The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More

False positive results could lead to further exposure of uninfected individuals to the SARS-CoV-2 virus, the agency said. Read More

The UK currently permits people over age 75 and people who are immunosuppressed to get the fourth COVID-19 vaccine shot. Read More

In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance. Read More

Raoult denied the gravity of the IHU’s practices. Read More

The swabs work with a variety of automated decappers to create hands-free workflows. Read More

No false positive or negative test results were reported, the company said. Read More

The WHO previously advised against using Veklury for any COVID-19 patients, regardless of disease severity. Read More

The research paper has not yet been peer-reviewed. Read More

Citing the risk of rare blood clots, the FDA announced late yesterday that it is limiting the Emergency Use Authorization (EUA) for the Johnson & Johnson/Janssen COVID-19 vaccine to certain individuals. Read More

One day after Pfizer CEO Albert Bourla said physicians could prescribe a second course of the company’s oral COVID-19 treatment Paxlovid to patients who suffer a rebound, the FDA refuted the executive’s statement. Read More

A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More