- A new study has investigated the side effects of the Pfizer-BioNTech vaccine against COVID-19 in extremely vulnerable adolescents aged 12–15 years.
- Results show that the side effects are likely to be mild to moderate and clear up after 1 week.
- The research also notes increased acetaminophen use after the first dose and more fever than observed in studies involving adult participants.
Every year, vaccination saves millions of lives. Vaccines work by training the immune system — the body’s defense network — to identify and ward off foreign bodies, which are usually viruses and bacteria.
When the body comes into contact with these offending agents after the vaccination, it is well prepared to destroy them, thus preventing illness.
As the world faces the COVID-19 pandemic, vaccines have become one part of an important strategy to protect against hospitalization and death. This is in addition to wearing a face mask, physical distancing, and following good hygiene practices, such as hand-washing.
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Recently, scientists have set out to investigate vaccine tolerability and safety in adolescents aged 12–15 years with neurological conditions — that is, diseases affecting the brain, spinal cord, nerves, and muscles — such as epilepsy, muscular dystrophy, and cerebral palsy.
The research pulls data of over 20 adolescents at risk who received the Pfizer-BioNTech BNT162b2 vaccine.
The results of the study appear in the journal Archives of Disease in Childhood.
Parents of 27 adolescents with severe neurodisabilities who met the criteria to receive the vaccine took notes of any side effects that their children might have experienced after vaccination.
The scientists assessed these data in order to determine the Pfizer-BioNTech vaccine’s safety.
The aim was to help the scientists in weighing the benefits against risks for future COVID-19 vaccinations for each participant.
The parents noted their observations in a diary, and their progress was monitored through phone calls.
Results showed mild to moderate side effects except for one person, who experienced severe fatigue and discomfort. Additionally, the person also showed increased agitation until the seventh day.
One family reported cluster seizures — that is, two or more seizures within a 24-hour period — that also resolved on day 7.
On administration of the first dose of the vaccine, the parents reported eight adverse events in six adolescents that resolved under 72 hours. The adverse events included headache, diarrhea, mild rash, presumed sore throat, difficulty sleeping, low blood sugar, and neck pain.
After the second dose, the parents reported eight additional events in five adolescents, including diarrhea, vomiting, and armpit swelling.
Fever — that is, temperature above 100.4°F (38°C) — was more common in the current study, affecting 13% of the adolescents, as opposed to 4% of people aged 16–55 years in the studies that followed adults. There were also reports of higher acetaminophen use following the first dose in the present study.
However, all recorded symptoms resolved within 1 week.
The authors of the study conclude, “The parents choosing to take up this vaccination at a time when it was off- license, with little available safety data, did so because they (and their clinicians) believed their children to be at high risk of COVID-19 disease. Indeed, many had been shielding and felt that vaccination would make a significant difference to their lives.”
This conclusion is in line with the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization, which recommends the Pfizer-BioNTech vaccine as suitable for use in adolescents.
According to WHO, “the [Pfizer-BioNTech] vaccine is suitable for use by people aged 12 years and above. Children aged between 12 and 15 who are at high risk may be offered this vaccine alongside other priority groups for vaccination.”
What the results mean
Medical News Today reached out to experts, seeking their opinion on the study.
Somto Chloe Keluo-Udeke, a public health research consultant and pharmacist, had a rounded take on the result of the study.
Keluo-Udeke explained, “The major bone of contention [among public health experts] is the benefit of vaccinating adolescents (at this time) when the overall risk of [COVID-19] is much lower in this age group, and global vaccine supply is still limited.”
“However, with vulnerable children,” she added, “the risk is increased, so vaccinating them in light of the safety and tolerability of the vaccine has become pertinent. What this study does is that it adds to the growing body of evidence in support of vaccinating vulnerable children and provides us some real-world data on their vaccination experience.”
Dr. Ayobola Adebowale, a senior pediatrician, sounded a note of caution, especially because of the limited sample size of this study.
She told MNT that the sample size used was not representative of all children and was too small to conclude from.
Dr. Adebowale explained, “The age range [in this study] is limited, so if you are thinking about children generally, adolescents were the focus of the study, and you cannot use them to represent the younger age group.”
“Also, the sample size is too small to draw a good conclusion about the vaccine, its effects on children and safety,” she concluded.
Given these expert opinions, it is difficult to ignore the fact that, despite promising results, this is just the beginning of research in this area. Scientists need to build from this body of work to get more answers.
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