Virus World

The Bill & Melinda Gates Foundation is committing up to $120 million to accelerate production of generic versions of Merck's Covid-19 drug. A s concern mounts over access to Covid-19 remedies, the Bill & Melinda Gates Foundation is committing up to $120 million to accelerate production of generic versions of an experimental Merck (MRK) pill to treat Covid-19 that would be available to dozens of low-income countries. But the effort was greeted with mixed reactions by patient advocates. The Gates Foundation plans to provide different types of incentives so that eight generic manufacturers, all of which have already signed voluntary licensing deals with Merck, will be positioned to produce a sufficient quantity of the drug, called molnupiravir, as quickly as possible. The goal is to convince the generic companies to ready their facilities rather than wait to gauge demand for the pill — which early data suggests could reduce hospitalizations and deaths — before ramping up. “They have the capacity. They can do this,” Trevor Mundel, president of global health at the Gates Foundation. “This is an incentive for them to do it earlier rather than wait to see what the market is like… They want to see (if there will be) enough volume. They (may) want to see who will pay at the end of the day. We don’t want to them to wait.”  Notably, the Gates Foundation will offer volume guarantees over a specified period of time, so the generic manufacturers have confidence their production investments will return acceptable profit margins. So far, the foundation has also awarded $2.4 million in grants to help the generic companies more quickly apply to the World Health Organization for manufacturing prequalification.

As of now, the Gates Foundation has agreed to provide up to approximately $1.9 billion to underwrite various efforts to combat Covid-19. These include the COVAX vaccine distribution program – which is overseen by the WHO, the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations – and guarantees to support at-risk manufacturing of monoclonal antibody treatments for low- and middle-income countries.  This latest move comes after Merck reached a deal with large generic makers such as Cipla, Dr. Reddy’s Laboratories, and Sun Pharmaceuticals to supply its pill to more than 100 low-to-middle-income countries. For the moment, though, it is not clear how many pills each company will produce, the production costs the companies will incur, or the pricing. The Merck pill has generated excitement because top-line study results indicated it reduced both hospitalization and death compared to a placebo by 50%. In the placebo group, 53 patients, or 14.1%, were hospitalized or died. For those who received the drug, 28, or 7.3%, were hospitalized or died. The data from the study were made public in a press release and have not yet been peer-reviewed. The findings set off another wave of anxiety, however, over inequitable access to Covid-19 medical products. Last year, wealthy countries quickly reached deals with vaccine makers, leaving low and middle-income countries to largely rely on the World Health Organization to organize programs to purchase and distribute vaccines. So far, the effort has fallen short.

As a result, there has been consistent pressure on the vaccine makers to share their intellectual property and other know-how so that generic manufacturers could more readily produce Covid-19 vaccines and make them available at lower costs to poorer countries. Pope Francis, for instance, urged the vaccine makers to do so in remarks earlier this week. By striking the voluntary licensing agreements, Merck is hoping to avoid a similar fate. But the company, which developed the pill along with Ridgeback Biotherapeutics, has not indicated any plans to share its intellectual property. However, Merck has said it is in discussions with the Medicines Patent Pool, a United Nations-sponsored organization, to explore the potential for additional licenses. Consequently, the specter of inequitable access has surfaced. ‘While any initiative to accelerate production and access, especially on the African continent and low income countries, is welcome, the Gates Foundation investment is incomplete. Vaccine and treatment apartheid affect all low and middle-income countries today due to intellectual property barriers,” said Rohit Malpani, a former director of policy and analysis at Doctors Without Borders and now a board member at UNITAID, which backs the Medicines Patent Pool. “It is necessary also to tackle these patent barriers to ensure access to these medicines. The Gates Foundation should be throwing it’s considerable power and influence behind a waiver of intellectual property rules at the World Trade Organization, as well as pressuring Merck to expand the voluntary license to include all countries.” The concern has been further fueled by uncertainty over pricing. The U.S. government signed a $1.2 billion deal to purchase 1.7 million doses. That works out to a $712 unit cost for a five-day treatment course, according to the contract. The company has indicated there are plans to produce 10 million doses by the end of this year and 20 million doses in 2022......

Philanthropist and Microsoft cofounder Bill Gates offers insights into the COVID-19 pandemic, discussing why testing and self-isolation are essential, which medical advancements show promise, and what it will take for the world to endure this crisis (Recorded March 24, 2020)

The Bill & Melinda Gates Foundation, Wellcome, and Mastercard today committed up to $125 million in seed funding to speed-up the response to the COVID-19 epidemic by identifying, assessing, developing, and scaling-up treatments. The partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer-term. Currently there are no broad-spectrum antivirals or immunotherapies available for the fight against emerging pathogens, and none approved for use on COVID-19.

The Gates Foundation and Wellcome are each contributing up to $50 million, and the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator. The Gates Foundation’s funding is part of its up to $100 million commitment to the COVID-19 response announced last month. “Viruses like COVID-19 spread rapidly, but the development of vaccines and treatments to stop them moves slowly,” said Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation. “If we want to make the world safe from outbreaks like COVID-19, particularly for those most vulnerable, then we need to find a way to make research and development move faster. That requires governments, private enterprise, and philanthropic organizations to act quickly to fund R&D.”

