North Carolina Vaccine Facility Certified for the Next Pandemic
If the U.S. government declares an influenza pandemic, a new vaccine production facility located in Holly Springs, North Carolina, is certified and ready to go.
New Jersey-based Seqirus announced today that the company's innovative manufacturing facility has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines as outlined by the Biomedical Advanced Research and Development Authority (BARDA).
The Holly Springs manufacturing facility, the largest cell-based influenza vaccine producer globally and the first of its kind in the USA, was purpose-built through this public-private partnership with BARDA.
With this recognition, the U.S. government confirms that Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccines within six months of an influenza pandemic declaration in the U.S.
This Seqirus site maintains ongoing seasonal vaccine production and delivery of pre-pandemic annual lots to the U.S. government. It is equipped to quickly transition from seasonal to pandemic vaccine production to respond to an influenza pandemic.
An alternative to egg-based manufacturing, cell-based manufacturing avoids egg-adapted changes, one source of strain mismatch between vaccines and circulating pandemic influenza virus.
"Serving as a primary partner to the U.S. government in support of its pandemic preparedness plans is both an honor and a tremendous responsibility," stated Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus, in a press release issued on June 2, 2022.
"We have specifically designed our platform technologies to be scalable, supporting our seasonal and pandemic vaccine manufacturing needs. We look forward to a continued productive partnership for many years to come."
To support rapid response to public health emergencies, Seqirus is prepared to supply the U.S. government with influenza vaccines and adjuvants, including:
- AUDENZ™ is the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic. Audenz's initial U.S. FDA Approval was in January 2020 and received supplemental FDA approval in 2021.
- The MF59® adjuvant, when added to an influenza vaccine, is designed to enhance and broaden the body's immune response by creating broad, cross-reactive antibodies.
Beyond pandemic preparedness, the joint investment enables Seqirus to sustain the production of differentiated seasonal influenza vaccines, including:
- FLUCELVAX® QUADRIVALENT is the first and only cell-based quadrivalent influenza vaccine for individuals six months and older without contraindication.
- FLUAD® QUADRIVALENT is the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 years and older.
According to the U.S. CDC, Seqirus's new capabilities are essential to protecting the USA from 'viruses of special concern.'
The CDC website says 'some novel influenza A viruses are believed to pose a greater pandemic threat than others and are more concerning to public health officials because they have caused serious human illness and death.'
'Novel influenza A viruses are of extra concern because of the potential impact they could have on public health if they gain the ability to spread easily from person to person, which might cause the next influenza pandemic.'
In 2022, the Eurasian H5N1 strain first appeared in North American wild birds in January 2022. Since then, it has affected poultry/birds in 36 states and led to the loss of about 38 million birds as of June 1, 2022.
The U.S. CDC says these are the first detections of HPAI A(H5) viruses in the U.S. since 2016.
In April 2022, the state of Colorado reported the first influenza A (H5) virus infection in a person. The CDC says this 'Colorado patient is the first human detection of any influenza A(H5) virus in the USA.'
BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS).
In addition, pandemic influenza news is posted at PrecisionVaccinations.com/Avian.
PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership. This article was edited for clinical clarity by Dr. Carlson.