✦ Documents that will be reviewed by an FDA panel on Dec. 10 conclude that Pfizer Inc.’s vaccine for the novel coronavirus offers meaningful protection against the virus within 10 days of initial dosing, tipping agency staff’s support for an emergency use authorization (EUA) of the vaccine. The Pfizer vaccine, which requires patients to be dosed twice, demonstrates “an estimated [vaccine efficacy] of 82% against confirmed COVID-19 occurring after Dose 1 of the 2-dose regimen, with [vaccine efficacy] of 52.4% between Dose 1 and Dose 2,” according to a briefing document. The same document’s executive summary concludes that “the efficacy, safety, and immunogenicity data in this EUA application” support a positive assessment of risk and benefit for the vaccine and meet the data requirements outlined in the EUA guidance. Read more at https://bit.ly/3n6KzFM.
✦ The Trump administration’s recent drug-pricing regulations have met roadblocks from both the pharmaceutical industry and the Canadian government. The Pharmaceutical Research and Manufacturers of America filed suits in federal courts that challenge a rule that allows the importation of drugs from Canada and another that will tie Medicare Part B prescription drug payments to an index of drug prices that other countries pay. The Canadian health minister, meanwhile, signed an order that limits bulk drug exports. Read about the suits at https://onphr.ma/3ozz5eb and https://onphr.ma/3gtWCdL and find the order at https://bit.ly/371nvCA.