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FDA Approves Ebola Vaccine For USe And Distribution In United States – Forbes

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On Thursday, the FDA announced the approval of the Ebola vaccine, Ervebo, for use in adults aged 18 and older. This follows the approval of the vaccine in Europe in November. Although Ebola is rare in the U.S., the vaccine’s approval will help in world-wide efforts to prevent future Ebola outbreaks and deaths. 

Ervebo’s U.S. approval is based on results from a study conducted between 2014-2016 during an Ebola outbreak in Guinea. These study results showed that the vaccine was nearly 100% effective in preventing patients from contracting Ebola with symptom onset greater than 10 days after vaccination. In addition, the vaccine was tested in Liberia, Sierra Leone, Canada, Spain and the U.S., with similar results. The approval was granted to Merck & Co., Inc.

The vaccine is administered as a single-dose injection that contains a protein from the virus. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.

“Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, in an FDA statement. “These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.”

Ebola, formally known as Ebola virus disease (EVD) is caused by the Zaire ebolavirus. Although rare, the virus can cause serious and often deadly results. The first cases of the disease were noted in Africa in the 1970s, and since then several breakouts have caused thousands of deaths on the African continent. Since 2014 alone, there have been more than 28,000 cases and 11,000 deaths from Ebola, the FDA statement reported. According to the World Health Organization, up to 90 percent of those infected with Ebola can die from the virus. 

The virus causes fever, fatigue, muscle pain, headaches and sore throat. This soon escalates to vomiting, diarrhea, rash, impaired kidney and liver function. In more extreme cases, patients will develop internal bleeding and eventually death may occur. 

The virus is also highly contagious and is transmitted through direct contact with bodily fluids, blood and tissue of infected people, or in some cases infected wild animals. For example, some of the cases in Africa are believed to have been begun through the consumption of infected animal meat, most notably bats. In addition, health workers who treat infected patients are at extremely high risk for contracting the virus themselves. 

Due to the extreme need for the vaccine, the FDA granted the vaccine’s application a Priority Review and a Tropical Disease Priority Review Voucher, as well as a Breakthrough Therapy designation, in the hopes to expedite the drug’s development. 

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First West Nile virus-positive mosquitoes of the year confirmed in Peel Region – CP24

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Mississauga, Brampton, and Caledon residents are being reminded to protect themselves from mosquito bites and remove any standing water from their property after the first West Nile virus-positive mosquitoes of the year were confirmed in Peel Region.

The infected insects were recently collected from three traps in Brampton, near the intersections of Chinguacousy Road and Williams Parkway, Hurontario Street and Steeles Avenue, and The Gore Road and Cottrelle Boulevard.

Peel’s public health unit monitors West Nile virus activity through 33 mosquito traps set across the region. Trapped mosquitoes are collected and tested weekly from late June to September.

The health unit also surveys public areas for stagnant water that could serve as breeding sites for mosquitoes. Identified locations are treated with larvicide, they said in an Aug. 9 news release.

So far this year, there are no confirmed human cases of the mosquito-borne illness, which is passed to humans through the bite of an infected mosquito, in the Region of Peel.

While the risk of acquiring the virus is low, the Region of Peel is urging people to protect themselves against mosquito bites by applying a Health Canada approved insect repellent containing an ingredient effective against mosquitoes, like as DEET or icaridin, to exposed skin and clothing.

They’re also advising people to wear light-colored, tightly woven, loose-fitting clothing like long pants, a long-sleeved shirt, shoes, and socks to protect exposed skin and avoid shaded or wooded areas with high mosquito populations, especially at dusk and dawn when mosquitoes are most active.

Residents should also ensure all windows and door screens fit securely and are free of tears and holes.

Further, people can help prevent mosquito bites by removing stagnant water or draining items on their property. Water stagnant for more than seven days is an ideal breeding site for mosquitoes, the region noted.

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Health Unit has limited number of monkeypox vaccine doses – BayToday.ca

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The North Bay Parry Sound District Health Unit says it has received a very limited number of monkeypox PrEP vaccine doses.

PrEP is a vaccine that is administered prior to contact with the virus.

“Due to low supply, appointments for the monkeypox vaccine for eligible individuals will be booked on a first come first served basis,” says a news release.

“We recognize the issues with such limited access to the monkeypox PrEP vaccines and regret that offering an equitable booking approach is difficult to do at this time,” explains Dr. Carol Zimbalatti, Public Health Physician at the Health Unit. “We continue to work with the province to advocate for additional supply, but understandably, with no evidence of transmission of monkeypox locally, we expect most of the vaccine to continue to go to public health districts with more monkeypox cases.”

Should more vaccine become available, the public will be notified.

To get on the list, call 1-800-563-2808 ext. 5252 and leave a message Wednesday between 9. to 10 a.m.   

