GSK's H1N1 Pandemrix vaccine receives positive opinion from European regulators
The European drugs regulator has issued a positive opinion of GlaxoSmithKline\'s (GSK) Pandemrix H1N1 adjuvanted vaccine and recommends its approval.
The European drugs regulator has issued a positive opinion of GlaxoSmithKline's (GSK) Pandemrix H1N1 adjuvanted vaccine and recommends its approval.
The European Committee for Medicinal Products for Human Use (CHMP) has agreed that the vaccine can be used in adults and children over six months old and pregnant women.
Each single dose of the vaccine will comprise 3.75ug antigen of pandemic (H1N1) 2009 influenza strain and GSK's proprietary adjuvant system AS03, which should be administered as two single doses at least three weeks apart.
"This positive opinion means that Pandemrix will now be immediately reviewed for approval by the European Commission, which is an important step closer to helping reduce the impact of the pandemic," said Jean Stephenne, president of GlaxoSmithKline Biologicals.
GSK is conducting 16 clinical trials in more than 9,000 subjects including healthy adults, the elderly and children (including infants) across Europe, Canada and the US to further evaluate the vaccine.