The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia.
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18.
Pediatric orthopedics company Orthopediatrics Corp. has signed a $33 million deal to buy competitor Pega Medical Inc. As part of the deal, Orthopediatrics will acquire Pega’s Fassier-Duval telescopic intramedullary system. The implant is designed to treat bone deformities in children with osteogenesis imperfecta. Orthopediatrics will pay a $31 million upfront cash payment plus $2 million in stock – which includes certain restrictions for three years.
After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older.
More than two years into the COVID-19 pandemic and nearly 18 months since a vaccine was first available for adults, the U.S. is on the cusp of having vaccines available to the youngest Americans.
Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose.
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
The FDA has granted emergency use authorization (EUA) to the COVID-19 vaccine created by Pfizer Inc.-Biontech SE for use in children ages 5 through 11. This is the first EUA for a COVID-19 vaccine to be awarded for this group of roughly 28 million children in the U.S. and it comes after weeks of lengthy debate among experts about the wisdom of targeting the young demographic.
