European Medicines Agency has recommended that the GlaxoSmithKline vaccine, called Pandemrix, be authorised for use and the European Union now needs to rubber stamp the decision.
Vaccinations of priority groups is due to start next month in Britain with pregnant women, people aged between six months and 65 years with long-term illnesses, health and social care workers and people living with patients who have a compromised immune system being offered the jabs.
The vaccine will be licensed on a two-dose basis even though some early clinical trials had suggested that one dose may be sufficient in healthy adults. The EMEA will monitor clinical trials on dosing and may update the recommendations at a later stage.
The British government has ordered enough vaccine from GlaxoSmithKline and Baxter, to provide two-doses for the whole population but will offer the vaccine to 13 million people in the priority groups first before deciding if it is necessary to offer the jabs more widely. The Baxter vaccine is still going through the licensing procedure.
Sir Liam Donaldson said the second wave of the H1N1 virus is starting to take off since the schools went back and there were an estimated 9,000 new cases last week. He said he had hoped for more ‘breathing space’ before cases took off again in order to get the vaccination programme in place.
The EMEA also recommended that the Novartis vaccine called Focetria be licensed. The recommendation to license the vaccines was based on mock-up products using the H5N1 strain of flu which was extensively tested. The products then had the strain switched for the current H1N1 pandemic strain with further smaller scale trials. This is how the seasonal flu vaccines are licensed every year and has proved extremely effective in allowing flu vaccines to be produced and licensed quickly, the EMEA statement said.
Further clinical trials in adults and in children are ongoing and more results will become available in the coming months.
A statement from the EMEA said: "As with all medicines, rare adverse reactions may only be detected once the vaccines are used in large numbers of people. “The Agency has requested that vaccine manufacturers implement plans to actively investigate and monitor the safety of vaccines as soon as they are used across the EU, so that action can be taken as early as possible if a safety issue emerges. " As part of this, the manufacturers have committed to carry out post-authorisation safety studies in about 9,000 subjects for each vaccine.”