Need of Vibrant Vaccine Pharmacovigilance During Current Global COVID-19 Pandemic: More Than Ever.

COVID-19 pandemic has brought the vibrant and vivacious human life to a grinding halt. Only a safe and effective vaccine will bring this dicey situation back to normalcy. Researchers across the globe are at present working hard to find an effective vaccine for COVID-19. However, in search of an effective vaccine at the earliest possible time to combat the epidemic, we cannot afford to compromise on the safety of it. Therefore, monitoring the safety of vaccines is a top priority to safeguard the health of vaccine recipients and only a robust vaccine pharmacovigilance can ably do that in this crisis. Copyright:

INTRODUCTION

The world is currently grappling with a crisis of unprecedented proportions. Since its detection in the Wuhan city of China in late December severe acute respiratory syndrome Corona (SARS-CoV-2) virus has infected more than 20 million people across the world. Nearly 7 lakhs of infected people have succumbed to this coronavirus disease 2019 (COVID-19) pandemic by mid-August.[1] At present, no country is insulated from the COVID-19 and it has caused enormous health, economic, and social upheavals in both high-income and low-income countries. Some historians even have the opinion that the impact of COVID-19 pandemic is more widespread and devastating than World War II.[2] Currently, no specific medication is available to treat COVID-19. Researchers are testing a variety of possible treatments. Some drugs are being repurposed and some drugs are being used off-label in patients suffering from COVID-19.[3] FDA has given an emergency use authorization for antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19.[4] Few other drugs like hydroxychloroquine, favipiravir, and dexamethasone have raised the glimmer of hope but ended with mixed results.[3] It is a hard truth that, despite many proclamations, we are still grappling for an effective remedy for COVID -19. However, scientists and researchers are working tirelessly to find a safe and effective remedy for it. Not only drugs but also researchers are looking for an effective vaccine to combat this pandemic.

CURRENT DEVELOPMENTS IN COVID-19 VACCINE RESEARCH

The vaccine is a biological preparation that functions by inducing the immune system of the body to elicit an immune response to a particular pathogen. It enables the immune mechanism of the body to recognize pathogens, confront them, and defend the body from diseases caused by them.[5] Vaccination is one of the most effective ways to prevent diseases, control morbidity, mortality, and minimize loss of life. Mass vaccination is a potent weapon to bring back a semblance of normalcy in society during a global pandemic by inducing herd immunity. Infectious disease experts, epidemiologists, health care agencies, and federal governments recognize the paramount importance of an effective vaccine in the fight against pandemic and therefore working in tandem to develop an effective vaccine within the shortest possible time. Prominent mutational pharmaceuticals companies and world-renowned universities and organizations have collaborated at this crucial juncture to find a potent vaccine. According to the DRAFT landscape of COVID-19 candidate vaccines prepared by the World Health Organization (WHO), there are 13 candidate vaccines in clinical evaluation and 129 candidate vaccines in the preclinical evaluation stage in the last week of June.[6] Indian Council of Medical Research (ICMR) is also working in collaboration with vaccine manufacturer, Bharat Biotech, to develop a vaccine against Covid-19.

WHY VACCINE SAFETY Is PARAMOUNT DURING A PANDEMIC?

Desperate times call for desperate measures. Everyone is aware that mankind is passing through a very turbulent time and there is an urgent need to combat COVID-19 with a potent weapon. A safe and effective vaccine is the answer to that, so there is a rush to develop the vaccine for COVID-19. A normal vaccine development usually takes 12 to 15 years which has to be shortened to a few months looking into the seriousness of the situation.[7] The fall out of this contraction of development time will be the availability of limited safety data from preclinical and three phases of human clinical trials. Therefore, it makes it essential to have a thorough monitoring of safety at the post-marketing stage of vaccine to fill any knowledge gap obtained from the premarketing clinical trial. This post-marketing surveillance should be even more rigorous in case of vaccine than drugs or devices as adverse events associated with the vaccine has more profound and debilitating impacts than that of drugs or medical devices. It is so because the majority of vaccines are administered to a healthy population and most of the time it is covered to a large population within a brief period. It has been often noticed that vaccine safety garner more attention in the media than the vaccine effectiveness. Any report of apparent lack of safety of a particular vaccine might jeopardize the whole immunization campaign for that particular disease as it results in loss of faith among common people.[8] Postmarketing monitoring of vaccines even warrants more attention during a pandemic situation like COVID-19 when huge media focus is already on the disease and its possible remedies and people across the world are looking with great anticipation and hope to the scientific community for a successful and safe vaccine. Any kind of safety issue of the vaccine will not only precipitate their mounting anxiety but also shake their confidence and affect the overall prospect of successful immunization. Hence, it is essential to evaluate an accurate risk–benefit assessment at every step of vaccine development and more so at the post-marketing stage.

