Phase III results of the vaccine, which s known as RTS,S or Mosquirix, announced last week showed that it protected children and infants from malaria for up to 18 months after vaccination. But overall, vaccine efficacy declined over time, according to GSK. The candidate is the furthest malaria vaccine along in clinical development.
As far as manufacturing is concerned, it doesn’t seem GSK is too focused on a timeline for ramping up to commercial manufacturing.
“We have announced our intention to start the regulatory process for RTS,S next year. If this is successful, we hope to be able to make the vaccine available from end of 2015/2016,” GSK spokeswoman Rachel Cooper told BioPharma-Reporter.com. “Given those timeframes, it is a little too early for us to discuss ramping up manufacturing capacity at this point.”
The World Health Organization also has indicated that a policy recommendation for the RTS,S vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by European Medicines Agency.
As far as the manufacturing supplies for the clinical trials at 11 sites in seven African countries, GSK is manufacturing its product in-house.
“We currently manufacture RTS,S at our vaccine headquarters in Belgium and have enough capacity to meet the needs of the trial,” Cooper told us.
And since RTS,S is a relatively new type of vaccine, it may be easier to produce and manufacture in house, depending on the cost of outsourcing that work to a contract manufacturer.
According to a perspective in Nature Biotechnology, RTS,S is a VLP (virus-like particles)-based vaccine and offers several advantages over other types of vaccines.
“The efficient self-assembly of certain viral capsids and the particulate nature of VLPs greatly facilitates production and purification of this type of vaccine compared to soluble recombinant protein vaccines,” the authors write.
But for now, GSK will wait for further data from 32 months follow-up and the impact of a fourth booster dose given 18 months after the initial three doses. Data are expected to become available in 2014.
“We’re very encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa,” Sir Andrew Witty, CEO of GSK, said in a statement. “While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive.”