From meningitisnow.org, again: 'This vaccine has been through ten years of trials in the laboratory and among volunteers.'
Wrt Bexsero licensed for administration for patients aged 10 to 25:
'Three studies evaluating Bexsero’s effectiveness were conducted in Canada, Australia, Chile, and the United Kingdom in approximately 2,600 adolescents and young adults. Among study participants who received two doses of Bexsero, after vaccination, 62 to 88 percent had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests carried out in a laboratory, compared with 0 to 23 percent before vaccination. These three strains are representative of strains that cause serogroup B meningococcal disease in the U.S.
The safety of Bexsero was assessed in approximately 5,000 participants who received the vaccine in studies conducted in the U.S. and abroad. The most commonly reported side effects by those who received Bexsero were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. In addition, safety was monitored in more than 15,000 individuals who received Bexsero prior to approval in response to two university outbreaks of serogroup B meningococcal disease in the U.S.
The FDA used the accelerated approval regulatory pathway to approve Bexsero. Accelerated approval allows the agency to approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public. In the FDA’s evaluation for accelerated approval, evidence of effectiveness was demonstrated by the ability of Bexsero recipients’ antibodies to kill the three representative N. meningitidis serogroup B test strains. As part of the accelerated approval process, the manufacturer will conduct further studies to verify Bexsero’s effectiveness against additional strains of N. meningitidis serogroup B.
Bexsero was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. The FDA worked closely with the company during the vaccine’s development, and was able to evaluate Bexsero’s safety and effectiveness and approve it two months in advance of its priority review goal date. At the time Bexsero was granted breakthrough therapy status, there were no other FDA-approved vaccines available to prevent serogroup B meningococcal disease'
Trumenba:
'Three randomized studies were conducted in the United States and Europe in approximately 2,800 adolescents. Among study participants who received three doses of Trumenba, after vaccination, 82 percent had antibodies in their blood that killed four different N. meningitidis serogroup B strains compared with less than 1 percent before vaccination. These four strains are representative of strains that cause serogroup B meningococcal disease in the United States.
The safety of Trumenba was assessed in approximately 4,500 individuals who received the vaccine in studies conducted in the United States, Europe and Australia. The most commonly reported side effects by those who received Trumenba were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue and chills.
The FDA used the accelerated approval regulatory pathway to approve Trumenba. Accelerated approval allows the agency to approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public. In the FDA’s evaluation for accelerated approval, evidence of effectiveness was demonstrated by the ability of Trumenba recipients’ antibodies to kill the four representative N. meningitidis serogroup B test strains. As part of the accelerated approval process, the manufacturer will conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B.
Trumenba was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. Working closely with the company, the FDA was able to evaluate Trumenba’s safety and effectiveness and approve it in well under six months, the usual timeframe for a priority review.'
I don't think effectiveness is really an issue.
in the news plus now Matt Dawsons son too, am having a bit of a freak out about it. Should I be considering the vaccinations for my DCs aged 4&8?