The German team behind the BioNTech-Pfizer COVID vaccine still hopes for swift approval for its jab in kids aged 5 to 11.
BioNTech-Pfizer is pushing for more vaccine-uptake to avoid a "hard winter"Image: Sebastian Gollnow/dpa/picture alliance
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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 BioNTech-Pfizer 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 joint-effort 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."
BioNTech co-founders Uğur Şahin (left) and Özlem Türeci think the kids' vaccine will be approved quicklyImage: Bernd von Jutrczenka/dpa/picture alliance
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 Spiegel interview: "As a society, we've got about 60 days to prevent a hard winter."
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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.
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.
COVID: Vaccinating people in the world's most remote places
Medical teams are making long, at times difficult journeys to vaccinate people all over the world against COVID-19. Their job takes them over mountains and across water, by boat or by plane — or by foot.
Image: Tarso Sarraf/AFP
A difficult mountain climb
Medical staff who want to vaccinate the inhabitants of the mountainous regions of southeastern Turkey must be physically fit. Ensuring vaccinations in the mountain villages is particularly important, Dr. Zeynep Eralp told DW. "People often live close together, and an infection could spread quickly," she said. Also, people don't like going to hospitals, so "we have to go to them."
Image: Bulent Kilic/AFP
Through snow and ice
Many elderly people can't make the journey to a vaccination center. In the Maira Valley in the western Italian Alps, close to the border with France, doctors go from house to house to give residents older than 80 their COVID-19 shot. A blessing from the roadside Madonna is a bonus.
Image: Marco Bertorello/AFP
Flight to the remote north
Carrying a single vial containing several doses of vaccine, this nurse is en route to Eagle, a town on the Yukon River in the US state of Alaska with fewer than 100 inhabitants. Indigenous people are prioritized in many immunization programs. Depending on where they live, the nearest health clinic can be far away.
Image: Nathan Howard/REUTERS
Some need convincing
Anselmo Tunubala washes his hands before vaccinating an elderly lady. Every day, the 49-year-old is out and about in the mountains of southwestern Colombia, telling people in the local language about the importance of a vaccination. He is a member of the Misak, many of whom are skeptical about vaccination because they tend to rely on traditional medicine and the guidance of religious leaders.
Image: Luis Robayo/AFP
Hours of walking
The men and women in the above photo walked up to four hours to get their coronavirus shot in the remote village of Nueva Colonia in central Mexico. They belong to the indigenous Wixarika people, perhaps better known under the name Huichol.
Image: Ulises Ruiz/AFP/Getty Images
Holding steady
For her shot, Olga Pimentel simply pulled up her boat next to that of the vaccination team. The community of Nossa Senhora do Livramento on the Rio Negro in Brazil can only be reached by river. "Beautiful! It hardly hurt," the 72-year-old laughed and shouted, "Viva o SUS!" — "long live Brazil's public health service!"
Image: Michael Dantas/AFP
Vaccination by candlelight
For a long time, right-wing populist President Jair Bolsonaro campaigned against COVID-19 vaccinations in Brazil. But in the meantime, the campaign has taken off. Indigenous people and quilombolas, descendants of African slaves, were among the first to be vaccinated. Raimunda Nonata, 70, lives in a community without power so she got her shot by candlelight.
Image: Tarso Sarraf/AFP
Paddle over the lake
After their vaccination, an elderly woman and her daughter paddle away from the island of Bwama, the largest in Lake Bunyonyi in Uganda. The government in the central African country is trying to supply remote areas with the vaccine.
Image: Patrick Onen/AP Photo/picture alliance
Rough terrain
Another journey over the water — but his time, no boat. On the way to the village of Jari in Zimbabwe, this vaccination team had to navigate a flooded road. According to the African Union's health agency, Africa CDC, fewer than 1% of the population in Zimbabwe has been fully vaccinated to date. Medical staff came first.
Image: Tafadzwa Ufumeli/Getty Images
Welcome house call
Japan may have huge, sprawling cities, but many people also live in small, isolated villages with only a few hundred inhabitants — like here, in Kitaaiki. Residents who can't make it to the next city are happy to welcome the doctor and a vaccine at home.
Image: Kazuhiro Nogi/AFP
Valuable goods
Indonesia launched its vaccination campaign in January. From Banda Aceh, the medical team traveled via boat to remote islands. The vaccines in the cooler are so valuable that the team was accompanied by security personnel.
Image: Chaideer Mahyuddin/AFP
Superspreader event?
India has been hardest hit by the pandemic in recent weeks. In mid-March, medical personnel made their way to the village of Bahakajari on the Brahmaputra River, where a group of women registered for their COVID-19 shot. None wore face masks or kept a safe distance.