Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon — a key step toward beginning vaccinations for youngsters.
The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
“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.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.
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.”
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what's the right dose and that it works safely. Cuba last week began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.
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 as the delta variant swept through the country.
“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 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’s Gruber 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.
___
AP journalist Emma Tobin contributed to this report.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
After months of investigation, board members from U.S. big oil companies were slated to appear before a House oversight committee this week to discuss their respective roles in pushing for climate initiatives internally. However, all four board members from Exxon, Shell, Chevron, and BP said they couldn't attend due to scheduling conflicts. Climate experts are testifying in their place about how effective big oil's climate promises have been so far. Meanwhile, President Joe Biden's lead science adviser Eric Lander has resigned after an investigation found he violated workplace policy. What will this mean for Biden's climate agenda? Amy Harder, executive editor of Cipher, a publication by Breakthrough Energy, joins Cheddar Climate to discuss.
Although this week's weather is predicted to be less severe than the 2021 storm, Texans are preparing for the worst - stocking up on supplies and emptying shelves in grocery stores, once again. Some Texans still have not recovered from last year's tragedy, and are heading into the next few weeks with anxiety for what's to come. Leslie Beyer, CEO of the Houston-based energy workforce & technology council, joins Cheddar News to discuss if the Texas grid will fail again.
The American Red Cross has declared its first-ever "national blood crisis" in the United States. Since COVID hit the U.S. in March 2020, blood donations have declined by 10 percent. American Red Cross Medical Director, Dr. Baia Lasky joined Cheddar News to discuss the country facing the worst blood shortage in over a decade. Dr. Lasky noted that as much as 40 percent of Americans are eligible to donate blood but only about 4 percent do so. "This is going to be ongoing," she said. "This is not an acute shortage. We really do need the commitment of people to come out and donate and donate again." Appointments to donate can be made by using the Red Cross Donor App, at RedCrossBlood.org, or calling 1-800-RED CROSS (1-800-733-2767).
Eight months after the National Football League announced $1 million in research into cannabinoids, the NFL-NFLPA Joint Pain Management Committee has awarded the funding to two teams of medical researchers at the University of California San Diego and the University of Regina. The NFL says the studies will investigate the effects of cannabinoids on pain management and neuroprotection from concussion in elite football players, respectively. Cheddar correspondent Chloe Ailello spoke with Jeff Miller, the executive vice president of communications, public affairs, and policy for the NFL, about the studies, as well as the recent lawsuit filed against the NFL by former Miami Dolphins head coach Brian Flores. "Maybe we can learn things from other alternative pain approaches that are going to benefit our player population and then sports medicine as a whole," Miller said.
On this episode of Cheddar Innovates: CEO of HereAfter AI discusses how artificial intelligence can be used to preserve family history and stories, and allow you to 'talk' to loved ones that have passed; Creator of the board game 'Travel Explore Discover' explains how she came up with the idea for this informative and educational board game, and how she's using the proceeds to give back to her community; Cheddar gets a look at Curiosity Stream's 'The Humboldt Current.'
Immunologist Dr. Purvi Parikh of the Allergy & Asthma Network joined Cheddar News to break down long Covid, in which Covid symptoms remain up to two years after infection; a phenomenon that has so far mystified health experts.
Solid-state battery maker Factorial Energy recently raised $200 million in a Series D round led by Mercedes-Benz and Stellantis. Factorial says the funding will be used to accelerate commercial production and deployment of its solid-state battery technology, which the company says is safer, and offers up to 50% more driving range than current lithium-ion technology. Factorial also has joint development agreements (announced in late 2021) with Mercedes-Benz, Stellantis, and Hyundai, three of the top 10 global automotive manufacturers, to commercialize its batteries. Factorial CEO Siyu Huang joined Cheddar News' Closing Bell to discuss.
David Malott, founder and chief architect at AI PlanetWorks joins Cheddar News to discuss the release of its augmented reality NFTs for the metaverse called 'TERA.'
A 2021 report from UK Research and Innovation found that the shipping industry makes up at least 2.5 percent of the world's total CO2 emissions. It's a problem that energy solutions company, Leclanché, is trying to solve. Founded in 1909, the company has been developing and producing batteries for more than 100 years. Today, Leclanché's lithium-ion battery is used to electrify not just ships, but also railroad locomotives, trucks, and specialty vehicles. Cheddar News spoke with Pierre Blanc, chief technology and industrial officer of Leclanché, to discuss.
