Wednesday, October 06, 2021

New!: WHO Approves Malaria Vaccine

One of the great scourges of mankind may soon go the way of measles, polio and smallpox. The World Health Organization approved a preventive vaccine for malaria, a tropical disease thakills 500,000 a year, mostly children. The disease is one of the oldest known and most lethal diseases. It has proved difficult to control since it is spread by abundant mosquitoes in Sub-Saharan Africa during the rainy season. Also, the parasitic amoeba Plasmodium falciparum is especially resilient causing children in some regions to have on average six malaria episodes a year, and is just one of five pathogens that cause the disease. The parasite is able to modify its genes to produce a variety of proteins that help it evade a person's immune defenses for months.  [photocredit: Omikron]
malaria in red blood cells

The new vaccine developed by parma giant GlaxoSmithKline is the first vaccine for any human parasitic disease. In clinical trials the drug was effective in forty percent of  severe malaria cases in the first year, but dropped off to near zero by the fourth year. Some experts have questioned the investment in the vaccine by poor countries with many other difficult problems. A model study estimated that countries with the highest levels of malaria infection could prevent 23,000 deaths of young children and perhaps 5.4 million cases. When coupled with other preventive drugs and mosiquito control it is much more effective. Despite its drawbacks, the vaccine represents a significant development in fighting human parasites. Malaria research is strewn with drug candidates that never passed clinical trials. Insecticide-treated mosquito nets, the most widespread preventive measure, have only cut deaths of children under five from malaria by about 20%.

Given in four doses between ages 1.5 and 5 years, more than 2.3 million doses have been administered in Kenya, Malawi and Ghana. The immunization has been relatively easy to distribute given the effort to immunize people during the corona virus pandemic. The next step to making the vaccine widely available is for the global vaccine alliance, GAVI, to determine if Mosquirix is a worthwhile investment. COVID-19 vaccine production and distribution presents a hurdle for any new vaccine coming to market.

In another big Pharma story, New Jersey based Mereck is seeking emergency approval for its proprietary new drug to treat COVID-19. Early trials indicate the pill, molnupiravir is effective in preventing hospitalization of patients with mild to moderate cases of COVID-19. Patients undergo a five day course of treatment with the antimviral drug. The pill was developed with tax dollar funding.

The United States Department of Defense contributed $10 million in funding to Emory University from which the drug was licnesed by a private drug company, Ridgeback Biotheraputecs in 2020. The US National Intitutes of Health also contributed $19 million in grants to Emory for drug research. The US government placed an intial order for 1.7 million courses of treatment. The cost is $712 per patient. However, researchers revealed tha the pill costs Merck only $1.74/ unit or $17.74 per regimen. That math results in a markup of $4,000%! Merick expects to produce 10 million courses of treatment that could garner up to $7 billion in revenue making it one of the ten most profitable drugs ever. Under a 1980 law (35 USC 203) the federal government can intervene and allow a third party to licence a proprietary drug, if a company which received public funding for research refuses to make the drug available to the pubic on reasonable terms. Understandably it has never exercised those rights. One more reason the US needs to allow Medicare to negotiate drug prices.