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Regeneron CEO says $450 million contract with U.S. secured 300k doses of antibody drug

Washington — Dr. Leonard Schleifer, the founder and CEO of Regeneron Pharmaceuticals, which developed the antibody cocktail heralded by President Trump, estimated Sunday that a $450 million contract the company won from the federal government over the summer will secure roughly 300,000 doses of the treatment.

“They bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free,” Schleifer said in an interview with “Face the Nation.” “We can’t do this alone. We need the entire industry.”

The Trump administration announced in July it signed a $450 million contract with Regeneron to supply the treatment. But with the number of new coronavirus cases outpacing the doses of the drug available, Schleifer conceded the federal government, together with ethics experts at the Food and Drug Administration, will have to decide who receives the limited supply.

“Coming up with a distribution system where we take what’s limited, and we try and give it to the people who most need it, who would most benefit from it — the vulnerable people, elderly people, people who are at high risk, household contacts perhaps,” he said. “We have to figure out ways to ration this.”

Mr. Trump was given a single dose of Regeneron’s antibody cocktail while he was being treated for COVID-19 and has gone on to praise the treatment, officially known as REGN-COV2, as a “cure” for the virus.

But the treatment has yet to undergo a peer-reviewed drug trial and has only been given to 10 people outside of clinical trials.

Schleifer called Mr. Trump’s case a “case report” and said while it is evidence of how the drug worked, it’s the “weakest evidence that you can get.”

“The real evidence has to come — about how good a drug is and what it will do on average — has to come from these large clinical trials, these randomized clinical trials, which are the gold standard,” he said.

Regeneron applied for an emergency use authorization from the FDA, and if it’s granted, the government has agreed “to making these doses available to the American people at no cost.”

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U.S. expects over 1 million COVID-19 antibody doses from Regeneron, Lilly in 2020

By Michael Erman and Manas Mishra

NEW YORK (Reuters) – The U.S. government expects to be able to provide at no cost more than 1 million doses of antibody treatments for COVID-19 similar to the one President Donald Trump received to treat his illness, according to a top U.S. health official on Friday.

The government’s Operation Warp Speed program currently has “a couple of hundred thousand doses” of the monoclonal antibody treatments being developed by drugmakers Regeneron Pharmaceutical Inc <REGN.O> and Eli Lilly & Co <LLY.N>, U.S. Department of Health and Human Services official Paul Mango said on a call with reporters. That would top 1 million doses by the end of the year, he said.

Trump received Regeneron’s treatment last week. In a radio interview with Rush Limbaugh on Friday, Trump said he is working to get both drugs approved quickly and that he may not have recovered without the treatments he received.

Both companies have said the drugs were shown to work in clinical trials and that they have submitted an emergency use authorization to the U.S. Food and Drug Administration (FDA).

The drugs are not identical: Regeneron’s treatment is a cocktail of two antibodies meant to protect against the virus, while Lilly’s is a single antibody. Because they have not been tested against the other, it is difficult to know if one is more effective than the other.

It is unclear how long the FDA process to authorize emergency use of the drugs will take. Unless the companies receive that authorization, doctors cannot administer the drugs to patients outside of clinical trials or without a compassionate use authorization like the one President Trump received.

If the drugs are authorized for use by the FDA, Mango said that the government will allocate the treatments to the states based on need, similar to the mechanism used with Gilead Sciences Inc’s <GILD.O> antiviral drug remdesivir for COVID-19.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

The company said it has not signed any additional deals with Operation Warp Speed, and has around 50,000 doses of its treatment ready now.

Lilly said on Friday it has not signed an agreement with Operation Warp Speed. It said earlier this week that it expects to produce around one million doses of the treatment this year.

(Reporting by Manas Mishra in Bengalaru and Michael Erman in New York; writing by Caroline Humer; Editing by Chizu Nomiyama, Aurora Ellis and Kirsten Donovan)

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Gilead Sciences to sell Europe 500,000 doses of remdesivir

Oct. 8 (UPI) — Gilead Sciences announced Thursday that it’s selling 500,000 doses of remdesivir to European countries as many experience a spike in cases of COVID-19.

The company, which produces the antiviral under the name Veklury, said it reached a deal allowing the European Commission to purchase the drug for 36 countries over the next six months.

Gilead says it ramped up its production of remdesivir in recent months after studies indicated it showed shortened recovery times for some coronavirus patients. The U.S. Food and Drug Administration took control of the distribution of the drug in May after giving it emergency approval for COVID-19 treatment.

