Once a week, the calendar of the approximately 40 executives of BioNTech, the research firm located in the city of Mainz in southwestern Germany, includes a 90-minute appointment that cannot be rescheduled. At the BNT162b2 meeting, all vaccine-related divisions must present to the board what they are currently working on. They explain whether the expansion of production is proceeding rapidly, for example, or what approaches against new mutants are being discussed.
In mid-January, there was a question about the meeting schedule that many parents had recently asked with increasing urgency: when could the vaccine for children be approved?
At the time, the issue still seemed far away. At that time, the first doses of the Pfizer / BioNTech COVID-19 vaccine were distributed worldwide and the whole company focused on making more vaccines with the aim of offering more, as quickly as possible, to billions of dollars. ‘adults.
Because children have a different physiology than adults, medications for children under 18 must be examined and approved separately, a long and costly process that usually takes years.
In January, BioNTech researchers responsible for clinical trials expected the vaccine to be approved for all age groups before the spring of 2022, an unusually rapid approval compared to the normal sequence of events.
But for Uğur Şahin, CEO of BioNTech, and Özlem Türeci, its chief scientist, this was too slow. Both were especially concerned about the new virus variants that were already spreading: much more contagious and aggressive mutants such as B 1.1.7. By summer, most adults would potentially be vaccinated, Şahin told the group, and the herd’s immunity would severely curb the virus, however, and if children continued to be exposed to a mutated and potentially more dangerous virus in the herd. schools and daycare without protection?
Things were moving much faster. “We are on track to achieve these goals,” Şahin now says, three months later. “It’s very important to allow children to get back to their normal school routine and make it possible for them to get together with family and friends.”
On Friday, the company applied to the European Medicines Agency (EMA) for approval of the BioNTech vaccine for children 12 years of age and older. The evaluation usually takes a few weeks. Therefore, early schoolchildren could be vaccinated in early June.
The second clinical trial, which includes about 4,600 young children, is also in advanced stages. Vaccines are given in descending order of age: if 10-year-olds tolerate the vaccine well, it is the turn of nine-year-olds. Now BioNTech has reached the youngest group: children six months or older.
“In July we could get the first results for children aged five to twelve and in September for younger children. The evaluation will take between four and six weeks,” says Şahin. “If all goes well, once the data has been evaluated, we can apply for approval of the vaccine for children of the respective age group in different countries.”
The CEO of BioNTech is confident that, according to data from the study they have already collected, the vaccine was 100% effective and well tolerated in children over 12 years of age. According to Şahin, these “encouraging results” suggest that “children are particularly well protected by the vaccine.”
Doses for children would be produced separately
If the chronology disappears, the consequences would be far-reaching. Children have been especially affected by the pandemic since the first closure, when even playgrounds were closed for months.
Studies suggest that many children and young people will suffer much more than adults from the long-term psychological consequences of the pandemic, as they have more difficulty compensating for and coping with the loss of social contact.
In a representative online survey conducted by Hamburg’s Eppendorf University Hospital, 40% of children and adolescents aged 11 to 17 said they had a reduced quality of life during the pandemic. One-third had depressive symptoms and 44% had sleep disorders.
Children from poor and educationally disadvantaged families retreat even further with the closure of schools, sometimes for months. It has also become clear in recent months that even young children can, in rare cases, suffer from severe COVID-19 diseases.
If young people aged 12 to 17 are vaccinated in a period of a few weeks, younger children could be vaccinated from the autumn onwards, which allows for a faster return to normal school and kindergarten operations. . This, of course, with the assumption that children will not be relegated to the back of the vaccination queue.
Last week, German Chancellor Angela Merkel said she would raise the priority of vaccines in Germany in June. Shouldn’t all school-age children be vaccinated to allow a safe return to face-to-face education?
Because children and adolescents should be vaccinated with existing vaccine stocks, this would mean that many young people in their 40s to 50s would have to receive their doses later.
Younger people would get the vaccine in lower doses, probably only one-tenth of the dose for the younger ones.
