FDA: Pfizer’s 3-Dose Covid Vaccine Is Safe And Effective For Youngest Kids
The Food and Drug Administration's review of Pfizer and BioNTech's covid shot regimen — as well as that of Moderna, which also yielded positive results — will be put to its panel of vaccine experts on Wednesday.
The Wall Street Journal:
Three-Dose Pfizer Covid Vaccine Works Safely In Young Children, Review Says
Three doses of the Covid-19 vaccine from Pfizer Inc. and BioNTech SE were effective at preventing symptomatic disease in children ages 6 months through 4 years in studies, according to U.S. health regulators. The FDA staff also said, in a review of study data posted online Sunday, that there were no new safety concerns using the vaccine in young children compared with older age groups. The assessment is the latest sign that authorities are moving closer to clearing inoculations for children under 5 years old, the last group ineligible for Covid-19 vaccination. (Loftus, 6/12)
AP:
US: Pfizer COVID-19 Shot Appears Effective For Kids Under 5
The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer. Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues. Moderna’s two-dose series was only about 40% to 50% effective at preventing milder infections, though the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing a booster for tots. (Perrone and Stobbe, 6/13)
The New York Times:
Pfizer Vaccine Effective In Children Under 5, The F.D.A. Says
Some public health experts are expecting the F.D.A. to authorize both Moderna’s and Pfizer’s vaccines, offering parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the F.D.A. acts. Roughly 18 million children younger than 5 are the only Americans who are not yet eligible for shots. (LaFraniere, 6/12)
In related news —
The Hill:
White House Faces Uphill Challenge Getting Kids Under 5 Vaccinated
The Biden administration faces an uphill battle to convince parents to give COVID-19 shots to children under 5 years old. ... Officials have outlined a plan that includes partnering with the online What to Expect community, as well as a range of national organizations, including a “speaker’s bureau” of pediatricians and family physicians who will be able to answer questions about the shots at community events. Vaccines will be distributed across thousands of different sites, but the administration will focus on front-line providers including pediatricians and primary care doctors, as that is where they expect many families will want to go. (Weixel, 6/12)
ABC News:
Key Challenges To Vaccinating Kids Under 5 Against COVID-19 And What We Can Do: Analysis
As of June 8, more than 254 million doses (40%) of COVID-19 vaccines have been administered and reported by retail pharmacies. Under the Public Readiness and Emergency Preparedness Act (PREP Act), pharmacists are authorized to order and administer childhood vaccines, including authorized COVID-19 vaccines, to children ages 3-18 years until Oct. 1, 2024. ... However, pharmacists do not receive extensive training in vaccinating young children, who are often unwilling to participate in the immunization process. Additionally, most 3-year-old children are vaccinated in the thigh, rather than in the arm, making the vaccination of this age group particularly challenging in a busy pharmacy that may not have the space to ensure privacy during vaccine administration. (Brownstein, Weintraub, Fiscus, Tewarson and Greene, 6/10)
