FDA Official Says Vaccines For Children Under 5 Waiting For Complete Data
Dr. Peter Marks, who oversees vaccine regulation for the F.D.A., was pressed by members of Congress about the delay but said, "We can’t actually finish our reviews until we actually have complete applications.” Moderna expects to file an application by the end of April, and Pfizer is expected to file its application in May.
The New York Times:
Vaccines For Young Children Delayed By Incomplete Data, F.D.A. Official Says
The Food and Drug Administration has not yet cleared a coronavirus vaccine for children under 5 because the vaccine manufacturers have not finished their applications for authorization to distribute doses, a top official at the agency suggested on Tuesday. The official — Dr. Peter Marks, who oversees vaccine regulation for the F.D.A. — said the agency will release a schedule this week for outside expert review of vaccines for the nation’s 18 million children younger than 5. That is the only age group still not eligible for coronavirus vaccination. (LaFraniere, 4/27)
FiercePharma:
Lawmakers Ask FDA To Lay Out Plans For Reviewing COVID Vaccines For Young Children
Even though most people in the U.S. have been eligible for COVID-19 vaccines and boosters for quite some time, children under 5 still don't have vaccine options. Now, lawmakers are asking the FDA to lay out its plans in this age group—and address a perceived delay for Moderna's product. Yesterday, Congress’s Select Subcommittee on the Coronavirus Crisis sent a letter (PDF) to FDA Commissioner Robert Califf, M.D., requesting a briefing on the status of COVID-19 vaccines for the under 5 age group. (Becker, 4/26)
In updates on boosters for children —
NPR:
Pfizer Asks FDA To Authorize Booster Shots For Kids Ages 5 Through 11
Children ages 5 through 11 who've received two shots of the Pfizer COVID-19 vaccine may soon be eligible for a booster. That's if the Food and Drug Administration agrees to a request made Tuesday by pharmaceutical companies Pfizer and BioNTech to authorize their booster shot for kids in this age range. The companies submitted data to the FDA showing that the low-dose booster shot is safe for children ages 5 through 11 and could help protect them against omicron. Currently, boosters are only authorized for people ages 12 and older. (Stein, 4/26)
In other vaccine news —
CIDRAP:
CIDRAP To Develop Vaccine Roadmap For Future Coronavirus Threats
New coronaviruses armed with the capacity to cause severe human disease are becoming more frequent, raising the stakes for global preparedness, along with a need for a vaccine that could broadly protect against the most dangerous ones, such as SARS-CoV-2. To help jump-start the process, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota announced today that it has received $1 million in grants from the Rockefeller Foundation and the Bill & Melinda Gates Foundation to create a Coronavirus Vaccines Research and Development (R&D) Roadmap. (Schnirring, 4/26)
WSAZ:
Pediatrician Encourages Families To Catch Up On Vaccines During National Infant Immunization Week
The COVID-19 pandemic forced many health care facilities to delay certain medical procedures in order to ... make those battling Coronavirus a priority. This includes agencies pausing early childhood immunization programs. According to Dr. Andrea Lauffer, a pediatric hospitalist with Marshall Pediatrics [in West Virginia], the organization did not halt its program, but she noticed a change during the height of the pandemic. “We did see a drop-off of patients,” she recalled. (Donahue, 4/25)
WILX:
Michigan Health Department: On-Time Vaccinations Are The Best Way To Protect Children From Disease
Monday is the second day of national infant immunization week, which recognizes the benefits that vaccinations have on infants and children. In honor of it, the Michigan Department of Health and Human Services is encouraging that families get up to date on their children’s vaccinations. The department says that on-time vaccinations are the best way to protect children from serious diseases and now more than ever is the time to get them. (Draugelis, 4/25)
