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Pfizer / BioNTech press for emergency vaccine use as WHO hits remilezivir on Gilead



The United States is one step closer to receiving its first vaccine against COVID-19, and BioNTech (BNTX), Pfizer’s development partner (PFE), is expected to apply for an emergency use permit.

As the coronavirus crisis reaches a global crescendo, CEO Ugur Sahin told CNN on Wednesday that the company plans to file a U.S. health and social services sector on Friday. Alex Hazard repeated during the briefing of the working group on coronavirus in the White House. Steps toward approving and spreading inoculation against COVID-19 have become increasingly urgent, with hospitalizations in the United States and new infections rising to new heights in recent days.

BioNTech̵

7;s move comes just days after the two companies announced that their two-dose vaccine is 95% effective against the coronavirus and plans to apply for regulatory approval “within days”.

Although data to support the statement have not yet been released, health officials are cautiously optimistic. Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the effectiveness of the vaccine was one thing, but its effectiveness in the real world was another.

“If you like highly effective vaccines over the years, they’ve crushed great outbreaks like smallpox, polio, measles,” Fauci said, calling the 95% threshold “extraordinary.”

However, there are concerns about the ease of distribution of the BioNTech / Pfizer vaccine, as well as other applicants, who could also soon be authorized to reach the far reaches of the country.

President-elect Joe Biden noted that the decision of Operation Warp Speed ​​- an initiative of the Trump administration to fund and produce local vaccine candidates – to partner with Walgreens (WBA) and CVS (CVS) is not ideal for reaching residents. of rural areas and some communities of color.

“So we need to make sure we have access to them,” Biden said during a press briefing on Thursday.

Coronavirus pandemic kills at least 250,000 in US (David Foster / Yahoo Finance)
Coronavirus pandemic kills at least 250,000 in US (David Foster / Yahoo Finance)

Rural access to vaccines – and significantly lower volume requirements that could affect prioritization – is a concern expressed by Amerisource Bergen, president of Good Neighbor Pharmacy.

But Warp Speed ​​officials said Wednesday that there are already plans to help areas that need an ultra-cold freezer or other support. On Thursday, General Gustave Perna said there were already 100 million sets of vaccines ready to be sent, along with the vaccines, 24 hours after an emergency authorization was issued.

Brandon Daniels, president of global markets at consulting firm Exiger, said now that the effectiveness of the vaccine is known, the efficiency of the supply chain has been tested.

“Now we see cryogenic and packaging companies starting to become more important names in the supply chain,” Daniels said.

A massive coronavirus testing infrastructure designed to help reach hard-to-reach communities could also play a key role in the spread of vaccines, he added.

Meanwhile, the states are already preparing to receive the first shipment of vaccines in mid-December, with the expectation that health workers and nursing homes will be at the top of the priority list.

The WHO rejects remdezivir

A group of doctors from the World Health Organization said they did not recommend the antiviral remdezivir of Gilead Science (GILD) marketed as Veklury for the treatment of Covid-19, in an article in the British Medical Journal (BMJ) late Thursday.

Based on recent results from WHO trials on Veklury and other proposed treatment options for coronavirus, doctors say there is not enough to support the use.

The article “contains a weak or conditional recommendation against the use of remdezivir in hospitalized patients with Covid-19,” doctors said.

In response, Gilead said it was disappointed with the decision, given that the United States and other countries such as Germany, Japan and the United Kingdom have approved the drug for use in hospitalized patients.

Countries that approved it did so “based on solid evidence from a number of randomized, controlled trials published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery that can free up limited hospital resources,” Gilead said.

In early October, SVB analyst Leerink Geoffery Porges said that based on all the results of the studies, “remdezivir looks as it did in previous studies and intermediate detection – moderately effective in patients in the sweet treatment area.”

Although “definitely not a miracle drug,” Porges noted that it is likely to be used in combination with monoclonal antibodies “in those countries and institutions that can afford the cost and can make complex diagnostic decisions about who to treat.” “.

Priced at more than $ 3,000, remdezivir and monoclonal antibodies are expensive treatment options compared to the more cost-effective, clinically effective corticosteroids such as dexamethasone, which are widely used to treat patients with Covid-19.

“Especially in view of the costs and resource implications of remdezivir, but in line with the approach to be taken with each new medicine, the Commission considers that the responsibility should be on demonstrating evidence of efficacy, which has not been established by the available currently data, “said WHO doctors.

In a separate move, the US Food and Drug Administration approved the treatment of Eli Lilly’s rheumatoid arthritis in combination with remdeysvir for emergency use.

Patricia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said the solution comes when the need for more treatment options grows.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical trials will be essential to identify therapies that slow disease progression and reduce mortality. the sick patients, ”Cavazzoni said.

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