Novavax submits vaccine for approval as Ottawa seeks EU reassurances on exports rules


Canada’s hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work to approve a new inoculation, even as the federal government sought to head off any restrictions on vaccine shipments from Europe.

Pharmaceutical company Novavax quietly submitted its COVID-19 vaccine to Health Canada for regulatory approval on Friday, less than two weeks after Ottawa finalized a deal with the Maryland-based company for 52 million doses of the shot.

Because of the emergency nature of the pandemic, Health Canada is accepting applications for vaccines before the final trial data is ready, allowing the review team to start poring over the documents on an ongoing basis rather than waiting until everything is finished.

The rolling review allows for much faster approval once the final results from clinical trials are complete.

Novavax is the fifth vaccine maker to submit an application for rolling review. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October; Johnson and Johnson followed suit at the end of November.

Health Canada approved the Pfizer-BioNTech vaccine on Dec. 9 and gave Moderna the green light on Dec. 23, both about three weeks after the companies completed their Phase 3 trials. A decision on AstraZeneca is expected in the next couple of weeks.

Johnson and Johnson reported results from its Phase 3 trial just last week.

Novavax also reported results Thursday from a trial in the United Kingdom, but a large trial in the U.S. is still at least a month or two away from yielding final results.

Novavax has said its vaccine was 89 per cent effective in the U.K. trial. It also touts its product as very effective against the two coronavirus variants first detected in the U.K. and South Africa.

Johnson and Johnson’s long-awaited COVID-19 vaccine appears to protect against symptomatic illness with just one shot, although it’s not as strong as some two-shot rivals. (AP)

Application comes as Ottawa faces criticism over vaccine rollout

Novavax’s application comes as the federal Liberal government faces withering criticism for the pace of vaccinations across the country, with opposition parties and some provincial governments complaining about a lack of shots.

Those critiques have come as Pfizer slows delivery of its vaccines to Canada so it can expand a production plant in Belgium. The pharmaceutical giant is also pressing Canada to allow six shots per vial of vaccine instead of the current five.

Moderna has also said that it will deliver fewer doses than originally promised, though the Liberal government insists the slowdowns are temporary and that both companies will make good on their promised deliveries over the coming months.

There are also concerns that Canada’s troubled vaccine supplies will be further affected by new controls on vaccine exports that have been imposed by the European Union, which is also struggling with delivery shortfalls from manufacturers.

The measures allow the European Union to deny vaccine exports if the manufacturer has not fulfilled its promised deliveries to the 27-country bloc, which is where most of Canada’s shots are being made.

Ottawa receives assurances Canada won’t be affected

Ottawa has been working to head off any impact on Canada’s supply, with International Trade Minister Mary Ng speaking by phone to her EU counterpart on Saturday for the second time in three days.

That followed Prime Minister Justin Trudeau’s own phone call with European Commission President Ursula von der Leyen late last week, after which Trudeau asserted that the new export controls would not affect vaccines destined for Canada.

European Commission President Ursula von der Leyen said the export transparency rule is temporary but has to be done as the continent is in an ongoing battle with vaccine-makers about slow deliveries. (Francisco Seco/Associated Press)

Ng was told the same thing during her phone call with Valdis Dombrovskis, the European Commission’s commissioner for trade, according to a summary of their conversation provided by Global Affairs Canada.

“I was really clear that Canada’s expectation is that our purchase contracts with the vaccine makers are not disrupted,” Ng said in a Sunday interview on Rosemary Barton Live. “I would note that in their regulation, there is absolutely consideration for advance purchase agreements that have been made, like that of Canada, with the vaccine makers, and our expectation is that there is no disruption or delay.

Ng also told CBC Chief Political Correspondent Rosemary Barton that Ottawa is taking a “whole of government approach” to tackle the issue.

“Minister Garneau has already spoken to some of his counterparts and continues that work, as will Minister Hajdu,” she said. “Minister Anand, of course, is in constant contact with the suppliers, and I have been speaking to my international counterparts.”

Von der Leyen said Friday the commission is following through on a threat to force COVID-19 vaccine makers to show them what vaccines they are producing in Europe and where those are going.

She said the export transparency rule is temporary but has to be done as the continent is in an ongoing battle with vaccine-makers about slow deliveries.

Both Pfizer-BioNTech and AstraZeneca are behind on their scheduled deliveries to European nations, but it is the latter with which Europe is having the loudest fight.

