What to Know
- Pfizer says new data shows its COVID-19 vaccine is safe and effective for kids ages 5 to 11, with immune responses at lower doses similar to older kids at higher doses; it plans to file for expanded approval
- The company said two other data sets in younger kids -- those 6 months to 2 years, and 2 years to 5 years -- are due later this year
- NYC Mayor Bill de Blasio said Monday he wants to see the Pfizer vaccine available for younger kids in the five boroughs "as soon as possible," ideally before Halloween
Pfizer said Monday data from a new trial show its COVID-19 vaccine is safe for kids ages 5 to 11, and it will file with regulators as soon as possible for expanded approval.
Pfizer said kids in the trial had a similar antibody response to young adults ages 16 to 25 in a previous study. The younger kids were given about one-third the dose of the older group.
"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," Pfizer's CEO Albert Bourla said in a statement.
The company said two other data sets in younger kids -- those 6 months to 2 years, and 2 years to 5 years -- are due later this year.
An outside expert said scientists want to see more details but called the report encouraging.
"These topline results are very good news,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported “appears likely to be protective.”
As of Monday morning, per NBC News data, the United States has now had 42.1 million cases of COVID-19, highest in the world, and almost 678,000 deaths.
In just the last month, the country has added another 4.5 million cases and nearly 48,000 deaths.
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 kids have risen as the delta variant swept through the country.
New York City Mayor Bill de Blasio said Monday he wants to see the Pfizer vaccine available for younger kids in the five boroughs "as soon as possible." The Democrat said ideally it would be available by the end of October -- and help make for a safer, more active Halloween than the last one for the "good of families."
Asked Monday whether he thought that timeline was viable, de Blasio said, "This is a global pandemic so calling on the federal government to prioritize shots for our youngest kids and really move heaven and earth, there is not just one way to do things. The review process needs to be thorough. Throw everything you've got at it because we need these shots now."
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A number of kids are eager to get dosed as well. In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and both teen brothers have.
Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn’t eased up on their masking and other virus precautions until they learn if Maya received the real vaccine or a dummy shot.
Once she knows she’s protected, Maya’s first goal: “a huge sleepover with all my friends.”
Maya said it was exciting to be part of the study even though she was “super scared” about getting jabbed. But “after you get it, at least you feel like happy that you did it and relieved that it didn’t hurt," she told the AP.
Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune “bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.
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.
Meanwhile, state plans for booster shots, once available, are well in development in the tri-state area.
New Jersey Gov. Phil Murphy reminded the people of his state Monday of the FDA's recent ruling -- that the boosters are approved but only for people age 65 and older, those at higher risk for COVID complications or for contracting it in general and those who received their second dose of the Pfizer vaccine by March.
Right now, Pfizer is the only booster shot that the FDA has recommended for emergency use in limited scenarios. Murphy says New Jersey is awaiting final federal eligibility guidance on the issue.
He says the Garden State won't open any windows for booster shot appointments or walk-ins until he gets that guidance, which he expects in a matter of days.
In the interim, Murphy and health officials are working on shoring up supply.