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WHO tells doctors don’t use Gilead’s remdesivir, splitting with FDA

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A lab technicians shows the coronavirus disease (COVID-19) treatment drug “Remdesivir”.

Amr Abdallah Dalsh | Reuters

A World Health Organization panel advised doctors Thursday against using Gilead Sciences‘ antiviral drug remdesivir as a treatment for patients hospitalized with Covid-19, saying there is currently “no evidence” that it improves survival or shortens recovery time — standing in stark contrast to U.S. regulatory guidance on the drug.

The WHO Guideline Development Group, a panel of international experts who provide advice to the agency, said its recommendation is based on new data comparing the effects of several drug treatments, including data from four international randomized trials involving more than 7,000 patients hospitalized with the disease.

“After thoroughly reviewing this evidence, the WHO GDG expert panel, which includes experts from around the world including four patients who have had covid-19, concluded that remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement,” the group wrote in a press release.

The recommendation was published in the British medical trade journal The BMJ on Friday in the U.K.

In an emailed statement, Gilead said remdesivir “is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany.”

“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries,” Gilead spokesman Chris Ridley said in a statement.

Remdesivir, under the brand name Veklury, is administered in a hospital setting via an IV. Gilead has said the medication should only be administered in a hospital or in a health-care setting that can provide acute care comparable with inpatient hospital care.

The majority of patients treated with remdesivir receive a five-day course using six vials of the drug. The company is also developing an inhaled version of the medication, which it will administer through a nebulizer, a delivery device that can turn liquid medicines into mist.

The drug received worldwide attention as a potentially effective treatment for the coronavirus earlier in the year after a study funded by the National Institutes of Health found that it modestly reduced the recovery time in some patients who were hospitalized with Covid-19. It was one of the drugs used to treat President Donald Trump, who tested positive for the virus last month.

On Oct. 22, the Food and Drug Administration formally approved the drug for adults and pediatric patients 12 years of age and older who require hospitalization for Covid-19. It is now the first and only drug approved in the U.S. to treat the coronavirus, which has infected roughly 56.4 million people worldwide and killed about1.4 million.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, has praised the drug, saying it would set “a new standard of care” for Covid-19 patients.

Some medical experts note data on the drug’s effectiveness has been mixed. In October, a study coordinated by the WHO indicated that the medication had “little or no effect” on death rates among hospitalized patients. The study was conducted in 405 hospitals across 30 countries on 11,266 patients, with 2,750 given remdesivir.

Gilead has publicly questioned the findings of the WHO study, telling Reuters in October that other trials show the treatment cut recovery time. “The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters.

The WHO panel acknowledged that evidence so far does not prove that remdesivir “has no benefit.”

But it added given the possibility of harm as well as the high cost and resources need to administer the drug, it is an “appropriate recommendation.” The group said it supports continued enrollment in trials evaluating the drug.


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Oxford-AstraZeneca Covid vaccine has some advantages over its peers

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AstraZeneca’s building in Luton, Britain.

Tim Ireland | Xinhua News Agency | Getty Images

LONDON — The coronavirus vaccine being developed by AstraZeneca and the University of Oxford was found to be “highly” protective, potentially paving the way for a vaccine that is more affordable and easier to distribute than some of its peers.

An interim analysis of clinical trials showed the Oxford-AstraZeneca vaccine had an average efficacy of 70% in protecting against the virus.

Researchers said this figure could be as high as 90% by tweaking the dose, but the overall results show the vaccine’s efficacy is slightly lower than other leading candidates.

Both PfizerBioNTech and Moderna reported preliminary results last week showing that their respective Covid vaccines were around 95% effective.

However, White House coronavirus advisor Dr. Anthony Fauci has previously said a vaccine that is 50% or 60% effective against the virus would be acceptable.

It is hoped a Covid vaccine could help to bring an end to the coronavirus pandemic that has claimed more than 1.3 million lives worldwide.

Huge challenges remain before a vaccine can be rolled out. The global battle to secure prospective supplies has raised concerns about equitable access, while questions remain over the logistics of mass production, distribution, and cost.

Logistics

Equity analysts at Jefferies said it was “challenging” to compare the efficacy of AstraZeneca’s vaccine with those of Pfizer-BioNTech and Moderna, citing key differences in how the trials have been conducted.

The analysts highlighted weekly swabbing to detect Covid-19 among participants involved in AstraZeneca’s trials — not just confirmation of suspected cases by symptoms as in U.S. trials. They also stressed that a meningococcal vaccine was used for comparison, not placebo.

The Oxford-AstraZeneca vaccine was assessed over two dosing regimens. One showed an effectiveness of 90% when trial participants received a half dose, followed by a full dose at least one month later.

The other showed 62% efficacy when given as two full doses at least one month apart.

No hospitalizations or severe cases of the disease were reported in participants receiving the vaccine.

A motorcyclist wears a protective mask while sitting at the side of the road at the Sabarmati Riverfront in Ahmedabad, India, on Thursday, Oct. 22, 2020. Prime Minister Narendra Modi said his government will ensure that all 1.3 billion people nationwide will have access to a Covid-19 vaccine as soon it is ready.

Sumit Dayal | Bloomberg | Getty Images

The Jefferies analysts said that when it comes to storage, affordability and distribution, AstraZeneca’s vaccine appears to have an advantage.

The British pharmaceutical giant has said its vaccine can be stored, transported and handled at normal refrigerated conditions (36-46 degrees Fahrenheit) for at least six months and administered within existing health-care settings. It has also pledged to distribute the vaccine at no profit “for the duration of the pandemic.”

The Financial Times has previously reported the Oxford-AstraZeneca vaccine, which requires two doses, is priced at approximately $3 to $4 — significantly lower than the prices reported for Pfizer-BioNTech and Moderna.

In comparison, Moderna has said its vaccine candidate remains stable at the temperature of a standard home refrigerator for up to 30 days. It can also be stored for up to six months at minus 4 degrees Fahrenheit.

In August, the U.S. biotechnology firm said it was charging $32 to $37 per dose for its vaccine for some customers.

The Pfizer-BioNTech vaccine requires a storage temperature of minus 94 degrees Fahrenheit and requires special storage equipment and transportation. This could make it difficult for some countries to distribute.

Pfizer is reportedly charging $20 per dose for its vaccine.

‘Big beneficiaries’

Strategists at Deutsche Bank described the news from AstraZeneca on Monday as a “big deal,” saying a string of encouraging vaccine developments in recent weeks constituted “an unprecedented victory for science.”

They suggested that emerging markets, most notably Brazil, Mexico, India and Indonesia, were likely to be the “big beneficiaries” of the AstaZeneca vaccine. That’s because “the cheaper cost of production and distribution of AstraZeneca is especially relevant for lower and middle-income countries,” they said.

AstraZeneca has said it is making “rapid progress” in terms of manufacturing, with a capacity to produce up to 3 billion doses of the vaccine next year.

The U.S. and India have agreed to procure 500 million doses of the Oxford-AstraZeneca vaccine, according to data compiled by researchers at Duke University’s Global Health Innovation Centre.

The EU has reached a deal to buy 400 million, and the COVAX facility, a global initiative aimed at ensuring equitable access to Covid-19 treatments and vaccines, has ordered 300 million.

The U.K., Japan, Indonesia, Brazil, and Latin America excluding Brazil have each confirmed orders of at least 100 million doses.


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5 things to know before the stock market opens November 23, 2020

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