France has cancelled its order for Merck & Co’s COVID-19 antiviral drug following disappointing trial data and hopes instead to receive Pfizer’s competing drug before the end of January, the health minister said on Wednesday.
France is the first country to publicly say it has cancelled an order for the Merck treatment after the company released data in late November suggesting its drug was markedly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by about 30%.
“The latest studies weren’t good,” Olivier Veran told BFM TV.
Merck did not immediately respond to Reuters’ request for comment.
While vaccines are the main weapons against COVID-19 for governments, there are hopes Merck and Pfizer’s experimental pills could be a game-changer in reducing the chances of dying or hospitalisation for those most at risk of severe illness.
France had placed an early order for 50,000 doses of the nucleoside analogue drug molnupiravir developed by Merck and Ridgeback Biotherapeutics.
The cancellation would not incur a cost, Veran said.
In Italy, the office of the special commissioner for the COVID emergency said on Nov 18 it had received a mandate from the health ministry to buy 50,000 courses of Merck’s pill and another 50,000 of Pfizer’s. “The contract has not yet been finalised, but is in progress,” a spokesperson for the commissioner told Reuters on Tuesday.
Italian drug regulator Aifa’s head Nicola Magrini told a Senate committee on Dec. 9 the two treatments could be available in Italy from the end of January.
However, regardless of the availability of the drugs, there will be assessments of their use, two top government scientific advisers told Reuters.
“There must and will be an evaluation, independently of the assessments of regulatory bodies,” Walter Ricciardi, top adviser of health minister Roberto Speranza, told Reuters.
Germany has already bought Merck’s antiviral treatment, health minister Karl Lauterbach told Reuters on Wednesday.
“This is a binding order,” he said, adding Berlin was also in talks with Pfizer about buying its antiviral drug.
The European Medicines Agency is expected to decide whether to approve the Merck and Pfizer pills in the new year.
Pfizer’s Paxlovid, a protease inhibitor, has shown near 90% efficacy in preventing COVID-19 hospitalisations and deaths in high-risk patients.
France had purchased that drug instead, Veran said, without saying how many doses it had secured.
“France is lined up to get it before the end of January,” Veran continued. It has not yet been decided whether the drug would be available over the counter in pharmacies, the minister said.
Why it's important to tell people that monkeypox is predominantly affecting gay and bisexual men – Medical Xpress
For decades, several African countries have experienced ongoing outbreaks of MPXV, driven primarily by contact with animals and transmission within households. However, before last year, most people in Europe and North America had never even heard of the disease. That was until the current outbreak among gay, bisexual and other men who have sex with men.
Debates over the epidemiology of MPXV
Over the past several months, a controversy has raged about whether it’s OK to say that the current MPXV outbreak is primarily affecting gay and bisexual men, and that it is primarily being spread through close personal contact, such as sex.
As a social and behavioral epidemiologist working with marginalized populations, including gay and bisexual men, I believe it’s important that people know that sexual and gender minority men are the primary victims of this MPXV outbreak. I believe this knowledge will help us end the outbreak before it bridges into other communities.
For reference, more than 90% of cases in non-endemic countries have been transmitted through intimate sexual contact, and the vast majority of cases are among gay men. Very few cases are linked to community transmission.
While these statistics are undisputed, some have feared that identifying sexual behavior as the primary cause of current MPXV transmission would dampen the public health response. Others have warned that connecting MPXV to an already stigmatized community will worsen stigma towards gay sex.
Non-sexual transmission is possible, and a considerable threat
However, months into the current outbreak, we have not seen these routes emerge as important pathways of transmission. This may be due to changes in the fundamental transmission dynamic of MPXV or due to enhanced cleaning procedures implemented in response to COVID-19 in places such as gyms and restrooms.
Why it’s crucial to know MPXV affects gay and bisexual men
Informing the public about MPXV is important because public opinion plays an important role in shaping public health policies, such as who gets access to vaccines and what interventions are used to stop disease transmission.
A recent study conducted by my team aimed to demonstrate the importance of public health education by asking Canadians to participate in a discrete choice experiment.
We asked participants to choose between two hypothetical public health programs across eight head-to-head comparisons. Descriptions for each hypothetical program identified the number of years of life gained by patients, the health condition it addressed and the population it was tailored for.
From our analyses of this data, we learned a lot about how the public wants public health dollars to be spent and how their knowledge and bias shapes these preferences. There were five major takeaways:
- People preferred interventions that added more years to participants’ life expectancy. In fact, for one year of marginal life gained, there was a 15% increase in the odds that participants chose that program.
- We found that people tended to favor interventions that focused on treatment rather than prevention. While this approach is emotionally intuitive, large bodies of evidence suggest that it is more cost-effective to prevent disease than to treat it. As the old saying goes: An ounce of prevention is worth a pound of cure.
- People generally preferred interventions for common chronic diseases—such as heart disease, diabetes and cancer—and were less likely to favor interventions for behavior-related conditions, such as sexually transmitted infections.