Gilead resumed control of distribution earlier this month. The company said it’s on track to produce more than 2 million treatment courses of the drug this year.

“Supply of Veklury is expected to meet global demand by the end of this month, enabling the purchase of Veklury both to treat patients and to support national stockpiling of the medicine for current and future surges of COVID-19,” the company said in a statement.

Clinical results for the antiviral have been mixed. A new National Institute of Allergy and Infectious Diseases study published Thursday in the New England Journal of Medicine said treatment with remdesivir shortened recovery time by five days compared to a placebo, and reduced mortality by 70% at Day 29 in patients with low-flow oxygen.

Another study in August showed the drug doesn’t improve outcomes in people hospitalized with moderate pneumonia caused by COVID-19.

Researched published last month showed that remdesivir administered in combination with baricitinib — treatment for rheumatoid arthritis — can reduce the recovery time for people with COVID-19 when compared to people treated with just the antiviral.

Originally developed to treat Ebola virus, remdesivir works by slowing the production of enzymes that play a key role in the replication of viruses, including coronaviruses, according to Gilead Sciences.

President Donald Trump received remdesivir as part of his own treatment for COVID-19.

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HHS Secretary Azar says U.S. could have enough doses for every American by March

Alex Azar, secretary of Health and Human Services (HHS), wears a protective mask during a House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C., U.S., on Friday, Oct. 2, 2020. Azar is appearing before the committee to testify on the coronavirus crisis and the Trump administration’s portrayal of Covid-19 deaths. Photographer: Michael A. McCoy/The New York Times/Bloomberg via Getty Images

Bloomberg | Bloomberg | Getty Images

Health and Human Services Secretary Alex Azar said Thursday the U.S. could have enough Covid-19 vaccine doses for every American as early as March, a more optimistic estimate than President Donald Trump has publicly said.

The Trump administration’s coronavirus vaccine program Operation Warp Speed expects to have up to 100 million doses by the end of the year, Azar said during a keynote speech at the Goldman Sachs Healthcare virtual event on the coronavirus. That’s “enough to cover especially vulnerable populations,” he said. 

“We project having enough for every American who wants a vaccine by March to April 2021,” he added. 

Because of the pandemic, U.S. health officials have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.

Azar said the U.S. is currently manufacturing doses for all six potential vaccines backed by the U.S. government across more than 23 manufacturing facilities. That includes vaccines from Moderna, Pfizer, AstraZeneca and Johnson & Johnson, which are all in late-stage testing. The U.S. is also obtaining the needles, syringes, bottles and other supplies needed for immunizations, he said. 

He touted the U.S. government’s partnership with medical supply company McKesson, which was tapped as the main distributor for Covid-19 vaccines.

“We are immensely pleased with our success so far,” he said. 

Trump has repeatedly insisted a vaccine could be authorized for emergency use as early as October with enough vaccine doses for every American by April. 

Azar said Thursday that U.S. health officials believe authorizing a vaccine for emergency use is appropriate in “only specific circumstances,” where there are “sufficient amounts of vaccine already manufactured.” 

The Centers for Disease Control and Prevention outlined a sweeping plan last month to make vaccines for Covid-19 available for free to all Americans. In the plan, the CDC said it anticipates a coronavirus vaccine will initially be granted an emergency use authorization before a full formal approval.

Much of the guidance, but not all, described in the plan will overlap with many routine activities for immunizations and pandemic influenza planning, CDC Director Dr. Robert Redfield said at the time.

When larger quantities of vaccine become available, the CDC said, there will be two simultaneous objectives: to provide widespread access to vaccination and to ensure high uptake in target populations, particularly those who are at high risk of death or complications from Covid-19.

Azar’s comments come as infectious disease experts and scientists fear a Covid-19 vaccine will be distributed before it’s been adequately tested. 

Earlier this week,

U.S. Government Asks Vaccine Makers To Hold Filing for Authorization Until They Have Enough Doses to Distribute

President Trump Makes Statement On Vaccine Development
President Trump Makes Statement On Vaccine Development

Moncef Slaoui, head of the White House’s “Operation Warp Speed” project to develop a coronavirus vaccine, listens to U.S. President Donald Trump deliversremarks about vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC. Credit – Drew Angerer—Getty Images

As the COVID-19 pandemic enters its 10th month, the pressure to develop an effective vaccine, or vaccines, continues to mount. Speaking at the Johns Hopkins University and University of Washington Vaccine Symposium online, Dr. Moncef Slaoui, scientific head of Operation Warp Speed—the government organization funding and supporting development and distribution of COVID-19 vaccines—provided the latest updates on when a vaccine (and how many doses) might be available in coming months.

