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New technologies require FDA review as influenza vaccine market grows
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ARLINGTON, Va. — With the global influenza vaccine market predicted to double by 2016, a variety of new influenza vaccine technologies are in development, and these emerging technologies require extensive FDA review.
Norman Baylor, PhD, director of the Office of Vaccines Research and Review of the FDA, gave an overview of FDA regulations, novel vaccine approaches, and addressed safety concerns with adjuvants and the parameters for clinical assessment of these products.
“Licensure of new vaccine approaches will require complex testing, not unusual for any new product. Regardless of the technology, the regulatory framework will continue to be the same,” Baylor said.
He addressed the requirements for vaccine development, including sterility of products, general safety tests to look at the toxicity of the product, tests on final container products and purity, identity and release tests.
“You may have a very good product in the clinic, it may be very effective, but if the product cannot be manufactured, that product will not go anywhere. So, good manufacturing processes are required,” Baylor said.
Many of these new vaccines under development will require an adjuvant. He said making sure that adjuvants are safe and tolerable for use in adults, as well as the pediatric population, is important.
Baylor also said preclinical testing is required, as well as animal toxicity screening. Local and systemic adverse reactions usually cause concern. These can include injection site pain, inflammation, swelling, ulcerations, nausea, fever, allergic reactions and organ-specific toxicity.
“Often times, we don’t really know whether it’s the adjuvant that may be associated with the adverse event, or if it’s the combination, or if it’s the antigen itself,” Baylor said, adding that this makes it difficult to determine the association of the adverse event.
“The challenge is to develop a potent adjuvant which minimizes or avoids reactogenicity and toxicity. There are a variety of adjuvants out there, and it’s really critical that we make sure, in developing adjuvants, to start with a rational design, and an understanding of the mechanism of the adjuvant or the adjuvant system. Each adjuvant or combination will have to be carefully evaluated,” he said.
Baylor said the added value of an adjuvant should be considering; notably, the superiority of the immune response, or noninferior immune response, antigen sparing, cross protection or superior clinical efficacy relative to an unadjuvanted vaccine.
“I try to emphasize not to use an adjuvant because you have one,” Baylor said. “You need a very rational reason to use that adjuvant because there could be potential safety issues involved.”
New scientific and regulatory requirements are necessary to evaluate new vaccines for safety and efficacy relevant to the technologies used to produce the vaccines.
“We’re [FDA] committed to fostering innovation in the regulation of novel vaccines regardless of the technology,” Baylor said.
For more information:
- Baylor N. Presented at: IDSA’s Seasonal and Pandemic Influenza 2011; Jan. 27-28, 2011; Arlington, Va.
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