The Pfizer-BioNTech alliance’s vaccine for COVID-19 is safe and effective for children ages six months to five years, the two companies said Monday, allowing for U.S. applications to be filed as soon as possible. soon and in the world.
During clinical trials, Pfizer-BioNTech evaluated the effectiveness of three injections, given at 3 micrograms each, a dose ten times lower than that used for adults and adolescents.
The alliance found that this vaccine elicited a strong immune response after three doses, comparable to that obtained by two doses in about 16-25 years of age. Side effects are usually mild, and the vaccine is well tolerated.
The effectiveness was 80.3% against symptomatic cases of the disease, according to a preliminary estimate.
The two companies said they will begin filing these results with the U.S. Drug Administration (FDA) this week, before doing so elsewhere in the world.
Ang FDA is already planning three meetings in June to review vaccine authorization at Pfizer for children under 5 years old, as well as by the pharmaceutical company Moderna for children under 6 years old.
Moderna filed its own clinical trial results in late April, with an effect against symptomatic infection of 51% for infants 6 months to 1 year of age, and 37% for children. 2 to 5 years old.
These youngest children represent the only age group that has not yet qualified for coronavirus vaccines in most countries.
” We look forward to finalizing our offerings to regulatory agencies around the world, with the hope of making these vaccines available to the youngest children soon. “
Ang FDA was originally scheduled to review Pfizer’s vaccine to be given in two doses in February. But at a dose of only three micrograms per bite to avoid side effects as much as possible, the immune response stimulated in about 2 to 4 years of age then proved inadequate.
So the American agency requested to see data related to a third injection.
Vaccination of children: parents are still skeptical
Many parents look forward to the opportunity to vaccinate their very young children. Others, on the other hand, show considerable skepticism, a challenge for health authorities when vaccination rates are already lower in minors than in adults.
According to a Kaiser Family Foundation survey conducted in early May, only 18% of adults with a child under 5 say they will vaccinate their child once given permission. Some 38% say they will wait to do it, and others say they will not do it unless necessary.
Serious health concerns associated with COVID-19 are rare in children under five years of age. In the United States, 477 deaths have been recorded in this age group since the pandemic began, or approximately 0.1% of all deaths.
However, like adults, some children infected with the coronavirus may have long -term symptoms of COVID. They may also have severe cases of pediatric multisystem inflammatory syndrome (MIS-C), as there are approximately 8,200 children in the United States.
Source: Radio-Canada
