Regulatory Focus™ > News Articles > Novel Vaccine Manufacturer Finds Operations Impacted by Shutdown

Novel Vaccine Manufacturer Finds Operations Impacted by Shutdown

Posted 16 October 2013 | By Alexander Gaffney, RAC

Here at Focus, we've been closely following the effects of the government shutdown on the US Food and Drug Administration's (FDA) operations. And so have some legislators, by the looks of it.

In a statement released on 14 October 2013, Rep. Nite Lowey (D-RI) said the shutdown was having a practical and negative impact on Connecticut-based manufacturer Protein Sciences, a company which first obtained approval for a novel new influenza vaccine in January 2013 and has a manufacturing facility in Lowey's district.

That vaccine, branded Flublok, uses a single hemagglutinin protein from the influenza virus, which is derived through a process that involves inserting a gene for the protein into an insect virus, baculovirus. The process is notable because it doesn't use chicken eggs, which can cause allergic reactions in some patients.

Further, the process is fast-really fast. An egg-based process can take six months or more to make a vaccine. Flublok's production process, in contrast, takes around two months.

That speed has attracted US biodefense dollars and interest from the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA), which apparently wants to further develop and scale up Flublok and another product called Panblock (bird flu variant H5N1) as well.

FDA officials were similarly impressed at the time of approval. "This approval represents a technological advance in the manufacturing of an influenza vaccine," said Karen Midthun, director of FDA's Center for Biologics Evaluation and Research (CBER). "The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus."

Fast Production, Slow Approval

There's just one problem: As fast as Protein Sciences' production process is, it's currently being stymied by an FDA that cannot, by law, accept its application under a shutdown scenario.

Lowey explained that the company is seeking to expand the product's indication for use for patients aged 50 and older. However, unless an application was submitted to the agency prior to 1 October 2013, the agency cannot, by law, accept the application or its user fees.

And that has Lowey worried about how that will affect patients during the next flu season.

"With FDA employees furloughed due to the shutdown, the delay in approval for new vaccines increases the chance the vaccine may not be available before next year's flu season." Many new drug applications take between six and twelve months to approve, though a supplemental NDA-the application type most likely to be used by Protein Sciences-could be reviewed more quickly. However, with the backlog of applications built up during the shutdown, it could take longer than normal to review an application once it is accepted by FDA for review.

The product is currently approved for use in individuals between the ages of 18 and 49.

We reached out to Protein Sciences for comment, but did not hear back by the time this article was published.

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