6/17/2014: Using data collected at two universities, Novartis submits application to FDA for Meningitis B vaccine. – industry report… Expect the marketing blitz to begin….
Novartis was “granted” Breakthrough Therapy status. “If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. ”
Pfizer follows suit… is there something brewing with ACIP recommendations?
“…conservative model yielded peak sales of about $225 million by 2019–a far cry from the blockbuster numbers its giant Prevnar 13 puts up each year. But Pfizer, looking to build out its vaccines lineup beyond Prevnar, will take any added revenue it can get.”
(this tweet popped up yesterday from a VT rep; ironically the campaign is from 2010 and sponsored by yet a third vaccine maker, Sanofi)
December 16, 2013
The claimed Meningitis Outbreaks at Princeton University and UCSB are creating one very special opportunity for vaccine maker Novartis: clinical trial subjects and early marketing towards their anticipated blockbuster sales. Read this blog post, which is arranged in chronological order, to watch the story unfold.
See also: Meningitis Considerations
Meningitis B Vaccine
“Princeton University and the CDC decided to administer the non-FDA approved [Bexsero(R) Meningitis B] vaccine in November. There will be two doses, one of which will be administered in December and the other in February.” – See informed consent information and read more, HERE at the Daily Princetonian.
November 27, 2013: Princeton Students Should Ask Questions About New Vaccine Before Becoming Guinea Pigs, Advises Association of American Physicians and Surgeons
November 25, 2013: Princeton U. will not assume liability for experimental vaccine
“Wisely, the [UK] JCVI refused to approve the vaccine due to lack of clinical efficacy studies. The vaccine was approved in the EU and Australia from a trial involving 1,800 infants that showed a “robust” immune response when given Bexsero alone or along with other vaccines. This was based on something called “surrogate protection,” meaning, protection is assumed (but not proven) due to the presence of antibodies in the blood stream. The JCVI noted that efficacy against disease has not been established and interestingly, that Bexsero’s antibody response waned rapidly.” – Dr. Sherri Tenpenny (click to read full article)
November 19, 2013
- Princeton’s Meningitis Crisis Cuts Through the Usual Vaccine Red Tape- Businessweek
- UC Santa Barbara outbreak – read
November 18, 2013:
- “Novartis ($NVS) has been wanting to get its meningitis vaccine Bexsero into the U.S. market. Thanks to an outbreak at Princeton University, that’s going to happen sooner than the Swiss drugmaker thought. Ahead of FDA approval, in fact.” Read More
- NYU Langone Director of Medical Ethics suggests those getting the vaccine should be treated as research subjects and plans be made for those refusing to take the vaccine, which was tested in limited numbers and uses a surrogate marker that assumes protection from disease.
July 25, 2013: Novartis “dismayed…banking on the meningitis shot to revive its troubled vaccines unit…” Read More.
“We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person,” Department of Health immunization director David Salisbury said.
January 29, 2013: Tibu children became sick after being “given” the MenAfriVac® vaccine against meningitis in a campaign from December 11 to 15, 2012 in Gauro, Northern Chad. Read more: The Plight of the Tibu Children and the Chad Vaccination Case.
Novartis Bexsero Summary of Product Characteristics (official medicines label): click here. From the labeling:
“The efficacy of Bexsero has not been evaluated through clinical trials. Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens (see section Immunogenicity).”
AVAILABLE CLINICAL DATA
– Administered with MMRV….The vaccine was given to healthy toddlers who either received MMRV at 12 months followed by two doses of 4CMenB at 13 and 15 months (separate), or MMRV and 4CMenB at 12 months and 4CMenB at 14 months (concomitant). (read more)
– Administered separately and concomitantly with 7-valent pneumococcal-vaccine and a combined DTaP/HepB/IPV/Hib-vaccine) (read more) – Expect: fever, irritability, perhaps a seizure…also expect that they first look to try this vaccine in a non-pediatric population since, “4CMenB when administered alone had a reactogenicity profile which was comparable to that produced by routine-vaccines, but systemic reactogenicity was increased when the study-vaccine was combined with routine-vaccination.”
“…two investigational vaccines are under investigation by the FDA for use in infants. For more than two years, the working group has discussed the question regarding whether the 4.1 million infants born each year in the US should be vaccinated routinely against meningococcal disease. Discussion has focused on a number of factors, including the burden of meningococcal disease and the relatively small amount of vaccine-preventable disease in this age group; the limited public health impact of routine immunization in this age group; the programmatic difficulties associated with implementation of an infant or toddler vaccine schedule; the immunogenicity data which demonstrate declining antibody concentrations 3 years after either a 2-dose or 4-dose schedule, indicating a booster dose would be necessary before the routine 11- or 12-year meningococcal vaccination; and the cost-effectiveness of infant-toddler vaccination.”
“No group B meningococcal vaccine is currently licensed in the US. Placebo-controlled clinical endpoint efficacy studies in the US are considered not feasible because of low disease incidence rates and thus, sample sizes required would be prohibitively large. Although evaluation of clinical efficacy in a geographic region and age group with a higher incidence of invasive meningococcal disease has been considered, the molecular epidemiology of disease isolates would likely be different from the US providing challenges to the extrapolation of vaccine effectiveness. “
2 days ago – … Bexsero is highly unlikely to be cost effective at any vaccine price …for cost effectiveness used in the UK and could not be recommended.”.
development and on the impact and cost effectiveness of a range of potential … Sinceno other meningococcal B vaccine has completed clinical ….. immunisation usingBexsero® is highly unlikely to be cost effective at any vaccine price.
3 days ago – … Bexsero because the vaccine is unlikely to prove cost–effective. … and without any pricing discussion with Novartis,” said Andrin Oswald, head of the …Views expressed in the comments do not represent those of Reuters.
4 days ago – Bexsero was approved in Europe in January to protect individuals from 2… Bexsero is highly unlikely to be cost–effective at any vaccine price based on … forcost–effectiveness used in the UK and could not be recommended.
3 days ago – UK JCVI Not Recommends Novartis’s Meningitis B Vaccine Bexsero For Immunization … driven by evaluation based on cost–effectiveness assumptions. …Novartis said the JCVI made its evaluation before any pricing …
3 days ago – … driven by evaluation based on cost–effectiveness assumptions. …Novartis said the JCVI made its evaluation before any pricing discussion with it and if the position is not changed, it will postpone Bexsero access. In January …
3 days ago –  Novartis was not asked for pricing information as part of the JCVI … by financial considerations and without any pricing discussion with Novartis. … of evaluating the cost–effectiveness of Bexsero fails to fully capture the …
2 days ago – Meningitis B vaccine, Bexsero, is highly unlikely to be cost–effective at any vaccine price for routine infant… Main image: Child receiving …