How Safe is FDA Authorised Pfizer’s COVID-19 Vaccine for Children Aged 5 to 11?
Once the CDC issues its recommendation, 28 million eligible US children will receive the Pfizer COVID vaccine.
The world headquarters of Pfizer in New York sports a sign on its window proclaiming the victory of science over COVID-19. The pharmaceutical company made the first COVID-19 vaccine to be approved by western nations.
(Photo: IANS)
Elementary school children in the United States will soon have one more layer of protection to keep them safe from COVID-19.
On Friday, 29 October, the Food and Drug Administration authorised emergency use of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11. The move came days after a tense and careful deliberation of its key scientific advisory committee, on 26 October, in which members voted 17-0 to authorise the Pfizer shot, with one abstention.
The next necessary step in the process is for the Centers for Disease Control and Prevention to issue its guidance on how to use the vaccine in this age group, based on the FDA’s authorisation. The CDC’s Advisory Committee on Immunisation Practices is scheduled to meet on Tuesday, 2 November, and the agency’s official recommendation is expected as soon as later that day. Rollout of the Pfizer shots for children aged 5 to 11 is likely to begin days after.
Once the CDC issues its recommendation, the 28 million eligible US children in this age group will have the opportunity to receive the Pfizer shot through health departments, medical institutions, doctor’s offices, and pharmacies, as well as school and community-based sites.
Moderna has also released preliminary results showing that its low-dose vaccine is safe and produces a strong immune response in children aged 6 to 11 years. It plans to submit data to the FDA for review soon.
As a paediatrician specialising in infectious diseases, I have worked closely on many aspects of the COVID-19 response at the University of Virginia. I have helped care for children with severe COVID-19 and also observed the burden of the pandemic on children and their families.
Vaccines, which work by teaching your immune system to make disease-fighting antibodies without giving you the actual disease, have emerged as the most important tool that we currently have to prevent severe COVID-19.
Here’s how the COVID-19 vaccine was tested for efficacy and safety on children and how access to these shots could alter the impact of COVID-19 for American kids.
The Risks of COVID-19 in School-Age Children
The FDA advisory committee openly grappled with the risks and benefits of the vaccine and the weightiness of the decision for younger children. Ultimately, it concluded that parents should be presented with the option to vaccinate their kids against COVID-19. One committee member – Centers for Disease Control and Prevention vaccine expert Amanda Cohn – noted that COVID-19 was the eighth-highest killer of kids in the 5-11 age group over the past year. She pointed out that children are continuing to be hospitalised and they have reportedly died or suffer adverse long-term effects from a largely vaccine-preventable disease.
As of 21 October, more than 6 million American children tested positive for COVID-19. Cases in children rapidly increased during the delta variant surge, which coincided with the opening of in-person schools across much of the country. Children now account for a quarter of new weekly cases.
While severe disease and hospitalisation from COVID-19 are far more rare in children than in adults, intensive care admission and the need for invasive ventilation do occur in children. There have been over 1.9 million COVID-19 cases in children aged 5 to 11, with nearly 100 deaths.
Rates of COVID-19 hospitalisation among children and adolescents rose to the highest rates ever in August and September 2021, with over 8,300 children in the 5-11 age group hospitalised since the beginning of the pandemic. Many children hospitalised with COVID-19 have underlying medical conditions, but one-third of them do not.
Additionally, more than 5,200 children have been diagnosed with the rare but serious condition called multi-system inflammatory syndrome in children, or MIS-C, in the weeks after COVID-19 infection. MIS-C can cause inflammation of the heart, brain, skin, gut, and other organs, requiring hospitalisation and often intensive care. The syndrome most commonly occurs in children 6 to 11 years of age.
Though serious cases of COVID-19 are more rare in children than adults, hospitalisations of children spiked over the summer during the delta variant surge.
The pandemic has also harmed children’s social, emotional, and mental well-being and delayed their educational progress. Safe and effective vaccines are one of the most promising ways that children can be protected from COVID-19, prevent spread and have as little disruption as possible in their schooling and everyday life.
COVID-19 Vaccine Development for Children
Before use in the general public, all vaccines go through rigorous phases of testing, starting with pre-clinical studies in the laboratory and in animals. Then they must go through three phases of clinical studies in people, allowing investigators and regulators to evaluate the vaccine’s safety at each stage before moving on to test it in larger numbers of people.
Once a vaccine is shown to be safe and effective in adults, trials move on to children, who may differ in their reactions and immune response to vaccines. Going down stepwise by age, Pfizer studied children aged 12 to 15 before the younger age groups. The FDA expanded its emergency authorisation of the Pfizer COVID-19 vaccine to include that age group in May 2021. In adolescents aged 12 to 18, the vaccine was shown to reduce hospitalisations by 93 percent from June through September 2021.
Even after vaccines are authorised or approved for use, monitoring for safety continues. This allows very rare side effects not seen in large late-phase trials to be detected and investigated. Safety surveillance with the COVID-19 vaccines following authorisation in adults and older adolescents aged 16 and up quickly identified a rare increase in inflammation of the heart known as myocarditis following COVID-19 vaccines, particularly in young males. Most patients responded well to supportive care and rapidly improved. Myocarditis can also occur with COVID-19 or as a complication of multi-system inflammatory syndrome.
The Pfizer trial for those under 12 years of age began with three different doses. Ultimately, researchers determined the optimal dosage for children aged 5 to 11 to be one-third of the dose given to adults and adolescents and administered as a two-shot regimen three weeks apart.
No serious side effects related to the vaccine, and no cases of myocarditis were reported. The Pfizer data also showed that the vaccine in that age group seems to provide similar high levels of protective antibody responses to those seen in older age groups. And the antibodies produced demonstrated an ability to neutralise the delta variant.
Next Steps
Ongoing studies will continue to follow vaccinated children closely for safety and to provide more insight into the durability of immunity. The results of the Pfizer vaccine trial for the younger two age cohorts, those in the 2 to 5 years and 6 months to 2 years age group, are expected later this year. Testing of the Moderna and Johnson & Johnson vaccines in clinical trials in children is also underway.
Given that the paediatric clinical trial data show the overall benefits outweigh risks in this age group. I look forward to being one step closer to offering the COVID-19 vaccine to newly eligible children and their families if the CDC recommendations make this possible.
(This is an opinion piece and the views expressed above are the author’s own. The Quint neither endorses nor is responsible for them. This article was originally published on The Conversation. Read the original article here.)
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