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PFIZER announced on Wednesday, March 31, that its Covid-19 vaccine is safe and highly protective in children as young as 12 years old, a step towards being able to start vaccines in this age group before they return to school in the autumn.
Most of the Covid-19 vaccines that are being rolled out around the world are for adults, who are at increased risk of contracting the coronavirus. The Pfizer vaccine is licensed for ages 16 and over. But vaccinating children of all ages will be critical to stopping the pandemic and helping schools, at least in the upper grades, start looking a little more normal after months of disruptions.
In the vaccine study of 2,260 American volunteers ages 12 to 15, preliminary data showed that there were no cases of Covid-19 among fully vaccinated teens compared to 18 among those who received sham injections, Pfizer reported.
It’s a small study, yet to be published, so another important piece of evidence is how well vaccines boosted children’s immune systems. The researchers reported high levels of virus-fighting antibodies, somewhat higher than those seen in studies of young adults.
Children had similar side effects to young adults, the company said. The main side effects are pain, fever, chills, and fatigue, especially after the second dose. The study will continue to track participants for two years to learn more about long-term safety and security.
Dr. Philip J. Landrigan of Boston College said the results are encouraging.
“It’s hard to get kids to comply with masking and distancing, so something that gives them tough protection and takes them out of the virus-spreading mix is for the better,” said Landrigan, who was not involved in the study.
It is another positive development in the race against the virus, even as cases in the United States, with 66,000 new infections a day, are on the rise again and deaths average about 1,000 a day. The director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, again warned Americans on Wednesday that “we cannot afford to let our guard down.”
Pfizer and its German partner BioNTech plan to apply in the coming weeks to the US Food and Drug Administration and European regulators to allow emergency use of the injections from the age of 12.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope to begin vaccinating this age group before the start of the next school year” in the United States.
Pfizer isn’t the only company looking to lower the age limit for its vaccine. Results are also expected by the middle of this year from a US study of Moderna’s vaccine in young people ages 12 to 17.
But in a sign that the findings were promising, the FDA has already allowed both companies to begin studies in the US in children 11 years and younger, up to 6 months of age.
“We long for a normal life. This is especially true for our children, ”BioNTech CEO Ugur Sahin said in a statement.
AstraZeneca began a study of its vaccine among young people aged 6 to 17 in Britain last month. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced that it submitted preliminary data to Chinese regulators showing that its vaccine is safe in children as young as 3 years old.
While most of the Covid-19 vaccines in use globally were first tested in tens of thousands of adults, pediatric studies won’t need to be that large. Scientists have safety information from those studies and subsequent vaccines in millions more adults.
A key question is dosage: Pfizer gave participants 12 and older the same dosage that adults receive, while testing different dosages in younger children.
It is not clear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. It has taken the agency approximately three weeks to review and authorize each of the currently available adult vaccines. That process included holding a public meeting of outside experts to review and vote on the safety and efficacy of each shot.
The data review process in children could be shorter, given the FDA’s familiarity with each vaccine. An agency spokeswoman said the FDA had no information to share about how the review would work, even if additional public meetings would be required.
Another question is when would the country have a sufficient supply of vaccines, and people to carry them into the arms of adolescents, for children to start lining up.
Supplies are projected to increase steadily through the spring and summer, as states are rolling out vaccines for the younger, healthier adults who haven’t had their turn so far.
Children account for about 13 percent of documented Covid-19 cases in the US And while children are far less likely than adults to become seriously ill, at least 268 have died from Covid-19 in the US alone. And more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than dying from the flu in an average year. In addition, a small number have developed a severe inflammatory disease related to the coronavirus.
Caleb Chung, who turns 13 this week, agreed to volunteer after his father, a Duke University pediatrician, introduced the option. You do not know if you received the vaccine or a placebo.
“I’m usually at home doing online classes and there’s not much I can do to fight the virus,” Caleb said in a recent interview. The study “was really a place where I could really help.”
His father, Dr. Richard Chung, said he is proud of his son and all the other children who volunteer for needle sticks, blood tests and other tasks that a study entails.
“We need children to take these tests so that children can be protected. Adults can’t do that for them, ”Chung said. (AP)
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