US FDA advisory committee approves emergency use of Pfizer-BioNTech vaccine in children ages 5-11. 10-year-old Maja has no doubt: children should also be vaccinated against the new coronavirus. She said she was happy to be among the first children in the world to receive a Covid-19 vaccine from Pfizer-BioNTech.
“The first thing I’m going to do is have a big sleepover or something with all my friends,” he said.
Maja was part of a US-based study that could pave the way for US authorities to approve Pfizer-BioNTech’s mRNA vaccine for children ages 5-11.
On Tuesday (26), an advisory committee of the Food and Drug Administration (FDA), responsible for approving vaccines and drugs in the US, discussed the study’s findings and unanimously voted that the vaccine’s benefits appear to outweigh any potential risks in this age group.
Following the green light from the expert panel, the FDA must make its final decision on formal authorization within a few days. The FDA is not legally obligated to follow the panel’s recommendations, but it usually does.
Next, the independent advisory committee of the US Center for Disease Control and Prevention (CDC) is expected to meet in early November to vote on the vaccine recommendation for this age group.
Study shows good effectiveness
The researchers tested the vaccine on 2,268 children aged between 5 and 11 years, and about the same number of children received a placebo.
After the study, the developers said they were confident their vaccine was safe and effective for children in that age group with the dose reduction. Children under 11 received about a third of the dose that adults receive. So far, the vaccine has only been approved for children aged 12 and over.
Pfizer-BioNTech wants approval in the US and the European Union. The EMA (European Medicines Agency) has indicated that it will take a decision in the coming months. The company also made submissions in other countries to obtain approval.
Other vaccine developers and manufacturers, such as AstraZeneca, Novavax and Johnson&Johnson, are also working on immunizations for children.
Should children get vaccinated or wait?
“I am absolutely in favor of vaccinating children under the age of 12,” said Kawsar Talaat, in an interview with DW. Talaat is an associate professor of International Health at the Johns Hopkins Bloomberg School of Public Health, USA.
“The only way to get rid of this pandemic is to vaccinate as many people as possible and that goes for all ages,” Talaat said.
Jakob Armann, a pediatrician in Germany, however, is more reserved. In an interview with DW, Armann said that children with comorbidities should be vaccinated, “for example, children with Down syndrome”. According to experts, people with Down syndrome tend to have a weaker immune system and are more susceptible to infections, for example, respiratory.
But Armann said he would wait “if it is a healthy child”. “I would wait until we had more data and had a chance to see rare side effects like myocarditis. And then I would do an analysis of who benefits from the vaccine and who doesn’t,” he said.
Armann stressed that the Pfizer-BioNTech study involved too few people so that communities could confidently initiate mass vaccination programs.
He said, for example, that there are signs that some boys and boys get myocarditis, an inflammation of the heart muscle, after receiving immunizations against Covid-19. Cases tend to be mild and rare — but specifically for that reason, said Armann, a study of just over 2,200 children is a very small sample.
Children’s immune system activates quickly
There is another reason why some experts advise to exercise caution: only a few children infected with Covid-19 have severe cases. The infection often resembles a mild cold.
The human immune system uses pattern-recognizing receptors — like the shape of a virus — to defend the body against a viral attack, Roland Eils said in an interview with DW. But these receivers need to be activated.
“Once activated, they trigger the production of interferon, which is the main line of defense against any viral infection,” said Eils, who heads the digital health department at Berlin’s Charité Hospital.
“And we found that the children’s immune system was [muito bom em ativar] these receptors compared to adults,” he added.
Schools as Covid-19 super-spreaders
Eils is not against vaccinating children because, even though infections tend to be mild, they can still transmit the virus to others.
In Germany, last year showed some evidence of this. Even when and where the overall incidence rate has increased relatively slowly, schools have sometimes become sites of overspread.
If there are dozens of unvaccinated children sitting next to each other, it is possible that higher incidence rates will occur. Some German communities have seen weekly incidence rates of 500 per 100,000 population, which is quite high.
Talaat says vaccinating children will contribute to collective immunity. That’s a global goal — and the main way we can eventually overcome the pandemic.
In addition, Talaat stressed that the effects of Covid-19 affect children’s lives in terms of lockdowns, quarantines, closed schools, inability to carry out normal activities and so on. “The best way to get their lives back to normal is to get them vaccinated,” he added.
That would be a way for 10-year-old Maja’s dream to come true and welcome all her friends to a huge sleepover.
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