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FDA approves first treatment for kids with peanut allergy

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WASHINGTON —
The first treatment for peanut allergies is about to hit the market, a big step toward better care for all kinds of food allergies — but still a long way from a cure.

Friday’s approval by the Food and Drug Administration promises to bring some relief to families who’ve lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants. Named Palforzia, it was developed by Aimmune Therapeutics.

“It’s been a life-changer,” said Nina Nichols, 18, of Washington, whose first encounter with peanuts as a toddler — a peanut butter cracker shared by a friend — required a race to the emergency room. She entered a Palforzia research study as a teen and calls it “a security blanket.”

The treatment is a specially prepared peanut powder swallowed daily in tiny amounts that are gradually increased over months. It trains children’s and teens’ bodies to better tolerate peanut so that an accidental bite is less likely to cause a serious reaction, or even kill in severe cases.

Palforzia users still must avoid peanuts just like they always have.

The treatment is not for everyone. Palforzia can cause side effects, including occasional severe allergic reactions. The FDA is requiring that doctors and their patients enrol in a special safety program, and patients must take the first dose and each increased dose under supervision in a certified health centre.

And if youngsters stop taking the daily dose, they lose the protection.

Shots have long been used to induce tolerance for allergies to bee stings or pollen. But swallowing an allergen to build tolerance is a new twist – one that scientists call “oral immunotherapy.” And peanuts are just the first food to be tackled. Tests for eggs, milk and tree nuts are underway.

But because of the drawbacks, scientists also are developing next-generation options that work differently. Next up for FDA review: A skin patch for peanut allergy.

“For so long, we had nothing to offer these patients,” said Dr. Pamela Guerrerio of the National Institutes of Health, which funded much of the research that led to food allergy therapies. “We finally have a treatment. That’s a big step.”

Aimmune executives said Friday they hope doctors can begin prescribing the treatment in “a matter of weeks.” They set the treatment’s list price at $890 a month, but how much patients will pay depends on their insurance. Aimmune says it is working with insurance companies for coverage, and will offer a patient co-pay assistance program.

FOOD ALLERGY IS A GROWING PROBLEM

Millions of Americans have food allergies, including about 1 in 13 children, and the numbers have increased in recent years. Peanut allergy is the most common one among children, and among the most dangerous. Accidental exposures are frequent, with about 1 in 4 affected children winding up in the emergency room every year.

What happens: The immune system overreacts to the food by triggering an inflammatory cascade. On average, children can experience hives, wheezing or worse from just a 30th of a single peanut, sometimes even less, said Dr. Hemant Sharma, who leads oral treatment studies at Children’s National Hospital in Washington.

Until now, all doctors could advise was to read food labels and avoid anything that might contain hidden peanuts. Decades ago, attempts at shots were deemed too risky for food allergies. Then, in 2006, researchers at Duke University and the University of Arkansas reported tantalizing signs that swallowed treatments might work instead.

HOW IT WORKS

Doctors prescribe a miniscule Palforzia starting dose. The powder, stored in a capsule, is mixed into any unheated food, such as Nichols’ favourite fruit smoothies. Patients take the first dose in a doctor’s office, in case of a bad allergic reaction. Every few weeks, the dose is increased until after about six months, they’re taking the equivalent of about one peanut.

In a study of nearly 500 children, two-thirds who received Palforzia could eat the equivalent of two peanuts – and some three or four – compared to just 4% of patients given a dummy drug.

A few hundred allergy doctors around the country already offer their own version of the treatment, using store-bought peanut flour – or similar options for other food allergies – to customize doses for patients outside of research studies.

THE WARNINGS

Palforzia users still must carry their rescue medicine, such as EpiPens, to treat severe allergic reactions. Most experience at least mild side effects, such as hives or stomachaches, and about a fifth dropped out of the study, said Dr. Scott Sicherer, a pediatric allergist at Mount Sinai Hospital in New York.

As for severe reactions, they struck about 9% of patients treated in the Palforzia study, nearly three times the number in the placebo group and prompting debate about the drug’s usefulness.

