Bioscope ‘06

by  Dr. Barbara Price

Vaccine Developments: Supplies and Shortages

           In 2001, there were shortages in 8 of the 11 recommended children’s vaccines and tetanus toxoid was in short supply and saved for emergency use. Through 2004, pneumococcal conjugate vaccine was in fluctuating supply and of course, the flu vaccine shortage was well known and often reported. Why does this happen? How did we become so vulnerable? The quick answer is economics, why should a drug company prevent a disease if they can make more money treating it? A longer answer involves understanding the science and the economics. There have been tremendous changes in how vaccines are made, but still it takes time to prove efficacy and safety. The economic danger in giving a drug (vaccine) to a healthy person results from very small chances of possible complications and is very different than when the same chance of complications is from a drug given to a sick person. As a result of these two financial issues, plus the tremendous cost for developing and manufacturing vaccines, the number of vaccine manufactures with license for products in the US decreased from 25 in 1967 to 6 in 2005 (Wyeth Vaccines, Merck Vaccines, Sanofi Pasteur, Medlmmune, Chiron, and GlaxoSmithKline Biologies -- these are multinational companies). Multinational is good, but multinational does not guarantee a nation the vaccines it may need. Also there are no multinational vaccine regulations, each country is required to meet different requirements, so a shortage in one country cannot be filled by extra capacity in another.

            Other financial issues include an estimated cost of $700 million dollars to develop a vaccine, plus the manufacturing equipment and costs. Vaccines that have been successful may need to upgrade manufacturing facilities to meet cGMP and several companies have closed the manufacturing rather than invest money they may not get a good return on. A successful vaccine becomes low cost; e.g., the DPT and MMR vaccines cost about $20 each in the US and the US CDC buys half of all produced as part of their children’s assistance programs. And some good vaccines do not sell well, either because of rumors or lack of perceived benefit.

           This information was from www.pediatrics.org/cgi/doi/10.1542/peds.2005-2427 available at http://www.redorbit. com/news/health/541284/vaccine_shortages_why_they_ occur_and_what_needs_to_beindex.html?source=r_health#

             Sinovac Biotech Ltd. in Beijing recently announced the preliminary results of its proprietary Inactivated Pandemic Influenza Vaccine (Human-used Avian Flu Vaccine) Panflu ™ in Phase I Clinical trials. This project of R&D on Avian Flu Vaccine for humans is sponsored and supported by Ministry of Science and Technology, and is co-developed by the Chinese Centers for Disease Control and Prevention (CDC) and Sinovac. The vaccine is being developed for possible sale inside China and outside. Sinovac announced that their preliminary results showed good immunogenicity, with a sero-positive rate of 78.3%, which exceeds the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union. Perhaps it will take a pandemic to harmonize international vaccine requirements?