The FDA announces it will streamline the review process to make it easier for foreign manufacturers to ship more formula to the US; researchers in Australia find babies with sudden infant death syndrome (SIDS) have low levels of butyrylcholinesterase in their blood; the federal government approves a third round of COVID-19 test kits and the FDA is expected to authorize booster shots for children aged 5 to 11 years.
The Associated Press reports that the FDA will make it easier for foreign manufacturers to ship more formula to the US by streamlining its review process. FDA Commissioner Robert Califf, MD, said that the United States will prioritize the companies that can provide the largest shipments and can show documentation that their formulas are safe and in line with US nutrition standards. Getting imports into the US supply chain will take several weeks, according to administration officials. This announcement comes after a deal with regulators that will allow Abbott Nutrition to restart production in their Sturgis, Michigan-based plant, which had been closed since products were recalled in February.
Researchers in Australia found that children who died of sudden infant death syndrome (SIDS) had low levels of an enzyme named butyrylcholinesterase (BChE), according to the New York Times. The study compared dried blood samples from the newborn heel pricks of 655 healthy babies, 26 babies who died from SIDS, and 41 babies who died from other causes. They determined that 9 in 10 babies who died of SIDS had significantly lower BChE levels than the other 2 groups of babies. The investigators noted that this is the first discovery of a potential biomarker for SIDS risk.
The FDA expanded its emergency use authorization to approve Pfizer-BioNTech’s COVID-19 booster shots for children aged 5 to 11 years. Expert advisors to the CDC will meet on Thursday to recommend boosters for children of that age group; the CDC is expected to approve of the booster soon after. Also, the US federal government plans to release more shipments of free at-home COVID-19 tests, available for order through the websites of HHS and the US Postal Service. Those who sign up to receive the tests will receive 8 tests in the mail rather than the 4 sent in previous rounds of at-home testing.