WASHINGTON – A high-level medical panel of United States government advisers will meet today to decide whether to authorise the Pfizer Covid-19 vaccine for children aged five to 11.
If, as is widely expected, the independent experts convened by the US Food and Drug Administration (FDA) vote in favour, an emergency authorisation could follow within weeks.
This would make 28 million younger children eligible for the shots in November.
The question before the panel: based on the scientific evidence available, do the benefits of the two-dose vaccine, given three weeks apart, outweigh the known risks?
Ahead of the meeting, FDA uploaded an analysis by Pfizer that shows the vaccine – given at 10mcg instead of 30mcg, as in older groups – is 90.7% effective at preventing symptomatic Covid-19, and there are no serious safety issues.
FDA also posted its own briefing document containing a risk-benefit analysis, which indicates that the agency’s scientists believe the benefits exceed the most worrying potential side effect for this age group: myocarditis, or heart inflammation.
“My initial thought is that the benefits of vaccinating children aged five through 11 outweigh the risks of myocarditis and other safety concerns that people may have,” Henry Bernstein, a paediatrician at Cohen Children’s Medical Centre in New York, said.
Overall, 160 children aged five to 11 have died from Covid-19 in the US since the start of the pandemic, according to official data – a tiny fraction of the more than 730,000 total.
But millions have been infected and thousands hospitalised. There have also been more than 5,000 cases of multisystem inflammatory syndrome in children, a rare but highly serious post-viral complication that has claimed 46 lives.
“Of course, (we) want to protect the children, but we also want them to not be transmitting Covid-19 to family members and other people in the community,” said Bernstein.
Myocarditis rate likely low
Pfizer evaluated safety data from a total of 3,000 vaccinated participants, with the most common side effects mild or moderate – including injection site pain, fatigue, headache, muscle pain, and chills.
There were no cases of myocarditis or pericarditis (inflammation around the heart), but the company said there are not enough study volunteers to be able to detect highly rare side effects.
Very rare instances of myocarditis were only detected in adolescents after the vaccine was authorised in June and given to millions of people in that age group, rather than the thousands that were tested in trials.
Scientists believe it will be even rarer among younger children, but don’t expect to know just how rare until it is green-lighted.
FDA acknowledged that, hypothetically speaking, if Covid-19 transmission was crushed within communities – as was the case last in June 2021 – the number of vaccine-induced myocarditis cases could exceed the number of Covid-19 hospitalisations prevented.
But even then, it added, the benefits might still exceed the risks because non-hospitalised Covid-19 cases can have more serious consequences than side effects, which are normally temporary.
The US is emerging from its latest wave driven by the Delta variant.
However, cases remain high in northern states such as Alaska, Montana, Wyoming, and Idaho that are experiencing colder weather and have lagging vaccination rates.
Overall, 57% of the total population is now fully vaccinated.
Vaccine confidence has risen in recent months, but the US remains behind every other G7 nation in the percentage of population fully vaccinated. – AFP, October 26, 2021