The COVID-19 Therapeutics Accelerator will work with the World Health Organization, government and private sector funders and organizations, as well as the global regulatory and policy-setting institutions. The Accelerator will have an end-to-end focus, from drug pipeline development through manufacturing and scale-up. By sharing research, coordinating investments, and pooling resources, these efforts can help to accelerate research. This kind of collaboration was a key lesson from the 2014 Ebola outbreak. By providing fast and flexible funding at key stages of the development process, the Accelerator will de-risk the pathway for new drugs and biologics for COVID-19 and future epidemic threats, ensuring access in lower-resource countries....

The program allows people in the Seattle area to easily take a coronavirus test at home. Researchers say such testing is essential for future monitoring of the virus. An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.

The program involved sending home test kits to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns. Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases. But the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.

“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the F.D.A. wrote in a memo. The delay is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up. Amid concerns about the reliability of a burgeoning number of coronavirus antibody tests — which check whether someone may have previously had the virus — the F.D.A. responded last week by ordering companies to submit data proving the tests’ accuracy. But the Seattle program does not test for antibodies and has wide backing, including from public health leaders, the Fred Hutchinson Cancer Research Center and Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.

Testing for the novel coronavirus in the Seattle area will get a huge boost in the coming weeks as a project funded by Bill Gates and his foundation begins offering home-testing kits that will allow people who fearthey may be infected to swab their noses and send the samples back for analysis.

Results, which should be available in one to two days, will be shared with local health officials who will notify those who test positive. Via online forms, infected people can answer questions about their movements and contacts, making it easier for health officials to locate others who may need to be tested or quarantined, as well as to track the virus’ spread and identify possible hot spots. The goal is to eventually be able to process thousands of tests a day, said Scott Dowell, leader of coronavirus response at the Bill & Melinda Gates Foundation. The project is ramping up as quickly as possible, but it’s not clear exactly when it will launch, he added. Among other things, software needs to be upgraded to handle the expected crush of requests, and a detailed questionnaire finalized for people who request tests. 

“Although there’s a lot to be worked out, this has enormous potential to turn the tide of the epidemic,” Dowell said. While Public Health – Seattle & King County has confirmed 71 cases and 15 deaths as of Saturday,  modeling by Trevor Bedford, a computational biologist at Fred Hutchinson Cancer Research Center, estimated on Wednesday that the actual number of cases in the Seattle area was about 600. Unchecked, that could theoretically increase to 12,000 cases – and possibly as many as 30,000 – by the end of March, according to projections from Mike Famulare at the Institute for Disease Modeling in Bellevue. But steps to slow transmission can significantly reduce the number of new infections, underscoring the importance of acting quickly to protect people from the virus. The new effort aims to leverage the formidable resources and expertise of the Gates Foundation, known for fighting disease and epidemics around the globe, to assist local health agencies struggling to keep up with a fast-moving outbreak.....

The National Institutes of Health and the Bill and Melinda Gates Foundation will together invest at least $200 million over the next four years to develop gene-based cures for sickle cell disease and HIV with an attribute even rarer in the world of genetic medicine than efficacy, the groups announced on Wednesday: The cures, they vowed, will be affordable and available in the resource-poor countries hit hardest by the two diseases, particularly in Africa.

The effort reflects growing concerns that scientific advances in genetic medicine, both traditional gene therapies and genome-editing approaches such as CRISPR, are and will continue to be prohibitively expensive and therefore beyond the reach of the vast majority of patients. Spark Therapeutics’ Luxturna, a gene therapy for a rare form of blindness, costs $425,000 per eye, for instance, and genetically engineered T cells (CAR-Ts) to treat some blood cancers cost about the same.  With CRISPR-based treatments already being tested in clinical trials for sickle cell disease, the blood disorder beta thalassemia, and another form of blindness, and with additional CRISPR treatments in development, scientists, ethicists, and health policy experts have grown increasingly concerned that the divide between haves and have-nots will grow ever-wider.

Gene-based treatments “are largely inaccessible to most of the world by virtue of the complexity and cost of treatment requirements, which currently limit their administration to hospitals in wealthy countries,” the NIH said in a statement. To help right that, its collaboration with the Gates Foundation aims to develop “curative therapies that can be delivered safely, effectively and affordably in low-resource settings.” Scientists whose research focuses on gene-based cures welcomed the infusion of funding and the recognition that genetic cures are on track to be unaffordable to the majority of patients. But they noted one irony. The most effective sickle cell drug, hydroxyurea, has hardly even been studied in sub-Saharan Africa, let alone made widely available. Yet a 2019 study found that giving children the drug cut their death rate by two-thirds and halved the pain crises that are common in sickle cell disease, caused by misshapen red blood cells that cannot flow through blood vessels. The NIH-Gates collaboration “is tremendously exciting and has the potential to have a great impact on sickle cell disease in sub-Saharan Africa,” said Dr. Vijay Sankaran of the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, who has done pioneering research on genetic cures for the disease. “But my hesitation is that even the inexpensive therapies we have today, such as hydroxyurea, are largely unavailable there. The question is, how do we best approach this disease, with therapies that are working today or with genetic therapies that might work?”...