Regeneron and Roche announce their antibody cocktail reduced hospitalization or death from Covid-19 by 70% in a phase III trial, a Covid-19 test has for the first time received full FDA approval, and more.
- The Biden administration is concerned that Johnson & Johnson (J&J) will not be able to deliver its promised 20 million Covid-19 vaccines doses by the end of this month, three senior officials told Politico earlier this week. Currently, according to CDC, J&J has delivered just 4.25 million doses of its vaccine to states. However, a J&J spokesperson on Monday dismissed those concerns, saying the company "expect(s) to deliver 20 million single-shot vaccines by the end of March." In addition, FDA on Tuesday issued an emergency use authorization (EUA) for a Catalent Pharma plant, allowing the facility to produce and ship doses of J&J's vaccine—a development that according to Reuters should increase the United States' supply of J&J vaccines by 20% (Roubein/Banco, Politico, 3/23; Kopp, Roll Call, 3/23; Anderson, Becker's Hospital Review, 3/23; Knutson, Axios, 3/24; Erman/O'Donnell, Reuters, 3/23).
- Pfizer on Tuesday announced it has launched an early-stage trial of an oral antiviral therapy for Covid-19 that, if proven safe and effective, could potentially be prescribed to patients at the first sign of infection. Currently, Pfizer is aiming to enroll 60 healthy study participants in the trial to assess the safety of different doses; depending on those results, the company then plans to assess whether the therapy works safely for patients with Covid-19. The drug, which is known as a protease inhibitor, is also being assessed in a different clinical trial, launched in the fall, that aims to determine its safety as an intravenous treatment. "Together, the two (oral and intravenous candidates) have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs," Pfizer’s CMO Mikael Dolsten said (Chander, Reuters, 3/23; Hopkins, Wall Street Journal, 3/23).
- Regeneron and Roche on Tuesday announced its antibody cocktail of casirivimab and imdevimab has been found to cut hospitalization or death from Covid-19 by 70% compared with a placebo, according to a phase III trial of 4,567 participants. According to the trial, both a lower and higher dosage of the drug proved effective, with just 1% of people on the lower dose requiring hospitalization or passing away, compared with 3.2% of those who received the placebo. Regeneron said it will seek FDA authorization for a lower dose of the drug as it proved similarly effective to a higher dose (Shields/Miller, Reuters, 3/23; Walker, Wall Street Journal, 3/23).
- FDA last week fully approved the Covid-19 test developed by BioFire Diagnostics, the first Covid-19 test to receive full approval from the agency. As of now, all other Covid-19 tests have received EUAs, meaning they will no longer be permitted to be used once Covid-19 is no longer categorized as a public health emergency. The BioFire test is approved only for symptomatic people who are suspected to have Covid-19 or some other respiratory tract infection (Anderson, Becker's Hospital Review, 3/18).
- Pregnant women who receive a Covid-19 vaccine may be able to pass along protective antibodies against the novel coronavirus to their babies both before and after giving birth, according to several preliminary studies. One study that has yet to be peer-reviewed looked at 130 vaccinated women, 84 of whom were pregnant and 31 of whom were lactating, and found their immune responses to the vaccine were similar to those of nonpregnant women. The study also found that 10 women who gave birth during the study all had detectable amounts of coronavirus antibodies in their cord blood, and almost all of the lactating women had antibodies present in their breastmilk. According to Brenna Hughes, vice chair for obstetrics and quality at Duke University, that study and several other not yet peer-reviewed papers are among "the first to show what we had hoped would be true, which is that these vaccines could be potentially protective through antibodies passed on to the fetus" (Bever, Washington Post, 3/22).