EMEA reaffirms safety of pandemic vaccines

November 27, 2009
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Pharmaceutical Technology Europe

After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.

After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.

According to data, Novartis's Focetria and GlaxoSmithKline's Pandemrix may both trigger a sufficient immune response with only a single dose in some age groups. In a press statement, the EMEA said that a single dose can be used in adults aged 18–60 years, and in children and adolescents from the age of 9 years for Focetria and from 10 years for Pandemrix. Pandemrix can also be used as a single dose in the elderly. However, for younger children and immunocompromised patients, the EMEA still recommends that two doses be given to ensure a good immune response.

Data on Baxter's Celvapan, the only other pandemic H1N1 vaccine approved in Europe to date, are still being assessed.

WHO H1N1 update
The WHO has also commented on the safety and efficacy of the currently available H1N1 vaccines, commenting that the results to date are "encouraging". In a briefing note on its website, the WHO explained: "Although intense monitoring of vaccine safety continues, all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years."

As of 20 November, laboratory-confirmed cases of H1N1 influenza have been reported in more than 200 countries and overseas territories or communities, including more than 6770 deaths, according to an update from the WHO.

Last week, the WHO also reported on the significance of a virus mutation detected in three cases in Norway. The viruses were isolated from the first two fatal cases of pandemic influenza in the country and one patient with severe illness; however, it is not believed that the mutation is widespread in the country. Similar mutations have also been detected in other countries, including Brazil, China, Japan, Mexico, Ukraine and the US, with the earliest detection occurring in April.

In another briefing note, the WHO said: "Although further investigation is under way, no evidence currently suggests that these mutations are leading to an unusual increase in the number of H1N1 infections or a greater number of severe or fatal cases."

www.emea.europa.euwww.who.int