Cape Town - Switzerland has rejected the AstraZeneca Covid-19 vaccine as the country’s medical regulator, Swissmedic, said the available data is insufficient for approval of the vaccine.
Earlier this week, France and Germany restricted the vaccine to over-65s. President Emmanuel Macron and the German Health Ministry said there was insufficient information on the vaccine’s effectiveness for the elderly.
South Africa received its first million doses of the Covid-19 Oxford University-AstraZeneca vaccine from the Serum Institute of India (SII) earlier this week. The vaccine is expected to be administered to health-care workers by the middle of the month.
Swissmedic said it was examining two authorisation applications for Covid-19 vaccines in the rolling assessment, including the AstraZeneca vaccine.
“Based on the data evaluated so far, the advisory external Swissmedic expert committee Human Medicines Expert Committee (HMEC) supported Swissmedic's interim assessment of the AstraZeneca coronavirus vaccine. The currently available data do not yet permit a positive benefit-risk decision,“ it said.
The Swiss federal government has signed three agreements for the delivery of more than 11 million vaccines with German pharmaceuticals company Curevac and Novavax, and another six million vaccine doses from Moderna.
The Swiss Federal Office of Public Health said: “Given that the development and availability of vaccines are subject to such great uncertainty, the federal government continues to pursue a diversified procurement strategy covering a variety of vaccine technologies (mRNA, vector-based and protein-based) and different vaccine manufacturers”.
Swissmedic said that as soon as more results on the Astrazeneca vaccine were available, temporary approval in the rollout could be granted very quickly.
“For a final evaluation, the applicant must, among other things, submit and evaluate additional efficacy data from a phase III study that is ongoing in North and South America”, said the medical regulator.
Earlier this week, results from a pre-print study from the UK, Brazil and South Africa found the AstraZeneca vaccine provided full protection against severe disease and kept people out of hospital more than three weeks after the first dose.