The EU is demanding the company ship doses made in the U.K. to make up for shortfalls due to production issues in its European plants.

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Is Novavax the dark horse of Australia’s COVID-19 vaccines?


“The phase one data was really convincing. The immune responses were really strong – up there in the realms we saw with the mRNA vaccines. That level of immune response tends to be a bit of a correlation … those are the vaccines that have ended up giving very strong efficacy,” said University of Sydney professor of medical microbiology James Triccas.

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Paul Young, co-leader of the University of Queensland’s aborted COVID-19 vaccine project, agreed the data “does look promising”.

“The preclinical animal data showed that viral titres in the upper respiratory tract were lower in vaccinated animals, suggesting but not proving that infectivity and transmission may be lower,” he said.

Paul Griffin, medical director of the Nucleus Network – contracted by Novavax to conduct clinical trials in Australia – said if all went well, the vaccine could be available for use by May or June.

“I think this is one, just based on where it’s up to timing wise, that has fallen off the radar in this country. There has been a lot of attention on Pfizer, AstraZeneca and Moderna,” he said. “It is looking very safe and effective.”

It is difficult to directly compare phase one trial results, but data reported in the New England Journal of Medicine in December suggested Novavax’s vaccine produced an immune response similar to vaccines from Pfizer and Moderna.

Paul Griffin, medical director of the Nucleus Network – contracted by Novavax to conduct clinical trials in Australia – said if all went well, the vaccine could be available for use by May or June.Credit:Justin McManus

“They were able to induce higher [antibody] titres than recovered COVID patients. And that’s a really good sign. When we were seeing results like that, it did highlight Novavax is one to watch, and a really promising formulation,” said Kylie Quinn, an RMIT vaccine designer.

Griffith University virologist Adam Taylor said the trials showed the vaccine was safe and generated good antibody responses. “Certainly, this is a useful candidate.”

Other vaccines have already shown themselves capable of inducing strong immune responses and protecting people from the virus.

What makes Novavax different is a hint in the early data it could not just protect people but also stop the virus spreading. Stopping or reducing transmission of the virus is valuable to protect people who cannot or will not get vaccinated. At this stage, it remains unclear if any of the vaccines available can prevent transmission.

In a small study, Novavax’s vaccine effectively prevented COVID-19 growing in the noses of monkeys. Results in animals often do not translate to humans. But other vaccines have struggled to repeat the achievement; they effectively protect the lungs but still allow the virus to grow in the nose, where it could spread.

A healthcare worker fills a syringe with the AstraZeneca vaccine.

A healthcare worker fills a syringe with the AstraZeneca vaccine.Credit:PAMPC

While other vaccines quickly moved from phase one to phase three trials and then approval, Novavax’s progress has been slower. The company started its key phase three trial on December 28 after several delays due to issues scaling up vaccine manufacture.

Novavax has had a chequered history. Two failed vaccine trials in recent years led to the company’s stock plunging; it sacked 100 employees and closed two manufacturing plants. In its near-30-year history it is yet to develop an approved vaccine.

Nevertheless, the company is aiming to produce 2 billion doses of vaccine this year.

Novavax’s jab combines traditional and cutting-edge technology. Inside each vial are copies of COVID-19’s spike protein – the cellular harpoon it uses to attach to and enter our cells – and a dose of the company’s adjuvant. The adjuvant triggers the immune system, which recognises the spike protein and builds antibodies and immune cells capable of defending the body against the virus.

“It’s more of a traditional vaccine – the same type we have used for other vaccines we have in use,” said Professor Triccas.

Novavax produces the spike proteins using moth cells, and then studs them on a nanoparticle, creating a shape that looks much like the spike-covered virus. In theory, immune cells should be much more likely to spot and attack these nanoparticles, as they look just like little viruses.

The company used similar technology in a flu vaccine it is developing. In a late-stage clinical trial, it produced much stronger antibody results than a current flu vaccine.

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Addressing the deaths in Norway, Chief Medical Officer Professor Kelly said on Tuesday: “In a normal week, 400 people do pass away in their aged care facilities.

“In general terms, they were very old, they were frail, some of them were basically terminally ill.”

It is not yet clear if the deaths are linked to the vaccine, and Australian experts have already said they are no reason to slow the vaccine’s rollout.

