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Swissmedic Approves Pfizer/ BioNTech Vaccine for Children Over 5

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Covid, Pfizer ,BioNtec, Corona, Virus, Dose, Vaccine, Approval, Children , Swissmedic , Doses


The clinical trial results show that the vaccine is safe and effective in this in this age group, it will thus be possible for children aged 5 years and older to be vaccinated against the new coronavirus (SARS-CoV-2) in accordance with the federal government’s updated vaccination recommendations.

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.

Covid, Pfizer ,BioNtec, Corona, Virus, Dose, Vaccine, Approval, Children , Swissmedic , Doses

Swissmedic Approve Pfizer Vax for Children above 5

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.

About Swiss Medical Agency

The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss surveillance authority for medicines and medical devices, registered in Bern. It began operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel (IKS), which was itself the successor of Schweizerische Arzneimittelnebenwirkungszentrale (SANZ). Swissmedic is affiliated to the Federal Department of Home Affairs.

Any medical products for humans or animals need approval from Swissmedic to be brought on the Swiss market. Moreover, Swissmedic must be notified of all clinical studies conducted in Switzerland.

When authorising new medicinal products, Swissmedic bases its decisions on internationally acknowledged criteria. The products may only be placed on the market if their quality, safety and effectiveness are sufficiently evaluated and proved. If the criteria for authorisation are fulfilled, Swissmedic grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.

Costs of approval are paid by the applicant. Approval must be renewed after five years.

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