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Lancet: Three Studies On The Immunogenicity Of The H1N1 Vaccine

 

 

 

# 4220

 

 

You wouldn’t know it by rhetoric of the anti-vaccine crowd, but the `rushed, experimental, and dangerous’ H1N1 vaccine rolled out in response to the pandemic this fall has proven to be both safe and effective. 

 

No vaccine is without some risks, of course.  

 

But flu vaccines have a solid safety record over the past 30 years, and the H1N1 pandemic vaccine appears to have roughly the same low incidence of serious side effects as the seasonal jab.

 

We’ve certainly not seen the sort of dire results predicted by some vaccine opponents.  

 

Today, in The Lancet, three studies (from China, Hungary, and the US) on the immunogenicity (level of protection) bestowed by the H1N1 vaccine, along with safety data. 

 

Free registration is required to access the full text of these articles.

 

First, the overview, entitled:

 

Large trials confirm immunogenicity of H1N1 vaccines

Heath Kelly, Ian Barr

Full Text | PDF

Since the recognition of a novel influenza A H1N1 virus, in March, 2009, the virus has spread throughout the world to cause the first influenza pandemic of this century, resulting in a cumulative incidence of death of 5–14 per million in populous southern hemisphere countries.1 In view of the high likelihood that pandemic H1N1 will circulate as a dominant strain for several years, a vaccine will be the most effective long-term mitigation measure. The Lancet today includes three studies of candidate vaccines against pandemic H1N1 that report on several separate randomised trials in China, Hungary, and the USA.

 

Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials

Eric Plennevaux, Eric Sheldon, Mark Blatter, Mary-Kate Reeves-Hoché, Martine Denis

Summary | Full Text | PDF

One dose of vaccine was highly immunogenic in adults, suggesting that it afforded sufficient protection against this pandemic influenza A H1N1 virus. Two doses of vaccine will probably be needed in children younger than 9 years. Safety and reactogenicity of the vaccine were acceptable and similar to those of seasonal vaccine.

 

Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomised controlled trial

Zoltan Vajo, Ferenc Tamas, Laszlo Sinka, Istvan Jankovics

Summary | Full Text | PDF

The present pandemic vaccine is safe and immunogenic in healthy adult and elderly patients, and needs low doses and only one injection to trigger immune responses to comply with licensing criteria. It can be safely co-administered with the 2009–10 seasonal influenza vaccine.

 

Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial

Xiao-Feng Liang, Hua-Qing Wang, Jun-Zhi Wang, Han-Hua Fang, Jiang Wu, Feng-Cai Zhu, Rong-Cheng Li, Sheng-Li Xia, Yu-Liang Zhao, Fang-Jun Li, Shao-Hong Yan, Wei-Dong Yin, Kang An, Duo-Jia Feng, Xuan-Lin Cui, Feng-Chun Qi, Chang-Jun Ju, Yu-Hui Zhang, Zhi-Jun Guo, Ping-Yu Chen, Ze Chen, Kun-Ming Yan, Yu Wang

Summary | Full Text | PDF

 

One dose of non-adjuvant split-virion vaccine containing 7·5 μg haemagglutinin could be promoted as the formulation of choice against 2009 pandemic influenza A H1N1 for people aged 12 years or older. In children (aged <12 years), two 7·5 μg doses might be needed. 

 

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