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Merck's experimental COVID-19 pill under review by Health Canada – CTV News

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TORONTO —
Health Canada says it is working with international counterparts to review an experimental pill from drugmaker Merck, which the company reports can reduce hospitalizations and deaths by half in patients sick with COVID-19.

During a news briefing Friday, the Public Health Agency of Canada (PHAC) said Merck first submitted an approval request for molnupiravir, a twice-daily oral antiviral agent taken within five days after the onset of symptoms, as a potential treatment for COVID-19 on Aug. 13.

According to PHAC, the submission was accepted under the Minister of Health’s Interim Order, which allows for the review of “early safety, quality and efficacy data” while later-stage clinical trials take place

Canada’s chief medical adviser Dr. Supriya Sharma said review of the treatment is ongoing as more data from trials becomes available. Sharma said Health Canada will make an approval decision only when all necessary evidence has been submitted and reviewed.

“We are looking at it. We’re going through … the data,” she said.

Sharma said Health Canada has no specific time for completion of the review as it can take “months,” but also that the pill will be evaluated and “held to the standards” as any other medication or treatment.

According to Health Canada, it only authorizes treatments, including those for COVID-19, following a “thorough scientific review of the safety, efficacy and quality data.”

“A treatment must show evidence that it works well, is of high quality and is safe. The available data must demonstrate that the treatment’s benefits outweigh its risks,” the agency said in a statement.

Canada currently has four approved treatments for COVID-19, including Canadian-made COVID-19 monoclonal antibody bamlanivimab and antiviral medication remdesivir. However, these treatments require an IV or injection.

If cleared, molnupiravir would be the first oral pill shown to treat COVID-19.

Merck and its partner Ridgeback Biotherapeutics announced Friday that early results from its trials show that patients who received molnupiravir within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a placebo.

The study tracked 775 adults with mild-to-moderate COVID-19 who were considered to be at higher risk for severe disease because of health problems such as obesity, diabetes or heart disease. Among patients taking molnupiravir, 7.3 per cent were either hospitalized or died at the end of 30 days, compared with 14.1 per cent of those who recieved the placebo.

The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.

“It really takes what is the devastating disease and hopefully gives people confidence that it can be manageable,” Merck CEO Robert Davis said in an interview with CTV News.

Davis called the pill a “game-changer” that could potentially be used to treat non-hospitalized, less severe cases of COVID-19 from home.

Earlier study results from Merck showed the drug did not benefit patients who were already hospitalized with severe disease. Experts say this is expected, given that antiviral drugs are most effective before the virus ramps up in the body.

The study results have not been reviewed by outside experts, which is the usual procedure for vetting new medical research.

Merck said it plans to submit the data in the coming days to health officials in the U.S. and other countries to authorize the pill’s use.

A decision from the U.S. Food and Drug Administration could come within weeks after that, and be distributed soon after.

Similar to other antivirals, molnupiravir works by interfering with the virus’s ability to copy its genetic code and reproduce itself, a process known as excessive mutagenesis or “error catastrophe.”

Virologists out of the University of Alberta (U of A) tested the compound to see its mechanism of action, independently of Merck. Their findings were published in May in the Journal of Biological Chemistry.

Matthias Gotte, a professor of medical microbiology and immunology at the U of A, led the research and said in an interview with CTV News that the drug attacks the virus, but doesn’t block or inhibit its replication.

Gotte said molnupiravir changes the viral genome, causing the replication engine of the virus to make “sloppy copies” of these altered genomes that are useless and not viable.

While Merck only studied its drug in people who were not vaccinated, Gotte said it may also potentially work in vaccinated patients who get less severe, breakthrough COVID-19 infections.

However, Gotte said it is important to note that molnupiravir is not a replacement for vaccines.

“The principles are completely different. Vaccines, they prevent severe disease, and the drugs are used to treat,” he said. “Once you are infected, the big problem is with these antiviral drugs you can’t use them late, you have to use them as early as possible.”

Eleanor Fish, a senior immunologist with the Toronto-based University Health Network who is not affiliated with the U of A study or Merck, says the approval of molnupiravir would help those who are ineligible for vaccination as well as those most at risk of severe disease.

“We can jump up and down in the U.S. and Canada and say, ‘Hey, we’ve got another tool in our armoury,’ [and] that’s going to be great,” Fish told CTV News.

She added that the drug’s approval in other parts of the world will help countries that are struggling to acquire COVID-19 vaccines.

“I see this more as [an] incredible opportunity, with a limited number of vaccines available globally, to send this out to those jurisdictions where vaccination rates are very, very low,” she said.

With files from The Associated 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.

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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