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meningitis b vaccine

(14 Posts)
Tillylils Mon 10-Mar-14 23:20:56

I've made an appointment for my daughter to have the bexsero jab next week. I know I'm doing the right thing but there's still a little niggle at the back of my mind about the long term side effects. I've looked online but the only information I can find relates to short term effects. I'm guessing that is because there are no concerns about the long term effects? What are your views?

recall Mon 10-Mar-14 23:23:59

I am speaking to my GP regarding this vaccine tomorrow, I'll be interested to see what others have to say, I share your concerns, but I also have a sort of phobia of Meningitis, so am keen to get them done.

recall Mon 10-Mar-14 23:24:19

I think there was another thread about this a few days ago

Tillylils Tue 11-Mar-14 19:28:48

Bump

foolonthehill Tue 11-Mar-14 19:36:55

Men B is the most common form of meningitis in the UK.

The Bexsero vaccination has only recently been licensed but there have been no concerns about long term effects raised in all the (extensive) trials throughout Europe and the USA.

The risks associated with men B are so serious (death 1/10 serious disability, loss of limb etc) that the Meningitis Research foundation is campaigning for it to be available free to all in the uk as part of the immunisation programme. As yet there is a stall due to the query over it's long term effectiveness, but not over it's safety.

hope that helps

Tillylils Tue 11-Mar-14 20:47:19

Thank you for that. That does make me feel a lot better. Will definitely be going ahead with it x

surfmama Wed 12-Mar-14 01:04:23

so is there anything saying it is safe in the long term?

foolonthehill Wed 12-Mar-14 19:24:33

science does not really work like that...it can only ever say that no long term effects have been observed...

our licencing system is extremely stringent and medicines and vaccinations have been in preparation and studies usually for decades before they meet real people, then years of human trials before they are generally available to the public.

Tillylils Wed 12-Mar-14 21:01:57

Thanks for the replies.

Fool, do you know how long this vaccine has been around? Has it been around long enough for them to know about long term effects?

foolonthehill Thu 13-Mar-14 09:40:51

I am not sure how long the process took for this particular vaccine but I have outlined below the procedure that is followed for EVERY vaccine...sorry it's loong!

For a vaccine to be approved:

Exploratory Stage
This stage involves basic laboratory research and often lasts 2-4 years.

Pre-Clinical Stage
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine. This phase is variable but may be up to 5-8 years long but is more usually 2-3 years

Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning that they vaccinate the animals and then try to infect them with the target pathogen. Challenge studies are never conducted in humans.

Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response.

Application to trial on human subjects
A sponsor, usually a private company, submits an application The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol.

Once the application has been approved, the vaccine is subject to three phases of testing.

Next Steps: Clinical Studies with Human Subjects

Phase I Vaccine Trials
This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded (also known as open-label in that the researchers and perhaps subjects know whether a vaccine or placebo is used).

The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. A promising Phase 1 trial will progress to the next stage.

Phase II Vaccine Trials
A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.

The goals of Phase II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.

Phase III Vaccine Trials
Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance).

One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group

Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to production of antibodies or other types of immune responses related to the pathogen?

Next Steps: Approval and Licensure

After a successful Phase III trial, the vaccine developer will submit a Application for licence to use.

After licensure, there is ongoing monitoring of the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity..

Post-Licensure Monitoring of Vaccines
A variety of systems monitor vaccines after they have been approved. They include Phase IV trials, the Vaccine Adverse Event Reporting System, and the Vaccine Safety Datalink.

Phase IV Trials
Phase IV trial are optional studies that drug companies may conduct after a vaccine is released. The manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.

Sneezecakesmum Fri 14-Mar-14 20:07:46

Where is the vaccine available and how much does it cost. What age should it be given? Tia

foolonthehill Fri 14-Mar-14 23:51:51

I think the cost of the vaccine was supposed to be about £70, though it can be free in some situations on the NHS for high risk groups

I would ask your own GP first as it is likely they will know which local clinics are offering it. It has only been available since last December so don;t be upset if it is difficult to get information...be persistent. Travel clinics are also a good bet.

foolonthehill Fri 14-Mar-14 23:53:08

Oh and I did a bit of digging and the vaccine has been in the pipeline for 20 years. HTH

Sneezecakesmum Sat 15-Mar-14 10:37:23

Thank you that looks encouraging. I think its one of my biggest fears meningitis. Saw too much in my A&E days!

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