Key Takeaways:
- According to federal health experts, Pfizer’s COVID-19 immunizations in kid-sized doses appear to be safe and effective for children under the age of five.
- Children who received Pfizer’s shots throughout testing had significant levels of virus-fighting antibody that should protect them from coronavirus, according to the FDA.
- Although the FDA is not required to accept the group’s recommendations, it is seen as a significant step in publicly evaluating the injections.
Pfizer’s COVID-19 vaccinations in kid-sized dosages appear to be safe and effective for children under the age of five, according to federal health experts, a major step toward a long-awaited choice to begin vaccinating America’s youngest children.
The FDA released its review of the Pfizer vaccine ahead of a conference on Wednesday where independent experts will vote on whether the vaccines are safe for the nation’s 18 million newborns, toddlers, and preschoolers. In the United States, only children under the age of five are not yet eligible for the COVID-19 vaccine.
The FDA published a similar examination of Moderna’s vaccinations for youngsters under six late last week.
Vaccinations might begin as early as next week if authorities approve one or both companies’ jabs, with drugmakers prepared to quickly deliver dosages needed by the government. Parents have been pleading with federal officials for months to allow them to protect their children as more adults forgo masks and other public health protections.
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Although only about 3% of COVID cases in the United States are in children aged six months to four years, hospitalization and death rates in this age group are higher than in older children, according to the FDA’s analysis, which is one reason experts believe protecting this group is critical.
According to the FDA, children who received Pfizer’s shots during testing had significant levels of virus-fighting antibodies that should protect them from coronavirus. That is the fundamental requirement for FDA approval. However, further testing revealed significant differences, with Pfizer achieving better outcomes.
Although that assessment was based on just 10 cases diagnosed by study participants, Pfizer’s vaccine, given in a three-shot sequence, proved to be 80 percent effective in avoiding symptomatic COVID-19. As Pfizer’s research continues, the figure could alter.
Though the two firms’ injections were tested simultaneously during the pandemic, when different strains were circulating, Moderna’s two-dose series was only around 40% to 50% effective at preventing milder illnesses. Moderna has started experimenting with a booster for toddlers.
Before voting, the FDA will invite an independent panel of vaccination experts to debate the facts presented by both businesses on Wednesday. Although the FDA is not obligated to accept the group’s recommendations, it is considered an important step in publicly assessing the shots.
Following Wednesday’s all-day meeting, the FDA will announce an official decision. The next stage will be for the Centers for Disease Control as well as Prevention, which makes vaccine recommendations, to convene its expert panel to discuss which children require vaccinations.
It’s unclear how high the demand for the shots will be at first. According to a recent survey, only one out of every five parents of small kids would get their children immunized immediately. Vaccines for older U.S. kids have been available since November, but government records show that only about a third of those aged five to eleven have received the two required doses.
Pfizer and Moderna offer varying dose amounts and quantities of shots for the youngest children, starting at 6 months and going through four years for Pfizer and five years for Moderna.
Pfizer and BioNTech intend to provide two shots three weeks apart, followed by a third shot at least two months later, each one-tenth the dose given to adults. Pfizer is now the sole manufacturer that offers a COVID-19 vaccine for older children in the United States.
Moderna is requesting FDA approval for two shots, each of which is a fourth of the adult dose and is administered four weeks apart.
Moderna’s vaccine is currently only approved for adults by the FDA. However, several countries allow full-size doses for teenagers and half-size doses for children aged six to eleven, which the FDA is also reviewing.
According to U.S. health officials, more than 30,000 children under five have been hospitalized with COVID-19, with approximately 500 coronavirus deaths reported in that age group.
Last Monday, the government gave pharmacies and stated permission to take orders for tot-sized pills, with five million initially available — half from Pfizer and half from Moderna.
Source: Global News