Professor Kelly said it was possible Australia’s drugs regulator would advise against giving the very elderly and frail the vaccine.

“That is a very tricky balance. We know elderly people, as is the case in Norway, elderly people in aged care facilities are towards the end of their life. We know from our own data from the Australian pandemic, of the 900 people who have died, they have mostly been in the very elderly group, they are of the greatest risk of severe infection,” he said.

“The mortality rate is very high once you get over 80 or 90 if you get COVID-19. It’s that risk balance equation which the [regulator] will need to do around which people should be excluded from the vaccine.”

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Novavax prepares for COVID-19 vaccine launch


The technology behind Novavax’s coronavirus vaccine is different from other products that Australia has ordered. The protein-based candidate contains one element of the virus, a version of the “spike protein” in SARS-CoV-2, and the vaccine delivers this to the body to prompt an immune response.

Unlike mRNA vaccines like Pfizer’s, which must be stored at very low temperatures, Novavax’s product is designed to be more easily stored with standard refrigeration methods.

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Novavax’s vaccine is in phase 3 testing in the US and Mexico and the company’s executive vice-president, chief commercial officer and chief business officer John Trizzino says it was preparing to deliver trial data to Australia’s Therapeutic Goods Administration (TGA) as soon as it becomes available.

“We would expect packets of information and rolling submissions to take place in advance of that final data-set in order to accelerate that approval as quickly as possible,” he says.

The company won’t disclose the value of the Australian deal, but Trizzino says Novavax would keep dose pricing consistent across the globe. “We believe that what we do with pricing is going to be fair,” he says.

The health department says it hopes Novavax doses will “be available in Australia as early as the first half of 2021”, though there are several hurdles to jump before this happens.

Meanwhile the TGA, which is working around the clock to secure the first approvals of COVID-19 vaccines, has so far only given ”provisional determinations” to Pfizer, AstraZeneca and Johnson & Johnson.

When asked whether it had received documentation yet from Novavax about its vaccine, a spokesperson said: “Due to the commercial-in-confidence nature of applications for registration of therapeutic goods, the TGA can neither confirm nor deny whether it has received an application for provisional determination from Novavax. If such an application is received and approved, details will be published on the TGA website”.

Griffith University virologist Dr Adam Taylor says because Novavax has only recently launched its 30,000-strong US phase 3 trial, results could be expected from the middle of this year.

Secretary of the Department of Health Professor Brendan Murphy, Health Minister Greg Hunt and Chief Medical Officer Professor Paul Kelly during a press conference on the COVID-19 vaccine road map on Thursday. Credit:Alex Ellinghausen

According to the government’s national immunisation road map, vaccine rollout will begin with the Pfizer vaccine, followed by AstraZeneca. Dr Taylor says having additional options like Novavax coming through later this year was positive.

“It’s going to be useful to have another string to our bow in the way we manage and treat COVID-19,” he says.

“As we move into this mass vaccination process, we’re going to need a number of candidates to rely on.”

Valued at $US8 ($A10.3) billion, Novavax is a minnow compared to the likes of Pfizer and AstraZeneca. However, US stock analysts have been considering how far the company can go from here.

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J.P. Morgan biotechnology analyst Eric Joseph believes Novavax’s vaccine design puts it in a unique position.

“We continue to view NVX-CoV2373 [the vaccine] as well-differentiated in the overall COVID-19 vaccine space, both clinically and logistically, and believe current levels under-reflect its long-term commercial potential.”

It’s a welcome assessment for a company that almost went belly up in 2019, facing the prospect of being delisted from the stock exchange because its share price had been trading below the $US1 mark for too long.

Then COVID-19 hit and amid the chaos of the global pandemic Novavax had better news to share with investors. In March 2020, it announced a late-stage trial for a new kind of flu vaccine had been successful, paving the way for approval.

Its research team was also working on its COVID-19 vaccine, and by July 2020 Novavax had announced it had $US1.6 billion from the US government’s vaccine project Operation Warp Speed to develop the project.

Investors started to take notice. Over the past 12 months, Novavax shares are up 2894 per cent to $US128.18, making it one of the biggest beneficiaries of the vaccine “sugar rush” which has propelled global markets.

Trizzino calls the company’s path to this moment a “fascinating story”, arguing that the company’s previous failures prepared it well for the unpredictability of COVID-19 and the development of a vaccine.

