The EMA signed a contract with Utrecht University to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines once they’re available for clinical use. As the coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, which includes 22 European research centers, Utrecht University will lead the ACCESS project in identifying a Europe-wide network of data sources and examining their usefulness in monitoring COVID-19 vaccines. The research team also will identify possible adverse events that might need extra consideration in monitoring the vaccines, according to the EMA. The first deliverables from the research are planned for August, with a final delivery by the end of the year. The ACCESS infrastructure will complement data from vaccine trials and post-authorization reporting.
Noting that a COVID-19 vaccination campaign in the U.S. will “require massive preparation and precise coordination,” the bipartisan leadership of the House Energy and Commerce Committee and its Subcommittee on Oversight and Investigations wrote to White House Coronavirus Task Force Coordinator Deborah Birx, urging the Trump administration to develop a national coronavirus vaccine plan now. Operation Warp Speed with its goal of developing a vaccine is a good step, according to the letter, but there must be a detailed plan on scaling up manufacturing capabilities; prioritizing and allocating vaccines to at-risk populations, including health care workers and other first responders; developing guidance on provider training, public education and outreach efforts; and addressing coverage considerations to achieve the recommended utilization of a vaccine. In the letter, Reps. Frank Pallone (D-N.J.), Greg Walden (R-Ore.), Diana DeGette (D-Colo.) and Brett Guthrie (R-Ky.) also expressed concern about the impact COVID-19 has had and will have on immunization levels for other infectious diseases. Immunization rates for preventable diseases, such as measles, have decreased due in part to social distancing efforts, they said. They cited experts who have cautioned that efforts to increase the manufacturing capability for COVID-19 vaccines may supplant production of other vaccines. “The development and implementation of a COVID-19 vaccine plan must also take these considerations into account,” the lawmakers said.
The U.K.’s National Institute for Health and Care Excellence (NICE) reversed course Wednesday, issuing new draft guidance recommending the use of Roche Holding AG’s Tecentriq (atezolizumab) with carboplatin and etoposide as an option for untreated extensive-stage small-cell lung cancer (ES-SCLC). NICE’s first recommendation was against using the drug for that indication, but Roche has since agreed to a lower, undisclosed price that makes the drug cost-effective, the agency said. At list price, the mean treatment cost per patient with ES-SCLC would be £32,798.39 (US$40,196.39) for Tecentriq, plus £76.18 for carboplatin and £30.89 for etoposide. Clinical trial evidence suggests Tecentriq, with the two chemo drugs, increases progression-free survival by about a month compared with standard chemotherapy and also improves overall survival in ES-SCLC. However, NICE said, the long-term benefit for overall survival is uncertain. The new ES-SCLC guidance reflects a similar change of heart NICE exhibited a few days earlier when it issued a new draft guidance recommending the use of Tecentriq and nab-paclitaxel to treat metastatic triple-negative breast cancer (TNBC). That reversal also came after Roche offered a larger discount. Evidence suggests that, in the TNBC indication, Tecentriq and nab-paclitaxel can increase overall survival by about 9.5 months, according to NICE. The agency said it expects to finalize both guidances next month.
The FDA will hold its annual user fee meeting June 22, 2020, on the financial transparency and efficiency of PDUFA, BsUFA and GDUFA, according to a notice in Wednesday’s Federal Register. At the virtual meeting, the agency will discuss the five-year plans for the agreements; its progress in implementing resource-capacity planning and modernized time reporting; and its progress in addressing the findings from last year’s independent third-party evaluation of the resource management associated with the agreements. In addition to making comments at the meeting, the public may submit comments, through July 22, via Docket No. FDA-2019-N-1875 at regulations.gov. Registration for the webcast meeting is due by June 19.
The FDA reported Tuesday that Acella Pharmaceuticals LLC, of Alpharetta, Ga., is voluntarily recalling 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid tablets due to superpotency. The product may have up to 115% of the labeled amount of liothyronine. So far, the company has received two reports of adverse events. Individuals who take the superpotent drug to treat hypothyroidism may experience symptoms of hyperthyroidism, the FDA said. When taken by pregnant women, the superpotent drug could cause miscarriages or impair fetal development.