The Food and Drug Administration’s decision aims to better protect the littlest kids from severe COVID-19 at a time when children’s hospitals already are packed with tots suffering from a variety of respiratory illnesses.
FDA
Philips initially estimated it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dutch company now says the effort will stretch into 2023.
The Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses — one made by Pfizer for 5- to 11-year-olds, and a version from rival Moderna for those as young as 6.
The move by the Food and Drug Administration tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives. The hope is that the modified boosters will blunt yet another winter surge.
The regulation creates a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations, the Food and Drug Administration said. That’s expected to increase competition and eventually lower costs. The devices will be sold online or over-the-counter at pharmacies and other retail stores.
The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges. Those already on the market must be removed. Consumers aren’t restricted from having or using Juul’s products, the agency said.
U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.
Production for Abbott’s EleCare specialty formula has been suspended, but there is enough supply to meet demand until production is restarted, the company said.
The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids.
U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020, according to federal records reviewed by The Associated Press.
Federal health officials said Sunday that kid-sized doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for kids under 5, a key step toward a long-awaited decision to begin vaccinating the youngest American children.
The company said that the peanut butter was sold nationwide and the recall includes more than 45 kinds of products.
The Food and Drug Administration’s authorization now opens a third shot to elementary-age kids, too — at least five months after their last dose. There is one more hurdle: The Centers for Disease Control and Prevention must decide whether to formally recommend the booster for this age group.
The White House said it is working with all major formula producers to boost production, including reaching out to their suppliers to encourage them to prioritize production and delivery of formula ingredients.
Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which was forced to shutter its largest U.S. formula manufacturing plant in February due to contamination concerns.
The meeting announcement follows months of frustration from families impatient for a chance to vaccinate their little children, along with complaints from politicians bemoaning the slow pace of the process.
