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WHO backs Regeneron COVID-19 drug cocktail – with equal access, price cut

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A technician carries out an experiment in the Regeneron laboratory. © Regeneron

The Regeneron antibody drug cocktail – casirivimab and imdevimab – has been added to the World Health Organization’s (WHO) list of treatments for COVID-19 patients, the UN agency said on Friday, before underscoring the need for lower prices and equitable distribution. 

“This is a major breakthrough in the care of COVID-19 patients”, said Dr. Janet Diaz, WHO head of clinical care. “This is our first recommendation for a therapeutic for those patients with mild, moderate disease,” she said, because it reduces “the need for hospitalisation if they are at high risk”. 

Effective ‘reduction in mortality’  

WHO’s conditional recommendations are for use of the drug combination on patients who are not severely ill, but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies.  

“Giving them this additional antibody seems to show an effect. And what effect is that? A reduction in mortality” Dr. Diaz told a briefing in Geneva. 

The antibody therapy was granted emergency use authorization in the United States November last year after it was used to treat former President Donald Trump when he was admitted to hospital with the virus. The United Kingdom has also approved Regeneron, while it is under review in Europe. 

‘Meaningful’ benefit 

The WHO recommendations were largely based on data from a British study of 9,000 patients in June which found that the therapy reduced deaths in hospitalised patients whose own immune systems had failed to produce a response. 

“We are taking the information (from the UK study) and generalizing it to other persons,” said Dr. Diaz. “We saw there was a benefit we thought was meaningful.” 

The treatment has been on the market for decades to treat many other diseases, including cancers. It is based on a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the human body to fight off infections. 

Equity, price cut call 

Swiss drugmaker Roche, has been working in partnership with Regeneron, which holds the patent, to produce the antibody treatment. 

Dr. Diaz urged Regeneron to lower the drug’s price and work on equitable distribution worldwide: “We know that the life-saving benefits and the benefits for patients with COVID-19 is significant and requires action.” 

She added that WHO-hosted health agency UNITAID, has been negotiating directly with Roche for lower prices and equitable distribution across all parts of the world, “including low and middle-income countries”. 

WHO has also been in discussions with the company for a donation and distribution of the drug through UN Children’s Fund UNICEF, following an allocation criteria set by the health agency. “We are working together with the company so we can address these very important issues so we can have equitable access” she said. 

Call to manufacturers 

In a statement, WHO said in parallel it had “launched a call to manufacturers who may wish to submit their products for pre-qualification, which would allow for a ramping-up of production and therefore greater availability of the treatment and expanded access. 

ACT-A partners are also working with WHO on an equitable access framework for recommended COVID-19 therapeutics”. On that subject, Dr Diaz added that “there are bottlenecks and we are aware of those. 

WHO has launched the pre-qualification expression of interest call so that the manufacturing companies can start to submit their dossiers to WHO”. 

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UN-backed COVAX mechanism delivers its 1 billionth COVID-19 vaccine dose

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photo © UNICEF/Aimable Twiringiyima

With a 1.1 million jab delivery in Rwanda this weekend, the World Health Organization’s multilateral initiative to provide equal access to vaccines for all reached the one billion milestone.

Along with the Coalition for Epidemic Preparedness Innovations (CEPI), the Vaccine Alliance GAVI, and partners, WHO has led the largest vaccine procurement and supply operation in history with deliveries to 144 countries to date.

According to a press release published on Sunday, as of 13 January 2022, out of 194 countries members of WHO, 36 have vaccinated less than 10% of their population, and 88 less than 40%.

COVAX’s ambition was compromised by hoarding/stockpiling in rich countries, catastrophic outbreaks leading to borders and supply being locked. And a lack of sharing of licenses, technology, and know-how by pharmaceutical companies meant manufacturing capacity went unused”, the agency explained.

On 24 February 2021, Ghana became the first country in the world to receive vaccines through COVAX when 600,000 doses of the Oxford–AstraZeneca vaccine were delivered to Accra. 

The work that remains

COVAX is currently working with governments, manufacturers and partners to ensure that when countries receive vaccines, they can get them to people quickly.

“The work that has gone into this (1 billion) milestone is only a reminder of the work that remains”, the UN’s health agency underscored.

They added that with updated vaccines in the pipeline, citizens should demand that governments and pharmaceutical companies share health tools globally and “bring an end to the death and destruction cycles of this pandemic, limit new variants and drive a global economic recovery”.

COVAX is one of three pillars of the Access to COVID-19 Tools (ACT) Accelerator, which was launched by WHO in April 2020 in response to the pandemic.

The ACT Accelerator is a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. 

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WHO recommends two new drugs to treat patients with COVID-19 

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Around two million doses of Sotrovimab are being produced globally in the first half of 2022. © GlaxoSmithKline

The World Health Organization (WHO) on Thursday reccommended two new drugs to treat patients with COVID-19, one for patients with critical disease, and another deemed effective for non-severe cases.

The first drug, baricitinib, is a Janus kinase (JAK) inhibitor- a class of drugs used to treat autoimmune conditions, blood and bone marrow cancers, and rheumatoid arthritis.

According to the WHO Guideline Development Group, it is “strongly recommended” for patients with severe or critical disease in combination with corticosteroids.

The group of international experts based their recommendation on “moderate certainty evidence” that it improves survival and reduces the need for ventilation.

