Lowey and Protein Sciences Announce FDA License for Facility in Pearl River to Manufacture Flu Vaccine

June 15, 2015
Press Release

Protein Sciences plans to hire upward of 70 additional employees at Pearl River facility to support manufacturing of Flublok

Lowey worked to protect funding for programs that helped facilitate groundbreaking Flublok flu vaccine development

PEARL RIVER, NY– Congresswoman Nita Lowey (Westchester/Rockland), the Ranking Member on the House Appropriations Committee, today joined Protein Sciences and Rockland business representatives to announce a U.S. Food and Drug Administration (FDA) decision to grant a commercial manufacturing license for Protein Sciences’ Pearl River facility to produce Flublok influenza vaccine.

“FDA’s approval of the Protein Sciences Pearl River facility to produce Flublok not only enhances our ability to help families stay healthy during many flu seasons to come, but also enables local job creation,” said Lowey during a visit to the facility today. “As Ranking Member of the House Appropriations Committee, I will continue to fund critical priorities that safeguard public health and support engines of economic growth in Lower Hudson Valley.”

FDA recently granted Protein Sciences a license to manufacture Flublok, the company’s seasonal flu vaccine, at a facility at 401 North Middletown Road in Pearl River. Protein Sciences acquired the facility at the end of 2012 and has invested millions of dollars through a partnership with the federal Biomedical Advanced Research and Development Agency (BARDA), which facilitates the development and purchase of vaccines, drugs, therapies, and diagnostic tools for public health emergencies. The Pearl River production facility offers four times the manufacturing capacity as their Meriden, CT-based headquarters alone.

To accommodate the production of Flublok, which will ramp up this year, the 30-employee Protein Sciences facility in Pearl River plans to hire upward of 70 new employees. Protein Sciences also recently announced that FDA awarded a regulatory exclusivity period of 12 years for Flublok, meaning no similar products will be approved by FDA before January 16, 2025.

Congresswoman Lowey worked to protect funding for FDA and BARDA.

“We are extremely pleased to once again have the opportunity to host Congresswoman Lowey,” said Daniel D. Adams Executive Chairman and Global Head of Business Development at Protein Science Corporation. “She has been tireless and amazing in her support of the acceptance and growth of our Company and our wonderful product, Flublok influenza vaccine. Congresswoman Lowey is a strong and extremely effective supporter of New York State business and it has been our pleasure to work with her.”

Assemblymember Ellen Jaffee (D-Suffern) said, “Congratulations to Protein Sciences Corporation (Protein Sciences) for securing an FDA license to manufacture Flublok seasonal influenza vaccine, the only flu vaccine made in America by an American company and the only flu vaccine manufactured right here in Pearl River, New York. According to the Centers for Disease Control, 90% of influenza associated deaths occur among adults 65 years and older. It is my hope that our older adults may now be protected from influenza with this groundbreaking, home-grown in New York product. Instead of outsourcing to foreign companies for seasonal influenza vaccine, New York State has an opportunity to build jobs, boost our local economy and the success of Protein Sciences' reactivated manufacturing facility.”

“The FDA’s approval for Protein Science to produce its Flublok vaccine at its Pearl River site is a major step forward for the Bio Science community in Rockland County and the region,” according to Al Samuels, President/CEO of the Rockland Business Association and voting member of the Mid-Hudson Regional Economic Development Council. “The resulting expansion will add scores of well-paying positions so vitally needed in our area. We are all grateful to Congresswoman Lowey for the assistance she provided in this endeavor.”

“Protein Sciences is an early stage life sciences firm we attracted to the Pfizer Pearl River Campus in 2013. The combination of world class bio-tech lab space, clean rooms, and a smart work force enhanced the expansion from Connecticut,” said Michael J. DiTullo, President and CEO of Rockland Economic Development Council. “Congresswoman Lowey has been with us every step of the way as she was the pivot in expediting FDA approvals to produce Flublok, the next generation seasonal flu vaccine. Working together, we are creating tomorrow's jobs today, here in Rockland County and proving once again that smart money follows smart people.”

“As Supervisor, I want to see good, clean business development at the Pfizer site, development like Protein Science that will help attract other great businesses,” said Town of Orangetown Supervisor Andrew Y. Stewart.

“The growth of the biopharmaceutical industry in the Mid-Hudson region has helped foster economic growth throughout the entire area,” said Empire State Development President, CEO & Commissioner Howard Zemsky. “Three years ago, we welcomed Protein Sciences - and the jobs they would create - to the Empire State and now with FDA approval, we congratulate them on the accomplishment and look forward to the company’s continued success into the future.”

The U.S. Department of Health and Human Services (HHS) awarded Protein Sciences $34.5 million in 2009 to develop Flublok, which was subsequently approved by the U.S. Food and Drug Administration in 2013 for use by individuals 18-49 years old. Flublok is the first egg-free flu vaccine, meaning that it can be made more quickly and accurately without the infectious risk traditionally associated with vaccine manufacturing. An Assistant Secretary of Health has called the approval of Flublok by the FDA a “landmark in influenza vaccine history.”

According to the U.S. Centers for Disease Control and Prevention (CDC), influenza (flu) is a serious disease that can lead to hospitalization and sometimes even death. Over a period of 31 flu seasons, which begin as early as October and last as late as May, between 1976 and 2007, estimates of flu-associated deaths in the United States range from a low of about 3,000 to a high of about 49,000 people per year.

Influenza activity for the 2014-2015 season started early and had a relatively long duration. People 65 and older were especially impacted by last flu season, accounting for more than 60 percent of all reported hospitalizations.

Congresswoman Lowey has worked successfully to triple the budget for the National Institutes of Health to better detect, cure, and prevent debilitating diseases.