FDA authorizes Pfizer COVID-19 vaccine for children ages 5 to 11

The U.S. Food and Drug Administration authorized the Pfizer-BioNTech vaccine for emergency use in children 5 to 11 years old, a key step in rolling out the shots to younger children. 

The authorization came after the FDA’s advisory panel recommended the vaccine for the age group. The panel of outside experts voted unanimously — with one abstention — that the vaccine’s benefits in preventing COVID-19 in children ages 5-11 outweighed any potential risks. That included questions about a heart-related side effect that’s been very rare in teens and young adults, despite their use of a much higher vaccine dose. 

The U.S. Centers for Disease Control and Prevention will next have to decide whether to sign off on the shots. 


FILE - A person receives a bandage after their first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic during a back to school event offering school supplies, Covid-19 vaccinations, face masks, and other resources for children and th

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Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older, but pediatricians and many parents are clamoring for protection for younger children. The extra-contagious delta variant has caused an alarming rise in pediatric infections, and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay. 

In the 5 to 11-year-old age group, there have been more than 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths since the start of the pandemic. The FDA’s models suggested the vaccine could prevent 200 to 250 hospitalizations for every 1 million children vaccinated — assuming virus spread remains high, something that’s hard to predict. FDA scientists also said younger kids likely won’t have as much risk of heart inflammation as teens, but if they did, it might cause about 58 hospitalizations per million vaccinations. 

Moderna also is studying its vaccine in young children, and Pfizer has additional studies underway in those younger than 5. 

States were already getting ready to roll out the shots — just a third of the amount given to teens and adults — that will come in special orange-capped vials to avoid dosage mix-ups. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccination, which will also be available at pharmacies and other locations. 

But for all that anticipation, there also are people who strongly oppose vaccinating younger children, and both the FDA and its advisers were inundated by an email campaign seeking to block the Pfizer shot. 

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Nevertheless, states and school districts will have to grapple over whether to make the vaccine a requirement for students, as many have with mask mandates. 

California imposed the nation’s first coronavirus vaccine mandate for schoolchildren, a move announced in early October that could push other states to follow as many did after Gov. Gavin Newsom ordered the first statewide stay-at-home order in the U.S. during the early days of the pandemic. 

Newsom said the mandate won’t take effect for all children until the U.S. government has finished fully vetting the vaccine for two age groups — 12 to 15 and 5 to 11. That means those in seventh to 12th grades probably will have until July to get their shots. It will be even longer for children in kindergarten through sixth grades because the government has yet to approve any COVID-19 vaccine for that age group. 

California will grant exemptions for medical reasons, plus religious and personal beliefs. 

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Colorado’s health department has said it is working on an informational campaign with public health agencies, youth-focused groups and school districts for parents and guardians. 

Other states have resisted imposing pandemic rules in schools, including a new law in Kentucky that overturned a statewide mask mandate. 

Texas Gov. Greg Abbott issued an executive order stating that no entity in Texas can mandate getting a COVID-19 vaccine. According to a statement from Abbott’s office, "no entity in Texas can compel receipt of a COVID-19 vaccination by any individual, including an employee or consumer, who objects to such vaccination for any reason of personal conscience, based on a religious belief, or for medical reasons, including prior recovery from COVID-19." 

Florida Gov. Ron DeSantis has threatened local governments with $5,000 fines per violation for requiring their employees to get vaccinated against the coronavirus that has overrun hospitals and killed tens of thousands across the state. 

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In Arizona, Gov. Doug Ducey barred districts that mandate masks from accessing a $163 million virus relief pool and said parents could receive $7,000 per student for private schools if their district mandates masks or goes into quarantine. More than two dozen districts, accounting for a third of the state’s 930,000 public school students, require masks. 

The Education Department in August opened civil rights investigations into multiple Republican-led states that have banned or limited mask requirements in schools, saying the policies could amount to discrimination against students with disabilities or health conditions. 

Tumbling COVID-19 case counts have some schools around the U.S. considering relaxing their mask rules, but deaths nationally have been ticking up over the past few weeks, some rural hospitals are showing signs of strain, and cold weather is setting in. 

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With required mask use reduced in much of the U.S., the University of Washington's influential COVID-19 forecasting model is predicting increasing infections and hospitalizations in November. 

Also, COVID-19 deaths per day have begun to creep back up again after a decline that started in late September. Deaths are running at about 1,700 per day, up from close to 1,500 two weeks ago. 

The Associated Press contributed to this report. This story was reported from Los Angeles.