Swiss and Canadian health authorities on
Wednesday lifted a ban on sales of flu vaccines made by Swiss
pharmaceutical giant Novartis after determining they were safe and
efficient.
"The partially visible white particles
are in no way external impurities, but are agglutinations of
ordinary protein components of the vaccine," Switzerland's national
drug agency Swissmedic said in a statement.
The Public Health Agency of Canada said in the statement it had
lifted their freeze after determining they were safe, saying it was
"now advising health care professionals in possession of these
vaccines that they can start using them once again."
Last week, Italy first froze the sale and use of Novartis's Fluad
and Begripal flu vaccines and Switzerland, Austria, Germany, France,
Spain and Canada soon followed suit.
Italian Ban on use of Novartis
Vaccines and Diagnostics seasonal influenza vaccines (25/10/2012)
The Italian Medicines Agency (AIFA) issued the prohibition to use
the seasonal influenza vaccines FLUAD – AGRIPPAL – INFLUPOZZI
SUB-UNITY and INFLUPOZZI ADJUVANTED manufactured by Novartis
Vaccines and Diagnostics S.r.l..The issuance of the quarantine
provision became necessary as Novartis Vaccines and Diagnostics
S.r.l. communicated the presence of a protein aggregation phenomenon
observed in the manufacture of seasonal influenza vaccines,
submitting quality, toxicology and pharmacovigilance
assessments/reports which did not provide sufficient information to
clarify the exact composition of the aggregates, nor the impact of
the defect on the quality and stability of the vaccines and,
consequently, on their safety and efficacy. Further and in-depth
investigations are expected and deemed necessary along with the
outcomes of the assessment of the integrative documentation that the
Company shall provide.
(MDN) |