Perhaps most strikingly, Slaoui said that the government has told vaccine manufacturers not to seek authorization of their drugs from the Food and Drug Administration (FDA) until they have enough doses to provide to a desperate public. “We have recommended to companies that if they achieve efficacy demonstration while no vaccine doses are available at industrial scale of several million doses to at least immunize a relevant fraction of the population, then they should refrain or consider refraining from filing an emergency use authorization, because the populations would have a major disappointment [over] expectation of the availability of the vaccine,” he said.

Emergency use authorization (EUA) is an accelerated review and authorization process by the FDA that would allow vaccine makers to distribute vaccines that are safe and effective but not fully approved by the agency.

Slaoui also supported the FDA in its recent conflict with the White House over stringent guidelines proposed by the agency for evaluating data from vaccine studies, which include a recommendation that all vaccine trial volunteers be followed for two months for any potential side effects. Vaccine makers supported the guidelines, but after initially rejecting them, arguing they would delay availability of the vaccines, the White House has accepted them.

At this point, meeting demand would not be a problem if an EUA were given to the two vaccines, made by Moderna and Pfizer, that are currently furthest along in testing. The companies began late-stage testing for these vaccine candidates in the summer, and Slaoui said the manufacturers have been manufacturing doses at large scale in parallel to testing. The government began stockpiling doses of these unapproved but promising vaccines “in the single digit millions” in September, and will continue to do so in October, he said, and both Moderna and Pfizer will likely have 20 to 30 million doses produced by November and December this year.

Two of the other most promising vaccines in development are from AztraZeneca and J&J, both of which are quickly enrolling participants in late stage studies outside of the U.S., and may deliver first hints of safety and effectiveness by late October or early November. However, even if those results prove positive, these companies would likely have to consider waiting until their manufacturing capabilities

Xellia Pharmaceuticals Launches New Doses of VANCO READYTM (Ready-to-use Room Temperature Premixed Vancomycin Injection Bags)

Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, is launching three new doses of VANCO READYTM, expanding its range of room temperature stable, ready-to-use (RTU) Vancomycin injection premix bags.

The VANCO READYTM availability will now cover all relevant doses from 500 mg to 2 g in 250 mg increments.

The availability of 750 mg in 150 mL, 1.25 g in 250 mL and 1.75 g in 350 mL are joining our range of presentations launched in 2019 – 500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL.

VANCO READYTM should not be administered during pregnancy, please see boxed warning below.

Carl-Åke Carlsson, Xellia’s CEO said: “With all seven VANCO READYTM presentations, Xellia can service the majority of needs of healthcare professionals in the vancomycin injection market. The success of our first four products has resulted in over 2,000 US institutions using VANCO READYTM. Since our announcement of approval, we have already seen strong interest and demand for the new codes from healthcare professionals on the basis of the product being room temperature and the most ready to use product available.”

Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of septicemia (sepsis), infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.

Craig Boyd, Xellia’s North American President said: “One of the uses for Vancomycin in the US is in the treatment of sepsis. The timely initiation of effective antibiotic treatments is universally recognized as a key intervention in the management of this life-threatening state as well as other infections. We are pleased to have been able to expand the range of doses available to clinicians, broadening their options to aid rapid and effective treatment.”

In the United States, sepsis is the third leading cause of death after heart disease and cancer, affecting more than 1.7 million people and killing more than 270,000 people within a single year1.

“Our room-temperature-stable VANCO READYTM premix has been critical in providing a truly ready Vancomycin Injection product. It aligns with recommendations from US agencies – such as the American Society of Hospital Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP) and Joint Commission – to use manufacturer-prepared products as part of safe medication practice. We will continue to build on this success and focus on our ready-to-use product pipeline and partnerships during 2020.”

– Ends –

References

1 Rhee, C. et al. Incidence and trends of sepsis in US hospitals using clinical vs claims data, 2009-2014. JAMA 318, 1241–1249 (2017).

