6 BioPharm International eBook October 2021 www.biopharminternational.com
The Real Danger of Substandard and
Counterfeit COVID-19 Vaccines
Low- and middle-income countries are at the greatest risk of receiving
substandard and falsified COVID-19 vaccines.
A
s t h e C OV I D -19 p a n d e m i c c o nt i n-
ues, one pressing concern for the indus-
tr y is ensuring the supply of legitimate
COV I D -19 v a c c i ne s . It i s e s t i m ate d
t h a t 3 0 .7 % o f p e o p l e g l o b a l l y h a v e
received at lea st one dose of a COV I D -19 v acc i ne ,
while 16% of the world population is fully vaccinated,
according to Our World in Data (1). In a 2021 report
from ResearchAndMarkets.com, three different potential
scenarios for the f ut ure of COV ID-19 vaccines were
forecasted (2):
• Annual COVID-19 vaccines for all.
• Indiv iduals 65 years of age and older will get annual
COV ID-19 vaccines, while ever yone else receives the
vaccine every two years.
• Individuals 65 years of age and older will get a COVID-19
vaccine every two years, while everyone else receives the
vaccine every five years.
No matter the scenario, COV ID-19 vaccines will be
important in the coming years. Therefore, now more than
ever, the supply chain needs to be secure to ensure the popu-
lation 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.
Accord ing to a statement f rom t he World Hea lt h
Organization (WHO):
• "A substandard medical product is one that is out of
specif ication (usually due to a manufacturing error,
degradation, or expired).
• "A fa lsif ied medica l product is one that deliberately
or fraudulently misrepresents its composition, identity,
or source."
MEG RIVERS
Regulatory Sourcebook Drug Safety
LEIGH
PRATHER
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