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European Commission authorises meningitis B vaccine

A vaccine to protect babies from meningitis B has been authorised for use by the European Commission.

Swiss pharmaceutical firm Novartis, which makes the vaccine, known as Bexsero, is now working to get it ready for use as quickly as possible. The European Commission will allow Bexsero to be given to babies from the age of two months.

MenB disease is the main cause of bacterial meningitis in Britain and is difficult for health professionals to diagnose as the symptoms often resemble other illnesses including the flu. In around 10% of cases the disease is fatal even with medical treatment and up to 20% of those who survive may lose limbs or suffer from brain damage, hearing loss or other serious permanent disabilities.

Steve Dayman MBE, the founder of the charity Meningitis UK, lost his son to meningitis B three decades ago. He welcomed news of the vaccine describing it as the “most important medical breakthough” since his child’s death and one that could save thousands of lives.

Andrin Oswald, the division head of Novartis Vaccines and Diagnostics, said that the firm’s main priority is to work with governments and official bodies across Europe to make sure the vaccine can be made quickly available to large numbers of people.

He said thousands of children die or are left seriously disabled die to meningitis B every year. He said the work to produce an effective vaccination to protect against it had involved a large number of people over 20 years.

He added: “Our vision is a world without meningitis.”

A decision on whether Bexsero will be available in the UK as part of the national infant immunisation programme has not yet been made. But it is currently being considered by the Joint Committee on Vaccination and Immunisation (JCVI).

 

Readers' comments (2)

  • Babies currently receive 25 vaccines before they are two years old making it a very congested vaccination programme.

    Your report raises some important questions:

    How do the UK vaccine-policy makers know this vaccine is safe and effective when given in combination with other vaccines?
    If a baby has a severe adverse reaction how will the health professional determine which vaccine component has caused it?
    Will the reporting of suspected adverse reactions be made compulsory? (Currently, in practice, it is at the health professional's discretion.)
    Will all reported adverse reactions be investigated thoroughly and followed up to determine if the child has fully recovered or deteriorated? (Currently, I understand, this is not done.)
    Will all parents be informed that there is a Government Vaccine Damage Payment Unit (VDPU) designed to assess cases were the child is 60% vaccine damaged or more? (Currently this is not done.)
    Will parents be informed that if their baby dies following routine vaccines the VDPU cannot investigate the case? (There is a clause in the Act which specifies that a parent can only apply for assessment once the infant has passed his/her 2nd birthday.)

    The UK Government accepts and condones the under-reporting of adverse vaccine reactions which is estimated to be in excess of 90%. If data on suspected reactions is not collected accurately and the few reports that are put forward are not investigated thoroughly by the MHRA how does the Government reach conclusions on the safety of vaccines?

    While I, and I expect every parent, welcomes the opportunity to reduce the risk of meningitis in some children, this vaccine will be rolled out across all children and we surely have to do everything possible to ensure no child is accidentally harmed in the process. A child damaged by meningitis or a child damaged by a vaccine, both matter, both count.

    Unsuitable or offensive?

  • Further to my posting yesterday:

    Here is an extract from yesterday's coverage of the same subject in 'Pulse' magazine:

    '...The Men B vaccine had ‘no clinically relevant interference’ with other routine vaccines given concomitantly, but it did increase the reactogenicity, with 77% of children showing febrile reactions after having the meningococcal B vaccine with other vaccines, and two cases of febrile seizures and two cases of Kawasaki disease in children who received the vaccine....'

    If anyone wishes to read the Lancet abstract it can be found here:

    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961961-8/abstract

    The study was funded by Novartis Vaccines and Diagnostics.

    Unsuitable or offensive?

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