Lauren Neergaard, The Associated Press Posted on Monday, May 23, 2022 7:00 AM EDT Last Updated on Monday, May 23, 2022 3:53 PM EDT
Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children under the age of 5, the company announced on Monday, a further step towards vaccines for younger children possibly in early summer.
Pfizer is scheduled to present the findings to U.S. regulators later this week. The Food and Drug Administration is already evaluating a request from rival Modern to offer two-dose vaccines to children, and set June 15 as the provisional date for its independent scientific advisers to publicly discuss one or both companies.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases rise again. The 18 million young people under the age of 5 are the only group in the U.S. that is not yet eligible for COVID-19 vaccination.
Pfizer has had trouble figuring out its approach. He aims to give children an extra low dose, only a tenth of the amount adults receive, but during his test he found that two injections did not seem strong enough for preschoolers. Thus, the researchers gave a third injection to more than 1,600 young people, from 6 months to 4 years, during the winter increase of the omicron variant.
In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, raising children’s anti-virus antibody levels enough to meet FDA criteria for use. Vaccine Emergency Without Safety Issues
Preliminary data suggested that the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but warned that the calculation is based on only 10 cases diagnosed among study participants at end of April. The rules of the study state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
While the effectiveness of the vaccine could probably change a bit, “all of this is very positive for parents who expect to have a vaccine for their younger children in the coming months,” said Dr. William Moss of Johns. Hopkins Bloomberg School of Public. Health, which was not part of the study.
If the FDA confirms the data, the vaccine could “be an important tool to help parents protect their children,” agreed Dr. Jesse Goodman of Georgetown University, a former head of vaccines at the FDA. But he warned that it is essential to keep track of how long the protection lasts, especially against serious illnesses.
What’s next? The head of vaccines at the FDA, Dr. Peter Marks, has promised that the agency will “move quickly without sacrificing our standards” when evaluating child-sized doses for both Pfizer and Moderna.
Comparing the approaches of the two companies to vaccinating younger children promises to be a challenge.
Moderna asked the FDA to authorize two injections, each containing a quarter of the dose given to adults. Although this stimulated good levels of anti-virus antibodies, Moderna’s study found that the effectiveness of symptomatic COVID-19 was only 40% to 50% during the increase in omicrons. just like adults who have only received two doses of vaccine.
“We’ve learned in older children and adults that … we really need three doses to get protection” against newer variants like omicron, Moss said.
This is something Moderna plans to study, and Moss said he did not expect the question to preclude FDA authorization of the first two doses.
Complicating Moderna’s progress, the FDA has so far allowed its vaccine to be used only in adults. Other countries allow it to be given up to the age of 6, and the company is also seeking FDA approval for teens and elementary school children.
The FDA has provisionally planned for its panel to consider the Moderna vaccine for older children one day before the issue of vaccinations for younger children is raised.
If the FDA approves one or both vaccines, the Centers for Disease Control and Prevention should recommend whether all children under the age of 5 should be vaccinated or only those at high risk.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some children get seriously ill or even die. And the omicron variant especially affected children, with children under 5 hospitalized at higher rates than at the peak of the previous delta surge.
It is unclear what demand there will be for vaccinating the little ones. Pfizer injections for children ages 5 to 11 were opened in November, but only about 30% of this age group have received the two recommended starting doses. Last week, U.S. health officials said primary school children should receive a booster vaccine as everyone should be given 12 years of age or older to get the best protection against it. the latest coronavirus variants.
___
The Associated Press Department of Health and Science is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.