BioNTech/Pfizer Covid vaccine triggers ‘robust’ response in younger children

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The BioNTech/Pfizer Covid-19 vaccine is safe and triggers “robust” immune responses in children aged five to 11, the companies said in a joint statement on Monday, announcing plans to submit the data to regulatory bodies “as soon as possible”.

In a phase 2/3 trial, the companies administered two 10-microgram doses of the shot to children 21 days apart. Antibody responses were similar to those seen in people aged 16 to 25 who received two 30-microgram doses, which are used in patients older than 12.

The Pfizer vaccine was the first to be authorised in the US for use in adolescents over the age of 12.

Albert Bourla, Pfizer’s chief executive, said the company was “eager to extend the protection afforded by the vaccine to this younger population” in the face of the increasing spread of the Delta variant worldwide. He said the trial results provided “a strong foundation for seeking authorisation of our vaccine for children 5 to 11 years old”.

Results from trials in children under the age of five were expected “later this year”, the companies said.

Sara Goza, a physician and former president of the American Academy of Paediatrics, said it was important the US Food and Drug Administration looked at the vaccine data as soon as it was submitted by the companies.

“We need to make sure that the studies are done and that the safety is checked. We want to make sure this vaccine is safe and effective in children,” she told The Financial Times. “Children aren’t just little adults so, as we go into the younger ages [with vaccines], we are going to have to look at different doses . . . and so that’s what is probably taking a little bit longer to get the results.”

There are growing concerns in the US and elsewhere about a rise in hospitalisations among children, which has coincided with the spread of the highly contagious Delta variant and a return to in-person teaching in schools.

The weekly Covid-associated hospitalisation rate per 100,000 children and adolescents in the US rose almost fivefold from late June to mid-August to 1.4, according to a recent Centers for Disease Control and Prevention report. For children aged four and under, the rate was almost 10 times higher than it was in late June, it said.

While the overall number of children in US hospitals with Covid has increased, it remains a small share of the overall total. But the surge in cases highlighted the critical need for preventive measures to reduce transmission, including vaccination, universal masking in schools and the use of face coverings by people aged two and over in other indoor public spaces and childcare centres, concluded the report.

A surge in Covid cases among children and adolescents, particularly in southern states, prompted some US schools to rethink their long-awaited return to classrooms at the start of the school year.

At least two school districts in Florida announced temporary closures in response to staff shortages due to Covid illness, while schools in Hamilton County, Tennessee, were closed for two days to allow students and staff to monitor potential Covid symptoms after the Labor Day holiday.

Sonja Rasmussen, a paediatrician at the University of Florida, said she was hopeful the review of the vaccine data by regulators would show it to be safe and effective.

“Although children are at lower risk than adults, they’re not at no risk — hundreds of children have died in the US since the pandemic began. A safe and effective vaccine can protect kids from severe illness and hospitalisation and allow parents to have more confidence in their safety as they send their kids to school each day.”