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Novavax submits coronavirus vaccine to Health Canada for approval – Global News

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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 pouring over the documents on an ongoing basis, rather than waiting until everything is finished.

Read more:
Canada finalizes Novavax deal to buy up to 72 million more COVID-19 vaccine doses

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

“Health Canada is expediting the review of all COVID-19 vaccines,” Health Canada spokesman Andre Gagnon said in an email. “This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.”

Novavax is the fifth vaccine maker to submit an application for rolling review. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October, and 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.


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Canada secures two new deals for possible COVID-19 vaccines


Canada secures two new deals for possible COVID-19 vaccines – Sep 1, 2020

The company has said its vaccine was 89 per cent effective in the U.K. trial. It also touts its product as very effective against the new British and South African strains of COVID-19, and says it could start delivering doses in the spring once it has received regulatory approval.

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“The doses that will ultimately be sent to Canada are being made outside the U.S.,” Novavax spokeswoman Amy Speak said in an email.

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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 European 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.

Read more:
Novavax vaccine 89% effective against coronavirus in U.K. trial

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.

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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 follows 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.

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.


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Coronavirus: Trudeau announces 2 new deals for possible COVID-19 vaccines – Aug 31, 2020

The federal department said Ng’s call was “part of a broader ongoing engagement across government … to minimize any impact of the EU’s Transparency and Authorization Mechanism on vaccines manufactured in Europe destined for Canada,” the summary read.

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Former Canadian diplomat Colin Robertson, who is now vice-president of the Canadian Global Affairs Institute, said the number of calls between the government and European officials _ and the fact they have been revealed publicly _ is unusual and “is the kind of thing you would do if you’re concerned.”

Robertson nonetheless expressed his hopes that Ottawa’s close relationship with the EU, formalized in various trade and political agreements, along with the contracts between Ottawa and the drug companies would prevent the Europeans from curtailing shipments to Canada.

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 United Kingdom to make up for shortfalls due to production issues in its European plants.

© 2021 The Canadian Press

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STD epidemic slows as new syphilis and gonorrhea cases fall in US

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NEW YORK (AP) — The U.S. syphilis epidemic slowed dramatically last year, gonorrhea cases fell and chlamydia cases remained below prepandemic levels, according to federal data released Tuesday.

The numbers represented some good news about sexually transmitted diseases, which experienced some alarming increases in past years due to declining condom use, inadequate sex education, and reduced testing and treatment when the COVID-19 pandemic hit.

Last year, cases of the most infectious stages of syphilis fell 10% from the year before — the first substantial decline in more than two decades. Gonorrhea cases dropped 7%, marking a second straight year of decline and bringing the number below what it was in 2019.

“I’m encouraged, and it’s been a long time since I felt that way” about the nation’s epidemic of sexually transmitted infections, said the CDC’s Dr. Jonathan Mermin. “Something is working.”

More than 2.4 million cases of syphilis, gonorrhea and chlamydia were diagnosed and reported last year — 1.6 million cases of chlamydia, 600,000 of gonorrhea, and more than 209,000 of syphilis.

Syphilis is a particular concern. For centuries, it was a common but feared infection that could deform the body and end in death. New cases plummeted in the U.S. starting in the 1940s when infection-fighting antibiotics became widely available, and they trended down for a half century after that. By 2002, however, cases began rising again, with men who have sex with other men being disproportionately affected.

The new report found cases of syphilis in their early, most infectious stages dropped 13% among gay and bisexual men. It was the first such drop since the agency began reporting data for that group in the mid-2000s.

However, there was a 12% increase in the rate of cases of unknown- or later-stage syphilis — a reflection of people infected years ago.

Cases of syphilis in newborns, passed on from infected mothers, also rose. There were nearly 4,000 cases, including 279 stillbirths and infant deaths.

“This means pregnant women are not being tested often enough,” said Dr. Jeffrey Klausner, a professor of medicine at the University of Southern California.

What caused some of the STD trends to improve? Several experts say one contributor is the growing use of an antibiotic as a “morning-after pill.” Studies have shown that taking doxycycline within 72 hours of unprotected sex cuts the risk of developing syphilis, gonorrhea and chlamydia.

In June, the CDC started recommending doxycycline as a morning-after pill, specifically for gay and bisexual men and transgender women who recently had an STD diagnosis. But health departments and organizations in some cities had been giving the pills to people for a couple years.

Some experts believe that the 2022 mpox outbreak — which mainly hit gay and bisexual men — may have had a lingering effect on sexual behavior in 2023, or at least on people’s willingness to get tested when strange sores appeared.

Another factor may have been an increase in the number of health workers testing people for infections, doing contact tracing and connecting people to treatment. Congress gave $1.2 billion to expand the workforce over five years, including $600 million to states, cities and territories that get STD prevention funding from CDC.

Last year had the “most activity with that funding throughout the U.S.,” said David Harvey, executive director of the National Coalition of STD Directors.

However, Congress ended the funds early as a part of last year’s debt ceiling deal, cutting off $400 million. Some people already have lost their jobs, said a spokeswoman for Harvey’s organization.

Still, Harvey said he had reasons for optimism, including the growing use of doxycycline and a push for at-home STD test kits.

Also, there are reasons to think the next presidential administration could get behind STD prevention. In 2019, then-President Donald Trump announced a campaign to “eliminate” the U.S. HIV epidemic by 2030. (Federal health officials later clarified that the actual goal was a huge reduction in new infections — fewer than 3,000 a year.)

