Vaccine production: a billion chicken eggs

How the H1N1 vaccine is made

Excerpt:

The most striking feature of the H1N1 flu vaccine manufacturing process is the 1,200,000,000 chicken eggs required to make the 3 billion doses of vaccine that may be required worldwide. There are entire chicken farms in the US and around the world dedicated to producing eggs for the purpose of incubating influenza viruses for use in vaccines. No wonder it takes six months from start to finish. But we'll get to that in a minute.

The most commonly used process for manufacturing an influenza vaccine was developed in the 1940s -- one of its co-inventors was Jonas Salk, who would go on to develop the polio vaccine -- and has remained basically unchanged since then. The process is coordinated by the World Health Organization and begins with the detection of a new virus (or rather one that differs significantly from those already going around); in this instance, the Pandemic H1N1/09 virus. Once the pandemic strain has been identified and isolated, it is mixed with a standard laboratory virus through a technique called genetic reassortment, the purpose of which is to create a hybrid virus (also called the "reference virus strain") with the pandemic strain's surface antigens and the lab strain's core components (which allows the virus to grow really well in chicken eggs). Then the hybrid is tested to make sure that it grows well, is safe, and produces the proper antigen response. This takes about six to nine weeks.

Comment: Still awaiting the opportunity to have the shot!

Modernizing flu vaccine production

Vaccine Makers Struggle to Speed Output

Excerpt:

... the U.S. is still struggling to modernize and speed up production of vaccinations against deadly pandemics like swine flu. The system is undermined by a lack of manufacturing plants and by decades-old technology that takes six to nine months to make flu vaccine.

The new Novartis plant, heavily financed by the U.S. government, represents one of the biggest steps in 60 years toward modernizing flu-vaccine manufacturing in the U.S. It uses new technology to grow flu viruses in vats of cells derived from dog kidneys, and uses these viruses to make vaccine. The decades-old process involves growing the virus in chicken eggs.

Novartis says the new approach could shave four to six weeks off the time needed to make each shot. The plant has other advantages: If a deadly avian-flu virus hit, it could kill scores of chickens and endanger the supply of eggs needed to make vaccine the old-fashioned way. Cell-culture technology removes that risk.

Comment: Interesting because explains cell-culture technology (select article for nice graphic). Democrats want to impose higher taxes on vaccine producers (below):

Reform tax would hit H1N1 vaccine manufacturers

H1N1 vaccine: adjuvants, thimerosal, and chicken eggs

Why You Can't Get the Swine Flu Vaccine

Excerpt:

Though the swine flu is widespread in 46 states many Americans are still waiting to get their vaccines. The Obama administration blames the shortage on manufacturing delays at the five firms making these products. But production issues only explain part of the shortfall. Also to blame are a series of policy decisions that reflect our extreme caution when it comes to these products.

From a regulatory standpoint, vaccines are unique in many ways. Since we distribute them widely to otherwise healthy people, they deserve careful oversight. But right now we are shunning new, superior vaccine science by being overly cautious.

On Saturday, when President Obama declared the outbreak a national emergency, he enabled the suspension of federal rules in order to speed the distribution of treatments. Yet less than half the projected vaccine has been actually shipped. Supply is far below the government's estimate of 40 million ready vaccines by November.

The first fateful policy decision, made last spring, was to forgo vaccine additives—called adjuvants—that activate the immune system and make shots more potent. Adjuvants allow a smaller supply of vaccine stock to be stretched across more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in the U.S.

Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.

The second cautious decision was to require that the H1N1 vaccine be a single shot. The government demanded single-dose syringes because they contain smaller amounts of thimerosal than multi-dose vials. This mercury-containing vaccine preservative continues to stir concern it can trigger childhood autism, even though this has been firmly disproven.

The third policy decision was to stick for too long with a proven, but slow process for making flu shots that uses chicken eggs to grow the raw vaccine material. Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe. The cell-based vaccines are unlikely to be approved in the U.S. Our precaution when it comes to vaccines means we don't easily embrace novel technologies, even if the Europeans would part with some of their limited supply.

Comment: Interesting!

H1N1 vaccine bottlenecks

H1N1 vaccine production running weeks behind

Excerpt:

The federal government originally promised 120 million doses of swine flu vaccine by now. Only 13 million have come through.

As nervous Americans clamor for the vaccine, production is running several weeks behind schedule, and health officials blame the pressure on pharmaceutical companies to crank it out along with the ordinary flu vaccine, and a slow and antiquated process that relies on millions of chicken eggs.

There have been other bottlenecks, too: Factories that put the precious liquid into syringes have become backed up. And the government itself ran into a delay in developing the tests required to assess each batch before it is cleared for use.

In depth article on egg based vaccine production: Egg-Based Production of Influenza Vaccine: 30 Years of Commercial Experience