“We know that we learned a tremendous amount from our failures and we weathered the storm with our RSV vaccine,” he says. In 2016, the failure of a late-stage trial for a vaccine for respiratory syncytial virus (RSV) sent the Novavax’s share price plummeting 84 per cent to $US1.29.

“But I believe that made us very well prepared for what we encountered in the beginning of 2020,” he says.

Trizzino added “biotech is not for the faint of heart” but that Novavax has shown persistence pays off.

“You pursue your goals, you don’t let your setbacks cause you to stop believing. Where we are with COVID is a perfect example of that.”

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Novavax Stock Is up Over 2,900% This Year. How Much Higher Can It Go?


Returns wise, Novavax (NVAX) has undoubtedly been the most successful coronavirus stock of them all, with 2020 gains hitting an amazing 2920%. However, heading into the year’s final stretch, the vaccine specialist’s COVID-19 vaccine candidate NVX-CoV2373 has been at danger of getting cut adrift from the competition.

Both Moderna’s (MRNA) mRNA-1273 and Pfizer (PFE)/BioNTech’s (BNTX) BNT162b2, have already been granted emergency use authorization and are already being distributed across the U.S. and the world.

But now Novavax can finally work toward closing the gap. At long last, on Monday, the company announced the U.S. and Mexico Phase 3 study’s lift off.

The PREVENT-19 trial evaluating NVX-CoV2373 has been launched in 115 locations and 30,000 participants are expected to enroll in the program. With more than 25% of participants over the age of 65, and black/African American patients making up an additional 15%, the study has been specially designed to assess the vaccine candidate’s impact on as diverse a population as possible.

Novavax already has a fully enrolled Phase 3 clinical trial in process in the U.K. with an interim data readout expected shortly.

The company might be lagging behind the competition, but its offering has unique properties differentiating it from the already available vaccines. Unlike Moderna’s vaccine which must be kept in a freezer and Pfizer/BioNTech’s offering which requires even more extreme ultra-cold temperatures, NVX-CoV2373 can be stored in a refrigerator.

B.Riley analyst Mayank Mamtani says a first interim data readout from the U.S. study is likely in early 2Q21. The analyst believes Novavax’ offering could still have a starring role in the global distribution of Covid-19 vaccines and tells investors to buy the recent dip.

“We remain favorably biased towards our bull case scenario of NVAX’s best-in-class immunogenicity translating into 90%+ VE and differentiated target product profile in terms of reactogenicity to position ‘2373 as a preferred global vaccine solution,” the 5-star analyst said. “We believe NVAX 12/28 equity weakness (-10%), largely attributed to AZ’s positive comments regarding AZD1222 being reviewed by U.K. regulators this week, presents a compelling buying opportunity.”

Accordingly, Mamtani’s rating stays a Buy, whilst the $223 price target remains, too. Gains of 85% could be in the cards, should the target be met over the next 12 months. (To watch Mamtani’s track record, click here)

Barring 1 Sell, all 5 other current analyst reviews rate Novavax a Buy. NVAX’s Moderate Buy consensus rating is backed by a $183.20 average price target, implying potential upside of 52% in the year ahead. (See NVAX stock analysis on TipRanks)

To find good ideas for coronavirus stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.



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Novavax aims for 2 billion Covid-19 vaccine doses with expanded India deal | India News


US drug developer Novavax Inc said on Tuesday it was doubling its potential Covid-19 vaccine manufacturing capacity to two billion doses annually under an agreement with Serum Institute of India, sending its shares up about 7%.
In August, Novavax signed a deal with Serum Institute, the world’s largest producer of vaccines, to produce a minimum of one billion doses of its vaccine candidate, when approved, for low- and middle-income countries and India.
Read our coronavirus live blog for all the latest news and updates

As part of the expanded agreement, Serum Institute will also manufacture the antigen component of the vaccine, dubbed NVX-CoV2373, which Novavax said will bring its manufacturing capacity to over two billion doses by mid-2021.
Coronavirus outbreak: Complete coverage
Novavax’s vaccine is currently in mid-stage trials after an early-stage study showed it produced high levels of antibodies against the novel coronavirus. The company plans to begin late-stage trials in the third quarter.
Last month, Novavax said it will supply 60 million doses of its coronavirus vaccine candidate to the UK beginning as early as the first quarter of 2021.
More on Covid-19

The company is also preparing to deliver 100 million doses to the United States by January after it was awarded $1.6 billion for its potential vaccine, and has also signed supply agreements with Canada and Japan.
Other drugmakers such as Pfizer Inc and Moderna Inc have already begun large late-stage studies of their experimental vaccines.



