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Exclusive-WHO-led programme aims to buy antiviral COVID-19 pills for $10 -document

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A World Health Organization-led programme to ensure poorer countries get fair access to COVID-19 vaccines, tests and treatments aims to secure antiviral drugs for patients with mild symptoms for as little as $10 per course, a draft document seen by Reuters says.

Merck & Co’s experimental pill molnupiravir is likely to be one of the drugs, and other drugs to treat mild patients are being developed.

The document, which outlines the goals of the Access to COVID-19 Tools Accelerator (ACT-A) until September next year, says that the programme wants to deliver about 1 billion COVID-19 tests to poorer nations, and procure drugs to treat up to 120 million patients globally, out of about 200 million new cases it estimates in the next 12 months.

The plans highlight how the WHO wants to shore up supplies of drugs and tests at a relatively low price after losing the vaccine race to wealthy nations which scooped up a huge share of the world’s supplies, leaving the world’s poorest countries with few shots.

There is precedent for lower prices of critical medicines for low-income countries during the pandemic.

AstraZeneca has pledged to sell its COVID-19 vaccines at cost of around $4 per dose during the pandemic and Pfizer is charging the U.S. government at cost – around $7 a dose – for 1 billion doses for the country’s donations to the ACT-A’s vaccine programme called  COVAX.

Still its COVID-19 vaccine will be a big revenue driver for the U.S. drugmaker – it charged wealthy countries around $20 for billions of doses in initial supply deals and will make an expected $33 billion in revenue from the shot this year.

A spokesperson for the ACT-A said the document, dated Oct. 13, was still a draft under consultation and declined to comment on its content before it is finalised. The document will also be sent to global leaders ahead of a G20 summit in Rome at the end of this month.

The ACT-A asks the G20 and other donors for additional funding of $22.8 billion until September 2022 which will be needed to buy and distribute vaccines, drugs and tests to poorer nations and narrow the huge gaps in supply between wealthy and less advanced countries. Donors have so far pledged $18.5 billion to the programme.

The financial requests are based on detailed estimates about the price of drugs, treatments and tests, which will account for the programme’s biggest expenses alongside the cost of distributing vaccines.

Although it does not explicitly cite molnupiravir, the ACT-A document expects to pay $10 dollar per course for “novel oral antivirals for mild/moderate patients”.

Other pills to treat mild patients are being developed, but molnupiravir is the only one which has so far showed positive results in late-stage trials. The ACT-A is in talks with Merck & Co and generics producers to buy the drug.

The price is very low if compared with the $700 per course that the United States has agreed to pay for 1.7 million courses of the treatment.

But Merck has said it is committed to providing timely access to its drug globally with plans for tiered pricing according to a country’s ability to pay. It also has licensing deals with eight Indian generic drugmakers.

A study carried out by Harvard university estimated that molnupiravir could cost about $20 dollars if produced by generic drugmakers, with the price potentially going down to $7.7 under an optimised production.

The ACT-A document says that its target is to reach a deal by the end of November to secure the supply of an “oral outpatient drug”, which it aims to be available from the first quarter of next year.

The money raised would initially be used to “support procurement of up to 28 million treatment courses for highest risk mild/moderate patients over the next 12 months, depending on product availability, clinical guidance, and volumes changing with evolution of needs,” the document says, noting this volume would be secured under an advance purchase agreement.

Larger additional amounts of new oral antivirals to treat mild patients are also expected to be procured at a later stage, the document says.

Another 4.3 million courses of repurposed COVID-19 pills to treat critical patients are also expected to be purchased at a price of $28 per course, the document says, without naming any specific drug.

The ACT-A also intends to address essential medical oxygen needs of 6-8 million severe and critical patients by September 2022.

TESTS

In addition, the programme plans to invest massively in COVID-19 diagnostics in order to at least double the number of tests carried out in poorer nations, defined as low income and low-middle income countries.

Of the $22.8 billion, the ACT-A plans to raise in the next 12 months, about one third and the largest share is to be spent on diagnostics, the document says.

Currently poor countries conduct on average about 50 tests per 100,000 people every day, against 750 tests in richer nations. The ACT-A wants to bring testing rates to a minimum of 100 tests per 100,000 in poorer states.

That means delivering around 1 billion tests in the next 12 months, around 10 times more than the ACT-A has procured so far, the document shows.

The largest share of diagnostics would be rapid antigen tests at a price of around $3, and only 15% would be spent to procure molecular tests, which are more accurate but take more time to deliver results and are estimated to cost around $17, including delivery costs, the document shows.

The push on tests is meant to narrow the gap between the rich and the poor, as only 0.4% of the about 3 billion tests reported across the world have been conducted in poor nations, the document says.

It would also help spot earlier possible new variants, which tend to proliferate when infections are widespread, and therefore are more likely in the countries with lower vaccination rates.

The document underlines that “vaccine access is highly inequitable with coverage ranging from 1% to over 70%, depending largely on a country’s wealth.”

The programme aims to vaccinate at least 70% of the eligible population in all countries by the middle of next year, in line with the WHO’s goals.

(Reporting by Francesco Guarascio @fraguarascio; Additional reporting by Michael Erman in New JerseyEditing by Susan Fenton)

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Islander living with HIV for 3 decades reflects on World AIDS Day – CBC.ca

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Troy Perrot-Sanderson has lived with human immunodeficiency virus for almost 30 years, but he’s only recently started talking about how he became infected. 

“It’s a very difficult thing for me to talk about,” said Perrot-Sanderson, in an interview tied to Dec. 1, which is World AIDS Day. “I’ve only really started dealing with it.” 

He said he was 21 years old when he was sexually assaulted, while he was living in Alberta. 

After the rape, Perrot-Sanderson said his life “spiralled” as he used drugs and alcohol to cope. 

He has just started to see a counsellor to help him deal with the trauma.

Perrot-Sanderson was a volunteer and later a staff member for AIDS P.E.I. He said his outlook on the disease has changed over the years and he feels much more optimistic now compared to when he was first diagnosed. (Submitted Troy Perrot-Sanderson)

HIV, human immunodeficiency virus, attacks the body’s immune system. If HIV is not treated, it can lead to acquired immunodeficiency syndrome, or AIDS.  

Perrot-Sanderson remembers that when he was first diagnosed, he thought his life was over. It took two decades after AIDS was first identified in the early 1980s to find an effective combination of drugs to treat it. In Canada alone, a 2017 report estimated, nearly 25,000 people had died of the disease by the end of 2016. 

“I just slowly prepared myself to die for a few years,” Perrot-Sanderson said. 

Advocate for others

He said he got more optimistic after he starting taking drugs to fight HIV. He volunteered and worked at AIDS PEI (later renamed PEERS Alliance) and was even acting executive director for a time. 

“We can take medication and live a pretty normal life,” he said.

PEERS Alliance recently relocated its office to downtown Charlottetown, and is planning an open house at 250 B Queen Street from 3 to 6 p.m. on Wednesday, Dec. 1. (Laura Meader/CBC)

Of today’s PEERS leader, he added: “I can’t thank them enough. They’re doing all kinds of amazing work in the community.” 

PEERS Alliance runs a number of education and outreach programs, working with a wide variety of people including gay and lesbian youth and adults; the trans community; and people who use drugs, who are susceptible to getting infected due to shared needles.

Still, as Perrot-Sanderson marks this World AIDS Day, he said it’s important to remember the people who have not survived, noting: “I have lost a lot of friends over the years.”

He worries there’s apathy around AIDS and HIV in 2021. 

“A lot of people just don’t talk about it or think about it any more,” he said. “We know how to protect ourselves now — we certainly know so much more, we know how to prevent this disease.”

Hopes for the future

Josie Baker is the executive director of PEERS Alliance, and hopes people will take part in an open house set up to mark World AIDS Day.

Baker noted that there is better access to testing now, with at-home kits available for use “in the comfort of someone’s own home.” 

Josie Baker of PEERS Alliance says she is looking forward to a day when there is no more stigma around HIV/AIDS. (Laura Meader/CBC)

Baker said non-nominal testing is also available, where each test is assigned a number instead of a name before going to the lab for analysis. That means people can be assured nobody at the lab will know who tested positive.   

