How Many Covid Vaccines Do We Need? Fate of Tier 2 Vaccines Seems Grim.
(Thursday, April 8, 2021)
There are still about 50 vaccines for Covid-19 in Phase 1 clinical trials, and 77 in non-clinical development. Of the 86 vaccines in clinical trials, 23 have reached Phase 3 clinical trials the world over, 13 of which have been approved or authorized in at least one country. The Covid vaccine market is already quite crowded. It may be mind-boggling as to what goes in the minds of developers of vaccines whose products have practically no chance of being used in the current pandemic and have questionable future uses. From the regulatory point of view, with several vaccines with very high effectiveness, the urgency to approve additional vaccines has vaned. True, that in the US, no vaccine has been formally approved; all have been granted Emergency Use Authorizations (EUA) only, but it is almost certain that these same vaccines will likely be the first approved as well. Currently, the focus is on producing enough doses to vaccinate most of the populations, not necessarily on finding more vaccines. The leading vaccines have demonstrated almost 100% effectiveness is protecting from serious diseases leaving little room for competition. At best any new vaccines can be me-too products with probably no market in the US and most developed countries and may not have any buyers even in the other places in the World. The early leaders have also set the bar to which all others will be measured. More importantly, testing a new vaccine in a clinical trial is already hard for lack of volunteers and are probably unethical due to availability of authorized/approved vaccines. It is too late to develop a new Covid vaccine by all reasonable practical considerations. Then why would most of these 50+ vaccines still be developed? Vaccines that use new untested technologies have other potential applications so even if they are not used for Covid-19, they may establish proof-of-concept for other future indications for these technologies. Another reason could be developing cheaper options for poorer countries. Most of the vaccine stocks so far have been gobbled up by richer, developed countries. The additional vaccines may fill the gap to vaccinate everyone else on the planet, although this argument may soon be moot as the leading vaccines have set their sights at unserved markets once they fill the current orders. There is no evidence yet of the need for repeated vaccinations or long-term markets, hence developing a product with undefined future is a highly risky proposition. The regulatory and business options available to tier 2 and tier 3 vaccines are disappearing rapidly. It is not long before many of these vaccines currently in Phase 1 or even preclinical stage, will be forced to be abandoned, if not by science, by the cold hard truth that no one needs them.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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