Families and paediatricians in the United States eagerly await the Food and Drug Administration's approval for a COVID-19 vaccine. The vaccine will be approved by the FDA for approximately 28 million children aged 5-11 years old. Yesterday, the FDA advisory committee reviewed data of a clinical trial that tested a low-dose vaccine from BioNTech and Pfizer on children aged 5-11 years old. They voted almost unanimously to approve the FDA's emergency approval.
Infectious-disease experts are anticipating that the FDA and US Centers for Disease Control and Prevention will soon approve the vaccine and that distribution will begin to children in the coming weeks.
Emma McBryde from the Australian Institute of Tropical Health and Medicine, Townsville, believes it will save lives. It could have a wider impact as many children in America aged 5-11 have returned to school without being vaccinated over the past few months. This group is responsible for a large portion of COVID-19 cases. They are capable of passing the coronavirus SARS/CoV-2 to others. She says that for every child's life saved, there are many more adult lives you can save.
The risks are outweighed by the benefits
On 26 October, the FDA advisory panel approved the vaccine based on clinical-trial data that showed the PfizerBioNTech vaccine was about 91% effective in preventing symptoms of SARS-CoV-2 in children aged 5-11 years. Nearly 4,650 children took part in the trial. Nearly two-thirds of them received vaccine doses one-third lower than an adult jab. The rest received placebos. The procedure was similar to the one used in the United States to vaccine adults with the messengerRNA jab. Children received two doses of vaccine, each three weeks apart.
The data from the vaccine's safety testing have been positive for the children who were tested. There has been a small risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart), with mRNA-based vaccines. This is especially true for young men. Andrew Pavia, chief of University of Utah Health's division of paediatric infectious disease, said that neither condition was reported in the children aged 5 to 11. This is an encouraging sign. Pavia points out that regulators would have to be on the lookout for side effects if the shot was distributed to a wider population.
Independent FDA reviews of Pfizers data were done before the advisory panels met. They evaluated six hypothetical US scenarios with different levels of virus and determined that the vaccine's benefits outweighed the risks. Officials concluded that the vaccine's overall benefits outweigh any potential heart risks, even though virus levels are low in the country. This is unlike COVID-19 which can cause death.
SARS-CoV-2 is less deadly in children younger than in those older. CDC reports that 440 children between 5 and 18 years old died from COVID-19 in the United States. This compares to 724,000 deaths in all age groups. The combination of returning kids to school and a spike in cases due to the highly transmissible SARS-CoV-2 Delta virus resulted in a dramatic rise in paediatric cases since late July. According to an American Academy of Pediatrics report, almost one-third of the nearly 6.3 million children in America who tested positive for COVID-19 during the pandemic started.
Pavia states that the risk-side of the equation is compelling because of the Delta's impact on this age group of children. It won't be difficult to approve the vaccine, I think.
Looking ahead
Since September, COVID-19 cases in the United States have fallen after the Delta surge. The trend is expected to continue into 2022 by most modellers, regardless of whether or not the Pfizer vaccine for children aged 5-11 years old has been approved. This is unless there's a new variant of concern, according to Katriona Shea (an applied theoretical ecologist at Pennsylvania State University in University Park). It would be a shame if there is a new variant.
Shea is co-lead of the COVID-19 Scenario Modeling Hub. This hub released its ninth forecast on the pandemics trajectory in September. It included a prediction about how a vaccine for children under 511 might affect the number of new infections and deaths in the United States. Shea states that the forecast is a combination of the predictions from nine other modelling teams. It shows that vaccines for children would result in lower cases, but it may not make a significant difference at the population level if the Delta variant is chosen. The data shows that inoculating children with vaccines could make a difference in the course of the pandemic in America if a worrying variant emerges by mid-November.
The White House released last week a plan to distribute lower-dose shots to hospitals, pharmacies and paediatricians in preparation for the possibility that the jabs will be authorized by US regulators.
Even if the PfizerBioNTech shot has been approved, it is still unknown how the children in the 511 age bracket will feel about being vaccinated and whether their caregivers will allow it. Mina Fazel, a child psychiatrist and adolescent psychiatrist at Oxford University, UK, conducted a survey of nearly 28,000 children aged 9-18 at 180 schools in the UK. They found that younger children were less likely to make a decision than their older peers.
Survey results also showed that social media played a role in the decision to give the vaccine. Students who spent more time on social networks than usual were less likely to accept it. Fazel states that there is a new generation of young people who engage with information and learn at an unprecedented scale. Fazel also says it is important to create public-health campaigns for children.
Global implications
It remains to be seen what the approval of a vaccine for US kids aged 511 will mean globally. Nearly 70 countries have vaccinated less that one-fifth their population and won't vaccinate children younger than this for months or years. Some countries, such as Israel, wait to see what the US regulators decide before they approve their jabs.
However, other countries are also vaccinating children younger than 12. Some countries, such as Chile, China and Cuba, have started to inoculate children with COVID-19 vaccines over the past three months.
McBryde states that childhood vaccination is essential in areas where there is low natural immunity due to community transmission. Australia plans to open its international border to citizens and permanent residents in November. This will allow them to enter and leave the country if their vaccination rate has reached 80%. McBryde warns that the move will allow the virus to enter the country. Therefore, it is important to make the landing as smooth as possible and to build up immunity through vaccination, which includes children. Australia's regulators have yet to approve shots for children younger than 12.
Moderna, a vaccine manufacturer based in Cambridge Massachusetts, stated that it is safe and effective to give a low dose of its mRNA based jab to children 6-11 years old on 25 October. However, FDA approval has yet not been granted. According to a statement made by Moderna's chief executive at an event hosted by The Atlantic, data on Pfizers jabs for children under 5 years old is expected by the end the year. Moderna is also running a trial for children as young as 6 months.
This article was published with permission on October 27, 2021.
