Frankfurt There is now a real choice of Covid vaccines for adults. For children under the age of five, on the other hand, there is currently not a single approval. It is now becoming apparent that a vaccine could soon be available for the approximately 3.6 million small children in Germany.
Mainz-based Biontech SE and its US partner Pfizer presented the first positive interim results from a study with children aged six months to five years. A triple vaccination with the preparation Comirnaty then generated a similarly strong immune reaction in the small children as in older children and adolescents. Biontech and Pfizer state the effectiveness at 80.3 percent.
Biontech describes the safety profile as favorable and comparable to that of the administered placebo. There were no new safety concerns. Most of the side effects were mild to moderate. The vaccine was administered at a dose of only three micrograms per vaccination, a tenth of the regular dose for adults.
“The study data indicate that our vaccine, with the carefully selected, low dosage of three micrograms, is effective enough to offer a high level of protection against the latest Covid 19 variants even in the youngest,” commented Biontech boss Ugur Sahin the results. Biontech and Pfizer want to submit the data to the US Food and Drug Administration (FDA) this week and to the European Medicines Agency (EMA) and other authorities in the coming weeks.
This indicates that the FDA and possibly also Ema will be advising and deciding on the use of Biontech’s Covid vaccine and Moderna’s vaccine in young children in the coming month. The US Food and Drug Administration has scheduled three dates for June for the Vaccine Advisory Committee to deal with Covid vaccines for children. The 8th, 21st and 22nd of June have been reserved.
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Biontech and Pfizer had already started submitting data in February at the request of the FDA. But the US authorities ultimately decided to wait for the results of a triple vaccination in small children.
Moderna has already applied for approval
Competitor Moderna had already submitted an application to extend the existing emergency approval to use in children aged six months to six years at the end of April. Unlike Biontech and Pfizer, the US biotech company relies on a double vaccination with a significantly higher dosage of 25 micrograms per vaccination. This corresponds to a quarter of the regular dosage of 100 micrograms in adults.
Measured against the data published so far, the results for the Moderna vaccination scheme look less favorable than with Biontech, despite the higher dosage. The US company reported a comparable immune reaction in small children as in adults, i.e. similarly high antibody concentrations.
Based on an interim analysis, Moderna stated that the vaccine against Covid-19 infections was only 43.7 percent effective in children aged six months to two years. In the case of two to six-year-olds, it was only 37.5 percent. These values are well below the effectiveness of around 94 percent that was determined in 2020 in the large pivotal study in adults.
When presenting the data in April, Moderna pointed out that the much more contagious omicron variant was already dominant at the time of the child study, and no longer the original virus. According to the company, the lower effectiveness is therefore roughly comparable to that observed with Omikron in adults.
Biontech and Pfizer, on the other hand, had decided against the background of the omicron wave and unsatisfactory results after only two vaccinations to expand their study in small children by a third vaccination at least two months apart – a strategy that has apparently been confirmed.
Possible side effects slow down Moderna
According to Biontech, 1,678 children in the study received a third dose of the three-microgram formulation at least two months after the second vaccination. And that too in a phase when omicron was already the predominant virus variant. The effectiveness analysis was based on ten symptomatic Covid cases among the study participants. The final evaluation is planned after 21 cases of infection have occurred.
If the previous results are confirmed, Biontech and Pfizer should have relatively good chances in the approval process. The mRNA-based vaccine from the two companies is also approved for all age groups from the age of five in both Europe and the USA.
A few days ago, the vaccine also received approval from the FDA for a booster vaccination for five to eleven year olds. Children in this age group receive a dose of 10 micrograms each, while children aged 12 to 18 receive the regular adult dose of 30 micrograms.
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The starting position for Moderna appears somewhat less favourable. Their mRNA vaccine has not yet been approved for use in children and adolescents, at least in the USA. The fact that some side effects were observed somewhat more frequently in young people with the Moderna vaccine than with the lower-dose vaccine from Biontech and Pfizer may have played a role here. These include heart muscle inflammation. Moderna’s study program, called Kidcove, includes a total of 11,700 children aged six months to eleven years, including 6700 infants up to six years.
The FDA advisors should therefore also deal with the use of the Moderna vaccine in older children and adolescents up to the age of 18 at their meetings in June. In Europe, the vaccine is already approved for children from the age of six. It will now be interesting to see whether the authorities decide to approve two vaccines for small children with different dosing regimens despite the divergent data.
The challenge of risk-benefit assessment
The key challenge is likely to be assessing the benefit/risk balance. Because the health risk from Covid-19 is still significantly lower in children than in adults, as the death data show. The American infection control agency CDC reported a total of 427 Covid-related deaths in small children aged zero to four years from the beginning of the pandemic to mid-May 2022, with almost 2.4 million cases of infection in this group. That’s a rate of less than 0.02 percent, compared to a case fatality rate of almost 1.2 percent in the general population. However, the rate of deaths among young children in the US is slightly higher than among children aged five to 18.
In Germany, the mortality rates are apparently significantly lower than in the USA. Here, the RKI had reported 47 confirmed Covid deaths in children and adolescents up to the age of 19 by the beginning of February, with around 2.9 million infections by then. Since then, only a few deaths are likely to have occurred, while the number of infections has doubled.
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Against this background, the side effects of the vaccines will play a particularly important role in the assessment with regard to young children. The two vaccine manufacturers are demonstrating confidence in this regard. Biontech and Pfizer report an advantageous safety profile, but did not publish any further data on Monday.
Moderna also speaks of an advantageous safety profile for their significantly higher-dose Covid vaccine for children. In both age groups – i.e. the six-month to two-year-old children and the two- to six-year-olds – a similarly good level of tolerability was observed as in the older children and adolescents.
According to the company, the rate of cases with a fever higher than 38 degrees was 17 or 14 percent, on a level with common, long-established child vaccines. No deaths, heart muscle inflammation or multisystem inflammation (MIS) occurred in the study participants afterwards.
Ultimately, however, the detailed data that both manufacturers will present in the next few weeks will be decisive.
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