Laurent Nirgaard is an AP medical writer

Pfizer announced on Monday that three doses of COVID-19 vaccine from Pfizer provide strong protection for children under 5, another step towards vaccination for the youngest children, possibly starting in early summer.

Pfizer plans to present the results to the U.S. regulator later this week. The Food and Drug Administration is already considering Moderna’s bid for two-dose vaccinations for babies – and sets June 15 as a preliminary date for its independent scientific advisers to publicly discuss data from one or both companies.

The news came after months of anxious anticipation by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases rise again. 18 million adolescents under the age of 5 are the only group in the United States not yet eligible for COVID-19 vaccination.

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Pfizer had a hard time figuring out his approach. It aims to give children a very low dose – only one tenth of the amount received by adults – but tests have shown that two injections do not seem strong enough for preschool children. Thus, the researchers made the third vaccination to more than 1,600 babies – aged 6 months to 4 years – during the winter surge of the omicron variant.

In a press release, Pfizer and its partner BioNTech said the additional injection did its job by raising levels of anti-virus antibodies, enough to meet FDA criteria for emergency vaccine use without safety concerns.

Preliminary data suggest that a series of three doses is 80% effective in preventing symptomatic COVID-19, but they warned that the calculation is based on only 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer has promised to update as more data becomes available.

Although the effectiveness of the vaccine is likely to change somewhat, “it’s all very positive for those parents who are looking forward to the vaccine for their young children in the coming months,” said Dr. William Moss of John Hopkins Bloomberg Public School. Health not involved in the study.

If the FDA confirms these data, the vaccine could be “an important tool to help parents protect their children,” agreed Dr. Jesse Goodman of Georgetown University, the former FDA head of vaccines. But he warned that it is very important to monitor how long the protection lasts, especially against serious diseases.

What’s next? The FDA’s head of vaccines, Dr. Peter Marx, has promised that the agency will “move fast without sacrificing our standards” when estimating small doses from both Pfizer and Moderna.

Comparing the approaches of the two companies to vaccinating the youngest children promises to be a challenge.

Moderna has asked the FDA to authorize two injections, each containing a quarter of the dose administered to adults. Although it stimulated good levels of anti-virus antibodies, the Moderna study found that efficacy against symptomatic COVID-19 was only 40% to 50% during the omicron burst, as for adults taking only two vaccine doses.

“We learned from older children and adults that … we really need three doses to get protection” from new options such as omicron, Moss said.

This is what Moderna plans to study, and Moss said he did not expect the issue to delay FDA approval for 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 giving it from the age of 6, and the company is also seeking FDA approval for teens and young children.

The FDA has previously scheduled its expert team to review the Moderna vaccine for older children the day before proceeding with the issue of vaccinations for the youngest.

If the FDA cancels the vaccine or both, the Centers for Disease Control and Prevention will need to recommend whether to vaccinate all children under 5 years of age or only those who are at high risk.

While COVID-19 is usually not as dangerous to young people as it is to adults, some children do get seriously ill or even die. And the omicron variant hit children particularly hard: those under 5 were hospitalized more often than at the peak of the previous delta burst.

It is unclear how much vaccination of the youngest children will be required. Pfizer injections for children 5 to 11 years of age began in November, but only about 30% of this age group received the recommended initial two doses. Last week, U.S. health authorities said that young children should receive regular vaccinations, believed to be everyone 12 years and older, for better protection against the latest coronavirus options.

The Associated Press Department of Health and Science receives support from the Department of Science Education of the Howard Hughes Medical Institute. AP is solely responsible for all content.

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