December, 22 2021, 03:36pm EDT

For Immediate Release
Contact:
Tim Shenk
Press Officer
Direct: 212-763-5764
E-mail: tim.shenk@newyork.msf.org
MSF Responds to FDA Approval of COVID-19 Treatment Nirmatrelvir/Ritonavir
WASHINGTON
The US Food and Drug Administration (FDA) today gave emergency use authorisation (EUA) for the oral antiviral candidate nirmatrelvir (PF-07321332) in combination with ritonavir, produced by the US pharmaceutical corporation Pfizer, for the early treatment of people with mild to moderate COVID-19 who are at increased risk of developing severe disease. With vaccination rates lagging behind in many parts of the world, people are left unprotected against COVID-19 and access to recommended, easy-to-administer medicines is critical. However, as with COVID-19 vaccines, high-income countries are tying up the available supply of nirmatrelvir/ritonavir through advance purchase agreements with Pfizer and leaving limited-to-no supply available in the near-term for low- and middle-income countries. As generic production of nirmatrelvir/ritonavir is only anticipated by the middle of next year, access for low- and middle-income countries is precarious.
Pricing is also expected to be a barrier to access. Pfizer, the only manufacturer currently producing this treatment, has still not disclosed a price for the antiviral though many countries continue to grapple with rising COVID-19 cases. The only indication of potential pricing of the medicine comes from a recently announced agreement with the US government for the purchase of 10 million treatment courses for US$5.29 billion - which amounts to around $529 per treatment course, an exorbitant price.
While Pfizer is expected to apply a 'tiered pricing' strategy for supplying low- and middle-income countries, this market segmentation could result in limited access for many middle-income countries. These same countries may also be excluded from an existing voluntary license, thus facing eventual patent barriers that block the entrance of more affordable generics. MSF highlighted this limitation in response to the recently announced voluntary license between Pfizer and the UN-backed Medicines Patent Pool on nirmatrelvir/ritonavir, which offers supply to only 95 countries by generic companies that take up the license, covering just 53% of the world's population and excluding many upper middle-income countries with manufacturing capacity, such as Argentina, Brazil, China, Malaysia and Thailand.
As there is no patent yet on nirmatrelvir and as ritonavir has been off patent since last year*, there is currently a window of opportunity for manufacturers, particularly in the countries excluded from the voluntary license, to establish generic production and supply domestically. Governments should reject patent applications on this life-saving medicine and use all possible measures to remove obstacles, including the use of compulsory licensing, to ensure no barriers for generic production globally. Generic companies in countries like Bangladesh and India are already developing generic versions of this drug, and other countries should follow suit.
Mihir Mankad, Senior Global Health Advocacy and Policy Advisor at MSF-USA:
"To tackle the global COVID-19 pandemic, there needs to be global access to COVID-19 medicines such as the now-FDA-approved antiviral treatment, nirmatrelvir/ritonavir, produced by Pfizer.
"Many low- and middle-income countries, including those in which MSF works, are grappling with overburdened healthcare systems and low rates of COVID-19 vaccination due to extreme inequity in global vaccine access and challenges to implement vaccination and potentially vaccine-evasive and/or more transmissible variants such as currently feared for Omicron. Easy-to-administer oral treatments could ease the burden on overwhelmed hospitals and other essential healthcare services, save lives, and serve as a key tool for health workers trying to manage this pandemic.
"We are deeply concerned by Pfizer's business-as-usual approach and rich countries' repeated hoarding of limited supplies, which may leave low- and middle-income countries with virtually no access to this treatment for at least the first half of 2022. Governments in low- and middle-income countries need to be in the driver's seat instead of companies, and should take immediate steps to ensure sufficient, timely and equitable access to nirmatrelvir/ritonavir. The global health priority must be to increase the supply of affordable treatments for all people in all countries--including by allowing the production and supply of lifesaving, affordable generic medicines for everyone who needs them.
"With patent applications still pending, countries should stand firm and refuse to grant any patents on nirmatrelvir/ritonavir, while generic companies should start preparing to produce the medicine without waiting for Pfizer's permission. If Pfizer is really interested in ensuring global access to this treatment, it should make clear that it will not stand in the way of generic production and competition anywhere, and refrain from imposing intellectual property barriers everywhere for the duration of pandemic.
"One additional way to ensure that everyone in need everywhere has access to COVID-19 therapeutics is for all governments to support the "TRIPS Waiver" proposed by India and South Africa at the World Trade Organization, which seeks to allow countries to remove all major intellectual property barriers in an effort to enable and expand broad global production of lifesaving COVID-19 medical tools."
