Skip To The Main Content

Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

When the first four COVID-19 vaccines from Pfizer, Moderna, AstraZeneca and Johnson & Johnson received authorization, many manufacturing facilities were contracted to produce the expected billions of doses. The world watched with eagerness, hope and, above all, confidence that the product would be of high quality.

Quality is an essential player in this equation

As a pharma quality professional, it is a challenge not to think of the necessity of maintaining product quality while pushing millions and millions of doses out of these facilities. The stakes could not be higher, and the contract manufacturing facilities should follow the most sophisticated quality systems with the help of health regulatory agencies to maintain safety quality of their products.

The U.S. FDA, the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Pharmaceutical and Medical Devices Agency of Japan and equivalent agencies in countries that purchased these vaccines from these four companies are continuing to monitor and inspect.

Quality functions in the pharmaceutical industry are tasked with maintaining attributes and characteristics which indicate that drugs are suitable for their intended purposes. These attributes include safety, identity, strength, and purity in addition to overall quality. In layman terms, the produced medicine should be presented in a safe dosage that is as effective as is stated on the drug label.

The public trust does not only fall into the hands of the regulatory agencies, but also within the quality organizations and professionals in addition to healthcare providers. Given the unprecedented demand to vaccinate the whole human population of 7.8 billion—or a number close to that depending on whom would choose to get vaccinated—some pharmaceutical manufacturing facilities are expected to continue to be in such production.

Janssen acquired the Emergency Use Authorization (EUA) of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. However, the FDA authorized two batches after placing some of lots on hold. These and other batches produced at the same facility have undergone review of their quality batch records. Furthermore, the FDA authorized to extend the expiration dating for the refrigerated vials to 4.5 months instead of 3 months. The vigilance of the FDA and compliance of Janssen is crucial and a good example of the collaboration of the pharmaceutical industry and authorities to instill public confidence in the system in place. This emphasizes the commitment of the pharmaceutical companies to manufacture and release quality products.

The eagerness of people to go back to their daily lives as they knew it before the pandemic would pose a pressure on these pharma plants to produce these vials within a shorter period of time  than ever seen before. The difficult first step in delivering a safe and effective vaccine was initially the effort to speed up trials to prove safety and efficacy. This was performed in an astonishing and commendable manner; then manufacturing was the next step, followed by supply, distribution and delivery. This complex network of actions needs to be synchronized in carefully detailed processes that, in reality, take place in pharma on a regular basis.

Supply chain and distribution

Raw materials that are part of drug compounding are needed, and components of the containers such as vials, stoppers, aluminum, and plastic capping material are also essential.

Filling facilities that require aseptic cleanrooms are going to be monitored to maintain contamination control and stay in their best shape surrounding the production of the  drugs that will be administered to all of us.

As expected, quality professionals look from a different angle upon the conditions of production to sign off on the best quality drug products that they are responsible for maintaining.

Quality forms a necessary partnership with all aspects of the pharmaceutical processes, from the inception of drugs, development and scale-up to manufacturing and continuous monitoring through stability programs. Raw materials have to meet quality measures, product steps have to be controlled and evaluated against standards, and final products will be exhaustively tested to make sure they meet the quality attributes set forth and written on the product label. These are very complex processes that require trained professionals with traceable records to maintain transparency and allow for follow-up with every step on the way.

Regain confidence and improve perception of the pharmaceutical industry

Now more than ever, the responsibility of the pharmaceutical industry is paramount. The example of how Janssen and the FDA collaborated in releasing two batches of COVID-19 vaccine is an indication of how the process needs to be monitored and issues could be resolved.

In the last few years, due to some unfortunate examples, the pharmaceutical industry faced some challenges to its policies in aspects such as pricing and distribution. Nowadays, there is too much at stake, and regulatory bodies, pharma firms and the whole industry should tread carefully but surely toward producing effective and safe vaccines to tackle the COVID-19 pandemic.

Moreover, research and development, pricing, distribution and all aspects of drug production have to be looked at with a modern approach that would not stifle innovation. This is the best time at which pharma has the opportunity to prove its role in society and improve its image to the general public.

Pharma will provide a reason for people to go back to their enjoyable lives and old routines that everyone seems to miss dearly. All eyes will not only be on the efficacy of the COVID-19 vaccines, but equally as important, on the quality of the products. With this great responsibility, pharma should always maintain the quality and integrity of its products. And this is an attainable goal that should never be forgotten.

About the Author

Tamer HelmyTamer Helmy, PhD, is a Quality Director at Molecular Templates (MTEM). Tamer has over 25 years as a scientist and has been a quality leader in international pharmaceutical companies over the last decade. His experience spans multiple disciplines including quality systems, aseptic processing, analytical development, R&D and process technology. Helmy enjoys operations and process improvement and has been certified in Lean 6-Sigma Green Belt and People Manager Qualification (PMQ).

PDA Members Save Substantially