The FDA sets a tentative date for a decision on authorizing a COVID-19 vaccine in children under 5 years of age; the American Academy of Pediatrics will review all of its guidance for unproven race-based recommendations contributing to health disparities; the FDA rejects 2 China-tested cancer treatments.
The New York Times is reporting that the FDA expects June 8 to be the earliest date for when it might authorize a COVID-19 vaccine in children under 5 years of age, who remain the last age group who are not yet eligible to be vaccinated against the disease. Data on the pediatric vaccine applications from Moderna and Pfizer/BioNTech will heard by the agency’s outside advisory committee. In addition, the FDA will present data on June 7 from Novavax regarding its protein-based vaccine in adults, which differs from the mRNA-based vaccines from Moderna and Pfizer/BioNTech.
The American Academy of Pediatrics (AAP) issued a new policy Monday that will assess all its guidance for the presence of flawed recommendations on race-based medicine and other factors that contribute to health disparities. As reported by the Associated Press, the lead author of the new policy noted that the move to reexamine AAP treatment recommendations came amid reports from doctors who were concerned that Black children have been undertreated and overlooked. The academy removed an unproven guideline last year indicating that Black children faced lower risks than White counterparts for urinary infections, with another guidance regarding race-based risk on newborn jaundice set to be reviewed this summer.
Reuters is reporting that the FDA issued a complete response letter (CRL) to 2 China-tested cancer treatments amid concerns that data are not representative of the US patient population. CRLs were sent to Hutchmed on its treatment surufatinib for advanced neuroendocrine tumors and Coherus BioSciences and Shangai Junshi Biosciences on their drug toripalimab to treat a type of nasopharyngeal carcinoma. The decisions were noted to raise concerns on the future of drugs tested in single-country trials, with regulators also citing issues regarding inspection of facilities for both treatments due to delayed travel during the pandemic.