Paxlovid goes generic — and global

The people and politics driving global health.

Mar 17, 2022 View in browser   By Daniel Payne THE BIG IDEA Ground crew transport a shipment containing the first batches of Pfizer's antiviral COVID-19 pill, Paxlovid, at a cargo terminal at the Incheon International Airport, west of Seoul, South Korea, on Thursday, Jan. 13, 2022. South Korea will begin manufacturing the drug itself under the new licensing agreement. | Jung Yeon-je/Pool photo via AP PAXLOVID UNLEASHED — Today, the UN-backed Medicines Patent Pool is expected to announce an agreement with 35 companies to manufacture a generic version of Paxlovid, the organization's officials told Global Pulse. The increased manufacturing through the MPP — which works to expand medical access through tech transfers and licensing — will help supply the promising Covid-19 therapeutic in 95 low- and middle-income countries, some of which are at the most risk for Covid-19 because of low vaccination rates and fragile health care infrastructure. Manufacturing will span 12 countries through the deal. India, China, Mexico, Brazil and Korea are home to the companies that have demonstrated the ability to produce quality products at capacity with regulatory compliance, the MPP said in a statement — as are Bangladesh, the Dominican Republic, Jordan, Israel, Pakistan, Serbia and Vietnam. A company in Ukraine was also offered a license, which will remain available even though the conflict has left them unable to participate. The generic drug, known as nirmatrelvir, has been found to reduce the risk of hospitalization or death by nearly 90 percent when taken with a low dose of ritonavir — a result particularly significant for countries that have had difficulty in boosting their vaccination rates. The announcement fulfills an agreement Pfizer, which created Paxlovid, made in November with the MPP, which promised royalty-free licensing through the pandemic. After the pandemic, middle-income countries will be subject to a 5 to 10 percent royalty — but low-income countries will not. The announcement is the latest development in governments, companies and health organizations deliberating how to increase fair access to — and manufacturing capabilities for — vaccines and treatments, especially those that fight Covid-19. The 35 companies that signed sublicenses to produce generic Paxlovid — 15 of which are signing their first agreement with the MPP — could bring the lifesaving drug to far more people around the world and also continue the trend of decentralizing key product manufacturings. Also new this morning on the global health equity front — The Biden administration wants the WHO to push vaccine manufacturers to voluntarily share more products and technology, POLITICO's Erin Banco reports. In an HHS document obtained by POLITICO, administration officials were coordinating with a WHO working group to improve access to vaccines and therapeutics through a global agreement. The U.S. would promote and facilitate voluntary licensing agreements for those products as well as work to increase manufacturing capacities around the world. "Identifying opportunities to promote equity in the response to health emergencies is a policy priority for the United States," the paper reads. "We … must consider how to tailor approaches to address underlying issues necessary to enhance equity in preparing for and responding to the next pandemic …" WELCOME TO GLOBAL PULSE WELCOME BACK TO GLOBAL PULSE, where we want to know what you think about making daylight saving time permanent. The Senate thinks it's a good idea, but some dissenters remain. Send your time zone opinions — and tips — to dpayne@politico.com. Global Pulse is a team effort. Thanks to editors Eli Reyes and Barbara Van Tine. Follow us on Twitter: @ErinBancoand @_daniel_payne.   SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.     BEYOND THE PANDEMIC GLOBAL HEALTH FUNDING GETS A BOOST — The omnibus package that President Joe Biden signed this week significantly boosts global health funding — the largest increase in years. For the first time, global health funding exceeds $10 billion, as measured by the Congressional Research Service. Most of the nearly $700 million increase in this year's budget comes from a massive bump in the Global Health Security budget, up from $190 million to $700 million. But some global health groups, still working to fight the pandemic and overcome public health setbacks connected to Covid-19, told Global Pulse they were disappointed to see their organizations' funding levels equal to last year's numbers — saying they thought this would be a key moment to increase investments across the board. Other groups, though, were happy to see levels remain stable from last year and are setting their sites on the next funding package: one to tackle the pandemic. Covid-19 funding delays impact global vaccinations — That package is still in the works, and the White House is warning there will be significant consequences both domestically and internationally without quick passage. Around the world, that could mean the U.S. would play a smaller role in donating and distributing Covid vaccines — as well as tests, therapeutics, oxygen and other medical aid, senior administration officials said. Plans to extend Global VAX surge support, which focus on last-mile vaccine delivery challenges, would be on hold for 20 or more countries. NOT OVER YET — The WHO, amid Covid-19 testing and sequencing "dropping substantially" around the world, is pleading with countries to not give up on fighting the pandemic. At a press conference, officials said many countries are seeing more protection from vaccines and therapeutics, but many others are still at high Covid-19 risk — and continuing surveillance on shifting variants remains important for the world. Omicron cases still make up almost all recorded tests, they said, with the BA.2 subvariant making up most of those cases. "The pandemic is not over," WHO Director-General Tedros Adhanom Ghebreyesus said. "I repeat: The pandemic is not over." In Ukraine, the WHO said supply lines have been established to many cities, but aid workers still have access problems. One hundred metric tons of supplies have been delivered in the country, and another 108 metric tons of deliveries are being planned — along with the deployment of 20 teams of health experts. Officials said that 43 attacks on health care workers, facilities and vehicles in Ukraine have now been verified. GLOBAL PULSE NUMBER 75 percent The approximate percentage of worldwide Covid-19 cases that are omicron subvariant BA.2, according to WHO surveillance over the last 30 days. AROUND THE WORLD A COMPROMISE ON VACCINE IP — The EU, South Africa, India and the U.S. have reached a compromise on intellectual property rights for Covid-19 vaccines, POLITICO Europe's Ashleigh Furlong first reported. According to a document obtained by POLITICO, developing countries that have exported less than 10 percent of the world's coronavirus vaccine doses in 2021 would be able to authorize the use of a patented coronavirus vaccine without the patent owner's consent. While officials said details have yet to be worked out, including the agreement's final text, this could mean the end of an 18-month deadlock on how intellectual property should be handled through the pandemic. Some business representatives oppose such a move. The U.S. Chamber of Commerce told Global Pulse a waiver distracted from the "real issues" preventing vaccinations, like logistics challenges, adding that those agreements could undermine tech transfers already underway. Several public health advocates, though, argued that an intellectual property agreement should have been completed months ago, which could have increased access to shots and saved lives. They also pointed to the need to include therapeutics, not just vaccines. U.K. DROPS TRAVEL MEASURES — The U.K. will drop any remaining international Covid-19 measures, including testing requirements, this week. After the transportation secretary announced the update, Heathrow Airport said masking would no longer be mandatory — though still encouraged. Virgin Atlantic and British Airways signaled they would begin to drop mandates as well, in accordance with the policies of destination and departure locations. NYC'S HEALTH DEPARTMENT WADES INTO GLOBAL HEALTH ADVOCACY — In a full-page ad in last Sunday's New York Times, the New York City Department of Health and Mental Hygiene presented a letter pleading with G-20 countries to boost global vaccination efforts. New York City's department was one of eight health authorities that signed the letter, with officials saying local leaders needed to lend their voices to promoting equity.   DON'T MISS POLITICO'S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE.     WHAT WE'RE CLICKING Nature: Covid's true death toll: much higher than official records The Wall Street Journal: Lockdowns spread across China as race to contain Covid-19 outbreak intensifies The Associated Press: Inside Mariupol's devastation: AP journalists document war's toll   Follow us

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