Children in Germany to be offered Covid vaccine 'in 2022'
Health Minister Jens Spahn expects Germany to offer children under 12 the Covid vaccine next year.
"I assume that the approval for a vaccine for children under 12 will come in the first quarter of 2022," Spahn told the Funke Mediengruppe newspapers, reported Spiegel. He said the move will lead to protecting "younger people even better".
On Monday Pfizer and BioNTech said trial results showed their coronavirus vaccine is safe and produces a robust immune response in children aged five to 11, adding that they would seek regulatory approval shortly.
The vaccine would be administered at a lower dosage than for people over 12, they said.
"In participants aged five to 11, the vaccine was safe, well tolerated and showed robust neutralising antibody responses," US giant Pfizer and its German partner said in a joint statement.
Spahn pointed out on Monday that there may be a slight lag between the approval by the European Medicines Agency (EMA) and a recommendation by Germany's vaccination panel STIKO.
"A recommendation by the Standing Commission on Vaccination will come somewhat later in this case," Spahn said.
The EMA approved the use of BioNTech's vaccine for children aged 12-17 in May.
However, Germany’s vaccine panel STIKO initially hesitated on issuing a general recommendation earlier this summer to receive the Covid vaccine, instead only advising that young people with underlying illnesses get it.
But in August the commission changed its mind after analysing new guidance and issued a general recommendation. Despite the hesitant guidance, the German government had called on young people to get their jabs anyway.
READ ALSO:
- Germany’s vaccine panel offers a Covid jab to everyone over 12
- Germany opens vaccine centres for teenagers: What you need to know
Delta worries
Although children are considered less at risk of severe Covid, there are concerns that the highly contagious Delta variant could lead to more serious cases.
Inoculating children is also seen as key to keeping schools open and helping end the pandemic.
Pfizer and BioNTech plan to submit their data to regulatory bodies in the EU, the United States and around the world "as soon as possible".
The trial results are the first of their kind for children under 12, with a Moderna trial for 6-11 year olds still ongoing.
Under-5s before year-end
The Pfizer vaccine received full, formal approval in the US in August and is therefore technically available to younger children if prescribed by a doctor, but US authorities have cautioned against doing this until the safety data was in.
The US regulator, the Food and Drug Administration (FDA), said in a statement earlier this month it would "carefully" review emergency authorisation requests for vaccines for under -12s, a process it expected to take "weeks rather than months".
Israel has already given special authorisation to vaccinate children aged 5-11 who are "at significant risk of serious illness or death" from Covid, using the Pfizer jab at the lower dosage.
Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.
The topline results for those trials are expected "as soon as" the fourth quarter of this year, the companies said.
All together, up to 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNTech trials in the US, Finland, Poland and Spain.
Like its Moderna rival, the Pfizer jab is based on novel mRNA technology that delivers genetic instructions to cells to build the coronavirus spike protein, in order to evoke antibodies when bodies encounter the real virus.
Comments
See Also
"I assume that the approval for a vaccine for children under 12 will come in the first quarter of 2022," Spahn told the Funke Mediengruppe newspapers, reported Spiegel. He said the move will lead to protecting "younger people even better".
On Monday Pfizer and BioNTech said trial results showed their coronavirus vaccine is safe and produces a robust immune response in children aged five to 11, adding that they would seek regulatory approval shortly.
The vaccine would be administered at a lower dosage than for people over 12, they said.
"In participants aged five to 11, the vaccine was safe, well tolerated and showed robust neutralising antibody responses," US giant Pfizer and its German partner said in a joint statement.
Spahn pointed out on Monday that there may be a slight lag between the approval by the European Medicines Agency (EMA) and a recommendation by Germany's vaccination panel STIKO.
"A recommendation by the Standing Commission on Vaccination will come somewhat later in this case," Spahn said.
The EMA approved the use of BioNTech's vaccine for children aged 12-17 in May.
However, Germany’s vaccine panel STIKO initially hesitated on issuing a general recommendation earlier this summer to receive the Covid vaccine, instead only advising that young people with underlying illnesses get it.
But in August the commission changed its mind after analysing new guidance and issued a general recommendation. Despite the hesitant guidance, the German government had called on young people to get their jabs anyway.
READ ALSO:
- Germany’s vaccine panel offers a Covid jab to everyone over 12
- Germany opens vaccine centres for teenagers: What you need to know
Delta worries
Although children are considered less at risk of severe Covid, there are concerns that the highly contagious Delta variant could lead to more serious cases.
Inoculating children is also seen as key to keeping schools open and helping end the pandemic.
Pfizer and BioNTech plan to submit their data to regulatory bodies in the EU, the United States and around the world "as soon as possible".
The trial results are the first of their kind for children under 12, with a Moderna trial for 6-11 year olds still ongoing.
Under-5s before year-end
The Pfizer vaccine received full, formal approval in the US in August and is therefore technically available to younger children if prescribed by a doctor, but US authorities have cautioned against doing this until the safety data was in.
The US regulator, the Food and Drug Administration (FDA), said in a statement earlier this month it would "carefully" review emergency authorisation requests for vaccines for under -12s, a process it expected to take "weeks rather than months".
Israel has already given special authorisation to vaccinate children aged 5-11 who are "at significant risk of serious illness or death" from Covid, using the Pfizer jab at the lower dosage.
Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.
The topline results for those trials are expected "as soon as" the fourth quarter of this year, the companies said.
All together, up to 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNTech trials in the US, Finland, Poland and Spain.
Like its Moderna rival, the Pfizer jab is based on novel mRNA technology that delivers genetic instructions to cells to build the coronavirus spike protein, in order to evoke antibodies when bodies encounter the real virus.
Join the conversation in our comments section below. Share your own views and experience and if you have a question or suggestion for our journalists then email us at [email protected].
Please keep comments civil, constructive and on topic – and make sure to read our terms of use before getting involved.
Please log in here to leave a comment.