Deutsche Welle (English edition)
BioNTech-Pfizer confident about their vaccine for kids
The German team behind the BioNTech-Pfizer COVID vaccine still hopes for swift approval for its jab in kids aged 5 to 11.
BioNTech's timeline has been out there for months — as DW was reminded in a snippy exchange in due diligence by email this Friday (10.9.2021).
"We have communicated the timeline months ago," wrote the press officer.
And indeed, back in May, the German half of the BioNTechPfizer COVID-19 vaccine team announced it was aiming to submit applications for emergency use authorizations in the US and the European Union for children aged 2 to 5 years and those aged 5-11 years by September.
Intentions are one thing, realities are another. But fortunately for BioNTech-Pfizer — the jointeffort vaccine now known as Comirnaty or just Pfizer — their side of the plans appear to be on track.
In an interview published by German weekly Der Spiegel on Friday, BioNTech's co-founder and chief medical officer, Özlem Türeci, is reported as saying that the firm is already preparing production of the vaccine for children — ahead of approval.
Türeci told the magazine, "It's the same vaccine but a lower dose."
All that's left for them to do now is to submit their latest trial results to the relevant authorities — the Food and Drug Administration (FDA) in the US, for instance, and the European Medicines Agency in the EU.
BioNTech expects to have further trial results from studies with kids of six months and up by the end of 2021. And it's got its foot on the gas elsewhere, too, calling for a greater effort to persuade people who haven't been vaccinated yet to get the jab.
The company's chief executive officer, Uğur Şahin, said in the same Spiegelinterview: "As a society, we've got about 60 days to prevent a hard winter."
Children and COVID vaccines
It's generally thought that COVID vaccines produce the same side effects in children as they do in adults.
Those side effects might include a slight pain in the upper part of the arm that gets the jab. And children may feel more tired than usual.
Johns Hopkins Medicine says kids may also experience headaches, achy muscles or joints, and even fever and chills, but that "these side effects are usually temporary and generally clear up within 48 hours."
COVID vaccines are considered "reactogenic" — they are expected to produce strong physical reactions.
There are, however, some (up-to-now) rare side effects for which authorities want more data.
Early trials 'inadequate'
Drug regulators have pressed for special clinical trials of COVID vaccines in children.
In the US, for instance, the FDA demanded BioNTech-Pfizer and their competitor, Moderna, which produces Spikevax, conduct broader trials — that was also back in May.
The New York Times reported then that the FDA had "indicated" to both vaccine developers that "the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects. Those include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart," wrote the NYT, citing "multiple people familiar with the trials."
Both companies have been testing their respective vaccines in Phase I, II, and III trials on healthy children in three age groups, and comparing three different dosages, since March.
Those age groups are 6 months to 2 years, 2 to 5 years and 5 to just under 12 years.
Details to follow
The US Centers for Disease Control and Prevention (CDC)
says it is actively monitoring reports of heart inflammation, such as myocarditis and pericarditis, after COVID-19 vaccination.
Inflammation in the heart causes damage and can lead to serious health problems.
Cases have been reported after both BioNTech-Pfizer and Moderna vaccines, usually after the second shot, and especially in male adolescents and young adults.
The CDC says most patients who received care responded well and were able to return to normal activities soon.
But Germany's vaccines authority, the Robert Koch Institute, says more data is needed on the long-term effects of heart inflammation after COVID vaccines in young people. BioNTech and Pfizer have yet to go public with their latest findings.