Autumn is well upon us. Nature is showing us how diverse her color palette really is and it is always important to take some time and stop and enjoy it — sometimes hard to do when the demands of world and work bear down — but important nonetheless. Soon we will be confined to the more limited hues of blues and grays.
- Ebola Vaccine Development Fast Tracked – On both sides of the pond, there appears every attempt to speed up development of an Ebola vaccine. This week NIH announced that it is beginning an early human clinical trial of a vaccine candidate – the second. The candidate vaccine is called VSV-ZEBOV will be assessed for safety and its ability to generate an immune system response in healthy adults given two intramuscular doses and will be tested as a single dose. Another vaccine candidate has testing underway with initial data results expected by the end of 2014. In a related note, the EMA issued a statement encouraging developers of Ebola vaccines to apply for orphan designation.
- FDA Commissioner Hamburg Talks on Orphan Products and Rare Diseases – Speaking of rare diseases, FDA Commissioner Hamburg spoke this week a the NORD Rare Diseases and Orphan Products Breakthrough Summit in Alexandria, Virginia – one of many FDA officials present at the meeting. The title of her talk was “A Pivotal Moment for the Treatment of Rare Diseases” and she used part of her talk to underscore the need for product development respecting Ebola and stated that the agency will do all it can to facilitate access to investigational products, responding “as flexibly as we can”. Among other things, she underscored the need understand the impact of rare diseases and that while rare, there are enough of them to impact large numbers of people.
- Blood Products AdComm Set for Early December on Multiple Issues – The Blood Products Advisory Committee has slated December 2 and 3 for a meeting that will consider several issues. Among them is a session where the panel will hear scientific data related to the long-standing gay male blood donor deferral policy. Currently FDA’s policy is that men who have had sex with other men at any time since 1977 are currently deferred as blood donors. The Committee will also be hearing an informational presentation on the first survey of the Rapid Donor Surveillance Project on MERS.
That’s it for me this week. Go out and look at all the colors. And have a good one.