Tag Archives: MMR

Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)



Filed under Allergy and Immunology, Dermatology, Drug And Device Safety, Family Medicine, IMNG, Infectious Diseases, Internal Medicine, Pediatrics, Primary care, Pulmonary Diseases and Sleep Medicine, Uncategorized

MMR, Autism and Wakefield: Unringing the Bell

Dr. Paul A. Offit/photo by Mitchel Zoler

On February 14, The Philadelphia Inquirer ran an essay by Dr. Paul A. Offit, pediatric infectious diseases specialist and childhood vaccine champion, with his take on recent developments in the Dr. Andrew Wakefield/autism/measles, mumps, and rubella vaccine fiasco. Dr. Offit, chief of infectious diseases at The Children’s Hospital of Philadelphia, has had a special interest in the spurious links between childhood vaccinations and autism, and he wrote a 2008 book on the subject.

On February 2, the editors of The Lancet retracted Dr. Wakefield’s controversial and ultimately fraudulent 1998 report that purported to document a causal link between administration of the MMR vaccine to children and their quick development of autism. Dr. Offit’s essay cited other scandalous events linked to the infamous paper, such as reporting by a British journalist that showed Dr. Wakefield received more than $750,000 from a personal-injury lawyer who planned to file lawsuits based on the autism links Dr. Wakefield reported in The Lancet.

Dr. Offit also cited some of the unfortunate consequences of Dr. Wakefield’s 1998 paper: “Wakefield’s belief that MMR caused autism has morphed into other strongly held beliefs: thimerosal…was responsible; or other vaccine ingredients, or too many vaccines given too soon.”

These cumulative vaccine slanders “had their effect,” Dr. Offit continued. “During the last few years, outbreaks of whooping cough in the United States have increased, in some instances mimicking epidemics seen in the pre-vaccine era. And, in 2009, three children in Philadelphia died from meningitis caused by” the Hemophilus influenzae type b bacterium, “which could have been safely and easily prevented” by following U.S. vaccine guidelines.

Even though The Lancet officially eradicated Dr. Wakefield’s 1998 report from the medical literature, it will be hard “to unring the bell,” Dr. Offit said in his essay yesterday. It is hard “to reassure people once you’ve scared them;” The Lancet’s retraction “will do nothing to restore the lives of children lost in this sad, tragic episode.”

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Drug And Device Safety, Family Medicine, IMNG, Infectious Diseases, Pediatrics, Practice Trends, Primary care