From Our Partners
Sunday, June 26, 2022
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Industry News

FDA Grants 12 Year Exclusivity to Flublok Influenza Vaccine

by Global Biodefense Staff
June 9, 2015
Biodefense Vaccine Development

Credit: Shutterstock, modified by Global Biodefense

Protein Sciences Corporation announced this week that in a rare move, the FDA is granting exclusivity to its influenza vaccine Flublok, for a period of 12 years.

Flublok is the world’s first recombinant protein-based vaccine for the prevention of seasonal influenza, and was approved by FDA in January 2013.

Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.

The vaccine is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex.

The US FDA determination of regulatory exclusivity means that no product similar to Flublok can be approved by US FDA before January 16, 2025.

“The FDA’s designation prevents a generic product maker from capitalizing on the hard work of our team,” said Manon Cox, President and CEO of Protein Sciences Corporation. “We are delighted that the FDA recognizes Flublok as a singular innovation in the prevention of an important and often deadly disease caused by the influenza virus.”

“I am honored to be representing Protein Sciences Corporation for nearly twenty years on matters of legal exclusivity,” said Tom Kowalski, Esq., Shareholder with Vedder Price, P.C. “This biologics regulatory exclusivity is only the third of such exclusivities granted by the US FDA under the Affordable Care Act, and the only one for an influenza vaccine.”

Source: Protein Sciences Corporation press release, adapted.

From Our Partners
Tags: Influenza

Related Posts

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control
Medical Countermeasures

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Biodefense Industry News
Industry News

Tonix Pharmaceuticals Opens Advanced Development Center for Vaccine Programs

June 20, 2022
Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine
Medical Countermeasures

Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine

May 30, 2022
Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors
Industry News

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors

May 26, 2022
Load More

Latest News

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

June 22, 2022
Monkeypox Diagnostics: CDC Authorizes Five Commercial Lab Companies

Monkeypox Diagnostics: CDC Authorizes Five Commercial Lab Companies

June 22, 2022
UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Influenza Research

New Way to Identify Influenza A Virus Lights Up When Specific Virus Targets are Present

June 20, 2022

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC