Scientists worldwide have been competing to develop a vaccine that will turn the tide against the Covid-19 pandemic. Currently, there are over 150 Covid-19 vaccine candidates at different stages of development. This week, Pfizer Inc.’s vaccine news sent hopes soaring across various social media and news platforms.
Preliminary phase 3 results suggest that Pfizer Inc.’s vaccine might be more than 90 per cent effective against Covid-19. This result is significantly higher than influenza vaccines, which only reduce the risk of contracting the flu by 40-60 per cent. The news about this vaccine was particularly energizing to the Canadian population currently experiencing intense pandemic fatigue. These trial results were so promising that Prime Minister Justin Trudeau organized a press release to announce that he had already secured millions of doses of the vaccine for Canadians. In a briefing with reporters, he said, “We see the light at the end of the tunnel.”
While the news of this vaccine is worth celebrating, the proverbial light seems a bit dimmer for developing countries. The limitations of supply chains mean that even if this vaccine is approved, developing countries will be the last to secure doses. If Pfizer Inc. manages to resolve supply limitations and surpasses its projected supply of 1.3 billion doses by the end of 2021, the logistics of vaccine delivery and storage will significantly limit accessibility.
Clinical trials in the U.S., Germany, Argentina, Brazil, and Turkey show that two doses of the vaccine need to be administered, three weeks apart, for the vaccine to be effective. A double-dose will require twice as many vials, syringes, and storage units. The difficulties of immunizing large numbers of people will be particularly pronounced in developing countries that do not have the medical systems to monitor and track vaccination records. Furthermore, very few developing countries have the capacity to ship and store this vaccine at temperatures below minus 70 degrees Celsius, as stipulated by the developers.
Arguably, logistical concerns are not the most pressing issue for developing countries. The lack of medical regulatory boards like the Food and Drug Administration (FDA) leaves many developing countries vulnerable to unsafe and low-quality medical products. In the U.S. and Europe, robust regulatory systems are tasked with preserving public health by assessing the quality, efficacy, and safety of medical products. Medical regulatory authorities collaborate with manufacturers during the product development phases to ensure that development schemas are scientifically appropriateenough to address questions about clinical safety and efficacy.
This contrasts with developing countries, particularly in Africa, that lack medical regulatory boards equipped with the resources needed to evaluate the quality and efficacy of new drugs and vaccines. A study conducted by the WHO in 2004 reported that 90 per cent of African countries lack medical regulatory agencies with a capacity to guarantee the quality and efficacy of drugs circulating in their countries.
In 2005, 87 per cent of African medical regulatory boards reported that they did not have the capacity to evaluate biological products such as vaccines. Many of these countries have no vaccine registry systems either. A metanalysis of antimalarial medicines showed that 20 per cent were falsified, while 35 per cent failed chemical analysis. The absence of well-functioning medical regulatory systems exposes the people in developing nations to unsafe, substandard, and falsified medical products.
Pharmaceutical companies operating in developed countries are primarily responsible for saturating African countries with substandard medical products. The Covid-19 pandemic has uncovered many of these unethical practices. Pfizer Inc. itself has a history of testing unapproved drugs in African countries without obtaining informed consent.
In 1996, Pfizer inc. violated international law by testing trovafloxacin (Trovan), an unapproved antibiotic for meningitis, on Nigerian children. According to Nigerian officials, this unlawful drug trial resulted in 11 deaths and left dozens of children disabled. The company bribed Nigerian government officials to avoid paying the families affected by their illegal drug trials. With Pfizer Inc. currently leads the vaccine development race, it is important to ask how African countries can trust that the vaccines distributed by Pfizer will be of the same quality and efficacy as those available in North America.
Experts have warned that it might be too early to determine the efficacy and safety of Pfizer Inc.’s vaccine. The stakes are particularly high for Pfizer Inc. It is estimated that Pfizer Inc. will spend about $1.95 billion on the development of its Covid-19 mRNA vaccine. If their vaccine is later proven to be ineffective, how will Pfizer mitigate its potential losses? A quick internet search reveals the lengths that Pfizer Inc. will go to recoup losses. In 2009, the company paid $2.3 billion to settle civil and criminal allegations for illegally marketing its pain killer, Brexta, which had been previously withdrawn from the market for failing to meet standards of efficacy and safety.
It is likely that Pfizer and other pharmaceutical drug companies will use some of these old tricks to minimize losses associated with research and development if their vaccines are not approved. Research shows that when pharmaceutical companies face increasing losses for profitable drugs in developed countries, they rebrand their products and expand to new markets. This expansion is often accompanied by unsavory practices.
Probability tells us that not all 150 of the vaccines in development will be successful. The lack of medical regulatory boards in developing countries means there are few, if any, obstacles for these pharmaceutical giants to sell to these vulnerable communities. Thus, the international community should not only focus on approving a safe and effective vaccine but also making sure that pharmaceutical companies in developing countries do not sell unsafe and substandard vaccines.