December 4, 2013

Physicians’ Organization Advises Caution Before Getting Vaccine

The vaccine being offered to Princeton University students to protect against type B meningococcal meningitis has raised concerns from an organization of medical professionals. The Association of American Physicians and Surgeons (AAPS) issued a statement last week advising students to consider the possible risks involved before getting the injections.

“In deciding whether to serve as the equivalent of an experimental subject for a potentially lucrative product, students should carefully weigh risks and benefits,” the statement reads …. “Ask questions and do your own research before participating in a study. Do not allow yourselves to be pressured.”

But on a question-and-answer page from the Centers for Disease Control that can be reached via the University’s website, the CDC and the Food and Drug Adminstration state that it is safe to get the vaccine, even though it has yet to be approved for use in the United States. “FDA has concluded that the benefits of using the vaccine to prevent meningococcal disease outweigh the risks of possible adverse events, supporting its possible use during the serogroup B meningococcal disease outbreak at the University,” it reads.

The first case of meningitis was reported at the University last March. Since then, seven new cases have been identified. The number of cases and lack of direct connection among them signify an outbreak, according to the CDC. The vaccine, a drug called Bexsero that is manufactured by Novartis, has been approved in Australia and Europe. Bexsero is touted as covering 91 percent of all circulating strains of the meningococcus said to cause disease in this country. It is being imported to Princeton under special approval by the CDC. The first dose is being offered to undergraduate students and graduate students living in undergraduate dormitories, as well as other members of the University community from December 9-12. The second dose will be available in February (two are needed for maximum protection).

The physicians’ organization that issued the statement of concern urges students to weigh the options. “If it were my kid, I’d say just wait a while, and see what the risks are,” said Dr. Jane M. Orient, a general internist in Tucson, Arizona and a spokesperson for the AAPS. “I think it’s good general advice for people to be aware of what’s going on before they participate in an experiment, which is what this is. It has not been approved by the FDA here. And it was rejected in the United Kingdom because it’s not cost-effective.”

The AAPS advises students to take antibiotics, whether or not they are vaccinated, to protect against the disease. Students should also practice good hygiene and avoid sharing personal items and engaging in casual sex. “Vaccines, like other medical products, can have serious adverse effects, which may not be discovered until they are in widespread use,” the statement reads. “Huge potential profits and immunity from legal liability for adverse effects of government-recommended vaccines provide incentives to understate risks and overstate benefits.”

The CDC, on the website, maintains that the risk of serious harm from the vaccine is “extremely small.” More than 8,000 infants, children, adolescents and adults were safely vaccinated as part of the studies that resulted in Bexsero’s approval in Australia and Europe. “The most common side effects take place where the shot was given (in the arm), which can include pain and tenderness, swelling, and hardness of the skin,” the statement reads. “Other common side effects for adolescents and young adults include nausea, feeling a little run down, and having a headache. These reactions usually last a short amount of time and get better on their own within a few days.”

Counter to Dr. Orient’s opinion, the CDC does not consider the vaccine to be experimental. “FDA is allowing the use of the vaccine at Princeton University under an Investigational New Drug application, which is a term FDA uses to describe a medication of vaccine not licensed (approved) in the United States but which is made available for healthcare providers to use in certain situations,” the statement reads, adding that clinical trials in other countries have shown the vaccine to meet safety and efficacy standards after a thorough review of the available data.

Bexsero has yet to be approved in the United States because of “many factors,” and “approvals in additional countries are expected soon.”

“I have been following the vaccine issue for a long time. We’re not opposed to vaccines in general, but we think patients should be informed,” Dr. Orient said. “All vaccines have risks. The tendency when evaluating vaccines is that they are a sacred cow. But they are also a money-making sacred cow.”

California Cases

Meanwhile, officials at the University of California at Santa Barbara have confirmed four cases of meningitis in less than a month, with the first student diagnosed requiring the amputation of both of his lower legs to save his life.

Preventive antibiotics are being provided to more than 500 students identified as close contacts of the affected students. Consultations are ongoing with the CDC, but Bexsero has not been recommended. The Princeton University outbreak is said to be caused by the same strain, but with a different genetic fingerprint than the UCSB cases, according to the CDC.