- People generally preferred programs focused on the general population as opposed to those tailored for key marginalized populations. In fact, people were least likely to prefer interventions tailored for sexual and gender minorities.
- The bias against behavioral interventions and those tailored for key populations was overcome when the programs addressed a health condition that was widely understood to be linked to the population the program was tailored to. For example, people were more likely to support interventions for sexually transmitted infections when these interventions were tailored for people engaged in sex work or for gay and bisexual men.
This study highlights why it is important to educate the public about health inequities. People are smarter, more pragmatic, and more compassionate than we give them credit for. If we take the time to share evidence with them about the challenges that stigmatized communities face, they will be more willing to support policies and efforts to address these challenges.
Ending MPXV quickly is critical, especially since the virus has the potential to evolve in ways that could make the disease more infectious. Protecting gay and bisexual men first, protects everyone.
We should, of course, always be aware of the potential harms and the corrosive effects of stigma. However, in public health, honesty really is the best policy.
Why it’s important to tell people that monkeypox is predominantly affecting gay and bisexual men (2022, August 15)
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How Worried Should You Be About New Reports on Polio? – The Suburban Newspaper
MONDAY, Aug. 15, 2022 (HealthDay News) — Poliovirus detected in New York City wastewater last week put public health officials on high alert, as it indicates the potentially paralyzing virus is circulating widely in the area.
But infectious disease experts say there’s no need for families of fully vaccinated children to panic.
“The inactivated polio vaccine is part of the standard childhood immunization schedule, so for most families, it really shouldn’t be a concern,” said Dr. Gail Shust, a pediatric infectious diseases specialist at NYU Langone Hassenfeld Children’s Hospital in New York City. “It happens to be an extremely effective vaccine.”
At this point, there’s also no need to seek out a polio booster for a fully vaccinated child or adult, she added.
“For kids who’ve gone through the normal vaccination schedule in the United States, there is zero reason for them to get a booster,” Shust said.
Instead, concern should be focused on communities with clusters of unvaccinated children and adults, because those are the people at risk for polio, experts say.
A young man in Rockland County, N.Y. — about 45 minutes northwest of the Bronx — was diagnosed in late July with the first case of paralytic polio identified in the United States in nearly a decade.
Subsequently, poliovirus was detected in the sewage of both Rockland County and neighboring Orange County, indicating community transmission of the virus.
Polio can lead to permanent paralysis of the arms and legs. It also can be fatal if paralysis occurs in muscles used to breathe or swallow.
About 1 in 25 people infected with poliovirus will get viral meningitis, and about 1 in 200 become paralyzed.
“A lot of people who get infected with poliovirus, they’re asymptomatic,” Shust said. “It’s entirely possible there are other cases that haven’t been diagnosed and there are more people infected than we’re aware of.”
Children should receive at least three doses of polio vaccine by 18 months of age, with a fourth dose delivered between ages 4 and 6, according to the U.S. Centers for Disease Control and Prevention.
New York state health officials said they are particularly concerned by neighborhoods where fewer than 70% of children between 6 months and 5 years of age have received at least three doses of polio vaccine.
About 86% of New York City kids have gotten all three doses, but in Rockland County the rate is just over 60%, and in Orange County the rate is just under 59%, state health officials said.
Statewide, nearly 79% of children have received three doses by their second birthday, officials said.
Poliovirus also has been identified in London’s wastewater, and health officials in the United Kingdom have decided to offer polio vaccine boosters to children.
“They’re starting to do that in London. We haven’t said that that’s necessary,” said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.
“The only time we’ve given boosters in the past is when someone who was vaccinated as a child then decided to travel to some developing country where there was a lot of polio, and we said, OK, to be on the safe side, to be prudent, we’ll give you a booster before you go,” Schaffner said. “It wasn’t really thought to be necessary, but it was a prudent, extra, easy, safe thing to do.”
Poliovirus lives in the intestinal tract and can be transmitted through stool, so wastewater surveillance is a logical way to track it, said Vincent Racaniello, a professor of microbiology and immunology at Columbia University in New York City.
“These viruses have probably been in the sewage for years,” he said. “We’ve just never looked for them, and now we started to look because of this case. And I would say the more we look, we’re going to find it all over the U.S., especially in major cities.”
These strains of poliovirus likely entered the United States from people in other countries who have had the oral polio vaccine, Racaniello and Schaffner said.
The oral vaccine was the first developed and the easiest to administer, so it is still used as part of the World Health Organization‘s polio eradication efforts around the globe, the experts said. But, Racaniello said, it’s an infectious vaccine, meaning it contains a weakened version of the virus itself.
“It reproduces in your intestines, and you shed it — that’s the virus in the sewage,” he said. “That virus gets around very easily, and it can cause polio even though it’s a vaccine virus. After it passes through the human gut, it can reacquire the ability to cause polio.”
The United States stopped using the oral vaccine in 2000, after the U.S. Preventive Services Task Force decided that the risk of even a few incidental cases of polio was too great, Schaffner said.
