Safety Concerns Disrupt Regeneron’s Trial Of COVID Antibody Therapy

AP: 2nd Study Testing A COVID-19 Antibody Drug Has A Setback
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 Wall Street Journal: Trial Of Regeneron’s Covid-19 Antibody Drug Is Halted In Sickest Hospital Patients
The moves don’t 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 —

AP: Trump Admin Funds Plasma Company Based In Owner's Condo
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’s “manufacturing facilities” 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)

Reuters: Russian Firm Seeks To Produce COVID-19 Drug Without Patent, Vedomosti Reports
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 а 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’s director, Vikram Punia, had told Reuters this year. (11/2)

More on the vaccine race —

Bloomberg: CureVac Covid Vaccine Shows Immune Response In Early Trial
A coronavirus vaccine under development from CureVac NV showed a good immune response in early trials, validating the biotech company’s 20 years of research into messenger RNA’s ability to train the body’s defenses. (Ring, 11/2)

Modern Healthcare: HHS Says Providers Can Use COVID-19 Relief Grants For Vaccine Distribution
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)

NPR: Who Should Get The COVID-19 Vaccine First? CDC Advisory Group Mulls Strategy
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 — 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)

Modern Healthcare: Trump Admin To Provide Vaccine Supply Kits For Providers
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.