Regulatory & Marketplace
Comparison of Regulatory Process of COVID-19 Vaccines; Between Emerging Markets, EU Coronavirus disease, COVID-19, has affected all of our lives primarily since the end of 2019. We have faced experiences and a period that we had never come across before. In particular, we have to wear masks, and we should have social distance and sterility in order to avoid it, because this infectious disease spreads through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, according to the definition of WHO. Some of us still may not know about the virus itself. So, what are coronaviruses? Well, they are a large family of viruses that cause illness ranging from the common cold to more serious diseases such as Severe Acute Respiratory Syndrome (SARS-CoV). The 2019 version of coronavirus, COVID-19, was not seen in humans before and it has caused viral pneumonia, which was first seen in China and came out from Wuhan’s South China Seafood City market in December 2019, and has spread all over the world since then.2
Please see the table below for the vaccines that have been approved3: Name
Vaccine Type
Developers
Country of Origin
Approval
BNT162b2
mRNA-based vaccine
Pfizer, BioNTech; Fosun Pharma
Multinational
UK, Bahrain, Canada, Mexico, US, Singapore, Oman, Saudi Arabia, Kuwait, EU
mRNA-1273
mRNA-based vaccine
Moderna, BARDA, NIAID
US
US, Canada
Oxford accine
Viral vector
The Oxford University, AstraZeneca
UK
UK, EU
Sputnik V
Non-replicating viral vector
Gamaleya Research Institute, Acellena Contract Drug Research and Development
Russia
Russia
EpiVacCorona
Peptide vaccine
Federal Budgetary Research Institution State Research Center of Virology and Biotechnology
Russia
Russia
CoronaVac
Inactivated vaccine
Sinovac
China
China
Unknown (not announced)
Inactivated vaccine
Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
China
China
BBIBP-CorV
Inactivated vaccine
Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
China
China, United Arab Emirates, Bahrain
The European Medicines Agency (EMA) plays a great role in regulatory guidance, as well as on the scientific evaluation, approval and monitoring of COVID-19 vaccines in the EU, as shown below for the flow of the stages:
Many pharmaceutical companies and scientists have been working on the solution. A lot of work and research have been done on vaccines, as well as on the pharmaceutical products for the treatment that could be the solution for the disease.
Figure 2. Flow of COVID-19 vaccine evaluation in EU
Globally, vaccine development for COVID-19 is being fast-tracked. Getting scientific advice from regulators helps to speed up the development process. EMA offers informal consultancy with its team “COVID19 Task Force (ETF)”, and they give fast scientific advice during this period.1
Figure 1. COVID-19 vaccine 28 INTERNATIONAL PHARMACEUTICAL INDUSTRY
Even though safe methods are used for development of the vaccine, new methods have also been tried and used for the vaccines for COVID-19 for increasing the stability, quality, process period, and production efficiency. However, existing methods for vaccine production have also been used for increasing capacity and to have production at a large scale. EMA, and most of the health authorities in EU as well Spring 2021 Volume 13 Issue 1
