Bioscope ‘09

by  Dr. Barbara Price

Vaccines, politics and money

          We have covered various aspects of this before, but vaccines, politics and money are making news together again. When US President Obama declared the current H1N1 epidemic, pandemic influenza, a national emergency on 24 October 2009, this declaration, among other things, helps the DHHS and its NIH, FDA, CDC, authorize and expedite extraordinary actions.

          These actions include Emergency Use Authorizations, such as one issued for use of the unapproved drug peramivir, and issuance of waivers to existing regulations which go from exceptions to payment exclusions to an increase in how many people a hospital can care for. Many consider these actions a reaction to much slower than expected vaccine production. Although the US had ordered 225 million H1N1 vaccine doses to be shipped by the end of the year and had expected 40 million by mid-October, only 22.4 million were made available to the public by 27 October.

          Several manufacturers had said earlier they were behind in H1N1 vaccine production schedules because of much lower than expected yields and production line problems. But now they are saying: "we really did a good job on producing the seasonal flu vaccine - and we will now be able to concentrate on H1N1 vaccine production.' They claim they will deliver. But the delivery may be after the H1N1 infection rate has peaked. Reuters (28 Oct.) quotes the CDC Director as saying "The US Government may end up throwing away unused doses of swine flu vaccine if people cannot get it soon enough"

          The US has ordered vaccines from GlaxoSmithKline and AstraZeneca Plc. (both UK), Sanofi-Aventis SA (France), Novartis AG (Switzerland), and CSL Ltd. (Australia). And so have many other countries as spelled out in ASA 09-4 (August). With major vaccine producers struggling with low H1N1 yields and lower than expected shipments, a scramble for supplies has taken place. Factors affecting supply include: adjuvants not approved in US perhaps because of political rather than scientific reasons. Adjuvants are used in other countries to extend vaccine supply. This in itself will not ease the US shortage or continuing worldwide demand. The only US Headquartered major H1N1 vaccine manufacturer, Baxter International of Deerfield, Illinois, after receiving EU/EMEA approvals, sold its H1N1 vaccines to non-US buyers including becoming a primary supplier to WHO. Why not US? Slow US response. Medimmune, nasal spray vaccine manufacturer, is fulfilling its contract, and although sprayer production is slow, Medimmune believes it will meet all delivery dates.

          How are the priorities for filling the orders determined and can those vary? ASA 09-4 explored the prices each country paid per vaccine. Does that determine who gets it first? Or perhaps political clout? Certainly the poorer countries have put off ordering vaccines because of price and production. Their best hope may be the WHO, who has the task of being primary supplier of H1N1 vaccine to many, many poorer countries.

          Production of seasonal flu vaccine affected H1N1 production. Some producers said they had a slower line conversion to H1N1 because of having to complete seasonal first. Based on previous flu seasons, pharmacists are ordering less vaccine because of cost and money they have to put out. If the public does not respond to the call for vaccinations, small pharmacies and doctor's offices are left holding vaccines with a limited shelf life that no one wants. This is exacerbated with late deliveries of H1N1 vaccine. Are the US and other countries committed to paying pharmaceutical companies for H1N1 vaccine delivered too late for anyone to buy? Will this be the next bail out? Reimbursing big pharma for vaccine production we did not use because of too late delivery?

          Production of influenza vaccines has been slow; the pharmaceutical companies are using old (chicken egg) technology. There are more modern techniques to make vaccines, but these have not been used and tried for the influenza vaccine, in part because of the safety and regulatory issues. If vaccine sales were lucrative, more pharmaceutical companies might be interested in exploring vaccine manufacture and production. Their annual revenues are huge (billions of dollars) and they can invest in these technologies better than the various public health services of many countries.

          One has to ask, is it easier and more profitable for pharmaceutical companies to make antiviral drugs to treat flu rather than make vaccines to prevent flu? Antiviral drugs, such as Tamiflu, are in more demand and shelf lives of the pediatric liquids are expiring. Pharmacists have approval from FDA to compound Tamiflu tablets and mix the powder in an oral suspension for children. And they can use Tamiflu tablets that expired in 2005 until Feb 2010.

          And finally a word of caution, because we have been taught to demand the vaccine (and antivirals), our demand is increasing the probability of counterfeit drugs entering our markets and increasing the money to be made from cargo diversion and pharmaceutical theft.

For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection