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Leaders of the U.S. Senate Foreign Relations Committee acted last week to strengthen America’s leadership on global health security by introducing the International Pandemic Preparedness and COVID-19 Response Act of 2021. Among many important elements, the bill includes authorization of U.S. participation in the Coalition for Epidemic Preparedness Innovations (CEPI), an authorization passed by the House in the previous Congress. The legislation also reiterates congressional intent for the U.S. Agency for International Development (USAID) to make an “immediate contribution” of $300 million to CEPI from funding allocated for that purpose in the American Rescue Plan Act (ARPA) passed in March.Overall, ARPA allocated a total of $905 million to USAID for pandemic-related global health activities. Congress stipulated that the funding include “a contribution to a multilateral vaccine development partnership to support epidemic preparedness”—a clear nod to CEPI. After two months passed without an allocation to CEPI, several lawmakers followed up in May with a letter specifically calling on the administration to expediently allocate $300 million to CEPI for work directly related to the “immediate phase of the COVID-19 response.” Yet today, nearly four months after APRA’s passage and with fresh legislative evidence of congressional intent, CEPI has yet to receive the funding.Jamie Bay Nishi, Director of the Global Health Technologies Coalition, said:“While today, much attention is rightly focused on procuring more vaccine doses for low-income countries, funding for CEPI’s research is also critical for successfully using vaccines to end the pandemic. That includes currently underfunded work to identify and assess threats from disease variants; validate two-dose regimens that ‘mix and match’ vaccines from different manufacturers; and develop innovative approaches for providing immunizations in low-resource settings.Congress has made it clear that CEPI is a priority for fighting this stubbornly resilient and adaptable disease. The International Pandemic Preparedness and COVID-19 Response Act introduced in the Senate follows House action last Congress to specifically authorize U.S. participation in CEPI. And it goes further, specifying that it is the sense of Congress that CEPI receive an “immediate contribution” of $300 million from the ARPA funding to expand research and development of vaccines that can combat the spread of COVID-19 variants.We applaud the Biden administration for taking a more active role in fighting for vaccine equity. Now they should follow the intent of Congress by providing CEPI the funding it needs—and which Congress has clearly appropriated—to pursue research and innovations that will ensure effective COVID-19 vaccines can reach every corner of the world.”

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Novavax’s COVID-19 vaccine showed 90 percent efficacy in preventing laboratory-confirmed symptomatic infection among adults aged 18 and older, according to phase 3 trial results released last week. The vaccine was also 91 percent protective in high-risk populations, 93 percent protective against variants of concern and variants of interest, and completely protective against hospitalization and death due to COVID-19. The recombinant protein vaccine is given in two doses, three weeks apart, and can be stored at refrigerator temperatures. Novavax plans to file for authorization with several drug regulators, including the US Food and Drug Administration (FDA), in the third quarter and expects to be able to produce 100 million doses a month by the end of that quarter followed by 150 million per month by the end of the year. Novavax also has an agreement with Gavi, the Vaccine Alliance, to deliver 1.1 billion doses of its vaccine, once authorized, to the COVAX vaccine-sharing facility.In new data from the UK Recovery Trial, Regeneron’s antibody cocktail reduced the chance of death among hospitalized COVID-19 patients who haven't produced their own antibody responses to the disease. The study showed REGEN-COV reduced risk of death by 20 percent among seronegative participants, or those who produced no natural antibody response, while for patients who had developed antibodies, the treatment didn't work at all. Among the seronegative group, the treatment also reduced the average hospital stay by four days and decreased the chance of a patient requiring a ventilator. REGEN-COV received emergency use authorization from the FDA late last year for patients with mild to moderate COVID-19 and recently received an expanded green light for a lower dose and delivery by subcutaneous injection. Regeneron now intends to take the new data to the FDA for expansion to use in seronegative hospitalized patients.CureVac’s two-dose mRNA COVID-19 vaccine was 47 percent effective against COVID-19 disease of any severity among participants in a 40,000-person trial, interim analysis shows. The broad diversity of variants makes it challenging to demonstrate high efficacy, according to a statement from CureVac’s chief executive—13 variants were recorded in the trial, with only a single case caused by the original SARS-CoV-2 virus. More than half of the cases were infections with variants of concern. The trial, conducted in ten countries in Latin America and Europe, will continue, and final data is expected in the coming weeks. The CureVac vaccine is of most importance to the European Union, which has preordered 225 million doses, with the option to buy 180 million more.