LONDON - At least 26 million people in Europe have been vaccinated against H1N1, and there have been no serious security problems with the shot, the drug situation in Europe, regulators said Friday.
The European Medicines Agency (EMEA) has also reiterated its position that Roche antiviral drug Tamiflu is safe and effective against the H1N1 virus, including the World Health Organization (WHO) has declared a pandemic in June.
The EMEA said 26 million people in the European Union has received the vaccine CELVAPAN, Novartis Focetria or GlaxoSmithKline Pandemrix between May and October, while 13 million patients worldwide to Tamiflu.
"The risk-benefit of vaccines against pandemic and Tamiflu is used for the current pandemic influenza H1N1 continues to be positive," said the drug regulator in a statement.
"The latest data on the safety of three vaccines against pandemic and Tamiflu shows no major security concerns and contingencies. The adverse reactions usually have been reported are not serious as expected.
Updated Risk of the EMEA Tamiflu is the first since a group of medical experts questioned its effectiveness in a study in the British Medical Journal (BMJ) earlier this month, he says n 'There was no evidence that it prevented complications such as pneumonia in people with influenza.
The EMEA has not decided whether the review in BMJ. Last week, the WHO has endorsed the report.
Sales of antiviral medicines, also known under the generic name oseltamivir, has exploded due to massive public orders since the beginning of a pandemic of H1N1 swine influenza in April. Roche has denied review in the BMJ and said it stood by its data showing that Tamiflu has been effective. The Authority said the doctor information as Focetria Pandemrix and confirmed that a single dose was "sufficient in certain age groups" to protect against H1N1.
She said she would continue to monitor all three vaccines and make recommendations if necessary.
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