Fate of Other Covid Vaccines? Where Regulations and Healthcare Collide
(Thursday, January 28, 2021)
With two vaccines being used to rapidly vaccinate most Americans, it seems the other vaccines under development are either moving to other countries or getting out of this program. Many countries have eased approval of 2nd and 3rd tier vaccines to vaccinate their populations purely for financial and logistical reasons. How the world vaccinates its diverse populations will be a case study of how healthcare events create unique regulatory environments that may impact the overall global populations for a long time. The first-tier vaccines are those that have been extensively evaluated in large clinical trials and have proven highly effective by established standards. At this time, there are two vaccines that meet these criteria: Pfizer and Moderna’s mRNA-based vaccines. Both vaccines have been tested in 30,000-45,000 patient randomized, placebo-controlled, multi-site, multi-national clinical trials and have exhibited >94% effectiveness and practically no major adverse effects. These vaccines are also highly adaptable in that these can be easily modified to counter new variants of the virus that are already emerging, making these vaccines robust tools to counter the infection. These vaccines have pretty much been assured wide-spread use in the US, Canada, and Western Europe - the developed rich countries with about a sixth of the World population. The main reason is supply and cost; most supplies of these vaccines were pre-ordered by the countries that could afford to buy them. The second-tier vaccines are those based on older technologies developed primarily in Russia, China and India. These vaccines have not been evaluated in large clinical trials and most results point out to lower effectiveness with the Chinese vaccines to have the lowest reported effectiveness of about 50%. The prominent vaccine is India is one developed by Astrazeneca/Oxford with effectiveness between 62-90% depending on dosing and other factors. However, these second-tier vaccines are the primary products used in China, India, Eastern Europe, Russia, South America, and Africa accounting for more than half of the world population. With massive vaccination programs and cost about a sixth of the Moderna vaccine, most populations in the world would be vaccinated with these second-tier vaccines. The third-tier vaccines include the even less tested Chinese vaccines and one vaccine from India with unknown effectiveness but the lowest cost. These vaccines will likely end-up in the poorest countries of the world. Although WHO and other non-profit entities are trying to harmonize the vaccines available across the globe, the vaccines available in all parts of the world are not equivalent. One could argue that this means that the harmonization of global regulatory standards for manufacture and approval of vaccines and therapeutic products have been shattered by the practical, logistical and financial pressures created by the pandemic. It seems the regulatory process took several steps back towards undoing the hard work of the past three decades to harmonize regulatory standards across the globe.  Yes, this is a special situation that should not be extrapolated to all medical products, and yes, the so-called second and third tier vaccines may end up being as good as other, but we would need to be extra vigilant that this stays a special event and that most medical products still get approved world-over under the same standards of quality and transparency.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
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