The United States allows corona vaccination for children

Frankfurt The US Food and Drug Administration (FDA) on Friday approved the two Covid vaccines from Pfizer / Biontech and Moderna for use in infants six months and older. A panel of experts from the authority had previously voted unanimously in favor of the approval.

The two companies have also submitted applications for approval for this age group in Europe. A decision by the responsible European Medicines Agency may also be pending in the next few weeks.

In contrast to the use of vaccines for adults, the two companies use different vaccination strategies for infant vaccines. Moderna has tested a procedure with two vaccinations in a dose of 25 micrograms each for the age group up to six years. This is equivalent to a quarter of the usual dose of 100 micrograms in adults.

According to the company, the resulting immune response and antibody concentrations in the young children corresponded to the levels previously observed in young adults.

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The effectiveness of the vaccine, that is, the relative reduction in the risk of infection, was determined by the FDA to be 36.8 percent in children aged two to six years and 50.6 percent in infants aged six months to two years. .

>> Also read: Biontech founder Sahin: “We need to be prepared that we always need booster vaccinations”

The significantly lower efficiency compared to the original study in adults is attributed to the fact that the study was conducted as part of the omicron wave. The previously approved Covid vaccines are less effective against the omicron variant than against previous virus forms.

Corona vaccination for young children: three vaccinations with Biontech / Pfizer

Pfizer and Biontech tested their vaccine at a significantly lower dose of only three micrograms per day. vaccination. However, it turned out that a double vaccination only gave insufficient immune responses. The two companies therefore decided to expand their study to include a triple vaccination with a dose of 3 micrograms.

This vaccination regimen finally led to a similarly strong immune response as vaccination in adolescents. The efficacy was reported at 80.4 percent, with the calculation based on three cases of infection in the group of vaccinated children and seven cases in the placebo group.

In view of the relatively small number of infection cases in both studies, the experts assessed the vaccines primarily on the basis of the measured immune responses and antibody concentrations.

The safety profile was described as favorable for both vaccines. The number of side effects was then roughly the same as that observed in the placebo group.

Experts see more benefits than risks

The relatively weak effect of the Biontech / Pfizer vaccine after only two doses was questioned by some experts in the FDA advisory board. Regardless, they confirmed that both vaccines in the planned doses of two or three vaccinations had an overall positive benefit-risk ratio in young children.

For both the Moderna vaccine and the Biontech and Pfizer vaccine, FDA advisors, by a vote of 21 to zero, recommended that existing emergency approvals be extended to infants six months of age and older.

The group of people who can be vaccinated with one of the two mRNA-based vaccines will be expanded to about eleven million children in the event of an official approval in the United States. In Germany, a similar approval would be relevant for around 3.6 million young children.

More: Moderna is hoping for approval of Omicron boosters in late summer

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