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Coronavirus: Johnson & Johnson's one-shot COVID-19 vaccine gets Health Canada approval – CTV News

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OTTAWA —
The first one-shot COVID-19 vaccine from Johnson & Johnson has been authorized by Health Canada, making it the fourth vaccine that can be administered to Canadians.

Health Canada is now the first major regulator to have approved four different COVID-19 vaccines for use, said chief medical adviser at Health Canada Dr. Supriya Sharma during a briefing announcing the approval.

The authorization follows “an independent and thorough scientific review for safety, efficacy, and quality,” Sharma said.

Canada can now use the Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson vaccines in its ongoing mass vaccination campaign, largely viewed as a key pillar in overcoming the nearly year-long pandemic.

Canada’s federal health agency has been assessing the viral vector Johnson & Johnson shot since Nov. 30, and like the AstraZeneca vaccine given the green light last Friday, it will be logistically easier to administer as it can be shipped at temperatures between two- to eight-degrees Celsius and stored in those refrigerated conditions for at least three months.

Vials of the Johnson & Johnson vaccine can be kept for three hours at room temperature once the seal has been punctured, while it can stay stable if unopened for up to 12 hours.

“This is a game changer,” physician Dr. Lisa Salamon said in an interview on CTV News Channel. “Family doctors can give it to their patients; it can be given in pharmacies, public health units.”

Overall, in clinical trials involving approximately 43,000 participants, the single dose of the Johnson & Johnson vaccine was shown to be 66 per cent effective in preventing moderate to severe COVID-19, two weeks after vaccination.

As with other vaccines, Sharma said common side effects include pain and tenderness at the injection site, headache, muscle pain, fever, and chills. The majority of adverse reactions reported during the clinical trials were mild to moderate in severity, and resolved within a few days.

The Johnson & Johnson vaccine has been approved for use in adults 18 years of age and older, and with nearly 20 per cent of the participants in clinical trials being 65 years of age and older, no difference in safety or efficacy was seen compared to the younger age groups.

Health Canada has also approved a clinical trial for the vaccine in children ages 12 to 17 that’s yet to recruit patients, while trials are underway with the other vaccines but do not have Canadian sites.

There is an also on ongoing study considering a second shot of the Johnson & Johnson vaccine, which federal health officials say they’ll keep an eye on.

Sharma said that the Johnson & Johnson shot has shown to provide “acceptable levels” of protection against the B.1.351 variant first discovered in South Africa and against the P.1 variant first identified in Brazil.

Seeking to clarify concerns around whether certain approved vaccines are superior given their higher efficacy rates, Sharma said that any of the Health Canada authorized shots will “greatly” reduce the change of contracting COVID-19.

“The efficacy rate does not mean that following vaccination with a vaccine with 66 per cent efficacy, that you will have a 34 per cent chance of contracting COVID-19,” Sharma said.

“It’s not just about getting COVID-19, what’s really important is whether any of the vaccines will prevent you from being hospitalized, or dying of COVID-19,” she said, noting that all the vaccines approved so far are effective at preventing severe illness or death.

WHEN WILL IT ARRIVE?

The federal government has secured access to up to 38 million doses of the Johnson & Johnson vaccine, with a deal in place for at least 10 million doses and the option to purchase 28 million more.

During a briefing on Canada’s vaccine rollout on Thursday, director general for vaccines at Public Services and Procurement Canada Joelle Paquette told reporters that the 10 million doses are expected by the end of September.

It’s unclear how quickly the initial delivery of these doses could arrive in Canada, but with the addition of this vaccine to Canada’s COVID-19 inoculations arsenal it’s likely this country’s overall immunization timeline can be accelerated.

MORE DATA COMING

Regulatory approval deeming the Johnson & Johnson shot safe and effective for use in Canada comes on the heels of the United States approving the vaccine candidate from pharmaceutical company Jannsen last weekend, while other medical regulators such as the European Medicines Agency, continue their examination of the vaccine.

The vaccine was authorized with terms and conditions, including requiring the manufacturer to continue provide information to Health Canada on the safety, efficacy and quality of the vaccine.

With the authorization, Health Canada released a series of documents that detail the consumer information, the regulatory decision summary, as well as more data about the adverse events reported.

The agency says additional detailed information will be published in the coming weeks.

Typically, the vaccine submission review process can usually take up to a year, but because of an emergency order, Health Canada has been able to expedite the authorization process and has been able to assess rolling information as it comes in, rather than having to wait until the end of its work to begin reviewing the findings.

There is still a fifth vaccine still under review by Health Canada, the Novavax vaccine. Health officials said Friday there is “a fair amount” of information outstanding and Health Canada’s decision to authorize or not could be months away.

More coming.

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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.

The Canadian Press. All rights reserved.

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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.

The Canadian Press. All rights reserved.

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