13 things to know about Pfizer-BioNTech Covid-19 vaccine for kids under 12

Parents of younger kids in the US can now heave a sigh of relief as the Centres for Disease Control and Prevention (CDC) and Federal Drug Administration (FDA) have officially approved emergency authorisation for kids aged five to 11 years to receive Pfizer-BioNTech's Covid-19 vaccine.
With this approval, roughly 28 million more kids across the US will become eligible for the coronavirus vaccine. It comes at a pivotal time as schools have now reopened globally and the Delta variant is affecting more kids than ever.
While kids' risk of severe illness from Covid-19 is still low, over 791 children have died of Covid-19 in the US. Over 40 deaths have also occurred there due to a rare but serious coronavirus-linked condition called multi-system inflammatory syndrome (MIS-C), according to the CDC.
While some parents are planning to get their kids vaccinated, others are planning to wait it out before scheduling those shots.
For those in Singapore and other countries, here's everything you need to know about the Pfizer-BioNTech Covid-19 vaccine for children under 12.
Pfizer's clinical trial which started in March included 4,500 children aged five to 11 years. Almost two-thirds received a lower dose of Covid-19 vaccines and others received a placebo. This is to compare the outcomes for efficacy and side effects.
It was found that the vaccine was 100 per cent effective at protecting kids from any severe illness from the coronavirus. The levels of antibodies produced by kids in this age group were comparable to the immune response seen in kids 12 and over and adults.
Elizabeth Lloyd, M.D., a paediatric infectious diseases expert at the University of Michigan Health C.S. Mott Children's Hospital, said that the vaccine produced a strong immune response in young kids and found that in multiple scenarios, the benefits of the vaccine outweighed the risks for this age group.
Younger kids also experienced minor side effects.
For instance, more than two-thirds had pain and soreness at the injection site and two-fifths faced fatigue and nearly one-third reported headaches.
These side effects worsened after the second dose, but usually lasted just a couple of days. Lloyd explained that there were four serious adverse events that occurred during the trial, but a further probe revealed that none of them were in any way related to the vaccine.
Out of the 3,000 children who received the vaccine, there were only three cases of Covid-19, but none of them led to any severe illness.
Myocarditis is a kind of inflammation in and around the heart and is an extremely rare side effect of the vaccine. It has predominantly affected men who are under the age of 30 and about 1 in 20,000 kids aged 12 to 17 years.
The good news is that none of the kids in the Pfizer trial between the ages of five and 11 years experienced myocarditis.
However, since it's so rare, experts will continue to monitor it as a large number of kids receive the vaccine.
Experts say that younger kids have an even lower risk of developing any rare side effects because they're receiving a lower dose of the vaccine and are less likely to get myocarditis due to their developing immune systems.
For those who are 12 and above and have experienced myocarditis after the second dose of the vaccine, their symptoms are usually mild and short-lived, such as shortness of breath and chest pain. They resolve after a couple of days.
Kids in the US who fall in the age group of five to 11 years will receive about a third of the dose as compared to those 12 and older — 10 micrograms compared to the 30 micrograms adults and teens receive.
The smaller doses will be distributed with smaller needles and it will be easier for paediatricians and pharmacists to administer the vaccine to younger kids.
Experts say that studies are in progress to see if a lower dose may eventually be appropriate for adults as well.
Children aged five to 11 years will receive two doses of the vaccine three weeks apart. They will be considered fully vaccinated two weeks after they are given their second jab.
Once kids in the US are officially eligible, they will be able to get a Covid-19 vaccine from their paediatrician, at retail pharmacies, hospitals, health clinics, or even school-based sites depending on the location.
Unlike the vaccine rollout for adults, where the priority was on high-risk groups, all kids aged five to 11 will be eligible to get the dose.
Several studies conducted in adults show that the Covid-19 vaccine doesn't offer the same protection after just one shot.
According to studies, just one dose of the Pfizer-BioNTech vaccine was only 30 per cent effective against the Delta variant specifically.
Llyod mentions that both doses are necessary to get immunity and therefore, full vaccination for all ages is recommended.
The Pfizer trial for ages five to 11 years didn't exclude kids suffering from allergies, asthma or any other comorbidities, like obesity, congenital heart disease, among others.
