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Parents of UC Santa Barbara students want meningitis vaccine

December 23, 2013

vaccineAfter four University of California, Santa Barbara students contracted meningitis B, parents are questioning why their children are not able to get the vaccine which was made available to students at Princeton. [ABCNews]

Even though the U.S. Centers for Disease Control and Protection recommends that all adolescents receive a meningitis vaccination, there is no vaccine approved by the U.S. Food and Drug Administration to protect against meningitis B. In January, the European Commission authorized the meningitis B vaccine for use.

Last month, the FDA approved the importation of the vaccine for students at Princeton where eight students have been treated for meningitis B this year.

However, health officials have not approved the vaccine for use at UCSB where freshman Aaron Loy had his feet amputated as a result of being infected by meningitis.

“We consider vaccinating when there’s a sustained outbreak and ongoing transmission, and it looks like there’s a continuing risk for the students,” said Dr. Thomas Clark, chief of the meningitis branch at the CDC to ABC News. “If you look back at the meningitis [strain B] outbreaks we’ve seen, out of the 13 we looked at, 11 were four cases or fewer.”

 


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MaryMalone – do you know the difference between a virus and a bacterium? Start here: http://en.wikipedia.org/wiki/Neisseria_meningitidis


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Our hearts and support go out to those affected by the terrible effects of meningitis. The Meningitis Foundation of America offers extensive information regarding diagnosis, immunization, recovery and the after effects of meningitis. MFA survives primarily by donations. For the past 16 years, we have assisted people through support groups, resources and advocacy in efforts to help those affected with meningitis overcome and those around them understand the journey ahead. We promote prevention and safety measure in at risk communities and help explain the short term, long term effects and recovery treatments of meningitis to the media and public at large. Meningitis is a dangerous & often times fatal infection that can lead to serious life-long physical problems and even death. We are here to provide emotional support to those who need it; please feel free to reach out to us at http://www.musa.org and customersupport@musa.org

Daisi Pollard Sepúlveda-Low

National President

Meningitis Foundation of America, Inc.

World Meningitis Day 24 April


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In the wake of Princeton University’s meningitis outbreak, healthy individuals on campus who are at risk for infection will be offered voluntary immunization with Bexsero (Novartis), a vaccine that has not been approved for use in the United States. Since March 22, 2013, health officials have confirmed eight cases of Neisseria meningitides serogroup B (MenB) meningitis among students and visitors at Princeton University. Bexsero is the only vaccine in production that protects against MenB. While the media have expressed concern about using an “experimental” vaccine on students, the authors of an article being published in Annals of Internal Medicine say “compassionate use” of the unlicenced vaccine is justified because epidemiologic evidence suggests that all Princeton University meningitis cases are related and that transmission is ongoing. They argue that the vaccine is not experimental, as it has been approved for use in Europe and Australia. A plea for broader access to the vaccine has been made by advocacy groups, but the vaccine is being limited to Princeton University students based upon policy and epidemiology. While more than a third of total cases in the U.S. are due to MenB, a monovalent MenB vaccine would need to be administered along with the current quadrivalent conjugate meningococcal vaccine to optimize protection against all of the serogroups that cause the majority of disease in the U.S. The authors suggest that a vaccine that prevents MenB still should be available in the U.S. They write, “our ability to mobilize resources in response to this situation should compel us to take measures to ensure access to this prevention tool with proven safety and efficacy to all who are at risk.” Full text of this article is available at http://www.annals.org/article.aspx?doi=10.7326/M13-2927.


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Finally! FDA, ball’s in your court now…


December 23, 2013


To: Campus Community


Fr: Henry T. Yang, Chancellor UC Santa Barbara

Mary Ferris, MD, Student Health Executive Director and Campus Physician


Re: Reminder: Meningococcal disease prevention and response


Dear Community Members,


We are writing with an update on the efforts to obtain approval to use a serogroup B meningococcal vaccine at UC Santa Barbara. The vaccine for serogroup B is currently licensed for use only in Europe, Australia and Canada.


While we are reassured that no additional cases of meningococcal disease have occurred in community members since November 21, 2013, the nature of the disease and the cases at Princeton University this fall support moving forward with vaccination. The University has been working with the Center for Disease Control and Prevention (CDC) and state and local health officials to expedite access to the vaccine.


Following a CDC site visit to campus earlier this month and a careful review of the historical epidemiology of the disease at our University and in the local community, the CDC with support from our University, Santa Barbara County Public Health Department and the California Department of Public Health, will be moving forward with an Investigational New Drug application (IND) with the Food and Drug Administration (FDA). Since this vaccine is not licensed in the United States, it is considered “investigational” and requires a special process in order to use it, similar to the one that took place at Princeton University earlier this fall. The IND would allow access to the serogroup B meningococcal vaccine for those identified by medical and health officials as being at increased risk.


The University would offer the vaccinations to community members identified by the IND as being at increased risk. Although the process is continuing to move ahead as rapidly as possible, there are still many steps that need to take place, including determining the population to receive the vaccine.


The CDC has posted a Q&A on their web site about the current situation at UC Santa Barbara and has a designated email for serogroup B vaccine questions.


The health and well being of our students and campus community is our highest priority. We will continue to send out timely notices and post updates and additional information on our Student Health site as more specific information becomes available.


We hope you have a safe and restful break and look forward to the start of the new quarter.


Sincerely,


Henry T. Yang Mary Ferris, MD

Chancellor Student Health Executive Director

UC Santa Barbara UC Santa Barbara


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UCSB and the CDC are “hoping” no more students get sick, basically waiting for more students to get meningitis before they make Bexsero available to UCSB students.


With a 10% fatality rate, this is not an appropriate response.


