10 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m
Drug Safety
A
s the COVID-19 pandemic continues, one pressing
concern for the industry is ensuring the supply of le-
gitimate COVID-19 vaccines. It is estimated that 30.7%
of people globally have received at least one dose of a
COVID-19 vaccine, while 16% of the world population is fully vac-
cinated, according to Our World in Data (1). In a 2021 report from
ResearchAndMarkets.com, three different potential scenarios for the
future of COVID-19 vaccines were forecasted (2):
• Annual COVID-19 vaccines for all.
• Individuals 65 years of age and older will get annual COVID-19
vaccines, while everyone else receives the vaccine every two years.
• Individuals 65 years of age and older will get a COVID-19 vac-
cine every two years, while everyone else receives the vaccine
every five years.
No matter the scenario, COVID-19 vaccines will be important in the
coming years. Therefore, now more than ever, the supply chain needs to
be secure to ensure the population can have access to legitimate vaccines.
But substandard and falsified COVID-19 vaccines—commonly referred
to as counterfeit vaccines—continue to be a threat globally.
According to a statement from the World Health Organization (WHO):
• "A substandard medical product is one that is out of specification
(usually due to a manufacturing error, degradation, or expired).
• "A falsified medical product is one that deliberately or fraudulently
misrepresents its composition, identity, or source."
The Real Danger of
Substandard and Counterfeit
COVID-19 Vaccines
Meg Rivers
Low- and middle-income
countries are at the greatest
risk of receiving substandard
and falsified COVID-19
vaccines.
LEIGH
PRATHER
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STOCK.ADOBE.COM
