Below we round up the latest news on efforts to combat the Covid-19 epidemic.
- The United Kingdom on Monday granted emergency approval to the Covid-19 vaccine developed by Pfizer and BioNTech, making Britain the first Western country to begin mass vaccinations against the novel coronavirus. The decision also makes the United Kingdom the first country worldwide to authorize a fully tested vaccine; while China and Russia have approved vaccines, they did so before Phase 3 trials were complete. According to the New York Times, Pfizer and BioNTech were packaging doses for shipment to the United Kingdom on Wednesday, with doctors and nurses in the country's National Health Service, nursing home employees, and adults age 80 and older with previously scheduled physician's appointments first in line to be vaccinated. The decision has put pressure on FDA to issue an authorization as well, the Times reports. U.S. regulators said they are independently reanalyzing clinical trial databases before issuing approval, whereas British and European regulators tend to rely on the companies' own analysis of trial data (Mueller, New York Times, 12/2; Herper, STAT News, 12/2).
- Moderna on Wednesday announced that it would soon start testing its novel coronavirus vaccine candidate among children ages 12 to 17. Specifically, the trial aims to enroll 3,000 children, half of whom will receive two vaccine shots 14 days apart and half of whom will receive placebo shots, according to a notice posted on clinicaltrials.gov. That said, the notice said the study had not started enrolling children, and a spokesperson for the company, Colleen Hussey, said it wasn't clear when the company would begin doing so. According to the New York Times, no vaccine can be "widely" administered to children until it has been tested among that age group (Grady, New York Times, 12/2).
- Officials with Operation Warp Speed on Wednesday told reporters that they plan to administer a coronavirus vaccine to 100 million people by the end of February—a number sufficient to include all health care workers and at-risk patient populations, FierceHealthcare reports. Moncef Slaoui, chief adviser to Operation Warp Speed, plans to have at least 20 million people vaccinated by the end of 2020, another 30 million people vaccinated in January, and another 50 million by the end of February. Slaoui said the goal is to have most Americans vaccinated by the middle of 2021. To meet those goals, the initiative plans to begin vaccine distribution within 24 hours of an EUA being issued for Pfizer and Moderna, starting with an initial deployment of 6.4 million doses of Pfizer's vaccine to states, cities, and certain federal agencies if and when that vaccine candidate is authorized, and 12.5 million doses of Moderna's vaccine, if and when that one is authorized (King, Fierce Healthcare, 12/2; Cunningham/Ellerbeck, "PowerPost," Washington Post, 12/2).
- FDA in November authorized a "new generation" coronavirus test, called COVID-SeroKlir, that is designed to assess how well-protected an individual is against infection by the pathogen. The test, developed by Kantaro Biosciences via a joint venture with Mount Sinai Health System and Renalytix, assesses the specific amount of neutralizing antibodies produced by a person's immune system after he or she has been infected or vaccinated. In comparison, most other FDA-approved tests assess only whether you've had the virus or not, or estimate your level of antibodies—but not specifically neutralizing antibodies. According to Kantaro, the test—which should help researchers better understand how Covid-19 antibodies are related to immunity—has a positive diagnosis accuracy rate of 98.8% and a negative diagnosis accuracy rate of 99.6% (Feuer, CNBC, 11/25).
- The biotech company Novavax on Monday said its late-stage trial for its vaccine candidate has been delayed as the company fields "additional questions" from FDA about the Novavax's intentions to rely on Fujifilm Diosynth Technologies' plant in North Carolina to manufacture the candidate. While Novavax didn't specify what FDA's questions were, FiercePharma notes that the company has changed its approach, having previously used smaller, clinical-scale batches of the vaccine for earlier trials before switching to a commercial-scale facility. Novavax, which previously thought it would start the U.S. trial by November, is now hoping to do so before the end of the year.The company has completed enrollment for several overseas trials, including one in the Untied Kingdom and another in South Africa (Blankenship, FiercePharma, 11/30).