Novartis cooks up first swine flu vaccine batch

pharmafile | June 16, 2009 | News story | Manufacturing and Production Novartis 

Novartis is ready to press ahead with clinical trials of its candidate vaccine against influenza (A)H1N1, having completed manufacturing of the first batch "weeks ahead of expectations".

The Swiss drugmaker has been able to get a jump on its rivals because it has invested in a cell culture-based technology for manufacturing vaccine antigens at its facility in Marburg, Germany.

Using cell culture is a much faster process than the conventional approach, which relies on growing the virus in chicken eggs and can take months to produce each batch.

In a statement, the company said a batch of viral antigen was based on the wild virus strain isolated in the early part of the outbreak. It has also started work on making a batch based on the seed culture supplied by the US Centers for Disease Control and Prevention (CDC) last month.

A second cell culture facility, which is being built in collaboration with the US Department of Health and Human Services, is under construction in North Carolina, US.

Novartis says it will start clinical trials of its swine flu vaccine candidate in July and hopes to win regulatory approval by the autumn, in time for the 2009/2010 flu season. More than 30 governments have put in orders for influenza (A)H1N1 vaccine ingredients.

Late last week the World Health organisation (WHO) officially upgraded the swine fly outbreak to pandemic status, the first one since the so-called Hong Kong flu of 1968, saying that it is expected to be of "moderate severity".

WHO director general Dr. Margaret Chan said that it was important for countries to strike a balance between "overreaction and complacency" when handling the pandemic.

One reason for the upgrade to a pandemic is that the virus is showing a different profile to seasonal flu. Although most of those infected are aged under 25, older people, and particularly the 30-50 age group, are most at risk of severe and fatal infections.

While the severity of the illness has not been severe in well-off countries, it is "prudent to anticipate a bleaker picture as the virus spreads to areas with limited resources, poor health care, and a high prevalence of underlying medical problems," she concluded.

Related stories:

Pandemic declaration will not change UK's response

June 12, 2009

Companies poised for swine flu vaccine drive

June 01, 2009

Related Content

Novartis shares new data about Fabhalta for IgAN treatment

Novartis has announced new results from a pre-specified interim analysis of its phase 3 APPLAUSE-IgAN …

chuttersnap-oijvdm3zx4i-unsplash

Novartis shares new data for Zolgensma in children with SMA

Novartis has announced new data to continue the support of the clinical benefits of Zolgensma …

Novartis to acquire MorphoSys AG for €2.7bn

Novartis has announced that it has entered an agreement to acquire MorphoSys AG for €2.7bn, …

Latest content