Pfizer/BioNTech vaccine approved for children by Swiss regulator

News Agencies 

The Swiss medical regulator has approved the use of Pfizer/BioNTech’s Covid-19 vaccine for children aged five to 11. However, the Federal Vaccination Commission has yet to recommend extending the immunisation campaign to this group.

“The clinical trial results show that the vaccine is safe and effective in this age group,” wrote Swissmedic on FridayExternal link. It said an ongoing study involving more than 1,500 people showed “almost complete protection against serious illness” caused by Covid-19 among those aged five to 11 and that side effects tended to occur less frequently than in adolescents or adults.

These side effects – slightly more frequent after the second dose – can include pain at the point of injection, tiredness, and occasionally headaches, joint pain, or fever.

The regulator recommends two doses of the vaccine, three weeks apart, but at just one-third the strength of a normal adult dose.

However, a recommendation by the Federal Vaccination Commission would be needed before the national immunisation strategy would be updated to include this age group, Swissmedic told the Keystone-SDA news agency.

As of Friday evening, the website of the Federal Office of Public Health indicated that “currently there are no plans to vaccinate children under 12”.

Moderna waiting
Meanwhile, Moderna’s Spikevax vaccine is still under review by Swissmedic for use on children, with no decision yet taken. The Janssen viral vector vaccine, the third being used on adults in Switzerland, has not been submitted for consideration on children.

Overall, despite efforts by authorities to spur interest, the Swiss are still among the most reluctant to vaccinate in Western Europe; as of Friday, some 68% of the population had received at least one vaccine dose, amounting to around 78% of the adult (aged 19 and above) population.

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وافقت وكالةُ الأدوية السويسريّة على تحصين الأطفال الذين بلغوا سنّ الخامسة وما فوق ضدّ فيروس كورونا بلقاح فايزر- بيونتيك (كومينارتي). وقالت الوكالة: إنَّ «نتائج التجارب السريرية تظهر أن التطعيم آمن وفعال في آن معًا» للأطفال الذين تتراوح أعمارهم بين 5 و11 عامًا، والذين لم يتم تطعيمهم حتى الآن.

ويُعطى «كومينارتي» في جرعتَين (10 ميكروجرامات) تفصل بينهما 3 أسابيع، وهو ما يمثل «ثلث قوة الجرعة الممنوحة للمراهقين والبالغين».

وأشارت الوكالة السويسرية إلى أنّ تجربة سريرية «تشمل أكثر من 1500 مشارك، تُظهر أنّ هذا اللقاح المضاد ل»كوفيد-19» يسمح بتجنّب الأمراض الخطيرة التي يُسبّبها فيروس سارس-كوف-2 بشكل كامل تقريبًا لدى الأطفال الذين تتراوح أعمارهم بين 5 و11 عامًا». وحتى الآن، كان التطعيم مخصصًا للأطفال من سنّ 12 عامًا فما فوق.