Vaccine Production For A/H1N1 (Swine Flu)

A pandemic sparks a production surge

On June 11th, as a result of the global A/H1N1 virus (swine flu) outbreak, the WHO declared its first flu pandemic in 41 years. As of June 15th, nearly 36,000 people in 76 countries have contracted swine flu; 163 have died. The WHO recently raised its pandemic alert level to the highest stage, spurring pharmaceutical companies to ramp up efforts to produce a vaccine. The CDC says a vaccine could be ready as soon as October if production and testing run smoothly. In light of the WHO alert level and drastically increased demand for a vaccine, Ergo asked four leading international public health experts to discuss the vaccine production process and expected availability of a A/H1N1 vaccine.

• Expert 1: Senior official responsible for A/H1N1 at Mexico’s National Institute of Public Health

  "In Mexico, we have found and will release the study soon that those that survived [the first wave of H1N1] had some protection via the regular seasonal flu vaccine. So now, we look at this, and think if there aren’t enough vaccines for the A/H1N1 virus then theoretically we could use the seasonal vaccine. It would be limited protection but still provide some protection."

• Expert 2: Director of influenza vaccine research at a leading medical center in Australia

  "The question is now not just whether a monovalent vaccine against the new swine flu strain will need to be developed, but just as importantly, should we start thinking about developing a new quadrivalent seasonal flu vaccine incorporating the existing 3 H1, H3, and B strains, and in addition the new H1 swine flu strain? We have previously successfully developed a quadrivalent vaccine covering H1/H3/B and H5 influenza strains, thereby providing protection against both avian pandemic influenza plus seasonal influenza. We are now applying the knowledge generated in development of the first combined seasonal/pandemic vaccine to develop and test a new quadrivalent vaccine that could effectively counter all major flu strains, including swine flu, currently circulating in the Southern hemisphere. [These strains] will inevitably return to cause further disease in the Northern hemisphere when they reenter their next flu season in six months time."

• Expert 3: Senior official at Colombia’s National Institute of Public Health responsible for A/H1N1

  "It is clear that the number of vaccine-producing countries is simply too small. However, there are some countries in Latin America with the capacity to accept technology transfer to start the production of vaccines, such as Mexico and Brazil. These [developing] countries which could domestically produce vaccines should receive technology transfer from the U.S. and others to produce an anti-pandemic [H1N1] vaccine. This was discussed with the WHO last year and the WHO has promised to provide $2 million for this vaccine production to these countries."

• Expert 4: Head of a viral diagnostic lab in Germany involved in testing for A/H1N1

  "The declaration of phase 6 by the WHO is a prerequisite to go ahead with the vaccine production. This is a step that will accelerate the vaccine production process. Once the WHO declared a phase 6, pandemic plans of countries went into place and they will have a clearly worded approval process for a vaccine. Any country that has the facilities to a produce vaccine will"

Ergo's House View

Ergo has developed extensive knowledge of emerging diseases from previous real-time studies on outbreaks of H5N1 (avian flu) and earlier this month, A/H1N1. Swine flu vaccine is expected to command a high price on the market, and production of it is the major manufacturers’ top priority this summer. The WHO has sent virus samples to Sanofi Pasteur, Novartis, and GlaxoSmithKline, all of whom are currently in the production process. On June 13th, U.S.-based Baxter International announced that it could have a vaccine ready for use as early as July, thanks to a patented technology that cuts in half the usual time required to produce a vaccine. Despite this apparent progress and a statement from the WHO director assuring that “the largest possible supply of pandemic vaccine [will be available] in the months to come,” a government’s ability to afford the manufacturers’ high prices will ultimately determine which countries will have access to the vaccine, and which will not.

This uneven distribution will fortunately be mitigated by two factors. First, the standard seasonal flu vaccine seems to provide limited protection against A/H1N1, so this could be administered by poor countries. Second, the major manufacturers may provide support to local companies so they can produce the vaccine domestically. While the manufacturers are rushing to get the vaccine on the market and governments are allocating resources for the purchase, WHO officials are closely monitoring the behavior of the virus in the southern hemisphere, where it is currently flu season, in an attempt to be better prepared for next winter’s flu season in the north.