There are still pressing issues that require lobbying, though, 40 years after the HIV crisis began. Baker said having an HIV care specialist on P.E.I. would help, since many have to go off-Island for specialized care. 

She also said being HIV-positive still carries a stigma on P.E.I. and elsewhere, and people should be able to access care and live in their communities free of judgment. 

“That would be my hope: to end the stigma,” said Baker. 

Perrot-Sanderson agrees, saying stigma often prevents people from seeking medical help. 

“People ignore it and don’t protect themselves,” he said.

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Singapore tests out ‘smart bandage’ for remote recovery

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Researchers in Singapore have developed a smart bandage to enable patients to have chronic wounds monitored remotely via an app on a mobile device, potentially saving them visits to the doctor.

A research team at the National University of Singapore has created a wearable sensor attached to a transparent bandage to track progress in healing, using information like temperature, bacteria type, and levels of pH and inflammation.

“Traditionally when someone has a wound or ulcer, if it’s infected, the only way to examine it is through looking at the wound itself, through visual inspection,” said Chwee Teck Lim, lead researcher at the university’s department of biomedical engineering.

“If the clinician wants to have further information then they will obtain the wound fluid and send to the lab for further testing,” he said.

“So what we’re trying to do is use our smart bandage to cut the number of hours or days to just a few minutes.”

The “VeCare” technology will enable patients to convalesce more at home and visit a doctor only if necessary.

The bandage is being tested on patients with chronic venous ulcers, or leg ulcers caused by circulation problems in veins.

Data collection by researchers on the wounds has so far been effective, according to Lim, who said the smart bandage could potentially be used for other wounds, like diabetic foot ulcers.

(This story refiles to correct to cut extraneous word in the first paragraph)

 

(Reporting by Ying Shan Lee; Writing by Masako Iijima; Editing by Martin Petty, William Maclean)

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Courts block two Biden administration COVID vaccine mandates

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The Biden administration was blocked on Tuesday from enforcing two mandates requiring millions of American workers to get vaccinated against COVID-19, a key part of its strategy for controlling the spread of the coronavirus.

U.S. District Judge Terry Doughty in Monroe, Louisiana, temporarily blocked the Centers for Medicare & Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can resolve legal challenges.

Doughty’s ruling applied nationwide, except in 10 states where the CMS was already prevented from enforcing the rule due to a prior order from a federal judge in St. Louis.

Doughty said the CMS lacked the authority to issue a vaccine mandate that would require more than 2 million unvaccinated healthcare workers to get a coronavirus shot.

“There is no question that mandating a vaccine to 10.3 million healthcare workers is something that should be done by Congress, not a government agency,” wrote Doughty.

Separately, U.S. District Judge Gregory Van Tatenhove in Frankfort, Kentucky, blocked the administration from enforcing a regulation that new government contracts must include clauses requiring that contractors’ employees get vaccinated.

The contractor ruling applied in the three states that had filed the lawsuit, Kentucky, Ohio and Tennessee, one of at least 13 legal challenges nationwide against the regulation. It appears to be the first ruling against the contractor vaccine mandate.

The White House declined to comment.

The legal setbacks for President Joe Biden’s vaccine policy come as concerns that the Omicron coronavirus variant could trigger a new wave of infections and curtail travel and economic activity across the globe.

Biden unveiled regulations in September to increase the U.S. adult vaccination rate beyond the current 71% as a way of fighting the pandemic, which has killed more than 750,000 Americans and weighed on the economy.

Republican state attorneys general, conservative groups and trade organizations have sued to stop the regulations.

Tuesday’s rulings add to a string of court losses for the Biden administration over its COVID-19 policies.

The most sweeping regulation, a workplace vaccine-or-testing mandate for businesses with at least 100 employees, was temporarily blocked by a federal appeals court in early November.

In August, the U.S. Supreme Court ended the administration’s pandemic-related federal moratorium on residential evictions.

(Reporting by Tom Hals in Wilmington, Delaware; Additional reporting by Nandita Bose in Washington; Editing by Jonathan Oatis and Peter Cooney)

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