FDA's Vaccine Committee Votes in Favour of Issuing EUA for Pfizer's COVID-19 Vaccine in Children Aged 5 to 11 Years
By Denise Baez
NEW YORK -- October 26, 2021 -- The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of issuing an Emergency Use Authorization (EUA) to the Pfizer-BioNTech BNT162b2 coronavirus disease 2019 (COVID-19) mRNA vaccine in children aged 5 to 11 years.
The vote was nearly unanimous, with 17 members voting “yes” for the EUA and 1 member abstaining from voting. No member voted against the EUA.
The FDA’s VRBPAC committee voted on the following question: Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine, when administered as a 2-dose series, outweigh its risks for use in children aged 5 to 11 years?
The almost 8-hour deliberation covered efficacy and safety data from 2 paediatric cohorts in the phase 2/3 C4591007 study. The evaluable efficacy population from both cohorts, without evidence of prior infection, included 1,305 participants who received the BNT162b2 vaccine and 663 participants who received a placebo. Of the children, about 12% were obese and about 8% had asthma. Most (71%) participants were from the United States.
Response rates in children aged 5 to 11 years were similar to those observed in adolescents and young adults aged 16 to 25 years (99.2% response rate for both age groups). There were 3 cases of confirmed COVID-19 in the vaccine group (occurrence from 7 days after dose 2) and 16 cases in the placebo group, for a vaccine efficacy of 90.7%. There were no cases of severe COVID-19 or cases that required hospitalisation in either group. Most cases occurred in July and August 2021 when the Delta variant was widely circulating; however, no virus sequence analyses were available to confirm the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant.
The most common unsolicited adverse event was lymphadenopathy, which occurred in 19 children in the BNT162b2 group and in 4 children in the placebo group. There were no reports of myocarditis, pericarditis, or anaphylaxis. There were no deaths.
Many Committee members, as well as people who spoke during the open public hearing session expressed concern about the exact benefit that the vaccine will provide in very young children, who generally fare well if infected with SARS-CoV-2, as well as the very limited safety data. According to the Centers for Disease Control and Prevention (CDC), over 40% of children in the United States have already been infected with SARS-CoV-2, and may be already adequately protected or may not need 2 doses of a COVID-19 vaccine. Many Committee members said that voting yes to the EUA would allow high-risk children, such as transplant recipients or children with comorbidities, to receive the vaccine. However, healthy children who are not high-risk should not be forced to be vaccinated, especially if the impact of prior infection is unknown.
“We know that about 68% of the children who are hospitalised with COVID-19 have underlying comorbidities, that means that about 32% do not,” said Committee member H. Cody Meissner, MD, Tufts University School of Medicine, Medford, Massachusetts. “Then if we take 40% of that group who may have immunity already, we are getting down to a very small percent of otherwise healthy 5- to 11-year-old children who might derive some benefit [from the vaccine]. And we simply don’t know what the side effects are going to be. It’s not even clear if this vaccine will reduce rates of transmission.”
“This vaccine should be available to parents who are very eager to get it because their child has a comorbidity,” he said. “However, I worry if we vote yes, the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that. I think that would be an error at this time until we get more information about the safety.”
The vaccine formulation for children aged 5 to 11 years is nearly identical to the one that is approved for those aged 12 years and older, except for the lower dose of mRNA (10 mcg vs 30 mcg for adults). This formulation, unlike the adult formulation, can be stored at refrigerator temperature (2-8 degrees Celsius) for up to 10 weeks prior to use. The proposed dose and regimen will be 2 doses (0.2 mL each, 10 mcg of mRNA), 3 weeks apart.
Although the committees provide recommendations to the FDA, final decisions are made by FDA, and may or may not take into consideration the committee’s recommendations. The final decision about whether to authorise the vaccine for emergency use in children aged 5 to 11 years is expected in the next few days.
SOURCE: US Food and Drug Administration