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Gilead Drug Shows Promising Results In Treating COVID, Ready For Distribution Says CEO

KEY POINTS

  • Gilead’s coronavirus treatment redemsivir was found to reduce recovery time in patients by several days
  • Redemsivir and other drug treatments could serve as stopgap measures until a proper vaccine is ready and approved
  • The Trump administration and Congress re-entered negotiations about a stimulus package to help a U.S. economy hit hard by the pandemic

Final results from Gilead Sciences’ latest remdesivir trial showed the antiviral drug was effective in treating coronavirus patients and cutting recovery time by at least a week.

Gilead’s CEO said, given the positive results, the company was ready for mass production and distribution of the drug.

As of Friday, Johns Hopkins said the U.S. has over 7.6 million confirmed cases of coronavirus and 212,805 reported deaths from it. The latest trial was conducted for nearly a month and involved over 1,062 patients hospitalized for coronavirus. Half of the patients were given remdesivir while the other half were given placebo as part of the randomized, double-blind trial. Trial sites were located in the U.S., United Kingdom, Denmark, Mexico, Japan, Germany, Greece, Korea, Spain, and Singapore.

Average recovery time for people given remdesivir was found to be shortened by five days. While overall data showed the drug was not significant in reducing mortality, it appeared effective in lowering the mortality rate among patients on oxygen.

“Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection,” the final report in the New England Journal of Medicine said.

Gilead CEO Daniel O’Day said the company was pleased with the results and ready for distribution, if and when the drug is approved.

“These results are meaningful,” O’Day told CNBC. “They’ll definitely help patients around the world who have the misfortune of entering the hospital to get better, and I’m really pleased to say that we have ample supply.”

Former Food and Drug Administration Commissioner Dr. Scott Gottlieb said while remdesivir, alone, is likely not enough to treat coronavirus, this data is a good sign in battling the pandemic.

“I think combined with the antibody drugs, which should be coming onto the market soon based on the data that we’ve seen, this is a pretty effective treatment regime in advance of a vaccine,” Gottlieb told CNBC.

While a drug like remdesivir, or the antibody treatment developed by Eli Lilly, serve as a stopgap means of addressing coronavirus, a vaccine will still be needed to serve as a long-term answer. The hope is that a vaccine will be approved and ready for distribution by the end of December, with timetables having life get back to some degree of normalcy by summer 2021.

Some of the vaccines furthest along include:

  • Moderna and the National Institute of Health’s mRNA vaccine, currently in Phase 3 trials
  • China’s CanSino Biologics and Russia’s Gamaleya Research Institute have vaccines in limited approval, though experts warned these were likely rushed and could still be harmful
  • AstraZeneca and the

China joins WHO’s plan for global distribution of COVID-19 vaccine

Oct. 9 (UPI) — China on Friday said it has joined a World Health Organization-led initiative that aims to manufacture and provide equitable access to a COVID-19 vaccine.

Hua Chunying, a spokeswoman for China’s foreign ministry, said the Asian nation signed an agreement with Gavi on Thursday to join COVAX, the vaccine pillar of the WHO’s Access to COVID-19 Tools Accelerator program.

Launched in April by the WHO, the ACT Accelerator aims to ramp up development, production and equitable distribution of COVID-19 tests, treatments and vaccines, and is co-led by the U.N. health body, Gavi and the Coalition for Epidemic Preparedness Innovations.

Hua did not state China’s financial contribution to the program but said it pledges to make domestically developed vaccines a public resource.

“This is an important step China has taken to uphold the concept of a shared community of health for all and to honor its commitment to turn COVID-19 vaccines into a global public good,” Hua said in a statement. “We are taking this concrete step to ensure equitable distribution of vaccines, especially to developing countries, and hope more capable countries will also join and support COVAX.”

As of Friday, more than 150 economies equalling nearly two-thirds of the world’s population have signed commitment agreements to the COVAX Facility in its effort to ensure low- and middle-income countries have equitable access to a vaccine when one is developed.

The United States, which has formally requested to leave the WHO, has declined to participate in the effort, as it accuses the U.N. health body of colluding with China in its efforts to cover up its initial outbreak of the virus late last year.

