How is the new swine flu vaccine going to be tested?
U.S. health officials announced this morning that trials of the experimental new H1N1 swine flu vaccine will start in August. The trials will take place at eight different university medical centers and some university clinics within the next thirty days. The first two vaccines to be tested are made by two pharmaceutical giants — vaccines made by Sanofi Aventis and CSL Limited will get the first tests.
This vaccine is in rush mode because of the impending flu season, which experts think could give us a resurgance of H1N1 cases. After all, a normal influenza season can be downright deadly, much less on that includes a strain of flu virus that is deadly and already resistant to most on the market flu medicines.
The first round of tests will be given to adults, for safet’y sake. According to the University of Maryland (the leading site for the vaccine trials) the tests will very quickly begin in children, once their efficacy and safety have been determined. Dr. Karen Kotloff of the University of Maryland, who is at the head of one of the drug trials, did not say much to the media, though Dr. Kotloff assured reporters that she has been “told that there is sufficient vaccine in existence to perform the studies”, and that people shouldn’t worry that the drug, though expensive to make, will be available only to the rich, as rumors have suggested.
The trials of the two new vaccines, scheduled tentatively to begin on August 10th, have already been swamped by people willing to volunteer, perhaps out of fear. In fact, according to Dr. Kotloff, there is “a great amount of interest” from people who are willing to risk a few side effects for free vaccination against the deadly ‘swine flu’.
H1N1 has caused the first true influenza pandemic of the 21st century. The virus spread around the globe in a manner of a few weeks, eventually infecting millions of people.
The reason H1N1 is so dangerous? It appears to behave very differently from traditional ‘seasonal’ flu — H1N1 causes very severe sickness, both gastrointestinal and respiratory, in young adults and older children, a strange focus group for a virus. On top of those two targeted groups, there are the traditional flu prone groups to worry about — pregnant women and people with asthma and diabetes and the elderly. “Swine flu” also appears to cause serious disease in obese individuals, although only small scale studies have confirmed this or provided any date, and strangely enough, other studies suggest that the elderly may have some natural immunity against it, strange considering that most of the population has no natural immunity to H1N1.
The first studies will look at dosing issues — the makers of these drugs want to know just how much of a dose of H1N1 vaccine will protect a patient without injuring them or causing serious side effects. For Sanofi-Aventis, this means determing if one or two 15 microgram doses of H1N1 vaccine are needed. The drug made by CSL will be testing at the 30 microgram dose level. The difference in dose size could be a big win for Sanofi-Aventis — when less of a vaccine is required to protect people from illness, more doses can be manufactured and distributed.
Unfortunately, we still have no idea just how many doses of either vaccine will be manufactured.
Other facets of the vaccine research involve examining the safety of each vaccine and any potential immune system response in adults and children. The study will be done concurrently with a study of the ability of the H1N1 vaccine to mix well with the traditional seasonal flu vaccine — the pharamaceutical industry wants to know if people will need both, just one, etc.
“As soon as early information from those studies indicates that these vaccines are safe for adults, similar trials in healthy children, aged 6 months to 17 years old, will start.” So said an official from the National Institute of Allergy and Infectious Diseases, which will oversee the trials.
Global and national health officials have said that H1N1 vaccination campaigns should begin no later than this coming October.