Pfizer and BioNTech announced this week that they applied to the U.S. Food and Drug Administration for emergency use authorization for an omicron bivalent COVID-19 vaccine for children younger than 5.
This 3-microgram dose would be the third COVID-19 vaccine dose for children as young as 6 months old and up to 4 years old.
“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” said Pfizer.
This week, experts from the U.S. Centers for Disease Control and Prevention and the American Medical Association met to discuss the latest information about respiratory disease circulation in the nation. In addition to COVID-19, influenza and RSV have been circulating.
Apart from the new COVID-19 vaccine FDA submission, Pfizer announced Wednesday that the FDA accepted a priority review of a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF. Currently, there is no vaccine to prevent RSV infection, according to the CDC.
“The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the RSVpreF application is in May 2023,” said the company. “This decision follows the FDA’s Breakthrough Therapy Designation of RSVpreF in older adults in March 2022.”
Pfizer’s vaccine candidate for RSV was developed for “prevention of lower respiratory tract disease caused by RSV,” for people age 60 and older.
“With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death,” said Pfizer’s Senior Vice President and Chief Scientific Officer of Vaccine Research and Development Annaliesa Anderson said.
Follow KNX News 97.1 FM
Twitter | Facebook | Instagram | TikTok
Related
Related
Related