Doctors don't recommend skipping vaccination because of any underlying medical condition.
Jesse Hansen, M.D., a paediatric cardiologist, says that vaccination is all the more important for kids who are immunocompromised in any way.
There are some kids who are on specific medications that may impact their immune response and make the vaccine less effective.
These families need to have conversations with their care teams as they plan to get their kids vaccinated.
Kids who are preparing for surgery should also consult their doctors on the best timing to get the vaccine. Experts recommend that kids with a history of any severe allergic reaction should consult with their healthcare provider.
Kids can get vaccinated as soon as they feel better and have no symptoms, and are also done with any required quarantine.
Llyod says, "It's beneficial for kids to get vaccinated after having coronavirus and I wouldn't recommend waiting longer than a couple of months."
She further explains that no harmful viral particles will be shed from those who got the Covid-19 vaccine. So, parents need not worry as there are no live viruses used in the Covid-19 vaccine.
Some kids may be scared of needles, so as parents, you can use child-friendly language to talk to them and explain why getting a shot is important not only for them but also for people around them.
Similarly, you can also use various distractions like a video on the iPad or mobile phone. Assure them that the needle prick will just be like a poke and that you will be there with them all throughout the process.
The recommendations may vary depending on how prevalent the virus is in the community. At present, both the American Academy of Paediatrics and CDC recommend kids to mask up in schools and indoors.
In Singapore, children aged six and above are legally required to wear masks. Similarly, many kindergartens and pre-schools also strongly encourage the same practice for younger kids.
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Even though children are at low risk of severe illness or death from Covid-19, unfortunately, there are some who do get hospitalised and their condition might turn fatal.
According to the federal data, ever since the start of the pandemic, in the US, over 1.9 million children aged five to 11 years have been infected, and there have been at least 94 deaths in the same age group.
There are some kids who are also experiencing other issues due to MIS-C and long-haul symptoms.
Parents, therefore, need to remember that while their child's risk of complications is low, vaccination is a simple way to protect children from Covid-19 risks and also at the same time prevent the development of new variants.
Moderna's vaccine for kids aged six to 11 is expected to be next in line to be reviewed by the FDA for emergency authorisation.
The company had announced that its Covid-19 vaccine is also safe and effective and that it plans to submit data soon.
On the other hand, Johnson & Johnson's clinical trials for kids as young as 12 are expected to start this fall.
Data from the other two age cohorts from the Pfizer trial — children aged two to five, and children aged six months to two years — are expected in the fourth quarter of this year.
Health Minister Ong Ye Kung said on Monday (Nov 8) that an expert committee will make a recommendation on whether to extend the Pfizer-BioNTech Covid-19 vaccine to children aged five to 11 in the second half of November.
His comments come after US FDA has authorised the use of the Pfizer vaccine in that age group.
Meanwhile, a fifth case of MIS-C was reported in Singapore.
This condition causes different body parts, including the heart, lungs, brain, kidney and eyes, to become inflamed following Covid-19 infection.
Kenneth Mak, Singapore's director of medical services said that of the 8,000 children infected with Covid-19 so far, two needed intensive care while another two required oxygen support.
He further added that vaccinating this age group of children will increase vaccination rates "well above" the current 86 per cent. It will allow Singapore to open up its economy further.
Amid the spike in coronavirus cases, Singapore opened up its vaccination programme to adolescents aged 12 to17 years from June 1.
The Health Sciences Authority (HSA) assessed that the Pfizer-BioNTech Covid-19 vaccine is safe for use on children in this age bracket.
The Moderna vaccine, on the other hand, is currently only given to individuals over the age of 18 years.
Children or wards below the age of 18 will require the consent of their parents/guardians to book an appointment.
To register your child for vaccination:
The health authorities in Singapore have been actively pushing for vaccination as more children have been infected with Covid-19 in 2021, as compared to infections reported last year.
Getting your kids vaccinated will give you and your child peace of mind to return to more typical activities like in-person schooling, and taking part in extracurricular activities.
However, even after vaccination, remember to mask up, maintain hand hygiene and avoid crowded places.
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This article was first published in theAsianparent.