“We will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” Judd Deere, a spokesman for the White House, said early last month.

In late August, WHO Director-General Tedros Adhanom Ghebreyesus said more than 170 nations were in talks to join the program, explaining that the plan consists of delivering at least 2 billion doses of a COVID-19 vaccine by the end of next year with a global rollout to begin with those who are at the greatest risk.

“There is light at the end of the tunnel,” said Tedros, who has warned against so-called vaccine nationalism.

Gavi said Thursday it has raised roughly $1.8 billion, nearly reaching its goal of $2 billion by the end of this year for the program.

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Gilead Sciences resumes control of remdesivir distribution

Mannequins with face masks and designer clothing fill a window at a Diane Von Furstenberg store in New York City on September 8, 2020. Photo by John Angelillo/UPI | License Photo

Moderna Coronavirus Vaccine Won’t Be Ready For Distribution Until Spring 2021

KEY POINTS

  • Moderna’s candidate vaccine may not be ready for widespread distribution until next spring
  • The company CEO said they could get an approval by the early second quarter of 2021
  • Trump has repeatedly claimed a vaccine will be available to the general population in weeks

Biotech company and coronavirus vaccine frontrunner Moderna announced Tuesday that its vaccine candidate would not be ready for widespread distribution until next spring. 

In an interview with the Financial Times, Moderna CEO Stephane Bancel said the company is unlikely to seek emergency authorization from the U.S. Food and Drug Administration for frontline workers and at-risk individuals until Nov. 25, at the earliest. 

Bancel also spoke at a health conference on Wednesday, saying the drugmaker would not seek approval for use in the general population until late January 2021. If the vaccine is proven to be safe and effective, its approval could take until early April 2021. 

“I think a late first quarter, early second quarter approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said.

The timeline is a setback for the pharmaceutical company that announced earlier this month that it could seek authorization for its vaccine candidate as early as Nov. 1. It also deals a blow to President Donald Trump, whose administration has already purchased 100 million doses of the company’s experimental coronavirus vaccine at $15 per dose. 

During the first presidential debate on Tuesday, Trump claimed that a vaccine will be available for widespread distribution in December, despite a prediction from Robert Redfield, director of the Centers for Disease Control and Prevention, that it is unlikely a vaccine will be available until the second or third quarter of next year, CBS News reported.

“We’re weeks away from a vaccine,” the president said during Tuesday night’s debate. “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to — Moderna, Johnson & Johnson and others. They can go faster than that by a lot.”

Seven potential COVID-19 vaccine candidates are now undergoing late-stage testing, including Pfizer. In media appearances, the company’s chief executive Dr. Albert Bourla has repeatedly said that they expect a “conclusive readout” of their vaccine by October. He also said Pfizer is prepared to apply for emergency authorization, as reported by the New York Times. 

“Right now, our model — our best-case — predicts that we will have an answer by the end of October,” Bourla said. 

A US biotech firm Moderna has reported 'positive interim' results in early testing of a vaccine candidate A US biotech firm Moderna has reported ‘positive interim’ results in early testing of a vaccine candidate Photo: AFP / Thibault Savary

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Salesforce.com adapts its software for pandemic vaccine distribution

(Reuters) – Salesforce.com on Wednesday said it has adapted some of its business software to help healthcare organizations and government entities distribute vaccines for the novel coronavirus once they become available.

The San Francisco-based company said the offering, called Work.com for Vaccines, will help cities, states and health-care groups track vaccine inventory levels, create online appointment portals and track how patients fare after being vaccinated.

Multiple companies and nations around the world are racing to develop a vaccine to provide some degree of immunity to the coronavirus, which causes the disease COVID-19. The chief executive of GlaxoSmithKline, the world’s largest maker of vaccines, on Tuesday said she was optimistic the industry will be able to make vaccine widely available next year.

Salesforce.com’s efforts build on tools rolled out in May aimed at modifying the company’s business software to help governments make re-opening decisions based on public health data and carry out contact tracing and other tasks related to the pandemic.

The company said pricing of the new tools will be “based upon the unique requirements of each public agency or private healthcare organization.”

(Reporting by Stephen Nellis in San Francisco; Editing by Leslie Adler)

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