FDA says Pfizer COVID vaccine appears to be safe, effective in children under 5 years old

FDA says Pfizer COVID vaccine appears to be safe, effective in children under 5 years old

FDA says Pfizer COVID vaccine appears to be safe, effective in children under 5 years old

Washington – Federal health officials said Sunday that Pfizer’s doses to children COVID-19 vaccines appear to be safe and effective for children under the age of 5, an important step towards a long-awaited decision to: start vaccinating the youngest American children

The Food and Drug Administration released its analysis of the Pfizer recording ahead of a Wednesday meeting where outside experts will vote on whether the photos are ready for the country’s 18 million babies, toddlers and preschoolers. Children under 5 are the only group not yet eligible for COVID-19 vaccination in the US

Late last week, the FDA released a similar analysis of Moderna’s shots for children under six.

If regulators approve the injections by one or both companies, vaccinations could begin as early as next week with drug manufacturers ready to quickly ship government-ordered doses. Parents have been pushing for months for federal officials to have the chance to protect their smallest children as more adults shed masks and abandon other public health precautions.

While only about 3% of U.S. COVID cases fall in the 6-month to 4-year-old age group, hospitalizations and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said. protecting this group is important.

The FDA said children who received Pfizer injections during testing developed high levels of virus-fighting antibodies that were expected to protect them against the coronavirus. That’s the basic threshold needed to get FDA approval. But additional testing revealed important differences, with stronger results for Pfizer.

Pfizer’s vaccine, given as a series of three injections, was found to be 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed in study participants. The figure could change as Pfizer’s investigation progresses.

The two-dose series of Moderna was only about 40% to 50% effective at preventing milder infections, although the two companies’ injections were tested at different times during the pandemic, when different variants were circulating. Moderna has started testing a booster for toddlers.

On Wednesday, the FDA will ask an independent panel of vaccine experts to discuss the data from both companies before voting. The FDA is not obligated to follow the group’s recommendations, but the process is seen as an important step in publicly vetting the recordings.

The FDA is expected to make its official decision shortly after Wednesday’s meeting all day. Next step: The Centers for Disease Control and Prevention, which makes recommendations for vaccine use, will convene its own panel of experts to discuss which toddlers need vaccinations.

It is not clear how much demand there will be for the shots initially. A recent study suggests that only 1 in 5 parents of young children would have their children vaccinated right away. Vaccines have been available to older American schoolchildren since November, but less than a third of 5 to 11-year-olds have received the two recommended doses, according to government figures.

For the youngest children, each company offers different dose sizes and number of injections, starting at 6 months to 4 years for Pfizer and up to 5 years for Moderna.

Pfizer and its partner BioNTech plan to offer two shots three weeks apart, followed by a third at least two months later – each one tenth of the dose given to adults. Pfizer is currently the only company with a COVID-19 vaccine for older American children.

Moderna is seeking FDA approval for two shots, each a quarter of the adult dose, about four weeks apart.

The FDA currently allows Moderna’s vaccine to be used only in adults. But some states allow large doses for teens and half-size shots for children ages 6 to 11 — a move the FDA is also considering.

More than 30,000 American children under the age of 5 have been hospitalized with COVID-19, according to US health officials, and nearly 500 deaths from the coronavirus have been reported in that age group.

The government allowed pharmacies and states to place orders for large doses last week, with 5 million initially available — half made by Pfizer and the other half by Moderna.