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When Protein Sciences first launched Flublok in 2013 — the only egg- and preservative-free flu vaccine on the market — Manon Cox, the company's president and CEO, expected the product to put the Meriden-based drug developer on the map in a global influenza vaccine market expected to be worth $3.8 billion by 2018.
“I thought it would take off,” Cox said, noting the Food and Drug Administration-approved product remains the only vaccination for people with egg allergies. “But it's taken longer than expected.”
While production of Flublok quadrupled from 300,000 doses two years ago to 1.2 million doses last year, Cox says her company's ambitious five-year goal to produce 30 million doses annually will require building many more relationships, including with national retailers like Walmart, Rite Aid and CVS. She anticipates vaccines will, over time, account for 90 percent of her company's revenue.
As part of a multi-pronged approach to promote and distribute Flublok, Protein Sciences recently collaborated with Wallingford-based Gaylord Hospital, Hartford Healthcare, and Hunter Ambulance to provide mobile vaccinations, a strategy that not only increased awareness of Flublok, but may also grow to serve as a national model for community vaccinations.
In fact, this past fall, according to Susan Mangenello, Protein Science's director of medical services, the collaboration helped vaccinate more than 2,200 people at 68 mobile clinics, including senior centers, fire departments, local businesses and healthcare facilities. More than one-quarter of the people served through the program were employees of Gaylord Hospital, which — like a growing number of healthcare providers — mandates that all employees receive an influenza vaccine.
“About 92 percent of our employees received their vaccination through this program,” said Dr. Stephen Holland, Gaylord's chief medical officer, who noted that collaborations among health-related organizations are becoming a bigger trend in the industry. “We are looking for these types of relationships, where we can meet joint goals, improve quality of care and cut costs,” he said.
“It's a very cost-effective solution for a hospital,” said Mangenello, adding the program saved the hospital staff time and reduced administrative paperwork — both of which were handled through program staff. But for Mangenello, the program was as much about raising understanding about a product that, although FDA-approved, still raises concerns as a new vaccine. “Some people were scared to try Flublok,” she said, “and needed to be educated.”
Mangenello, who is also a registered nurse, understands those concerns. She explained that while traditional flu vaccines have been made using an egg-based manufacturing process for the past 70 years, Flublok is a recombinant vaccine, which uses a production technology only approved in the U.S. since 2013 — and does not include an egg-grown vaccine virus.
Not only has the recombinant approach made the product the only vaccination option for people with egg allergies — with fewer side effects, Mangenello says — but it involves a much faster production schedule than traditional egg-based production, according to the Center for Disease Control (CDC).
“We can [mass] produce a vaccine in 12 weeks,” Cox said, noting egg-based manufacturing typically takes six to eight months. “It's a major advantage of our technology.”
Those production capabilities have proven to be a cash boon for Protein Sciences, which has benefitted from hefty government investment — $150 million to date — to help accelerate vaccine production methods to address a potential pandemic outbreak, like the H1N1 virus in 2009.
That infusion of government capital helped Protein Sciences expand its workforce, manufacturing capabilities, and revenue — $45 million in 2014 in alone — but Cox says some of that past funding is less available as government entities like the National Institutes of Health are investing in the development of their own vaccine, which just adds one more potential competitor to a landscape dominated by a handful of major players.
That's been a challenge for Protein Sciences. “Because we produce smaller doses [than the market leading companies] our wholesale price of $35 is higher than the average of $32,” Cox said. She said her company is seeking a partner — a larger drug manufacturer — to help expand Flublok's marketing and distribution to the world's largest retailers.
For now, Cox says, Protein Sciences is encouraged by success of its mobile vaccinations and is looking to expand its grassroots outreach to more sites next flu season. The program is also helping test new healthcare delivery models.
“Mobile integrated health care is part of our company's short- and long-term planning,” said Donna Hunter, owner of Hunter's Ambulance, which provided the fleet of vehicles as mobile vaccine units. “Our healthcare system is moving from fee-for-service treatment to a preventative care model.”
Cox is happy her flu vaccine has part of that solution. “We continue to experiment,” she said. “It might serve as a national model,” and put her vaccine — and company — on the map in the vaccine market.
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