Monkeypox is a rare disease not common in North America. It spreads through close contact with a person infected with the virus, or their clothing or linens. Monkeypox can enter the body through skin-to-skin contact with body fluids and through mucus membranes or respiratory droplets during prolonged face-to-face contact.

Anyone, regardless of sexual orientation, age, or gender can spread monkeypox through contact with body fluids, monkeypox sores, or by sharing contaminated items.

For more information on monkeypox and its symptoms visit myhealthunit.ca/monkeypox. If you believe you may have monkeypox, please call the Health Unit at 1-800-563-2808 ext. 5229.

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Ontario confident in monkeypox vaccine strategy, Moore says, but some seek expansion – Cornwall Seaway News

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TORONTO — Ontario’s top doctor says the province’s current monkeypox vaccination strategy is working and cases of the virus appear to be levelling off, but some who work with people in shelters say the immunization program should be expanded to better serve those communities.

Chief Medical Officer of Health Dr. Kieran Moore said the province has vaccinated more than 20,000 people against monkeypox so far, with the priority group being gay, bisexual and other men who have sex with men that meet certain criteria.

“We have been able to get the vaccines that we need from our federal partners, we’ve been able to staff our immunization clinics to meet the needs of our population, we have the funding necessary and the partnerships to ensure that our health system protects those at risk from this virus,” Moore said in a recent interview.

“Our response in Ontario has been quite robust. We’ve got a long ways to go still, but it appears that our total number of (monkeypox) cases is plateauing.”

But for some, the province’s vaccination strategy doesn’t do enough to protect those living in high-risk settings like homeless shelters, noting a recent confirmed monkeypox case in a person who attended a Toronto shelter.

Diana Chan McNally, a community worker at a Toronto centre for people in need, said she believes monkeypox vaccines should be broadly available to those living in shelters given the congregate nature of the settings and the fact those who live there might share belongings.

“This kind of laissez-faire attitude towards the vaccine is part and parcel of the fact that we don’t seem to prioritize creating special protocols or really taking into account the unique conditions that can lead to monkeypox infection in the shelter system,” said Chan McNally.

She also said the current monkeypox vaccine strategy doesn’t account for intersections between people who live in shelters and those who might be eligible for the shot, such as sex workers and people in the LGBTQ community experiencing homelessness, who may not have access to city-run immunization clinics.

“Why we can’t bring, even in small amounts, dedicated amounts of the vaccine to the priority groups within the shelter system, I don’t know,” she said. “I think that’s something that could potentially help mitigate any potential for spread.”

Chan McNally also said she wants to see the shot offered to shelter workers. “If we protect their health, we can protect other people in the shelter system,” she said.

Toronto Public Health held pop-up monkeypox vaccine clinics at the shelter where a case was recently reported, which Moore says is part of Ontario’s “ring immunization” strategy targeting those who may have been exposed to a known case.

Patricia Mueller, CEO of Homes First, the company that oversees the shelter where the case was confirmed, said there have been no further cases of monkeypox linked to that one. She said their staff, the city and Toronto Public Health acted quickly to move the infected individual to an isolation and recovery site and set up a vaccination clinic.

Mueller added that shelter workers are considered low risk for monkeypox infection.

Rita Shahin, associate medical officer of health at Toronto Public Health, said the city is not currently planning a larger monkeypox vaccine program for all shelter residents, though those who meet the criteria are eligible for the shot.

“We need to watch where the disease is, who’s most at risk, and if we see additional cases or spread in the shelter system, that’s certainly something we would look at,” Shahin said.

Shahin also said the city’s monkeypox vaccine supply is “fairly limited,” though Moore said the province has a “significant reserve” of doses ready for emergency situations.

Thomas Tenkate, a professor at the School of Occupational and Public Health at Toronto Metropolitan University, said he agrees men who have sex with men should remain the primary group targeted for monkeypox vaccination based on transmission trends, but added that pop-up clinics in shelters could be a way to proactively curb spread of the virus.

“If you’re going to vaccinate people who are in shelters, the strategies have to be different than the general community,” Tenkate said. “People who use shelters or are homeless, you really have to go to them.”

He said another challenge to vaccinating those in shelter settings is understanding their health history to flag any possible complications from getting the shot. “That might be a limiting factor to implementing it as well,” he said.

Public Health Ontario reported a total of 449 confirmed cases of monkeypox in the province as of Thursday, up from 423 on Tuesday. The agency’s latest report said the majority of cases — more than 77 per cent — were reported in Toronto.

It also said almost all the people infected are male, with only two reported in female patients. The virus generally doesn’t spread easily and is transmitted through prolonged close contact via respiratory droplets, direct contact with skin lesions or bodily fluids, or through contaminated clothes or bedding.

— With files from Allison Jones.

This report by The Canadian Press was first published Aug. 8, 2022.

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