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Morning Briefing

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Monday, Nov 2 2020

Full Issue

Safety Concerns Disrupt Regeneron's Trial Of COVID Antibody Therapy

Regeneron paused testing its two-antibody drug combo on COVID-19 patients requiring oxygen, due to possible safety issues. Trials for less sick patients will continue.

For the second time, a study testing an experimental antibody drug for COVID-19 has been paused to investigate a possible safety issue in hospitalized patients. Regeneron Pharmaceuticals Inc. said Friday that independent monitors had recommended placing on hold enrollment of the most severely ill patients -- those who need intense oxygen treatment or breathing machines -- because of a potential safety problem and unfavorable balance of risks and benefits. (Marchione, 10/30)

The moves don鈥檛 affect other testing of the antibody drug, which proved in a separate trial to reduce virus levels and doctor visits. The drug is now up for authorization by the Food and Drug Administration, along with a similar drug from Eli Lilly & Co. The Regeneron study will continue enrolling hospitalized patients receiving low amounts of oxygen or no oxygen support, who tend to be less sick than those who require heavy oxygen or mechanical breathing assistance. The company said the risk-benefit for the less serious hospitalized patients remains acceptable. (Walker, 10/30)

And in other news about COVID treatments 鈥

When the Trump administration gave a well-connected Republican donor seed money to test a possible COVID-19-fighting blood plasma technology, it noted the company鈥檚 鈥渕anufacturing facilities鈥 in Charleston, South Carolina. Plasma Technologies LLC is indeed based in the stately waterfront city. But there are no manufacturing facilities. Instead, the company exists within the luxury condo of its majority owner, Eugene Zurlo. (Lardner and Dearen, 11/1)

Russian drugmaker Pharmasyntez has asked the Kremlin for permission to produce a generic version of U.S. firm Gilead Sciences's COVID-19 treatment remdesivir without 邪 patent, the Vedomosti newspaper reported on Monday. Siberia-based Pharmasyntez previously approached Gilead requesting a voluntary licence to produce and distribute the drug in Russia, the company鈥檚 director, Vikram Punia, had told Reuters this year. (11/2)

More on the vaccine race 鈥

A coronavirus vaccine under development from CureVac NV showed a good immune response in early trials, validating the biotech company鈥檚 20 years of research into messenger RNA鈥檚 ability to train the body鈥檚 defenses. (Ring, 11/2)

Healthcare providers that received COVID-19 relief grants can use the funds to pay for supplies needed for vaccine distribution, HHS said. The agency in recent weeks has issued guidance on what expenses and lost revenues healthcare providers can legally count toward the COVID-19 Provider Relief Fund grants they received beginning in April. Congress set aside $175 billion for provider grants, and HHS as continually updated guidance since the funds were issued. (Cohrs, 10/30)

States should be working toward being ready to give out COVID-19 vaccines by Nov. 15, according to a target date made public by the Centers for Disease Control and Prevention on Friday. That's an aspirational date so far 鈥 there is still no vaccine approved for use, and there may not be one until later this year or beyond. But, in preparation for that day, the CDC's Advisory Committee on Immunization Practices, a group composed mainly of doctors and public health experts outside of CDC, met virtually Friday and debated how best to distribute such a vaccine when it becomes available, weighing who would be in line to get it first. (Neel and Huang, 10/30)

The Trump administration will provide ancillary supply kits for healthcare workers to administer COVID-19 vaccines, HHS said Friday. McKesson Corporation will produce, store and distribute kits containing enough supplies to administer up to 100 vaccine doses. The kits will include needles, syringes, alcohol prep pads, surgical masks and face shields, vaccine record cards and a needle information card. McKesson will also make mixing kits available for vaccines that require reconstitution.

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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