After the COVID-19 outbreak and during the subsequent race for the fastest possible approval of vaccines and medicines, the pharmaceutical industry was the focus of global public attention. Groundbreaking developments in Russia and Germany, among others, led to the rapid approval of vaccines.

In the first year of the pandemic, the pharmaceutical industry was also negatively affected. Demand for medications initially fell in 2020, partly because operations were postponed and because there were apparently fewer cases of infectious diseases due to people wearing masks. In addition, people avoided going to doctor's offices, often for fear of infection, which in turn led to fewer prescriptions. In addition to these obstacles to sales growth, there were also organizational problems. For example, GMP inspections by numerous pharmaceutical manufacturers had to be canceled or postponed, which delayed the approval of new drugs abroad. After the initial shock, however, the pharmaceutical industry was able to recover quickly and even become a major profiteer of the crisis.

The development of vaccines by the pharmaceutical industry in Russia, Germany and other countries - research findings by our pharmaceutical interpreters and GMP translators

It usually takes ten to fifteen years before a vaccine can be approved, in rare cases "only" takes five to eight years. The development of a vaccine is a complex process that goes through various stages. Only when the safety and efficacy of the medicinal product (or the active ingredient) is has been verified can it be approved by the competent drug authority. If a foreign manufacturer or authorization holder is involved, the pharmaceutical manufacturer must pass a GMP inspection as proof of the highest quality assurance, quality control and production standards. During this inspection, employees of the regulatory authority check the manufacturing site for compliance with the applicable GMP guidelines. If a medicinal product is to be approved abroad, it must pass a GMP inspection by the competent authority of the target country. For example, if a pharmaceutical manufacturer from Germany, Austria or Switzerland wants to sell a product on the Russian market, Russian GMP inspectors travel to inspect the production site. The new remote GMP inspection format was created to enable approval even in times of a pandemic. Only when the GMP certificate is issued at the end of the GMP inspection can approval be granted in Russia or the EAEU, see Standardization of GMP regulations in the EAEU.

The lengthy approval process for the development of vaccines against the COVID-19 virus has been greatly shortened: It took less than a year to produce several effective and safe vaccines while complying with all approval rules. The Russian vector vaccine Sputnik V was the world's first vaccine to be approved in August 2020 and used starting in September 2020. However, to date, the vaccine has not yet been approved in the EU. Here in Germany, it was the mRNA serum Comirnaty, developed by the German pharmaceutical company BioNTech that was approved as the first COVID-19 vaccine in December 2020.

Various factors made the accelerated development up to approval possible, above all the high level of development of vaccines against SARS and the prioritization of vaccine development in pharmaceutical companies. Other vaccines from the USA and the UK were also approved in record time, meaning that large production capacities were available in industrialized countries from spring 2021 and large parts of the population could be immunized. In addition, several oral medicinal products against COVID-19 have already been approved.

Diversification of production capacities - a long-term consequence of COVID-19?

The pandemic has painfully exposed global imbalances in the healthcare system. While a large proportion of the population in industrialized countries was vaccinated relatively quickly, the vaccination rate in Africa and large parts of Latin America and Asia remains very low to this day. This is partly due to the fact that the USA and the EU in particular have secured most of the vaccine doses produced on their own territory. In this vein, the African Union has already announced its intention to produce around 60% of all vaccines itself by 2040. In countries such as India, China and Russia, where there is already a significant pharmaceutical industry, the desire for independence from the pharmaceutical superpowers of the USA and EU has also continued to grow. Conversely, the pandemic has also shown once again how dependent we in Europe are on pharmaceutical production in India and China. This applies above all to the production of generic medicines and the manufacture of active ingredients. Supply bottlenecks for numerous medicinal products have made patients in this country aware of how far-reaching the consequences of globalization can be. Building up independent production capacities in all parts of the world could therefore be a far-reaching, long-term consequence of the COVID-19 pandemic.

Pharmaceutical interpreters and GMP translators are still needed

For the time being, however, nothing will change the fact that medicinal products are exported in large quantities from Western countries. Therefore, the services of specialized and highly qualified pharmaceutical interpreters and pharmaceutical translators for GMP inspections will remain important for pharmaceutical manufacturers in Germany, Austria and Switzerland. Internationalization cannot be reversed and pharmaceutical interpreters or GMP translators for Russian, English, German and other languages are indispensable for a smooth approval process in other countries. It remains to be seen whether the still new format of remote GMP inspections will prevail or whether the tried and tested method of GMP inspection directly on site will prevail in the future.

Of course, not all the consequences of the pandemic are foreseeable. However, it is becoming apparent that the pharmaceutical industry - in Germany, Russia and worldwide - will emerge stronger from the crisis.

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