As Angry Parents Criticize Official Footdragging, the Center for Disease Control Quietly Signals Intent

to Request Investigational New Drug (IND) approval from FDA

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New Webpage Settles Mixed Signals, Concedes on Likelihood of New Meningitis Cases at UCSB, That Unapproved Vaccine Works on Santa Barbara Strain, and Gives Thumbs Up to Vaccine Request

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BREAKING

Santa Barbara, CA

Dec 23, 2013

Revised Dec 24,2013

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An outbreak of bacterial meningitis B has cost an eighteen year old athlete both feet and sickened three other students in this college town known for its party scene and natural beauty. Parents have demanded that the CDC approve the Novartis Bexsero vaccine which is only approved in Europe, Australia and Canada.

As Princeton students lined up to received the vaccine under an Investigational New Drug permit, angry bloggers traded unflattering remarks about the discrepancies between government policy at the two universities. UC Santa Barbara, far from the corridors of power, is a state school with less money and more students to vaccinate than Ivy League Princeton.

However. bloggers and the media seem to have not yet fully appreciated the implications of a new webpage posted at CDC.GOV which sends a strong signal that CDC has reached a determination that it will indeed seek the IND as requested by the California Department of Health.

Moreover, the page clarifies issues which heretofore had been subject to much confusion and mixed messages apparently even within the Federal agency itself. The bare fact of creation if the new webpage had been reported by KEYT ithout teference to its stunning implications.The page settles the question with official assertion that the outbreak would be expected to continue unless vaccination is implemented, contrary to previous official scepticism. It also settles the question that the vaccine is indeed efficacious for the California strain.As much had been hinted and reported by JoNel Alec CIA, senior health reported at NBC, but many news outlets continued to report official ambiguity.

The real blockbuster is however the assertion that CDC is now clearly intent on moving forward on the IND application.Previous accounts had been freight with qualifications, uncertainties and predictions that the outbreak would likely due out on its own.

For worried parents of UCSB parents, this shift in official tone is welcome news. Perhaps then one can conclude that "yes Virginia, there is a Santa Claus".



Update Dec 24

Although NBC had reported that the vaccine had been determined to be efficacious against the UCSB Santa Barbara meningitis strain and that more cases could be expected to occur, her source was unclear and most news accounts continued to cite Dr.Thomas Clark's scepticism over the likelihood of any new cases. Virtually all news sources continued to suggest that it was unknown whether the vaccine worked on the Santa Barbara strain.

A Massachusetts physician whose son attends UCSB had however peppered the internet with contradictory assertions based upon private phone conversations with another CDC expert. Dr. Clark had cited a low likelihood of additional all cases but theactivist mom asserted that if one looked at historical data restricted to college campus outbreaks, the likelihood of additional cases was five times higher.Clark was also roundly criticized for emphasizing the dangerous ness of the meningitis outbreak at Princeton, a wealthy Ivy League university, while downplaying the risk at UC Santa Barbara, a state school far from the east coast corridors of power.

With the Christmas holiday coming up, and news of a major development in the unrelated fungal meningitis litigation, the mainstream media has completely missed the implications of the new CDC webpage.although California's KEYT reported creation of the page, no mention was made of the blockbuster assertion that the CDC had in fact decided to go forward on the InvestigationL New Drug application for Novartis' Bexsero.

Touted as a breakthrough in reverse vaccinolgy, this vaccine manages to outwit the wily meningococcus B strain which heretofore evaded vacvinologists by hiding behind a sugar coating which so closely resembles human cells that it had been impossible to rouse an immune response. By targeting instead protein sequences in day he microbe, the new vaccine enables recipients to develope effective antibodies. Now legally approved in EU and Canada, debate is raging over whether to finance it under national subsidized health plans.

ditional cases are likely to occur at UCSB. Based on that conclusion, the request will be made to FDA.

The Alliance to Teach has a petition urging inclususivity of any vaccine drive at WWW.causes.com/teach