Tag Archives: influenza vaccine

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)

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A Government Official’s View on Pandemic Flu

How well do you think the federal government performed in handling the 2009-2010 pandemic H1N1 influenza outbreak? Here’s the view of the physician who oversaw the effort at the U.S. Department of Health and Human Services (HHS), Dr. Nicole Lurie: “Looking back, I just feel very proud of what we accomplished as a nation.”

HHS Photo of Nicole Lurie, MD by Chris Smith

Dr. Lurie spoke last week at a meeting sponsored by the Infectious Diseases Society of America, in which participants reviewed the response to the pandemic flu in terms of what worked and what didn’t, and brainstormed to devise a list of priorities for future approaches to both pandemic and seasonal influenza.

The IDSA will incorporate those discussions into a revision of its January 2007 document, “Pandemic and Seasonal Influenza Principles for U.S. Action.” Back then, public health officials were concerned about the H5N1 “bird flu” virus as a possible pandemic strain.

“We were planning for a ‘different’ pandemic. But planning let us ‘pivot.’ Prior investments paid off in terms of vaccine manufacturing capacity and a strengthened public health system,” noted Dr. Lurie, who became the HHS Assistant Secretary for Preparedness and Response in June 2009, 2 months after the first case of pandemic H1N1 influenza was detected. Prior to that, she directed public health and preparedness work at the RAND Corporation.

Among the government’s major accomplishments, she noted, were the initial identification and sequencing of the virus, provision of test kits for states and for other countries, and delivery of the vaccine “in record time” to more than 70,000 sites, over 116,000 providers, and 10,000 retail pharmacy stores. As a result of the combined efforts of several different agencies within HHS, more than 80 million people were vaccinated.

“All-hazards public health preparedness paid off . … Unprecedented, cross-government, whole of community response is indeed possible,” Dr. Lurie said.

But, of course, there were gaps and opportunities for improvement. Response time needs to be faster for making vaccine and implementing other medical countermeasures, and for obtaining funding. Indeed, there was a time lag of about 6 months for Congressional budget appropriations to reach the federal, then state and local levels to the actual shot in a person’s arm. “We have to be more nimble about moving money.”

Photo by G C Lee via Flickr Creative Commons

Communication with the public could also be improved. “Addressing public concerns is key. The health care system handled this one well, but would be challenged in a more severe pandemic. You can never communicate enough,” she noted.

HHS is addressing these and other concerns, including building stronger day-to-day systems within those already in place, incorporating surveillance and scientific endeavors along with clinical care. The ultimate goal, as informed by the 2009 H1N1 influenza pandemic: “Ensure that we are prepared for something we have never seen.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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