There was no observed increase in adverse effects.

The experts note that it has a similar effectas other arthritis drugs called interleukin-6 (IL-6) inhibitors. Because of that, when both drugs are available, they suggest choosing the best option based on cost, availability, and clinician experience.

It is not recommended to use both drugs at the same time.

The experts also advise against the use of two other JAK inhibitors (ruxolitinib and tofacitinib) for patients with severe or critical cases of COVID-19 infection.

According to them, trials undergone using these drugs failed to show any benefits arising using either drug,and suggested a possible increase in serious side effects with tofacitinib.

Non-severe cases

In the same update, WHO makes a conditional recommendation for the use of a monoclonal antibody known as sotrovimab in patients with non-severe cases.

According to them, the drug should only be administered to patients at the highest risk of hospitalisation. In those at lower risk, it onlyshowed “trivial benefits”. 

A similar recommendation has been madepreviously, for another monoclonal antibody drug, casirivimab-imdevimab, and the experts say there is insufficient data to recommend one over the other.

For both, the effectiveness against new variants, like Omicron, is still uncertain. 

The group will update their guidelines for monoclonal antibodies when more data becomes available.

Recommendations

These recommendations are based on new evidence from seven trials involving over 4,000 patients with non-severe, severe, and critical infections.

Developed by WHO with the methodological support of MAGIC Evidence Ecosystem Foundation, the guidelinesprovide trustworthy guidance and help doctors make better decisions with their patients.

According to the agency, the guidelines are useful in fast moving research areas, because they allow researchers to update evidence summaries as new information becomes available.

The latest guidance also updates recommendations for the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19; conditional recommendations for the use of casirivimab-imdevimab (another monoclonal antibody treatment) in selected patients; and against the use of convalescent plasma, ivermectin and hydroxychloroquine, regardless of disease severity.

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Omicron fuels record weekly COVID-19 cases, but deaths ‘stable’

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Fuelled by Omicron, more than 15 million new cases of COVID-19 were reported around the world last week, by far the most cases reported in a single seven day period, the World Health Organization (WHO) informed on Wednesday. 

Briefing reporters in Geneva, the UN health agency chief, Tedros Adhanom Ghebreyesus, said the “huge spike” is being driven by the Omicron variant, which is rapidly replacing Delta in almost all countries. 

Despite the number of cases, the weekly reported deaths have “remained stable” since October last year, Tedros added, at an average of 48,000. The number of patients being hospitalized is also increasing in most countries, but it is not at the level seen in previous waves.

He told reporters this is possibly due to the reduced severity of Omicron, and widespread immunity from vaccination or previous infection.

‘50 thousand deaths too many’

For the WHO chief, while Omicron causes less severe disease than Delta, it remains a dangerous virus, particularly for those who are unvaccinated.

Almost 50 thousand deaths a week is 50 thousand deaths too many”, Tedros said. “Learning to live with this virus does not mean we can, or should, accept this number of deaths.”

For him, the world cannot “allow this virus a free ride” when so many people around the world remain unvaccinated.

In Africa, for example, more than 85 per cent of people are yet to receive a single dose of vaccine.

“We cannot end the acute phase of the pandemic unless we close this gap”, he said. 

Making progress

Tedros then listed some progress towards reaching the target of vaccinating 70 per cent of the population of every country by the middle of this year. 

In December, COVAX shipped more than double the number of doses it distributed in November. In the coming days, the initiative should ship its one billionth vaccine dose. 

Some of the supply constraints from last year are also starting to ease, Tedros said, but there’s still have a long way to go. 

So far, 90 countries have still not reached the 40 per cent target, and 36 of those countries have vaccinated less than 10 per cent of their populations.

New vaccines

Tedros also highlighted an interim statement from the WHO Technical Advisory Group on COVID-19 Vaccine Composition, released on Tuesday, stressing that further vaccines are needed that have a greater impact on preventing infection. 

Until such vaccines are developed, the experts explained, the composition of current vaccines may need to be updated. 

The Group also said that a vaccination strategy based on repeated booster doses is “unlikely to be sustainable.”

A heavy toll

According to Tedros, the overwhelming majority of people admitted to hospitals around the world are unvaccinated.

At the same time, while the immunizations remain very effective at preventing severe disease and death, they do not fully prevent transmission.

“More transmission means more hospitalizations, more deaths, more people off work, including teachers and health workers, and more risk of another variant emerging that is even more transmissible and more deadly than Omicron”, Tedros explained. 

The sheer number of cases also means more pressure on already overburdened and exhausted health workers.

A study published last year showed that more than one in four health workers have experienced mental health issues during the pandemic. Data from several countries also show that many have considered leaving or have left their jobs.

Pregnant women

On Tuesday, WHO hosted a global webinar, attended by clinicians from around the world, on the clinical management of the virus during pregnancy, childbirth and the early postnatal period. 

As stated earlier in the pandemic, pregnant women are not at higher risk of contracting COVID-19, but if they are infected, they are at higher risk for severe disease.

That’s why it’s vital that pregnant women in all countries have access to vaccines to protect their own lives, and those of their babies”, Tedros said. 

The agency chief also called for pregnant women to be included in clinical trials for new treatments and vaccines. 

He also stressed that, fortunately, mother to baby transmission in utero or during birth is very rare, and no active virus has been identified in breast milk. 

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