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The issue with the strain of virus present in the UCSB students who developed encephalitis is outlined in the quote from the following (LATimes, http://articles.latimes.com/2013/dec/13/local/la-me-meningitis-vaccine-california-20131214), below.


The UCSB B strain isn’t even the same as the Princeton B strain. Since the mechanism of activity by the Bexsero vaccine targets protective layers of proteins, since the vaccine has not been licensed for distribution, and since the mechanism the developers THINK will allow the vaccine to both destroy the virus protein while NOT destroying the rest of our cellular protein, I think a little bit of caution needs to be considered here.


While the vaccine may not have caused problems with Princeton students, the long-term impact cannot be known. Coming up with antiviral vaccines is not an exact science, and since there have been just a few encephalitis victims at UCSB, and since the last known onset of encephalitis in a victim was over a month ago, IMO, caution in using an unlicensed and untested vaccine should be required.


“A vaccine that prevents four types of meningococcal disease — A, C W135 and Y — is administered routinely to children 11 or 12 years old, with a booster offered at 16 to 18, Hudson said.

But it has been difficult to develop a similar vaccine against type B, said UCLA professor of pediatrics Dr. James Cherry.

The meningococcal vaccine currently in use stimulates the body to create antibodies that target a sugar envelope that encases the bacterium that causes the illness. But because the sugar envelope in the type B bacterium is very similar to sugars in various cells in the human body, there have been concerns that a vaccine that worked the same way would stimulate the body to attack its own healthy tissues.

Bexsero avoids that problem by targeting surface proteins in the bacterium instead of the sugar envelope around it, Cherry said.

Before it might be approved for use at UC Santa Barbara, scientists will have to determine if Bexsero will work against the particular microbe detected in the four students there, he added.“


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http://podcastdownload.npr.org/anon.npr-podcasts/podcast/1172/510156/256225275/WILL_256225275.mp3?_kip_ipx=1066890675-1387814974


This is an audio of an interview given by CDC epidemiologist Dr. Tom Clark to an NPR affiliate in Illinois yesterday. In it, he talks out of both sides of his mouth. When speaking about Princeton, he emphasizes the safety and efficacy of the Bexsero vaccine, and the serious, swift and deadly nature of meningococcal disease. When speaking about “other campuses” (UCSB is not mentioned at all!) he resorts to calling the vaccine “unlicensed” and claims that in the “vast majority of cases” these outbreaks stop at 2 or 3 or 4 cases…


It’s a long podcast, but here are the relevant bits:


At 04:56 Dr. Clark answers the question of why Bexsero has not been cleared by the FDA, and he does NOT mention any qualms about the vaccine’s safety or efficacy. He implies but does not directly state that the reason is that Novartis is saving up their efforts for a blockbuster pentavalent vaccine that would have a large U.S. market: “All the data collected are..have been submitted to FDA, but the company has actually kind of taken the next step to work on a vaccine that would protect against B C and Y. They have an ACYW vaccine, and they’re working to combine it with their B vaccine, so it would protect against 5 groups of meningitis, and the 3 important ones that cause disease in the U.S.”


At 08:25 Dr. Clark responds to a question regarding how serious the Princeton cases were and once again admits that it was LUCK that no one died at Princeton: “They have done quite well…but that’s due in large measure due to the excellent medical that was received quickly there but it’s also probably due in some measure to luck…”


At 13:01 Dr. Clark is asked about the process by which Princeton University received the emergency clearance from the FDA. Here he emphasizes again how safe and efficacious Bexsero is: “There’s a lot of things that need to happen in order for this mechanism to be invoked, and one of those is that the manufacturer has an open file with the FDA so that the data has been reviewed for years, and so the FDA as well as the CDC were very comfortable with the effectiveness of the vaccine as demonstrated by your immune response to being vaccinated, and for the safety record of the vaccine in the clinical trials, and we’ve actually gone the extra step to test the individual bacteria that caused disease at Princeton, and we know that the antibodies that you get from vaccination killed those bacteria.”


At 25:07 Dr. Clark is asked about “other campuses…in California” and whether “they” would be receiving the same emergency vaccine program that was put in place at Princeton: “Of course we’re working with the states and the campuses involved to understand the cases, the patterns of transmission and working towards making vaccine available if that’s needed but I think that one thing that’s should be reassuring is that we do see clusters of 2,3, 4 cases, and uh, we, the great majority of the time we don’t see more than that, so using an unlicensed vaccine; there’s a precedent certainly, and there’s a process but it’s really a kind of, an exceptional circumstance, and so we’ll make thoughtful consideration about every time that it happens and use the vaccines as driven by the science.”


Infuriating. Obfuscating. They are waiting for another student at UCSB to fall ill before getting the vaccine program up and running. He claims that the “vast majority” of outbreaks stop after 2 or 3 or 4 cases. In prior public statements he estimated the risk at 2 out of 13, or 15%. In my private conversation with Dr. Cohn at the CDC, she targeted that estimate to include specifically outbreaks on college campuses and told me that the risk of a prolonged outbreak was 2 out of 4, or 50%. Their choice to watch and wait may be a pure motive in the realm of epidemiologic science, but it’s utterly immoral.


http://www.tubechop.com/watch/1748098


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href=”http://www.youtube.com/watch?v=RfdZTZQvuCo”>P&T call BS to anti vac http://www.youtube.com/watch?v=RfdZTZQvuCo


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They are not “waiting for another student at UCSB to fall ill before getting the vaccine program up and running.”


They are acting responsibly by being cautious in releasing a vaccine which has not been tried on this particular strain and, if something goes haywire, could outright kill those who were given the vaccine.


Proteins are an important part of what makes us tick. In fact, we can’t tick without them. Unleashing an untried, unlicensed vaccine that attacks proteins is the drug industry acting responsibly for a change.


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