“Each year we had about 4 million births and we had somewhere between six and 10 cases of vaccine-associated poliomyelitis,” he said. “We were giving a very small number of children and adults paralysis by using the oral vaccine.”
The U.S. now exclusively uses a four-dose inactivated polio vaccine.
“The virus is killed. There’s no possibility it can multiply. It cannot mutate. It cannot cause paralysis,” Schaffner said. “But as an inactivated viral vaccine, it has to be given by needle and syringe, which is more cumbersome and considerably more expensive and, of course, added to the number of inoculations little children were getting, which didn’t make moms too happy.”
Schaffner said it’s “notable” that vaccine-related poliovirus is circulating in the United States.
“We wouldn’t have expected it to be widely disseminated, so we’re just finding there’s even more intercontinental transmission of these oral polio vaccine viruses than we thought,” Schaffner said.
“If you had asked me before this case, I would have said that unless somebody has just gone abroad or had a visitor from abroad, you wouldn’t find it here because we’re not using [the oral vaccine] in the United States,” Schaffner added. “But we may be a smaller global community even than I thought.”
The only true protection is vaccination, and Racaniello hopes that wastewater surveillance data will help persuade the vaccine-hesitant to go ahead and get their jabs.
“Maybe they thought there was no poliovirus in the U.S., right? And so they say I don’t need to get vaccinated,” Racaniello said. “And so now we can show them that there is. In fact, I think we should do more surveillance of wastewater and show people, look, it’s in every major metropolitan city. You better get vaccinated.”
The U.S. Centers for Disease Control and Prevention has more about polio.
SOURCES: Gail Shust, MD, pediatric infectious diseases specialist, NYU Langone Hassenfeld Children’s Hospital, New York City; William Schaffner, MD, medical director, National Foundation for Infectious Diseases, Bethesda, Md.; Vincent Racaniello, PhD, Higgins Professor, Department of Microbiology and Immunology, Columbia University, New York City
Monkeypox outbreak 'shows signs of slowing' in Britain, health officials say – CBC News
British health officials say the monkeypox outbreak across the country “shows signs of slowing,” but that it’s still too soon to know if the decline will be maintained.
In a statement on Monday, the Health Security Agency said authorities are reporting about 29 new monkeypox infections every day, compared to about 52 cases a day during the last week in June. In July, officials estimated the outbreak was doubling in size about every two weeks. To date, the U.K. has recorded more than 3,000 cases of monkeypox, with more than 70 per cent of cases in London.
The agency also said more than 27,000 people have been immunized with a vaccine designed against smallpox, a related disease.
“These thousands of vaccines, administered by the [National Health Service] to those at highest risk of exposure, should have a significant impact on the transmission of the virus,” the agency said.
It said the vast majority of cases were in men who are gay, bisexual or have sex with other men and that vaccines were being prioritized for them and for their closest contacts and health workers.
Last month, Britain downgraded its assessment of the monkeypox outbreak after seeing no signs of sustained monkeypox transmission beyond the sexual networks of men who have sex with men; 99 per cent of infections in the U.K. are in men.
British authorities said they bought 150,000 doses of vaccine made by Bavarian Nordic, the world’s only supplier. The first 50,000 doses have already been rolled out or will be shared soon with clinics across the country, and the next 100,000 vaccines are expected to be delivered in September.
Canada will use wastewater testing to track disease
The Public Health Agency of Canada (PHAC) has repeatedly declined to provide the number of monkeypox vaccines Canada has in the national stockpile, citing security concerns, despite providing that number for other vaccines and other countries sharing that information.
Chief Public Health Officer Dr. Theresa Tam said during a news conference Friday that Canada has so far deployed 99,000 vaccines to provinces and territories.
She said that it was “too soon to tell” if cases were slowing in Canada, although there may be “some early signs” that they are not increasing at the same rate as during the beginning of the outbreak.
There are now 1,059 monkeypox cases across Canada, with the bulk of them in Ontario and Quebec, and Tam said Canada will soon move to testing wastewater in different regions of the country to better track the spread of the disease, building off the infrastructure developed to monitor COVID-19 during the pandemic.
Anyone can become infected with monkeypox through multiple forms of close, physical contact with an infected person’s lesions, including skin-to-skin contact such as touching or sex, as well as through respiratory droplets in a conversation, or even being exposed to contaminated clothes or bedding.
Most people recover without needing treatment, but the lesions can be extremely painful and more severe cases can result in complications including brain inflammation and death.
Globally, there have been more than 31,000 cases of monkeypox reported in nearly 90 countries. Last month, the World Health Organization declared the outbreak to be a global emergency and officials in the U.S. have classified the epidemic there as a national emergency, but Canada has not followed suit.
Outside of Africa, 98 per cent of cases are in men who have sex with men. With only a limited global supply of vaccines, authorities are racing to stop monkeypox before it becomes entrenched as a new disease.
Tam said more than 99 per cent of monkeypox cases in Canada are in men and the median age of those infected is 35. Late last month, PHAC urged gay and bisexual men to practise safe sex and limit the number of sexual partners, in an effort to slow the spread of the virus among sexual networks.
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