New pandemic flu vaccine gets EU approval
gained approval in the EU. The Novartis vaccine, Focetria,
will be manufactured containing the offending virus should the
World Health Organization's warning system rise to a level 6 alert,
signifying that a pandemic has taken hold.
Alongside the pandemic flu strain, the vaccine will contain Novartis' proprietary adjuvant MF59, which boosts the immune system and can significantly reduce the amount of antigen required in each vaccine dose by up to 50 per cent.
The vaccine has been approved in all 27 member states of the EU, as well as Iceland and Norway, giving Novartis a foothold in the intense battle to produce effective flu pandemic protection products.
If and when a pandemic is declared, Novartis will submit a revised application to the European Medicines Agency (EMEA) to incorporate the identified viral strain within the vaccine.
Approval of the updated formulation would be expected to take no longer that seasonal flu updates regularly submitted to the EMEA for approval, according to a spokesperson for Novartis.
Once approved, the company would begin manufacture of the new vaccine at its manufacturing plants in Siena and Rosia in Italy.
Currently used for seasonal flu vaccine production, the plants churn out around 20m doses of trivalent vaccines using a similar egg-based production method as would be used for Focetria.
Should any further capacity be required, Eric Althoff of Novartis' vaccines and diagnostics division told in-PharmaTechnologist.com that the manufacturing facilities at the company's Liverpool, UK, site could also be turned to pandemic flu vaccine production.
The site is currently used to manufacture Novartis' Fluvirin systemic flu vaccine and uses a slightly different production method, but could be converted to Focetria production if need be.
Back in early 2006, Novartis submitted a mock-up file on Focetria to the EMEA based on clinical studies involving the company's MF59 adjuvant and several viral flu strains considered to have pandemic potential, including H9N2 and the infamous avian flu virus, H5N1.
In addition to the approval of Focetria in case of a flu pandemic, Novartis has also submitted a pre-pandemic H5N1 flu vaccine for EU approval.
The pre-pandemic vaccine also incorporates the proprietary adjuvant and is based on the same technology as Focetria.
While these vaccines still use egg-based production methods, the company is also in the midst of developing a cell culture-based antigen production technique using a proprietary cell line.
Promising to reduce production time to meet increased demands during flu outbreaks and potentially help develop antigens for viral strains that are difficult to grow in egg-based systems, the company's drive to develop this technology reflects a growing trend in the industry to find more efficient methods of vaccine production.
The firm's current lead candidate for a cell culture-derived seasonal flu vaccine is OptaFlu, which only last month received a positive opinion from the Committee for Medicinal Products for Human use (CHMP) supporting EU approval of the product.
According to Althoff, the company is also concentrating on developing a H5N1 vaccine based on the cell culture technique.
While the company has secured EU approval for the Focetria pandemic flu vaccine, US approval may be a little slower in coming.
"We are in discussions in the US," Althoff told in-PharmaTechnologist.com, "but until recently there were no real pre-approval pathways like in the EU."
As such, no approval applications have been submitted in the US as yet.
Novartis does, however, have a contract with the US government to provide H5N1 vaccine for stockpiling in preparation for a flu outbreak, as well as a recent $55m (€40.5m) contract with the US Department of Health and Human Services (HHS) to further develop the company's MF59 adjuvant to help stretch vaccine supplies in the case of a pandemic.
Fellow vaccine manufacturer Sanofi Pasteur also recently announced US Food and Drug Administration (FDA) approval of its vaccine to protect humans against bird flu, upping production capacity at its French plant to accommodate the anticipated increase in demand.
Sanofi also has a deal with the HHS, though worth more than twice as much as the Novartis agreement at $117.9m for the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine.
