Number of deaths and ICU admissions that may have been prevented without the pause is ‘striking,’ CDC advisory committee member says; ACIP votes to reaffirm use of J&J’s vaccine in persons 18 and older based on positive risk-benefit analysis and reports of only nine additional cases of TTS.
Additional analysis of the pros and cons of Johnson & Johnson’s COVID-19 vaccine, along with only a few new cases of rare blood clots, persuaded the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) to vote to lift the pause on its administration, a step it was not ready to take a week earlier.
With the extended stoppage now over, the question for sponsors and public health officials is what impact it will have...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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