BackUS weighs authorizing Pfizer Covid vaccine for younger children
If, as expected, the independent experts convened by the FDA vote in favor, it will set in motion a series of actions leading to 28 million more Americans becoming eligible for immunization.
PremiumA high level medical panel of US government advisors was meeting Tuesday to decide whether to authorize the Pfizer Covid-19 vaccine in five-to-11-year-olds, likely paving the way for younger children to get their shots within weeks.
If, as expected, the independent experts convened by the Food and Drug Administration (FDA) vote in favor, it will set in motion a series of actions leading to 28 million more Americans becoming eligible for immunization.
Opening the meeting, senior FDA scientist Peter Marks said younger children were "far from being spared harm of Covid-19," adding there had been 1.9 million infections, 8,300 hospitalizations, roughly a third of which required intensive care.
There have also been around 100 deaths in this age group, making it a top 10 leading cause of death, he added.
Marks acknowledged there had been "strong feelings" expressed by the public on vaccine mandates for school children, but stressed this issue was outside the panel's purview and it must focus solely on the science.
The question before the experts: 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, the FDA uploaded an analysis by Pfizer that showed the vaccine -- given at 10 micrograms instead of 30 micrograms as in older groups -- was 90.7 percent effective at preventing symptomatic Covid-19, and there were no serious safety issues.
The FDA also posted its own briefing document containing a risk-benefit analysis, which indicated 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 five through 11 years outweigh the risks of myocarditis and other safety concerns that people may have," Henry Bernstein, a pediatrician at Cohen Children's Medical Center in New York, told AFP.
There have also been more than 5,000 cases of multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, which has claimed 46 lives among children of all ages.
"Of course, we want to protect the children, but we also want them to not be transmitting SARS-CoV-2 virus 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 were 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 authorized 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.
The 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 hospitalizations prevented.
But even then, it added, the benefits might still exceed the risks, because non-hospitalized Covid-19 cases can have more serious consequences than side-effects, which are normally temporary.
The United States is emerging from its latest wave driven by the Delta variant. There are currently around 70,000 daily cases, down a quarter from last week.
But infections remain high in northern states such as Alaska, Montana, Wyoming and Idaho, which are experiencing colder weather and have lagging vaccination rates.
Overall, 57 percent of the total population is now fully vaccinated.
Vaccine confidence has risen in recent months, but the United States remains behind every other G7 nation in percent of population fully vaccinated.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!
