Rolling authorisation application for COVID-19 vaccines Swissmedic requests additional data

Swissmedic examines the data on the vaccine from AstraZeneca it receives on an ongoing basis
03.02.2021
Swissmedic is currently reviewing two applications for the authorisation of COVID-19 vaccines. With regard to the AstraZeneca vaccine, the data submitted and analysed so far are not yet sufficient to permit authorisation. To obtain more information about safety, efficacy and quality, additional data from new studies are needed.
Swissmedic is currently reviewing two applications for the authorisation of COVID-19 vaccines in the rolling review procedure, including the application for the authorisation of the “COVID-19 Vaccine AstraZeneca” (AZD1222) for the coronavirus. At an extraordinary meeting on 2 February 2021, the external Swissmedic advisory body HMEC (Human Medicines Expert Committee) confirmed Swissmedic’s interim assessment of the AstraZeneca coronavirus vaccine based on the data analysed to date. The data currently available do not point to a positive decision regarding benefits and risks.
Continue reading at www.swissmedic.ch

Switzerland REFUSES to approve AstraZeneca jab and says ‘new studies’ are needed after France, Germany and Sweden rejected it for over-65s

By Rachael Bunyan For Mailonline and Afp
3 February 2021
Switzerland has refused to approve the AstraZeneca Covid, vaccine with regulators raising concerns over insufficient test data and arguing ‘new studies’ are needed.
It comes after France, Sweden and Germany advised against administering the jab to those over 65 and Emmanuel Macron claimed it was ‘almost ineffective’ for the age bracket.
That is despite Oxford data published this week suggesting the jab is 76 per cent effective after just one dose, and may also prevent 67 per cent of infection.
British Prime Minister Boris Johnson has also weighed in, saying the jab is ‘is very good and efficacious’ in all age groups.
Continue reading at www.dailymail.co.uk