Infectious Disease Update: June 17, 2022
This past week has been extremely busy in infectious disease with a lot of vaccine news that could impact young children. In addition, GSK reported on its phase 3 study on its RSV vaccine for seniors.
FDA Authorizes Expansion for EUAs for mRNA Vaccines for Children as Young as 6 Months
Today, the US Food and Drug Administration (FDA) authorized expanding the Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccine for children as young as 6 months old. This news comes just 2 days after the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend amending the EUA of the Pfizer-BioNTech vaccine for children 6 months through 5 years of age, and the Moderna vaccine for children 6 months through 5 years of age.
Moderna Will Study COVID-19 Vaccine for Babies
Moderna is planning to study its vaccine in babies 3 months to 6 months old, according to The Wall Street Journal. The study is being named BabyCove and is expected to begin recruiting in September and will include up to 700 babies.
Florida Not Ordering COVID-19 Vaccines for Children
The State of Florida is not planning on stocking mRNA vaccines for young children, even after the news the Pfizer and Moderna vaccines were authorized today.
At a press conference yesterday, Florida Governor Ron DeSantis explained the state’s policy and beliefs on vaccines in the youngest pediatric population.
“I would say we are affirmatively against the COVID vaccine for young kids,” DeSantis said. “These are the people who have zero risk of getting anything.”
“To do an emergency-use authorization for a six month old or a one year old simply to placate anxiety, that’s not the standard when you’re doing this,” he stated inthe same press conference.
GSK Announces its Phase 3 Study for its RSV Vaccine for Seniors
GSK reported its investigational respiratory syncytial virus (RSV) vaccine demonstrated it was “statistically significant and clinically meaningful efficacy in adults aged 60 years and above.”
This result comes from its AReSVi 006 phase 3 trial, which is a randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA vaccine in individuals aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries.
To learn more about the study, go here.