There were nearly 32,000 new HIV infections in 2022, the CDC estimates. But a boost in public health funding for HIV could also also help bring down other sexually transmitted infections, experts said.

“When the government puts in resources, puts in money, we see declines in STDs,” Klausner said.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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World’s largest active volcano Mauna Loa showed telltale warning signs before erupting in 2022

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WASHINGTON (AP) — Scientists can’t know precisely when a volcano is about to erupt, but they can sometimes pick up telltale signs.

That happened two years ago with the world’s largest active volcano. About two months before Mauna Loa spewed rivers of glowing orange molten lava, geologists detected small earthquakes nearby and other signs, and they warned residents on Hawaii‘s Big Island.

Now a study of the volcano’s lava confirms their timeline for when the molten rock below was on the move.

“Volcanoes are tricky because we don’t get to watch directly what’s happening inside – we have to look for other signs,” said Erik Klemetti Gonzalez, a volcano expert at Denison University, who was not involved in the study.

Upswelling ground and increased earthquake activity near the volcano resulted from magma rising from lower levels of Earth’s crust to fill chambers beneath the volcano, said Kendra Lynn, a research geologist at the Hawaiian Volcano Observatory and co-author of a new study in Nature Communications.

When pressure was high enough, the magma broke through brittle surface rock and became lava – and the eruption began in late November 2022. Later, researchers collected samples of volcanic rock for analysis.

The chemical makeup of certain crystals within the lava indicated that around 70 days before the eruption, large quantities of molten rock had moved from around 1.9 miles (3 kilometers) to 3 miles (5 kilometers) under the summit to a mile (2 kilometers) or less beneath, the study found. This matched the timeline the geologists had observed with other signs.

The last time Mauna Loa erupted was in 1984. Most of the U.S. volcanoes that scientists consider to be active are found in Hawaii, Alaska and the West Coast.

Worldwide, around 585 volcanoes are considered active.

Scientists can’t predict eruptions, but they can make a “forecast,” said Ben Andrews, who heads the global volcano program at the Smithsonian Institution and who was not involved in the study.

Andrews compared volcano forecasts to weather forecasts – informed “probabilities” that an event will occur. And better data about the past behavior of specific volcanos can help researchers finetune forecasts of future activity, experts say.

(asterisk)We can look for similar patterns in the future and expect that there’s a higher probability of conditions for an eruption happening,” said Klemetti Gonzalez.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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Waymo’s robotaxis now open to anyone who wants a driverless ride in Los Angeles

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Waymo on Tuesday opened its robotaxi service to anyone who wants a ride around Los Angeles, marking another milestone in the evolution of self-driving car technology since the company began as a secret project at Google 15 years ago.

The expansion comes eight months after Waymo began offering rides in Los Angeles to a limited group of passengers chosen from a waiting list that had ballooned to more than 300,000 people. Now, anyone with the Waymo One smartphone app will be able to request a ride around an 80-square-mile (129-square-kilometer) territory spanning the second largest U.S. city.

After Waymo received approval from California regulators to charge for rides 15 months ago, the company initially chose to launch its operations in San Francisco before offering a limited service in Los Angeles.

Before deciding to compete against conventional ride-hailing pioneers Uber and Lyft in California, Waymo unleashed its robotaxis in Phoenix in 2020 and has been steadily extending the reach of its service in that Arizona city ever since.

Driverless rides are proving to be more than just a novelty. Waymo says it now transports more than 50,000 weekly passengers in its robotaxis, a volume of business numbers that helped the company recently raise $5.6 billion from its corporate parent Alphabet and a list of other investors that included venture capital firm Andreesen Horowitz and financial management firm T. Rowe Price.

“Our service has matured quickly and our riders are embracing the many benefits of fully autonomous driving,” Waymo co-CEO Tekedra Mawakana said in a blog post.

Despite its inroads, Waymo is still believed to be losing money. Although Alphabet doesn’t disclose Waymo’s financial results, the robotaxi is a major part of an “Other Bets” division that had suffered an operating loss of $3.3 billion through the first nine months of this year, down from a setback of $4.2 billion at the same time last year.

But Waymo has come a long way since Google began working on self-driving cars in 2009 as part of project “Chauffeur.” Since its 2016 spinoff from Google, Waymo has established itself as the clear leader in a robotaxi industry that’s getting more congested.

Electric auto pioneer Tesla is aiming to launch a rival “Cybercab” service by 2026, although its CEO Elon Musk said he hopes the company can get the required regulatory clearances to operate in Texas and California by next year.

Tesla’s projected timeline for competing against Waymo has been met with skepticism because Musk has made unfulfilled promises about the company’s self-driving car technology for nearly a decade.

Meanwhile, Waymo’s robotaxis have driven more than 20 million fully autonomous miles and provided more than 2 million rides to passengers without encountering a serious accident that resulted in its operations being sidelined.

That safety record is a stark contrast to one of its early rivals, Cruise, a robotaxi service owned by General Motors. Cruise’s California license was suspended last year after one of its driverless cars in San Francisco dragged a jaywalking pedestrian who had been struck by a different car driven by a human.

Cruise is now trying to rebound by joining forces with Uber to make some of its services available next year in U.S. cities that still haven’t been announced. But Waymo also has forged a similar alliance with Uber to dispatch its robotaxi in Atlanta and Austin, Texas next year.

Another robotaxi service, Amazon’s Zoox, is hoping to begin offering driverless rides to the general public in Las Vegas at some point next year before also launching in San Francisco.

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