Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children under 5, the company announced on Monday, another step towards vaccines for the little ones possibly early summer.
Pfizer plans to submit the findings to US regulators later this week. The Food and Drug Administration is already evaluating a request from rival Moderna to offer two-dose vaccinations to toddlers – and set June 15 as a tentative date for its independent scientific advisers to publicly debate data from one or both companies.
The news comes after months of anxious waits by desperate parents to get their babies, toddlers and preschoolers vaccinated, especially as COVID-19 cases rise again.. The 18 million young people under the age of 5 are the only group in the United States who are not yet eligible for vaccination against COVID-19.
Pfizer has fallen on hard times understand his approach. It aims to give toddlers a very low dose – just a tenth of the amount adults get – but found during its trial that two shots didn’t seem strong enough for preschoolers. The researchers therefore gave a third injection to more than 1,600 young people – aged between 6 months and 4 years – during the winter surge of the omicron variant.
In a press release, Pfizer and partner BioNTech said the extra dose did the trick, boosting children’s anti-virus antibody levels enough to meet FDA criteria for emergency use of the vaccine. no security issues.
Preliminary data suggests the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned that the calculation is based on just 10 cases diagnosed among study participants at the end of April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update as soon as more data becomes available.
Although the effectiveness of the vaccine could probably change somewhat, “this is all very positive for parents who are looking forward to having a vaccine for their young children in the months to come,” said Dr William Moss of the 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 in helping parents protect their children,” agreed Dr. Jesse Goodman of Georgetown University, the FDA’s former chief of vaccines. But he warned that it is essential to track the duration of protection, especially against serious illnesses.
And after? FDA Vaccine Chief Dr. Peter Marks has pledged the agency “will act quickly without sacrificing our standards” in assessing Pfizer and Moderna’s early doses.
Comparing the two companies’ approaches to vaccinating the smallest children promises to be difficult.
Moderna asked the FDA to authorize two injections, each containing a quarter of the adult dose. Although this stimulated good levels of anti-virus antibodies, Moderna’s study found that efficacy against symptomatic COVID-19 was only 40% to 50% during the omicron surge, a much like for 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.
It’s something Moderna plans to investigate, and Moss said he doesn’t expect the issue to delay FDA clearance for the first two doses.
To complicate Moderna’s progress, the FDA has so far licensed its vaccine for use only in adults. Other countries allow it as young as 6 years old, and the company is also seeking FDA clearance for teens and elementary-aged children.
The FDA tentatively scheduled its expert panel to review Moderna’s vaccine for older children a day before addressing the issue of shots for younger children.
If the FDA approves either or both vaccines, the Centers for Disease Control and Prevention should recommend whether all children under age 5 should receive the shots or only those at high risk.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some children become seriously ill or even die. And the omicron variant has particularly affected children, with those under 5 being hospitalized at higher rates than at the height of the previous delta surge.
It is not known how many requests there will be to vaccinate the youngest children. Pfizer vaccines for ages 5 to 11 opened in November, but only about 30% of that age group received the recommended initial two doses. Last week, US health officials said elementary-aged children should be given a booster shot just like everyone 12 and over is supposed to get it, for the best protection against the latest coronavirus variants.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.
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