Starting in late summer, BioNTech would produce the children’s doses separately. It is unclear whether the initially planned adult deliveries would be subtracted or whether an additional quota is possible.
“Children have the right to the best possible medical care”
This again raises complicated ethical issues. What is desirable and what is morally acceptable?
“Looking at countries like India, where millions and millions of doses of vaccine are urgently needed for the elderly, we need to think about whether low doses of vaccine are really better given to children in rich countries,” he argues, e.g. , Harvard epidemiologist Michael Mina.
Others believe that vaccinating teens, at the very least, is inevitable. Virologist Angela Rasmussen of the Canadian Organization for Vaccines and Infectious Diseases (VIDO-InterVac) argues that “it cannot be avoided.” He explains that teenagers have a particularly large number of contacts outside the home, much more so than, for example, six-year-olds.
To vaccinate between 80 and 85 percent of the population, children will probably also need to be included in the vaccination campaign. This would be the only way to prevent the virus from spreading if it came back. “Only when children and young people are vaccinated with a vaccine approved for their age group can the pandemic end,” says Jörg Dötsch, director of the Department of Pediatrics and Adolescent Medicine at University Hospital. Cologne and president of the German Society of Pediatrics and Adolescent Medicine.
As so many times in this pandemic, the situation raises issues of solidarity and equity and what is really the top priority of the country. In recent months, it has been shown everywhere that schools and education are important not only for children and young people, but for the future of the knowledge-based economy. But this has led to few concrete actions. School digitization has not been successful and schools have not been equipped with technology such as ventilation systems.
“According to the United Nations Convention on the Rights of the Child, children have the right to the best possible medical care,” says Thomas Fischbach, president of the Professional Association of Pediatricians of Germany. “Therefore, we consider it correct and necessary for children to be immunized against COVID-19.” He argues that denying them vaccination would jeopardize school reopening and the participation of the younger generation in society. “It would be discriminatory,” Fischbach says.
“We think things can happen pretty fast now”
But first, BioNTech must successfully complete pediatric studies and demonstrate that the vaccine is not only effective, but also harmless. Wolfgang Becker-Brüser, editor of Remei Telegamm, an industry-critical magazine, argues that this is not true.
“Children are a developing organism,” explains the doctor and pharmacist, “they react differently to many things, so it cannot be simply extrapolated from studies with adults to children.”
Pediatric research plans have been agreed with the European Medicines Agency (EMA) for the four COVID-19 vaccines approved so far: BioNTech, Moderna, Johnson & Johnson and AstraZeneca. These plans specify what clinical studies in children and young people are needed to demonstrate that a vaccine is safe and effective in all age groups up to 18 years of age.
In response to a consultation from DER SPIEGEL, the EMA said that clinical trials to test vaccines in children are constructed so that, after the vaccine for adults is approved, it is tested in adolescents and, step by step, in children under 12, and in the younger age groups. Once the data shows that the vaccine is safe and provides a good immune response in an age group, researchers can submit data for market approval in that age group. If the data are very good, the duration of the study can be shortened.
According to BioNTech, so far there have been no signs of side effects. However, very rare side effects would not appear until the vaccine is placed on the market and after vaccination of hundreds of thousands or millions of children and young people. Therefore, it is important that the individual benefit-risk assessment of children is clearly positive. “Anything else would be unethical,” Dötsch says.
The German Society of Pediatrics and Medicine for Adolescents promotes COVID-19 vaccination for children. This is because young people may be less likely to get COVID-19 than older people, but they are not yet fully protected from the virus. Long COVID is known to occur in children. In countries with a particularly high number of cases, such as Brazil, hundreds of children are said to have died from the disease.
It is estimated that one in a thousand infected children also contract pediatric multisystem inflammatory syndrome (MIS-C). It occurs when, weeks after a COVID-19 infection, often asymptomatic, a misdirected immune system causes violent inflammatory reactions in various organs. Numerous children have had to be hospitalized, including some in intensive care.
“We think things can happen pretty quickly now,” Şahin says. “Observations so far on tolerability and efficacy are encouraging.” People around the world want to get back to their normal lives, says BioNTech CEO. “Especially our children.”