Masterstudiengang "Drug Regulatory Affairs"
Drug shortages for supply-relevant medicinal products exemplified by vaccines - Notifications, reasons and effects ***
Dr. Tanja Lidy (Abschlußjahr: 2019)
Is there reason to complain about drug shortages for vaccines in Germany? According to the Paul Ehrlich Institute in Langen (PEI), Germany has an adequate stock of vaccines. Nevertheless, it is vital that this supply is and remains secure, as gaps in vaccination lead to inadequate immune protection with correspondingly high risks for the population.
From a global perspective, the complaint of a vaccine shortage is unfounded, because all essential medicines, such as vaccines, are usually available, according to the World Health Organisation (WHO). The European Medicines Agency (EMA) will also soon introduce new approved vaccines to the German market.
Nevertheless, the present document demonstrates gaps in vaccination in the European and, especially, German markets. Already initiated and planned or proposed countermeasures are presented in this document. Various perspectives are offered, including those of the pharmaceutical companies, the pharmacy, the authorities and the public. Special attention is paid to the influence of national and international approval with their interrelations.
Although the causes of vaccine shortages often appear to be somewhat complex, the problems are resolvable. This master's thesis offers proposals for short-, medium- and long-term measures to remedy these drug shortages. If a shortage is inevitable, the presented strategies may prevent the endangerment of patients or their fellow humans.