“There is a trade-off,” Sicherer said. Families and doctors together will have to decide “does it make sense for me or my child?”

OTHER OPTIONS

Other allergy treatments in the pipeline:

— DBV Technologies’ Viaskin is a daily patch that contains small amounts of peanut protein absorbed through the skin, in hopes of fewer side effects.

— Allergen drops under the tongue are in early-stage testing but showed promise in a recent study from the University of North Carolina, Chapel Hill.

— Shots to block allergic reactions deliver antibodies that tamp down the inflammatory cascade that follows accidental exposure. A Stanford University pilot study suggested a single shot could block a peanut reaction for two to six weeks.

“Palforzia is a step forward,” said Children’s National’s Sharma. “What all of us hope for that would be truly revolutionary is a treatment that’s curative, that really gets rid of the food allergy permanently.”

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Foreigners flock to Canada for monkeypox vaccine – Medical Xpress

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Credit: Pixabay/CC0 Public Domain

With the monkeypox vaccine in short supply in the United States, thousands of foreigners, including Americans are flocking to Montreal to get their shots.

Canada’s second-largest city, located about 70 kilometers (43 miles) north of the US border in Quebec province, has decided to make the vaccine available to all those who consider themselves to be at risk.

ackRobb Stilson, an art director from Denver, Colorado, took advantage of the opportunity during a visit to Montreal last week.

“It’s very difficult in the States to get vaccinated,” Stilson said as he lined up to get a shot at a pop-up vaccination center together with his husband and two daughters. “I’ve friends who have waited 8 or 9 hours to get in.”

Because contact tracing is difficult, authorities in Montreal decided to offer the vaccine to all those who are at risk to stem the spread of the virus.

“As tourists, they may participate in activities that may expose them and so in a way, we’re combatting the pandemic by letting them become vaccinated here so that they don’t transmit the infection either here or when they go back home,” Donald Vinh, infectious disease specialist at the McGill University Health Center, told AFP.

Since the vaccination campaign was launched in mid-May, as soon as the first cases of monkeypox were detected, Montreal has inoculated 18,500 people, 13 percent of them foreigners.

The goal is to administer 25,000 doses and vaccinate some 75-80 percent of the population deemed to be at risk, in particular men who have sex with men or with multiple partners.

“I hope the strategy used by the public health agency of Montreal is a beacon for other public health agencies to use as a vaccination strategy,” Vinh added.

In the western province of British Columbia, health authorities decided last week they will no longer offer the vaccine to foreigners citing limited supplies and the fact that it was becoming more available in the United States.

Faced with a lack of available doses, American health authorities on Tuesday authorized a new injection procedure which will make it possible to inoculate five times the number of people with the same amount of the drug.

As of August 11, Canada has registered 1,059 confirmed cases of monkeypox, but authorities see signs of infections beginning to slow.


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Elevated risk of Monkeypox in Saskatchewan: SHA – CTV News Regina

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The Saskatchewan Health Authority (SHA) has alerted the public to the elevated risk of acquiring Monkeypox through anonymous sexual contact.

“So far we’ve had three cases, who were exposed out of the province,” said Saskatchewan’s Chief Medical Health Officer, Dr. Saqib Shahab.

“We think the situation has changed now, in the last week. Where we have had evidence of exposures happening in Saskatchewan, in many cases happening through anonymous sexual contacts with people who have been coming into the province.”

Shahab noted that the exposures were happening almost exclusively to those in the gay, bisexual and men who have sex with men (gbMSM) community.

“We think now that there is a higher risk that we may see ongoing transmission within Saskatchewan … particularly in this community.”

Shahab noted that these trends were similar to what is being seen across Canada. He urged those in Saskatchewan at risk not to hesitate and reach out.

“If you belong to the gbMSM community it’s really important that at the first sign of illness you do contact the Healthline (811) for advice and seek testing and isolate till the diagnosis is made.”

INCREASED ELIGIBILITY FOR VACCINES

The SHA announced that Monkeypox vaccine requirements would be expanded to both post and pre exposure, following the alert.

The Public Health Agency of Canada has set aside 99,000 doses of the vaccine, with 50,000 doses being given to provinces so far, according to Shahab.

