The NIH’s National Institute of Allergy and Infectious Disease (NIAID) is conducting a phase II study in the U.S. to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the mRNA COVID-19 vaccines developed by Moderna Therapeutics Inc. or Pfizer Inc.-Biontech SE. “Most of the rare, severe allergic reactions to these vaccines have occurred in people with a history of allergies. A substantial number of these people had previously experienced a life-threatening allergic reaction,” according to the NIAID. The blinded, randomized study will enroll 3,400 adults – 60% of whom must have either a history of severe allergic reactions or a diagnosis of a mast cell disorder, while 40% will have neither. One-third of the participants in both groups will initially be given a placebo while one-third each will be randomized to the Pfizer and Moderna vaccines. The participants are to be closely monitored by allergy specialists.
EC provides emergency funding for COVID-19 research
The European Commission (EC) is releasing its first emergency funding from Horizon Europe, the EU’s new research and innovation program, for research into coronavirus variants. The €123 million, about US$146 million, will be granted for three types of projects, including the further development of promising COVID-19 therapeutic or vaccine candidates. The funding also will be used to support research infrastructures designed to speed up data sharing and deliver fast research support and expertise to confront variants and prepare for future epidemics. The third goal is to establish new or build on existing large-scale, multicenter and regional or multinational cohorts, including outside of Europe, that can rapidly advance the knowledge about SARS-CoV-2 and its emerging variants.
Final judgment against former Retrophin attorney
Evan Greebel, a former lawyer to Retrophin Inc., of San Diego, agreed to a formal consent order filed this week in a U.S. district court that bars him from serving as an officer or director of a public company. In light of Greebel’s conviction in a related criminal case, the judgment doesn’t impose civil penalties, the SEC said. It does resolve an SEC complaint, filed in 2015, alleging that Greebel assisted in fraudulent conduct orchestrated by Martin Shkreli, then CEO of Retrophin. According to the complaint, Greebel, serving as Retrophin’s outside counsel and corporate secretary, drafted sham consulting agreements to pay disgruntled investors in Shkreli’s hedge funds. Greebel then failed to disclose the true purpose of the agreements to Retrophin’s directors.
FDA hits company for deviations from drug, device GMPs
The FDA recently posted a Nov. 9, 2020, warning letter to Tarmac Products Inc., of Miami Gardens, Fla., for device and drug violations. The device violations included failure to exhaustively qualify equipment used in the manufacture of wound dressing products, as demonstrated by out-of-specification results for total aerobic microbial contact or Staphylococcus aureus counts. Other deviations from the device quality system regulation involved failure to perform antimicrobial effectiveness tests for wound care dressing at time points prescribed in the company’s standard operating procedures. The company also failed to comply with validation requirements, including validation of changes to finished device specifications, according to the letter. Among the drug violations was a finding that the company’s lab records appeared altered in connection with testing for a species of Escherichia. The initial result of the test wasn’t found in the audit trail for the product or in the lab notebook, a deviation the FDA said was a repeat finding from two prior inspections. Other violations included a failure to follow a written testing program for drug stability and inadequate calibration of testing equipment.