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U.S. drug company Novavax signs deal to supply 76 million doses of possible COVID-19 vaccine to Canada


Canada’s federal government has signed an agreement in principle to acquire up to 76 million doses of a potential COVID-19 vaccine being developed by an American company.

Maryland-based biotechnology company Novavax announced in a press release Monday that it has struck a deal to produce a vaccine it is working on for the Canadian government, should the vaccine ever get Health Canada approval.

The company’s vaccine is one of dozens in development around the world, each of which targets the virus that causes COVID-19 in a different way.

At last count, the virus has killed more than 846,000 people around the world since the start of this year.

Novavax’s vaccine is known as a “protein subunit” vaccine, which has the advantage of being manufactured faster than some other types of vaccine but generally doesn’t produce as strong an immune response as some other potential options. 

The company released promising results of a very small clinical trial earlier this month, which showed it produced higher levels of the antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients.

The initial trial tested 106 subjects aged 18 to 59 with the vaccine, along with 25 people who received a placebo. The next phase of testing currently underway in the U.S. and Australia will include many more people, and at least half of them will be between the ages of 60 and 84, an age bracket of people who face the highest risk of having the worst outcomes from being infected, based on what we know about the virus.

Potential rollout in spring

The company plans to start much larger late-stage clinical trials soon, and told Reuters last month that if all goes well, they expect they could obtain regulatory approvals as early as December. The company said Monday the vaccine, should it work and be safe, would be available to Canadians as early as the second quarter of 2021. 

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said CEO Stanley C. Erck in a release.

“We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate,” Canada’s minister of public services and procurement, Anita Anand, said in a news release.

“This is an important step in our government’s efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves.”

Novavax has signed similar deals with the United Kingdom, India, the Czech Republic, South Africa and Japan to supply doses of the potential vaccine.

Financial terms of the deal were not disclosed.

The deal with Novavax is one of many similar ones that the federal government has signed with drug companies, including Pfizer, Moderna and Johnson & Johnson.

“Taken together, our vaccine agreements will give Canada at least 88 million doses, with options to obtain tens of millions more,” Prime Minister Justin Trudeau said at a press conference on Monday morning, at which he announced $126 million to expand a bio-manufacturing facility in Montreal, to produce drugs and vaccines to combat COVID-19 and other things.

“In the weeks and months ahead, our government will continue to take the steps needed to make sure Canada gets a COVID-19 vaccine as soon as possible,” Trudeau said.

“Once a vaccine is proven to work, we’ll also need to be able to produce and distribute it here at home.”

Novavax’s vaccine is one of roughly a dozen that has been singled out by the U.S. government for funding under the so-called Operation Warp Speed plan to speed up treatments for the coronavirus that has swept the world into economic chaos this year.



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Novavax expects results from new human trial of coronavirus vaccine in July


Novavax Inc. initiated testing of its coronavirus vaccine candidate in people and anticipates providing a first look in July at what sort of immune responses are generated.

In the first part of the study, 130 healthy adult volunteers at two sites in Australia will get two doses of NVX-CoV2373, the biotech’s experimental vaccine. If the initial results look promising, the company plans to quickly move into the second phase of the trial, which would expand testing to other countries and age groups outside of 18 to 59.

Novavax’s valuation has swelled by more than 1,000% to about $2.7 billion since the start of the year despite having no products on the market. With about $388 million in funding from the Oslo-based Coalition for Epidemic Preparedness Innovations in its pocket, Novavax has said it is targeting emergency-use authorization and production could be scaled up to 100 million doses by year end.

“Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay,” CEPI chief executive Richard Hatchett, said in a statement.

The Gaithersburg, Maryland-based company is one of an estimated 10 that have begun testing vaccines for the pandemic in people, according to the World Health Organization. WHO estimates there are more than 100 other vaccine candidates in earlier stages of development. Moderna Inc. reported the first Covid-19 vaccine results in humans last week.

Smaller vaccine developers are racing alongside larger, profitable drugmakers like Pfizer Inc., AstraZeneca Plc. as well as academic institutions. Even if a vaccine is eventually shown to be effective, there will be hurdles to manufacturing as well as distribution.

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