Full prescribing information for Vancomycin Injection Premix RTU can be found at www.vancoready.com and www.xellia.com/us

About Vancomycin Injection

Vancomycin Injection, Ready to use (RTU) is a proprietary formulation of vancomycin, provided as a premixed solution in single-dose flexible bags, stable at room temperature (up to 25 °C) for 16

India seeks up to 500 million coronavirus vaccine doses by July

NEW DELHI (Reuters) – India hopes to receive up to 500 million doses of coronavirus vaccine by July to inoculate about 250 million people, health minister Harsh Vardhan said on Sunday, as infections in the world’s second-worst affected country continue to surge.

India’s has recorded some 6.55 million infections, with 75,829 in the past 24 hours, while COVID-19-related deaths have totalled 101,782, health ministry data showed.

“There is a high-level expert body going into all aspects of vaccines,” Vardhan wrote on Twitter. “Our rough estimate and the target would be to receive and utilise 400 to 500 million doses covering (200 million-250 million) people by July 2021.”

Serum Institute of India and private companies have been teaming up with organizations from the Bill & Melinda Gates Foundation to U.S. drug developer Novavax Inc in a scramble to secure vaccines for the country of 1.3 billion people.

India has set up committees to look into various aspects of the vaccine supply chain, including availability timelines for various vaccines, while obtaining commitments from manufacturers to ensure the maximum doses are available, Vardhan said.

He said the federal government is committed to taking all measures to ensure “fair and equitable” distribution of vaccines once they are ready.

The South Asian nation, second only to the United States in caseload, has scope for higher infections as a large chunk of the population remains unexposed to the virus, a survey showed on Tuesday.

To prioritise the distribution of coronavirus vaccines, the health ministry aims to prepare a list of key personnel, such as frontline health workers, by the end of the month.

(Reporting by Nidhi Verma; Editing by William Mallard)

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Flu shot shortages in your areas? Record number of doses are on the way

October is prime time for flu vaccinations, and the U.S. and Europe are gearing up for what experts hope is high demand as countries seek to avoid a “twindemic” with COVID-19.

“There’s considerable concern as we enter the fall and winter months and into the flu season that we’ll have that dreaded overlap” of flu and the coronavirus, Dr. Anthony Fauci of the U.S. National Institutes of Health said Thursday. He got his own flu shot earlier this week.

A record number of flu vaccine doses are on the way, between 194 million and 198 million for the U.S. alone — seemingly plenty considering last year just under half of adults got vaccinated and there usually are leftovers.

Still, there’s no way to know how many will seek shots this year and some people occasionally are finding drugstores or clinics temporarily out of stock.

Related: The soreness many people feel after getting the flu shot is a sign the body is developing influenza-fighting antibodies.

Be patient: Flu vaccine ships gradually. Less than half has been distributed so far, and the CDC and manufacturers say more is in transit.

“This year I think everyone is wanting to get their vaccine and maybe wanting it earlier than usual,” Dr. Daniel Jernigan of the Centers for Disease Control and Prevention told The Associated Press. “If you’re not able to get your vaccination now, don’t get frustrated” but keep trying.

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Pharmaceutical giant Sanofi Pasteur, which is supplying nearly 250 million doses worldwide including 80 million for the U.S., says it has shipments staggered into November.

Vaccine maker Seqirus is exploring if it could squeeze out “a limited number of additional doses” to meet high demand, said spokeswoman Polina Miklush.

Brewing flu vaccine is time-consuming. Once production ends for the year, countries can’t simply order more — making for a stressful balancing act as they guess how many people will roll up their sleeves.

Germany usually buys 18 million to 19 million doses, and this year ordered more. As German Health Minister Jens Spahn put it: “If we manage, together, to get the flu vaccination rate so high that all 26 million doses are actually used, then I’d be a very happy health minister.”

Spain purchased extra doses in hopes of vaccinating far more older adults and pregnant women than usual, along with key workers in health facilities and nursing homes.

In contrast, Poland, which last year had 100,000 doses go unused, didn’t anticipate this fall’s high demand and is seeking more.

Related: Cold is easier to distinguish from flu and COVID-19, but symptoms of COVID-19 and the flu are very similar.

The good news: The same precautions that help stop spread of the coronavirus — wearing masks, avoiding crowds, washing your hands and keeping your distance — can help block influenza, too.

Winter just ended in the Southern Hemisphere and countries like South Africa, Australia, Argentina and Chile diagnosed hardly any flu thanks to COVID-19 restrictions