Swine flu or H1N1 virus is still spreading at a fast rate and has been responsible for death of 19 children in October, which totals up to 76 children been killed by swine flu since April in the United States. In the U.S. 37 states have now reported widespread swine flu cases for the week ending Oct. 3, up from 27 the week before. Anne Schuchat, director of center for Disease control (CDC) says that “We are seeing more
illness, more hospitalizations, and more deaths”. The good news is that the much awaited swine flu vaccine has come into market, but the supply is still limited. As per the latest report world’s five swine flu vaccine makers have produced 6.8 million doses of the vaccine and U.S. has ordered 3.7 million of them. U.S. is expecting 200 million doses of vaccine by the end of this year.
A Harvard poll revealed that only 40% people were sure that they will go for swine flu shots, while Department of Health and Human Services (HHS) said that many people, who would like to get flu shot may not get it due to the shortage. Let us take a closer look at the supply of swine flu vaccine:
- Nation’s vaccine program depends on 50 year old flue vaccine technology, 30 year old testing technologies and frequent production problems.
- U.S. government failed to invest enough in new technologies that can produce billion of flu vaccines doses per month.
- Money was invested in sterility and other aspect of production that do not benefit increased throughput.
Has US government put a goal on production of flu vaccine?
U.S. government has put a goal of producing 600 million doses of flu vaccine in flu season by 2011, which is far from reality. Two companies have already backed out of the initiative that government has started. This year U.S. is producing 30% of swine flu doses and...
rest will be manufactured in Europe, Australia and Canada.
The 50 year old flu vaccine technology involves growth of flu virus in chicken eggs. Then the vaccine is purified and tested. The test involves confirmation of presence of right amount of antigen to protect against the flu. Robin Robinson, director of the Biomedical Advanced Research Development Authority within HHS said that this year, some manufacturers struggled with production and got vaccine yields of about 30% to 40% of normal. The lower yields forces manufacturers to tweak the production process as told by Daniel former president of flu vaccine maker Chiron Vaccines, now part of Novartis.
One of the major challenges of testing is development of new reagents, which are the substances that combine with antigen (virus) and spit out numbers if manufactures are producing correct dose of the vaccine. Each time new flu strain like H1N1 for swine flu, surfaces, new reagent has to be developed. The development of reagents is done by Food and Drug Administration (FDA), which typically takes 10 weeks. The process includes growing of antibodies inside animals, typically sheep. Manufacturers depend on FDA in order to develop new reagent and hence test and release the product.
HHS is investigating new technologies for production of flu vaccines to increase developmental cycle and re-combination vaccines involving use of protein and DNA is on horizon. This process is expected to be two times faster than the egg technique. Government is aware and hopefully is taking steps to speed the vaccine development process and as said by HHS Secretary Kathleen Sebelius “with unprecedented speed, we have completed key steps in the vaccine development process”.