The US Government Shutdown has delayed the regulatory review of a new egg-free influenza vaccine production process developed by Protein Sciences.
The political agreement that ended the two-week US Government shutdown last night hours before the country was due to reach its debt ceiling was welcomed by money markets, US citizens and the thousands of Federal employees furloughed when cash strapped agencies were forced to prioritize essential activities and cease other work.
This includes nearly 5,000 US Food and Drug Administration (FDA) staff who were sent home without pay on October 1 who now face what healthcare advocacy group the Alliance for a Stronger FDA called a huge backlog of ‘non-essential’ work that has been building up since October 1 .
This backlog includes the revue of a novel egg-free, cell –based vaccine manufacturing process developed by Meriden, Connecticut-based firm Protein Sciences according to Congresswoman Nita Lowey (D-Westchester/Rockland) who cited the firm in her call for an end to the shutdown.
Lowey, who spoke at the Pearl River manufacturing facility of Protein Science last week, said the firm faced delays in securing an extended approval for its approved influenza vaccine – Flublok – to US citizens 50 years and older as a result of the shutdown.
“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.”
Flublok – as we reported earlier this year – is produced using an insect virus-based expression system that is capable of making large quantities of viral hemagglutinin, which is the protein that elicits the strongest immune response.
Protein Sciences want to gain regulatory approval to use the vaccine to protect older people from flu infection. The problem is that to grant the FDA must review the manufacturing process, which is something the agency is not doing as the confirmed for in-Pharmatechnologist.com yesterday .