First-generation smallpox vaccines are the vaccines that were used during the eradication programme. Although previously licensed and shown to be effective against smallpox, most of these vaccines are 20 to 30 years old and do not meet current standards for manufacture.
The basic criteria outlined for a modern, second-generation vaccine are that it should retain the important biological properties (e.g. immunogenicity) of the first-generation vaccine on which it is based and that it should be manufactured using fully qualified and tested cell culture systems. In addition, it should be tested for safety and efficacy to ensure that it is licensable.
'The EMEA expert group on smallpox vaccines agreed on a number of points in relation to first-generation vaccines, including that they could not be authorised according to modern day standards and that additional batches should not be used manufactured using the old techniques. However, it was agreed that existing stocks of first-generation vaccine could be used in an emergency until second-generation vaccines are available and have shown positive clinical study results (safety and immunogenicity).'
US view
The US Government has developed a stockpile of smallpox vaccine sufficient to provide a dose per citizen. The majority of vaccine in the stockpile is the investigational second-generation vaccine, ACAM2000, which is not yet licensed. The US has approved a supplement to the Dryvax® license application so that a US -licensed, first-generation vaccine is currently available to immunize military, health care workers and other first-responders, as needed.
| alarm battery |
| security batteries |
| cialis |