Pfizer says lower dose COVID-19 vaccine ‘really hit the sweet spot’ for children ages 5 to 11
The COVID vaccine could be coming soon to an elementary school near you.
Drugmaker Pfizer said its vaccine against COVID-19 is safe and effective for children ages 5 to 11, a key step toward winning official approval for younger children to get inoculated against the deadly virus.
Mayor de Blasio hailed the news that approval may soon be on the way for younger children in the Big Apple.
“This is the piece that so many of us have been waiting for,” de Blasio said during Monday’s COVID briefing in Queens. “I’m guaranteeing you as soon as it’s available, you’ll see huge numbers of parents wanting to get their kids vaccinated.”
Hizzoner added it would be a “wonderful Halloween gift, a treat for all kids” if the feds approve the lifesaving vaccine by the end of October.
“Let’s do something wonderful,” he said. “Get the vaccine for five to 11-year-olds authorized by Halloween.”
Pfizer will seek authorization from the federal Food & Drug Administration soon, opening the door to elementary school kids to potentially get vaccinated within a few weeks.
So far, only adolescents 12 and older have been approved to be vaccinated in the U.S.
If the vaccine is approved by the feds, it would add 28 million children to the rolls of those eligible to be vaccinated.
The new announcement answers the call of anxious parents of younger children who have watched nervously as the virulent delta variant has caused a huge jump in pediatric infections since kids returned to school in recent weeks. Younger children will receive a dose equivalent to about a third of the vaccine that is given now to teens and adults.
But Pfizer said the younger children who took the kiddie dose vaccine developed coronavirus-fighting antibody levels just as strong as teenagers and young adults.
Dr. Bill Gruber, a Pfizer official also said the vaccine proved very safe, with similar or fewer temporary side effects as older kids and grownups experience.
“I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician.
Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.
FDA chief Dr. Peter Marks has said it would take “hopefully [only] a matter of weeks” after the application to decide if the test data shows the shots are safe and effective enough for younger kids.
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics.
Cases in children have risen dramatically as the delta variant swept through the country just as kids were returning to physical classrooms.
“I feel a great sense of urgency” in making the vaccine available to children under 12, Gruber said. “There’s pent-up demand for parents to be able to have their children returned to a normal life.”
In New Jersey, 10-year-old Maya Huber, who participated in Pfizer’s trial of the vaccine, knows what she wants to do first once she gets her shots: “a huge sleepover with all my friends.”
Pfizer said it studied the lower dosage in 2,268 kindergartners and elementary school-aged kids and found evidence that the younger children developed antibody levels already proven to be protective in teens and adults.
The study still is ongoing, and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated group and those given a placebo, a key piece of evidence the FDA may want to see.
The study isn’t large enough to detect any extremely rare side effects, such as myocarditis, heart inflammation has been identified in a very small number of young people, mostly male teenagers and young men.
A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
With News Wire Services
