The request, filed with the US Medicines Agency (FDA), concerns a series of two doses, but it will eventually have three.
Le Monde with AFP
Pfizer announced, Tuesday 1 Er February, ask for emergency authorization in the United States of its VVID-19 vaccine for children aged 6 months to 4 years. The request, filed with the US Medicines Agency (FDA), initially concerns a series of two doses, but it will eventually have three.
“We believe that three doses of vaccine will be needed for children from 6 months to 4 years to reach a high level of protection against current and future variants,” said Pfizer, Albert Bourla. But “if two doses are allowed, the parents will have the opportunity to start the VVID-19 vaccination series for their child, pending the potential authorization of a third dose,” he added. ” / p>
Pfizer said that data deposit had been done “after a” FDA request, visibly eager to not waste time and accelerate the process. Some experts have already expressed to criticize this unusual approach. “Have a safe and effective vaccine available for children in this age group is a priority for the agency,” said the acting leader of the FDA, Janet Woodcock, Tuesday in a statement.
The request of Pfizer should be completely finalized “in the coming days”, said the American company. The vaccine could be available for this age group in the coming weeks. Shortly after the announcement, the FDA announced that its Committee of Experts to review the data would meet on February 15th. The opinion of this committee is not binding, but it is generally followed by the Agency.
A reduced dose
For these very young children, a dose of three sting micrograms was chosen by the pharmaceutical giant (against thirty for adults and ten for 5-11 years), in order to limit side effects. But with this reduced dose, the immune response caused among the 2 to 4 years has proved less than hopes, had announced Pfizer in December.
The company had thus said he wants to test a third dose of vaccine for this age group and had amended the protocol of its clinical trials to that effect. As part of these tests, the third dose must be injected at least two months after the second, the first two remaining injected at three weeks apart from each other. Data on the third dose are expected “in the coming months”, said Tuesday Pfizer.
The United States has approximately 23 million children under 5 years old. Many parents look forward to the opportunity to vaccinate their very young children, last age category that can not be possible for the moment. But the health authorities will also face a great skepticism on the part of other parents.
Immunization rates are much lower in minors. The vaccine has been available for three months in the United States for 5-11 years, but to date only 30% of them received at least one dose, and about 22% are fully vaccinated, depending on the data of the centers of centers. Prevention and control of diseases (CDC).
Young children are less likely to fall badly sick of COVID-19, but some are still hospitalized. Young children can also develop severe cases of pediatric multisystem inflammatory syndrome (MIS-C).
Some 400 children between 0 and 4 years old died from COVID-19 in the United States since the beginning of the pandemic, according to CDC figures.