Federal Drug Administration (FDA) has approved vaccination for swine flu. For those who are in the healthcare business, may know that developing a product like drug and getting it approved from FDA is a long process, which has in part to do with the fact that FDA wants to ensure safety of patient and would like to make sure that manufacturer is following good manufacturing practices. As far as I look at the case with swine flu vaccine, there has been great achievement from development and approval front of the H1N1 vaccine. Health and Human secretary, Kathleen Sebelius told congress that, limited supply of the swine flu vaccine should be available in first week of October, one week earlier than expected. Let us look at some facts related to the swine flu vaccine:
There are two types of vaccines available for flu, one is the shot or the injection that contains killed virus and other one is nasal spray that contains live but weakened virus. Flu shot is an inactivated vaccine, i.e., it contains killed influenza virus. This flu shot is injected into the person through muscles to stimulate the immune system. Human immune system produces a response in form of antibodies to fight against the dead virus (foreign body). These antibodies attack the influenza virus, when virus enters a person and hence protects the infected person.
Nasal spray vaccine is also called LAIV for live attenuated influenza vaccine, which contains weakened influenza virus. The vaccine is termed an attenuated vaccine because the viruses are weakened so that they do not cause severe flu symptoms. I wrote about the nasal spray vaccine (FluMist), its use and side effects in my previous post.
How many companies got approval to make swine flu vaccine?
Four out of five manufacturers have been given approval by FDA as per Sebelius. The companies include: CSL Ltd. of Australia, Switzerland’s Novartis Vaccines, Sanofi Pasteur of France that produces flu shots at its Swiftwater, PA., factory, and Maryland-based MedImmune LLC, which makes the only nasal-spray flu vaccine (FluMist). Fifth manufacturer GlaxoSmithKline, which is a London based company, is in final stages of getting approval from FDA.
As per the articles that I have read, the amount of vaccine (dose) to be given to a patient is still an outstanding question. National Institute of Health is responsible for determining the right dose and it has indicated that one dose seemed to protect adults. It was also stated that one does appeared to protect adults in 8-10 days after the shot was given, which was faster than predictions made by scientists.
How much quantity will be available in the market?
US Government has placed an order of 195 million doses of swine flu vaccine, although it is expected that 45 million doses should be available by 15th Oct 2009. Historically, 100 million Americans seek flu vaccine every year, so 195 million doses should be enough to cover the swine flu epidemic. Sebelius said that 90,000 sites, including schools and hospitals have been chosen for availability of swine flu vaccine.
There is no doubt that swine flu has spread rapidly around the globe. Although, it seems that vaccine to fight against swine flu is taking a long time to come to market, but appreciate the effort put forth by the whole healthcare industry to bring it to market. It is not an easy task to go through the whole life cycle from development, manufacturing, approval to launching it into market in just six to seven months. There is mix reaction from people with respect to use of swine flu vaccine according to Harvard poll; where in 51% people said that they will use the vaccine. None the less CDC has issued guidelines for use of swine flu vaccine to manage the distribution of the vaccine effectively.