Doctors Without Borders/Medecins Sans Frontieres (MSF) is an international medical humanitarian organization created by doctors and journalists in France in 1971. MSF's work is based on the humanitarian principles of medical ethics and impartiality. The organization is committed to bringing quality medical care to people caught in crisis regardless of race, religion, or political affiliation. MSF operates independently of any political, military, or religious agendas.
LATEST NEWS
Henry Kissinger Dies at 100 Without Facing Justice for His War Crimes
"A true tally will probably never be known of everyone who died so Kissinger could be national security adviser," wrote journalist Spencer Ackerman.
Nov 30, 2023
Henry Kissinger, the former diplomat whose efforts to prolong and expand the U.S. war on Southeast Asia and undermine democracy in Latin America and elsewhere took millions of lives, died Wednesday at 100 years old.
Treated like royalty in elite U.S. political circles until his death at his home in Connecticut, Kissinger—who served as secretary of state and national security adviser under Nixon and Ford—never faced justice for the secretive carpet bombing of Cambodia that he helped orchestrate, the overthrow of Chile's democratically elected president, or the murderous "dirty war" in Argentina that killed tens of thousands.
The scope of his crimes was so vast that he had to watch where he traveled, lest he be detained to face questioning for his role in assassinations, massacres, and violent military coups whose reverberations are still felt in the present.
"The covert justifications for illegally bombing Cambodia became the framework for the justifications of drone strikes and forever war. It's a perfect expression of American militarism's unbroken circle," historian Greg Grandin, author of "Kissinger's Shadow," toldThe Intercept earlier this year. Grandin has estimated that Kissinger was responsible for at least 3 million deaths.
Observers of Kissinger's impact have said it's difficult to convey the true extent of the destruction he inflicted across the globe.
In his obituary of Kissinger for Rolling Stone, journalist Spencer Ackerman wrote that "measuring purely by confirmed kills, the worst mass murderer ever executed by the United States was the white-supremacist terrorist Timothy McVeigh."
"McVeigh, who in his own psychotic way thought he was saving America, never remotely killed on the scale of Kissinger, the most revered American grand strategist of the second half of the 20th century," Ackerman continued. "Every single person who died in Vietnam between autumn 1968 and the Fall of Saigon—and all who died in Laos and Cambodia, where Nixon and Kissinger secretly expanded the war within months of taking office, as well as all who died in the aftermath, like the Cambodian genocide their destabilization set into motion—died because of Henry Kissinger."
"We will never know what might have been, the question Kissinger's apologists, and those in the U.S. foreign policy elite who imagine themselves standing in Kissinger's shoes, insist upon when explaining away his crimes," he added. "We can only know what actually happened. What actually happened was that Kissinger materially sabotaged the only chance for an end to the war in 1968 as a hedged bet to ensure he would achieve power in Nixon's administration or Humphrey's. A true tally will probably never be known of everyone who died so Kissinger could be national security adviser."
Keep ReadingShow Less
Colorado District Passes First Green New Deal for Schools Resolution
"This is a project of our generation, and we're not gonna stop until every school across the country has a Green New Deal and the kind of schools we deserve," said a 16-year-old student.
Nov 29, 2023
Youth advocates with the Green New Deal for Schools campaign notched up their first victory on Tuesday when Colorado's Boulder Valley School District Board of Trustees unanimously approved a resolution drafted by students at Fairview High School.
"This is a project of our generation, and we're not gonna stop until every school across the country has a Green New Deal and the kind of schools we deserve," said 16-year-old Emma Weber, a student leader in the district. "The Green New Deal for Schools is the kind of action and urgency that we need in order to address the climate crisis and prepare students to live with the realities of it."
The Daily Camerareported that the board's president, Kathy Gebhardt, "urged the students to take their advocacy beyond Boulder Valley to local governments and the state Legislature, saying most school districts in the state are struggling to pay teachers and don't have the resources to add solar panels or buy electric buses."
Colorado Public Radio on Tuesday laid out the long history of such policies in the district, which serves over 30,000 students:
Resolutions on the environment go back to 1978. In 2009, BVSD created a sustainability action plan, with updates in later years with a long-term goal of reducing greenhouse gases by 80% and also committed to a goal of zero net energy by 2050. It was one of the first school districts in the nation to make such a commitment.
As a part of its efforts to track carbon and lower emissions, the district has increased the number of buildings with renewable energy, purchased 19 electric buses, reduced greenhouse gas emissions by a quarter, reduced water consumption by 11% in three years, and hit a target of diverting 50% of waste from landfills. BVSD has already become a leader in providing locally sourced lunch to students.
"The students' resolution asks the district to continue and amplify efforts toward reducing carbon emissions, asking for all school buildings and buses to run on renewable energy," CPR added. "By 2026, they want a comprehensive curriculum for all students in all grades to develop sustainability knowledge and behaviors, including information on how climate change affects communities differently."
