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Using Real-World Evidence (RWE) in Covid-19 Vaccine Research

By March 25, 2021December 6th, 2022No Comments

COVID-19 – the pandemic dealt its deadly blow and the entire world is still fighting to deal with it. No one expected this pandemic and the havoc it would create. So many lives were lost, families shattered and the economy of several countries striving to stay afloat. With the advent of vaccinations, we can see some hope at the end of the tunnel.

Now the next series of questions that arise are about the distribution of vaccines, their drug toxicity, and if the vaccines can be modified for better results if required. To get the answers to such quintessential questions can we turn to Real-World data & Real-World evidence?

Real-World Data and Real-World Evidence

In simple terms, Real-World Data (RWD) is the health information of people who avail of healthcare services and the Real-World Evidences (RWE) is collected from various sources like prescriptions, health reports, surveys, and more. The data-sets are processed & analyzed in a manner to provide valuable evidence for the betterment of healthcare services.

The importance of RWD and RWE has been recognized by researchers, doctors, and pharmaceutical companies for a while. With the advent of the novel coronavirus, many researchers have analyzed various data-sets to determine and identify how and why the virus spread so rapidly among people. They studied data about treatment taken and its outcome. These data-sets have been a valuable source of information for decision-making.

RWE opportunities but not without risk

Due to the urgency to find a solution for the virus, researchers have extensively used the evidence to use existing drugs to treat the virus. However, how far the studies will hold is yet to be determined because of the unique nature of the virus. The test results have not been consistent and hence to a certain extend RWE gathered is still controversial. But a few studies have shown reliable results. Let us take the example of Epi-Phare.

This research organization compared the Evidence of Hydroxychloroquine used to treat autoimmune diseases and how it would be effective for the general population affected by the virus. The studies showed it lacked preventive protection. RWE provides valuable insights. There could be long-term health consequences for people who have contracted the coronavirus. The effect of vaccination is yet to be seen. The vaccination may not be the end of the coronavirus. There will be pockets of a certain world population who would contract the virus. Hence it is important to understand how to find, trace, and provide treatment to these people.

RWE can provide valuable insights

RWD can trace the population that has been vaccinated, provide treatment guidelines, and analyzes the risk factor. The data will provide the actual impact of disease and the coping effect of the vaccination. The data will also provide insights if any new health risks develop and if there would be long-term complications.

Effects of vaccination

With the roll-out of vaccinations, it would be a huge task to get the people population vaccinated. It is done in a phased manner and the people are worried about possible side-effects. The way to address people’s concerns will be to collect data and assess the safety and effectiveness of the vaccines. RWD will play a major role in assessing the safety of vaccines across subpopulations. The data collection agency will capture data of people who are vaccinated and will look out for possible adverse effects if any. This will have to be done in real-time using the technology of RWD. Basis the evidence, the government will prepare to deploy vaccination to the wider population. Studies based on the RWE show the recently rolled-out vaccine by Moderna & Pfizer can prevent the infection and, also reduce its incidence.

Manufacturers are also gearing up to implement the right method to improvise upon the vaccine. The platforms analyzing RWD are so technically advanced that the manufacturers get consistent evidence to improve their end products. Real-time patient results & activities also enable the manufacturers to respond effectively to the questions raised by the regulators as well.

Vaccine & its accessibility

We have discussed the research and development of the Covid-19 vaccine using RWE, let us know now how RWD will help in the distribution of the vaccine. The vaccine will protect those vaccinated and disable transmission to people not vaccinated. Equitable distribution of vaccines across the globe is now essential. RWD can be assessed to fortify herd immunity. The people who are in the high-risk category are vaccinated first so that they stay protected. For this, the complete data can be retrieved through RWD. There is various RWD management company who keep a track of people who get vaccinated. The numbers are updated in real-time.


Real-World Data & its Evidence have been beneficial for the development of the healthcare system. Now with the advent of Covid-19, it has been a boon for researchers and pharma companies. Without the availability of systematically analyzed Real-World data, it could have been a long wait for a vaccine. Due to the evidence, the clinical testing time has been drastically reduced. Within 12 months of the advent of the virus, the scientists were able to develop and deploy vaccines using RWE. Though there are certain pitfalls in the RWE and its true potential is yet not seen by us, we are sure RWE will soon provide us a breakthrough for all future studies and research in the medical field.

Aventior’s Clinical Data Integration & Restructuring amalgamates structured & unstructured data from pharma companies, clinical patient details, and data from other sources into datasets. These datasets are used by platforms like TIBCO, Spotfire, Tableau, SAS, and more. They analyze these data for various research work. For further inquiries or questions, reach us at

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