- Swissmedic approves the extension of the booster vaccination to all persons aged 16 and over.
- The Heilmittelinstitut has checked the documents subsequently submitted for the third dose and adjusted the drug information.
- For the time being, Swissmedic’s approval only applies to the Covid-19 vaccine from Pfizer / Biontech.
After reviewing the data submitted in the last few days, the specialist information for the mRNA vaccine from Pfizer / Biontech was adjusted, writes Swissmedic on Tuesday. This paves the way for a wider use of the booster vaccination for people under 65 years of age. The condition for this is in any case: The second dose must have been given at least six months ago.
Data from 10,000 test subjects
According to the notification, Swissmedic bases its decision on a study with 10,000 participants aged 16 to 87, among other things. The interim results of this investigation had “no indications of new risk aspects for the vaccine”. Swissmedic continues to monitor the benefits and risks of the vaccine to prevent coronavirus disease in Switzerland and internationally “very closely”.
Booster for people at risk from the age of 12
For people at particular risk, a booster vaccination is possible from the age of 12, as provided for in the Swissmedic decision of October 26, 2021. This also applies to Moderna’s vaccine. The FOPH currently recommends a third vaccination dose for three groups of people: all over 65-year-olds (especially over 75-year-olds); all residents and those cared for in old people’s and nursing homes (including those under 65) and particularly vulnerable people between 12 and 64 years of age.
The number of vaccination centers has been reduced since the summer – this was only logical in view of the demand, says Tobias Bär, media spokesman for the Conference of Health Directors (GDK). “But this infrastructure can be brought up again quickly,” he assures. “Of course, the staff is a limiting factor. But the cantons will take on this task with a renewed effort. “
The cantons will take on this task with a renewed effort.
At the moment, the priority is for those over 65, says Bär. «Booster vaccinations are already being given throughout Switzerland for people over 65 and other people who are particularly at risk. These people have priority because their data show a decrease in protection against severe Covid 19 disease from six months onwards. ”
Three times the same dose from Pfizer / Biontech
The basic immunization with the vaccine from Pfizer / Biontech takes place with two doses of 0.3 milliliters at an interval of around three weeks. The booster vaccination should take place with the same dose, writes Swissmedic.
The benefit of a booster vaccination is currently greater for people who have been primed with the Pfizer / Biontech vaccine. The few available data on persons completely primed with Moderna show no significant decrease in protection against a serious illness due to a corona infection.
In a next step, other groups would follow. According to the GDK spokesman, the recommendation of the Federal Commission for Vaccination Issues (Ekif) is decisive for the cantons. “And this is currently being worked out.” At Keystone-SDA’s request, Swissmedic also announced that it was ultimately up to Ekif and the Federal Office of Public Health to define and / or specify the vaccination strategy.
For its part, the BAG confirmed that the modified vaccination recommendations for the entire population aged 16 and over would be published by the end of the month. The Ekif has already announced that the recommendations will be expanded accordingly.
Moderna files are still being assessed
In mid-September, Pfizer / Biontech and Moderna submitted their applications for an extension of the authorization to Swissmedic. Both vaccines are based on mRNA technology. According to Swissmedic spokesman Lukas Jaggi, the data submitted by Moderna are currently still being assessed. “As soon as open questions have been clarified, we can decide very quickly.” This would be possible in a few days.
A booster is currently not recommended for people who have received a dose of Johnson & Johnson’s vaccine – neither with the same vaccine nor with either of the two mRNA vaccines.