The Sunrise Movement—which is behind the national Green New Deal for Schools campaign—said on social media that the resolution also commits the district to "pathways to green union jobs for students, and increased collaboration with local, state, and federal agencies to strengthen responses to climate disasters."
With the resolution, the board is also asking U.S. President Joe Biden—who plans to skip COP28, the United Nations climate summit beginning this week—and Congress "to support the Green New Deal for Public Schools Act, reinforcing the call for a nationwide commitment to an education that prepares our generation to navigate the realities of the climate crisis," according to Sunrise.
Spearheaded by U.S. Sen. Ed Markey (D-Mass.) and Rep. Jamaal Bowman (D-N.Y.), a former educator and principal, the legislation would invest $1.6 trillion to transform the country's education system while "creating 1.3 million jobs and eliminating 78 million metric tons of carbon emissions" over a decade.
While the win in Colorado was a first for the campaign, Sunrise and students across the United States are pushing for more. The group noted Wednesday that young people in dozens of districts—from Bozeman, Montana to Philadelphia, Pennsylvania—have recently testified at school board meetings and attended daylong trainings in cities including Chicago, Illinois; Detroit, Michigan; and Washington D.C.
"Shoutout to the incredible students and their tireless advocacy that led to the Green New Deal for Schools resolution, which passed the Boulder Valley school board this week!" Bowman said Wednesday on social media. "Thank you for your incredible work. Now let's make this happen everywhere!"
Keep ReadingShow Less
'Huge Win for the Planet' as Panama Court Shuts Down Massive Mine
"The people have spoken and expressed that they don't want more mines, that they want sustainable economic development, and have no intention of destroying the country for profit," said one campaigner.
Nov 29, 2023
Indigenous and environmental campaigners this week hailed a landmark win for the Rights of Nature movement, the Panamanian Supreme Court's unanimous ruling that the contract for the Cobré mineral mine—one of the world's largest—is unconstitutional and must be shut down.
The November 24 ruling against Minera Panamá, a subsidiary of the Canadian company First Quantum Minerals, followed weeks of nationwide protests against the open-pit mine, which began operations in 2019 and where mainly copper, but also gold, silver, and molybdenum, are extracted. Opponents say the mine threatens area water supplies. A gunman shot and killed two people at a protest against the mine earlier this month.
Last year, the Cobré mine produced over 86,000 tons of copper, approximately 1% of the world's total production, 5% of Panama's gross domestic product, and 75% of the Central American country's export revenue. More than 2% of Panama's workforce is employed at the mine.
Cobré—which is located in a biodiverse area on Panama's Caribbean coast—will now shut down as a result of the ruling.
"The Panamanian people have spoken," Kherson Ruiz, executive director of the London-based Sustainable Development Foundation, toldMongabay. "The people have spoken and expressed that they don't want more mines, that they want sustainable economic development and have no intention of destroying the country for profit."
Referring to his introduction of Panama's Rights of Nature law, Juan Diego Vásquez Gutiérrez, an independent—and, at age 27, the youngest—member of Panama's National Assembly, said Wednesday that "I am very happy to have been part of a fundamental legal instrument to end the metal mining industry in the country."
"This is one of many tangible effects that we must repeat in defense of the environment thanks to legislation like this," Vásquez added.
Rengifo Navas Revilla, secretary of the National Coordinator of Indigenous Peoples of Panama, said in a statement that "when all this nature is contaminated, we all die."
"Even the planet itself, even Mother Earth herself, dies," he added. "This is the principle that has been instilled in us and that is why we continue to fight."
Since Ecuador became the first country to constitutionally enshrine the Rights of Nature in 2008, more than 30 nations have taken similar actions to protect their environment.
The advocacy groups Leatherback Project and Earth Law Center noted Wednesday that the Panamanian ruling "comes after a similar blocking of a copper mine earlier this year in Ecuador, where a provincial court ruled a mining project violated the constitutional Rights of Nature in the Intag Valley of the tropical Andes."
Constanza Prieto Figelist, Latin America legal director at Earth Law Center—which provided input and expertise on the Rights of Nature as the law was being drafted—said of the Panama ruling that "this case demonstrates that under a Rights of Nature framework, governments must give stronger consideration to the health and intrinsic value of nature when overseeing mining and other activities, elevating the interests of species and ecosystems to a higher status alongside human interests."
"The case also shows that the Rights of Nature can be an effective tool to protect the environment where traditional laws might fall short," she added. "We hope this will inspire other governments to give nature a formal voice and rights in the legal system, as Panama did."
Keep ReadingShow Less
Most Popular