Today Pfizer and BioNTech submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA) for their mRNA COVID-19 vaccine for use in children 6 months to 4 years — the last age-group ineligible for COVID-19 vaccination in the United States.
Anonymous sources told the Washington Post the FDA was eager to review the application and hoped shots could be in the arms of this cohort as soon as the end of the month. Data on a third dose of vaccine in this age-group are expected in March.
Late last year, Pfizer reported that the two-dose regimen of vaccine was safe in children 6 months to 5 years, but was not as effective at preventing infection compared to other cohorts.
Three doses likely needed
"Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants," said Albert Bourla, chairman and chief executive officer of Pfizer in a press release. "If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose."
The EUA is based on results from a trial which saw participants get two doses of 3-microgram shots—a tenth of the dose given to adults—3 weeks apart. Results from the trial should be released when the EUA application is submitted.
In related news, Novavax said it had submitted an EUA application for its protein-based COVID-19 vaccine, to be used in adults.
"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," said Stanley C. Erck, president and chief executive officer of Novavax, in a press release.
CDC: Boosters offer protection against Omicron
Despite a significant uptick in breakthrough infections during the Omicron surge, COVID-19 vaccines are still effective in preventing severe outcomes from infection.
Today the CDC published new data in Morbidity and Mortality Weekly Report, which showed COVID-19 incidence and hospitalization rates in Los Angeles County among unvaccinated persons were 3.6 and 23.0 times, respectively, those of fully vaccinated persons with a booster, and 2.0 and 5.3 times, respectively, those among fully vaccinated persons without a booster.
The analysis was conducted from Nov 7, 2021, to Jan 8, 2022.
The vaccines, however, were more effective during the Delta wave: The incidence and hospitalization rates among unvaccinated persons were 12.3 and 83.0 times, respectively, those of fully vaccinated persons with a booster and 3.8 and 12.9 times, respectively, those of fully vaccinated persons without a booster at the end of November and the first week of December—a period when Delta was still the dominant variant in the United States.
"Being up to date with COVID-19 vaccinations is a critical component of reducing the strain on health care facilities," the authors said.
Pediatric cases continue to climb
More than 808,000 child COVID-19 cases were reported for the week ending Jan 27th, according to the latest update from the American Academy of Pediatrics (AAP).
"Reported COVID-19 cases among children have spiked dramatically in 2022 during the Omicron variant surge, over 3.5 million child cases were reported in January," the AAP said.
Since the pandemic began, children represented 18.6% of total cumulated cases in the United States.
Amid the spike in child infections, New Orleans is set to become the nation's first major school district to mandate COVID-19 vaccination for children 5 and up, the Associated Press reports. But state regulations will allow parents to opt out easily.
Five states report case increase
Maine, Minnesota, Montana, Idaho, and Washington state all reported a 10% increase in new cases, ABC News reports, in contrast to most states in the nation, which are seeing a significant decline in daily cases.
The United States reported 608,201 new COVID-19 cases yesterday, and 2,422 deaths, according to the Johns Hopkins COVID-19 tracker. The 7-day average of new daily cases is 456,871, with 2,558 daily deaths, according to the New York Times tracker.
The Centers for Disease Control and Prevention (CDC) COVID Data Tracker shows 63.8% of Americans are fully vaccinated against COVID-19, 75.3% have received at least one dose of vaccine, and 41.5% of vaccinated Americans have received a booster dose.