Those eligible for vaccinations include select high-risk contacts 18 years and older who are identified ideally within 4 days and up to 14 days after an exposure. Those who are at a high risk of exposure are also eligible. The SHA’s criteria includes:

  • Are transgender or self-identify as two spirit, bisexual, gay or men who have sex with men (MSM)

And one or more of the following:

  • Have had a recent sexually transmitted infection (in the past six months);
  • Report having had two or more sexual partners in the past six months;
  • Had (in the past six months) or plan to have sexual contact involving an exchange of money or other goods for sexual services;
  • Report having had (in the past six months) or planning to have sexual contact at an event or social gathering where there is MSM-themed sexual activity (sauna, bath house, club);
  • Have had (in the past six months) or plan to have sexual contact with an anonymous partner (at an event or via a hook-up app);
  • Planning to travel in the next three months to an area in Canada or internationally currently reporting monkeypox cases;

OR

  • Individuals 18 years and older who work or volunteer at an event or social gathering where there is MSM themed sexual activity (sauna, bath house, club).

The SHA has outlined how to properly isolate and protect others while contagious with Monkeypox on its website.

Monkeypox is a rare viral illness that causes fever, headache, swollen lymph nodes and lethargy, followed by the development of a rash over a person’s body. The disease is not easily spread from person to person according to the SHA. Monkeypox is spread through:

  • Close, personal, often skin-to-skin contact.
  • Touching bodily fluids or lesions of a person who is sick with the disease.
  • Exposure to contaminated objects such as bed linens or clothing.

There are currently around 30,000 Monkeypox cases globally, with approximately 1,000 of those occurring in Canada.

Saskatchewan’s current criteria for vaccination and its overall approach has been informed by other provincial responses such as in Ontario and Quebec, according to Shahab.

“We really hope that by this approach in Saskatchewan we can try to avert a quick or high surge of cases and also prevent further transmission.”

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Canadian Blood Services in talks around paid donations of plasma as supply dwindles

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Canadian Blood Services is in talks with companies that pay donors for plasma as it faces a decrease in collections.

The blood-collection agency issued a statement on Friday saying it is in “ongoing discussion with governments and the commercial plasma industry” on how to more than double domestic plasma collection to 50 per cent of supply.

Canadian Blood Services has previously cautioned that letting companies trade cash for plasma — a practice banned in British Columbia, Ontario and Quebec — could funnel donors away from voluntary giving.

The bulk of the non-profit agency’s supply currently comes from abroad, including via organizations that pay donors.

It issued a plea earlier this week for donors to book and keep appointments, noting collections have been falling since July 1 despite a constant need for plasma in transfusions for surgery, cancer patients and accident victims.

The number of people who donate blood regularly dropped by 31,000 during the COVID-19 pandemic, leaving the organization with its smallest donor base in a decade, it said.

The agency has opened five new plasma donor centres in the last few years, with six more planned by 2024 in an effort to draw 25 per cent of its supply from Canadian donors.

“But this only gets us halfway there. More needs to be done,” Canadian Blood Services said in the statement.

Working with private partners may offer one way to reach the 50 per cent threshold.

“Any options considered must necessarily include controls to ensure plasma collected in Canada is used exclusively to manufacture immunoglobulins for patients in Canada, while also ensuring no negative impacts on Canadian Blood Services’ current and future blood and plasma collections network,” the agency said.

It said Monday it had only four days’ worth of O+ blood type supply and five days’ worth of O- and B- blood types.

The O- type is the one most commonly used in transfusions for traumas and emergency surgeries, since anyone can receive its red blood cells. The O+ blood type is also in high demand due to its compatibility with any other positive red blood cell.

Spokeswoman Delphine Denis said ongoing illness and isolation requirements related to COVID-19, heat-related weather issues and the return of pre-pandemic activities and summer travel that have left many people with less time to donate are all factors contributing to the shortage.

There are 57,000 open appointments that must be filled before the end of August across Canada, the agency said.

This report by The Canadian Press was first published Aug. 13, 2021.

 

Christopher Reynolds, The Canadian Press

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