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Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical advice for test developers preparing for the end of the public emergency.
When does an EUA declaration terminate?
EUAs for diagnostics to detect SARS-CoV-2
What happens when the EUA declaration expires?
Since the start of the coronavirus pandemic, the Food and Drug Administration (FDA) has issued almost 400 emergency use authorizations (EUAs) for molecular diagnostic tests, antibody tests, and antigen tests combined. As life returns to something approximating “normal,” many are wondering what happens to tests offered pursuant to EUAs once the public health emergency is terminated.
Science s COVID-19 reporting is supported by the Heising-Simons Foundation
The questions are urgent, and the funding is in place. But a highly anticipated, $130 million clinical trial, meant to test the efficacy of the novel messenger RNA (mRNA) vaccines for COVID-19 against a key variant of the pandemic coronavirus as well as in people living with HIV and pregnant women, is stalled. It is ready to launch in eight countries in sub-Saharan Africa, yet neither maker of the vaccines, Pfizer and Moderna, wants to participate or even provide their vaccines.
A group of prominent HIV advocates and activists in South Africa has written a letter complaining about the delay to U.S. government officials, including Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), which agreed to pay for the study. They stress that COVID-19 strikes people living with HIV especially hard, and that dangerous variants of SARS-CoV-2 evolve in them because many have
The Biden administration is poised to announce which countries will receive the first shipments of vaccines donated from the U.S. stockpile, amid the risk that more coronavirus variants will arise in countries lacking access to the shots, people familiar with the matter said.
Read more about Biden to begin Covid-19 vaccine donations abroad as variant threat looms on Business Standard. The White House, which has faced pressure from a range of countries to share its vaccines, has settled on its plan and an announcement is imminent, according to the people, who discussed the matter