The European Medicines Agency announced on Friday that five million people in the European Union have been vaccinated against swine flu, after it conducted a fresh round of tests.
"With vaccination campaigns ongoing in the European Union, about five million people have been vaccinated so far," said the London-based EMEA in a statement.
"To date, the side effects reported have mainly been mild symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the expected safety profile of the three vaccines."
The latest statement followed a review of data, according to the European regulator.
"The EMEA has reviewed further data on the centrally authorised pandemic vaccines, Celvapan, Focetria and Pandemrix," it added.
"The agency has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic."
The EMEA also announced that one dose was sufficient for most people of swine flu vaccines Pandemrix and Focetria, which are produced respectively by Swiss drugs firm Novartis and British peer GlaxoSmithKline.
"The data on Focetria and Pandemrix indicate that a single dose of these vaccines is able to trigger an immune response that may be sufficient to give protection against the H1N1v pandemic influenza in some age groups," it said.
"For both vaccines, a single dose may be used in adults aged between 18 and 60 years and in children and adolescents, from the age of nine years for Focetria, and from 10 years for Pandemrix."
Both vaccines can be used in conjunction with seasonal influenza vaccines, it ruled.
"Further data will become available in the coming months. Data on Celvapan are still being assessed," the EMEA added. The Celvapan vaccine is made by US firm Baxter.
More than 5,700 people have died worldwide since swine flu was first discovered in April, with most deaths in the Americas, according to the World Health Organisation.
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