Children with immediate allergic reactions to their first dose of the Pfizer-BioNTech COVID-19 vaccine safely received the second dose, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice. Children with a history of allergy to polyethylene glycol (PEG) or polysorbate also safely received the second dose, Joel P. Brooks, DO, MPH, staff allergist and immunologist at Children’s National Hospital in Washington, D.C., and colleagues wrote in the study
“We began this study as we were receiving several referrals at Children’s National Hospital from the community regarding patients who had reactions to their first dose of their Pfizer-BioNTech COVID-19 vaccine,” Brooks told Healio. “We sought to help these families protect themselves during the COVID-19 pandemic by completing their vaccination cycle.”
When the COVID-19 vaccines first became available, the CDC recommended that patients who experienced reactions to a first dose abstain from receiving a second. Studies later reported that adults with these histories who received a second dose did so safely. However, the researchers indicated that there have been no similar studies among children, with limited guidance for evaluating and proceeding with the second dose for children who reacted to the first dose.
Safe second shots
The researchers evaluated nine children (average age, 13 years; range, 8-17 years; girls, n = 2) who experienced an allergic reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine. Seven of these children had a history of allergic rhinitis, food allergy, asthma or penicillin allergy, with three reporting a history of anaphylaxis in response to food or medicine.
After the first dose of the vaccine, three of these children experienced symptoms of anaphylaxis in line with the National Institute of Allergy and Infectious Disease and Food Allergy and the Anaphylaxis Network and Brighton criteria. The other six children reported symptoms, but they did not meet this case definition. The children received the second dose of the vaccine in clinic (n = 8) or at a local pharmacy (n = 1). All nine children received the second shot in a single dose without premedication, and they experienced no or minimal symptoms.
“We were very pleased to find that all the patients who reported previous reactions to their first dose of the Pfizer-BioNTech COVID-19 vaccine were able to tolerate their second and, in some cases, third doses without any adverse reactions,” Brooks said. “This suggests that their symptoms might not have been triggered by the traditional allergic pathways.” These results were consistent with data from studies of reactions to the Pfizer-BioNTech vaccine among adults, according to the researchers. Also, most of the initial reactions to the vaccine did not support a mechanism mediated by IgE, which is why they did not use any premedication before the second dose.
Next, the researchers evaluated four children (average age, 16 years; range, 15-17 years; girls, n = 2) who had clinical histories concerning PEG or polysorbate allergy. mRNA vaccines contain PEG 2000, an excipient that stabilizes the lipid nanoparticle of the vaccine. Each of these children tolerated PEG 3350 laxative without any issues. Three of them then received the first and second doses of the Pfizer-BioNTech COVID-19 vaccine without any symptoms. The fourth received the Johnson & Johnson COVID-19 vaccine. “We were also reassured to find that patients with suspected polyethylene glycol or polysorbate allergies were able to safely receive their Pfizer-BioNTech COVID-19 vaccine without any adverse reactions,” Brooks said.
Talking with patients, parents
Although the researchers cautioned that their study used a small sample size and that it was characterized by referral bias and a lack of objective diagnostic measurements, they concluded that children with mild to moderate reactions to the first dose of an mRNA COVID-19 vaccine could safely receive the second. “The second dose of Pfizer-BioNTech vaccine can be administered safely in children with a history of immediate and potentially allergic reactions to the first dose, as well as in children with a history of polyethylene glycol or polysorbate allergy,” Brooks said.
Brooks also advised clinicians to engage in clear communication with parents who may be hesitant about their children receiving the vaccine. “When discussing the Pfizer-BioNTech COVID-19 vaccine with hesitant parents, we recommend building trust, presenting vaccination as the default approach, describing the benefits of vaccines, being honest about side effects, providing reassurance on a robust vaccine safety system and focusing on protection of the child and community,” he said. “While the Pfizer-BioNTech COVID-19 vaccine was created quickly, it was rigorously tested for safety.”
Noting how their research provides insight into the safety of administering the Pfizer-BioNTech COVID-19 to children who had reactions to the first dose, Brooks said these findings will help them resume their normal activities and keep communities safe and healthy. “Our next project is to analyze the data reported to the Vaccine Adverse Event Reporting System for pediatric patients to better understand the complications affecting this unique population,” Brooks said.
- Children with a history of allergic reactions to first dose of Pfizer COVID-19 vaccine can safely receive second dose. https://www.aaaai.org/About/News/News/reaction. Published July 13, 2022. Accessed July 22, 2022.