Pharmaceutical Technology - September 2021

Pharmaceutical_Technology_PTE_Regulatory_Sourcebook_September_2021

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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 - STOCK.ADOBE.COM

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