WHAT IS THE VACCINE PHARMACOVIGILANCE?

Monitoring vaccine safety can be done by both active and passive surveillance. Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization (AEFIs), or any other vaccine or immunization-related issues.[9] The adverse event could be any undesirable or unintended sign, any abnormal symptom, disease, or laboratory result.[10] The principal purpose of the vaccine pharmacovigilance program or AEFI surveillance program is to secure the safety of vaccine recipients. The majority of the countries have a robust vaccine pharmacovigilance program, an effective national AEFI surveillance system. United States has a Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of US-licensed vaccines.[11] Similarly, Medicines and Healthcare products Regulatory Agency (MHRA) looks after monitoring the safety of all marketed medicines, including vaccines in the United Kingdom through the Yellow Card Scheme.[12]

India is also not far behind and long back in 1986 it had commenced the AEFI surveillance program. Since then vaccine pharmacovigilance has evolved significantly in the country. At present, National AEFI Secretariat and National AEFI Technical Collaborating Centre coordinate this along with the state as well as district AEFI committees.[13]

ULTIMATE GOAL OF VACCINE PHARMACOVIGILANCE DURING COVID-19 PANDEMIC

Vaccine pharmacovigilance will play a substantial role once the anti- COVID-19 vaccine is successfully developed and available for use in the general population. The basic objective of vaccine pharmacovigilance during anti-COVID-19 vaccination is the timely detection and appropriate response to any suspected adverse events associated with vaccination.

It is expected that once the vaccine is available, a large number of people across the world will be vaccinated in a short period. It might become very difficult to follow them and aggregate any suspected adverse events occurring following vaccination unless all stakeholders pull up their shocks and work in tandem. The collaboration of patients, caregivers, private portioners, government doctors, field-level health care workers, personnel involved in the AEFI program, and pharmacovigilance program is more important than ever. Adequate information about the adverse reactions of the vaccine used against COVID-19 is highly imperative, and it is critical that all adverse reactions are recorded and reported as early as possible so that remedial action can be taken promptly. This will not only help in safeguarding the health of vaccine recipients but also allay the unnecessary skepticism about COVID-19 vaccination. International collaboration and sharing of data between national agencies helming the vigilance program is necessary during a crisis of this proportion as it will enable in disseminating information regarding any suspected adverse reaction and help in limiting its undesirable consequences in a vast majority of the population.

Traditionally spontaneous reporting by healthcare professionals is the backbone pharmacovigilance program and a major limitation of this method is under-reporting. As healthcare professionals have been stretched to the extreme, it is desirable to facilitate self-reporting by the vaccine recipients. With the deep penetration of smartphones in India and other parts of the World, many people in both urban and rural areas have become internet savvy.[14] More and more people are using social networking sites to stay in contact with family, friends, and the outside world. Thus, various social networking sites can be harnessed for reporting any suspected adverse events associated with vaccination. They can be made aware to report any untoward occurrences they are noticing after receiving the anti-COVID-19 vaccine.[15] There should be designated social medial platforms like twitter, WhatsApp’s attached to national, and various regional monitoring centers where patients can directly report any of their undesirable experiences in real-time. It will help in limiting undesirable consequences by taking timely measures.

CONCLUSION

The safety of the vaccine is very important for the success of any vaccination program. A robust vigilance system will go a long way in identifying, reporting, and preventing any untoward occurrences of adverse reactions associated with vaccination. Effective pharmacovigilance of the COVID-19 vaccine when it is ready for use will prevent any kind of untoward occurrences associated with the vaccine and allay all unfounded fears among the vaccine users.

Financial support and sponsorship

This is a self-funded study.

Conflict of interest

There are no conflicts of interest.