The U.K.’s National Institute for Health and Care Excellence (NICE) published two new COVID-19 rapid guidelines. The first one deals with treating children and young people who are immunocompromised. Even though immunosuppression doesn’t appear to increase the risk of severe COVID-19 in this population, the guideline urges children and young people who are immunocompromised, or their caregivers, to contact their specialist team as soon as possible. Also, parents and carers of children and young people with complex care needs should have a plan in place should they become ill so that the children can continue to safely receive care, NICE said. The second guideline discusses the antibiotic management of pneumonia in hospitalized adults. While it cautions against using antibiotics for viral-caused pneumonia, which is more prevalent in COVID-19, the guideline recommends using a broad-spectrum antibiotic as soon as possible against bacterial pneumonia.
The U.K.’s Medicines and Healthcare Products Regulatory Agency launched a new online site this week dedicated to reporting suspected side effects from drugs, future vaccines and incidents involving medical equipment relating to COVID-19 treatment. The tailored Yellow Card COVID-19 reporting site is intended to make it quicker and simpler for health care professionals, patients and carers to report side effects or incidents during the pandemic.
A bipartisan group of senators is pushing for the next COVID-19 stimulus package to include $26 billion to help U.S. researchers who have had their work disrupted by the coronavirus. “Although COVID-19-related research is now in overdrive, most other research has slowed or stopped due to closures of campuses and laboratories,” the senators said in a letter to Senate leadership Monday. “We are deeply concerned that the people who comprise the research workforce – graduate students, postdocs, principal investigators, and technical support staff – face financial and other hardships from the cessation of their research activities.” The senators requested the funding to cover supplements for research grants and contracts caused by the pandemic, provide emergency relief to sustain research support personnel and base operating costs for core research facilities and user-funded research services until the facilities reopen and research activities return to pre-pandemic activity levels, and fund additional graduate student and postdoc fellowships, traineeships and research assistantships for up to two years.
Biopharma companies that use Delhi-based Shriram Institute for Industrial Research as a contract testing laboratory could have trouble getting the FDA to approve their drug applications until the lab successfully responds to a warning letter, the agency said in the letter posted May 5. The warning stems from an October 2019 inspection in which the FDA investigator noted repeat deviations in the lab’s testing processes. For instance, the lab hadn’t enabled the audit trail function on high-performance liquid chromatography units until October when the inspection was announced. The lab also failed to investigate out-of-specification results unless requested by the customer.