stage human studies in the U.S. If enrollment goes as expected, the trial could yield results as soon as year-end, allowing the company to seek emergency authorization early next year, should it prove effective, according to Chief Scientific Officer Paul Stoffels.

“A single dose could be a very efficient tool to combat the pandemic as it is faster acting,” he said Wednesday in an interview. Animal models and early human studies showed that one shot of its vaccine generated a strong immune response in just 15 days, he said.

The final-stage study will pit the vaccine against a placebo injection, with a goal of showing whether it reduces cases of moderate to severe COVID-19, “the most important part of the disease to prevent,” Stoffels said. J&J is also looking at whether the shot curbs the virus’s spread.

The company’s shares rose as much as 2.3 per cent in New York.

The New Brunswick, New Jersey-based company published detailed trial plans on Wednesday. Frontrunners Pfizer Inc., Moderna Inc. and AstraZeneca Plc have already done the same in a broader transparency push.

“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement. J&J’s vaccine “may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

The study is nearly two months behind those of Moderna, working with NIAID, and Pfizer, partnered with BioNTech SE, whose final-stage trials started in late July. Pfizer has said it could get efficacy results by the end of October. Those vaccines use two-dose regimens.

J&J’s vaccine could offer an advantage in distribution over those inoculations, which require vaccination sites to ensure recipients return for their second dose. The company also said its vaccine can be stored at refrigerator temperatures for three months, far longer than the Pfizer vaccine that requires deep freezing for long-term storage.

“In countries where there is less health-care infrastructure, it can be much better used at a very large scale,” Stoffels told Bloomberg. “Single dose, easy to use in the field are the main characteristics that make it different.”

Years in the Making

The J&J product is made from a cold virus, called an adenovirus, that’s modified to make copies of the coronavirus’s spike protein, which the pathogen uses to enter cells. The altered virus can’t replicate in humans, but it induces an immune response that prepares the body for an actual COVID-19 infection. The vaccine was developed with researchers at Harvard University who have spent years working on the adenovirus vaccine platform, which is also used in J&J’s Ebola vaccine.

The health-care behemoth is running the study in conjunction with NIAID and the Biomedical Advanced Research and Development Authority at sites in the U.S., Brazil, Mexico, South Africa and other countries. It will include significant representation among those over the age of 60, as well as minorities at disproportionate risk of becoming infected, including Black, Hispanic, American Indian and Alaskan Native peoples, according to a statement.

J&J has also agreed to collaborate with the U.K. on a separate phase 3 clinical trial that will test a two-dose regimen of the vaccine in multiple countries, with two months between each dose, according to Stoffels. That booster could be critical to providing long-term protection, he said.

Trial Protocol

The decision to begin the final-stage trial was based on data from an earlier human study that showed a single shot was safe and stimulated a strong immune response, Stoffels said.

Like other final-stage vaccine trials, J&J’s study is monitored by an independent board of doctors and statisticians who wait for a certain number of coronavirus cases to accumulate before looking at the data.

The trial aims to accumulate 154 cases for a final analysis. If the vaccine turns out to be more than 90% effective, the study could produce results after just 20 cases, Stoffels said. He said that scenario is unlikely, though.

J&J’s trial appears to have stringent criteria for declaring early success that prevent a readout based on very short-term results in patients with relatively moderate symptoms. Based on discussions with U.S. regulators, the data won’t undergo its first analysis until at least half of participants have been vaccinated for two months or more.

The study will also have to accrue at least 5 severe cases for an early readout. And to be considered a success, the absolute number of severe cases needs to be half of that in the placebo group, along with other benchmarks, according to documents posted on J&J’s website.

Still, the study will take less time to complete than it would with two doses. Scientists will start counting cases just 15 days after patients get their inoculations or placebo shots.

Despite accelerated timelines, Operation Warp Speed won’t cut corners in confirming vaccine safety or efficacy, National Institutes of Health director Francis Collins said on the Tuesday media call. “That absolutely will not be allowed to happen,” he said.

Stoffels said J&J will continue to clinch new manufacturing partnerships to meet its 1 billion dose production goal for 2021. The company has already kick-started at-risk manufacturing in hopes the shot will prove successful in the clinic.

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The 6 Big Takeaways From Tesla’s Battery Day – CleanTechnica

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The overall content of the Tesla Battery Day presentation might have been overwhelming for those who do not have a technical background in battery development. The level of abstraction that Elon Musk and Drew Baglino presented relative to Tesla’s battery tech was surprisingly low, even though I’m sure they thought their presentation was just an overview.

Elon Musk talks batteries (Source: Tesla)

Given that, it might be a good idea to “pull the lens back” just a bit and discuss the major takeaways:

1. The holy grail of battery tech — a cost of less than $100 per kWh — will be achieved and production-ready in less three years. That means a significant reduction in vehicle cost and the real likelihood that a mass-market, $25,000 Tesla will be available in three years.

2. The technical breakthroughs and improvements presented during the battery day presentation mean that a transition away from fossil fuels for most, if not all, energy needs is no longer a pipe dream. If Tesla can achieve (and it’s likely that it will) a 3 TWh battery production capability within the next decade, the entire face of the energy and power delivery system will be transformed.

3. The new paradigm that Tesla uses for building the “machine that builds the machine” is groundbreaking, representing substantial improvement that will increase production capacity and lower production costs. Tesla used vertical integration, avoids sub-optimization, and makes the entire production process more efficient. This paradigm will bode well for Tesla’s ability to produce cars and trucks in great volume. The capital investment (CapEx) in production facilities will be less costly than originally assumed, making the company more profitable.

4. Tesla is building an increasingly bigger “moat” that will enable it to keep even the most able competitors at bay. Batteries are the pivotal element for long range, high performance and low cost EVs. From what we’ve seen, there’s no other company that’s even close to the battery tech that was previewed during Battery Day.

5. Tesla and Musk care more about the stuff that really matters — the underlying tech infrastructure for building EVs — than they do about the “bling” of new vehicle designs every years. It’s the tech infrastructure that really matters for long-term success.

6. Tesla is not resting on its laurels. It appears that they’re working to jettison existing methods and approaches to EV design and production, replacing them with new and better ideas.

And finally … it’s hard to imagine any other CEO at a major auto company that can drive technical effort in the manner that Elon Musk has accomplished to date. Much like SpaceX, this rate of progress could accelerate in the coming years. As Musk says, Tesla is a “hardcore engineering” company … and it shows in their relentless pursuit of improvement.

 

 

 

 

Source: – Alberni Valley News

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