- Ayushi Gupta
Global Standards For Vaccination
Over the years, Immunization has helped enhance our global health care system. The advent of vaccines is a means to end the effect of infectious diseases. The vaccination helps respond, control and protect the lives of millions affected through ever looming epidemic diseases that spread across nations. The process of finding a cure to the pandemic diseases involves intricate clinical stages and economical resources which have to be contributed by various countries and international health authorities for the betterment of public health. The global standards for vaccines change over time. In this article, we will be tracing the development of vaccination standards across the globe and discussing the structure, distribution process and emergency protocols involved in the mass production of these vaccines.
A. Tracing The History From Spanish Flu To Covid-19
In 1918-19, there was a spread of an influenza pandemic that killed around 40-70 million people worldwide. With no treatment of Spanish flu, the pandemic ravaged the world with more than a 2.5% mortality rate. The importance of vaccination to help fight against the flu was recognized and later in the year 1938, the development of the first ever influenza vaccine was introduced by Jonas Salk and Thomas Francis. The influenza vaccine was clinically studied, tested and then put into application. The 19th century marks the advent of several vaccines related to flu, smallpox, rabies, plague, cholera, and typhoid but there were no standardized procedures to regulate the vaccination process. It was until the 20th century where the regulations and global standards were set by various countries and international health organizations to prevent the widespread increase of infectious disease which led to the killing of millions of people.
The year 2020 witnessed a rebound of a pandemic situation reminiscent of the 1918 influenza epidemic. The novel Coronavirus(Covid-19) causes Severe Acute Respiratory Syndrome (SARS) in humans spread across nations on brink of the pandemic, killing millions of people and still counting. Researchers all over the world are baffled and constantly working on the vaccination to curb the current pandemic situation. During the course of this Covid-19 pandemic, various international health organizations like World Health Organization (WHO) have circulated protocols for protection against the virus and have provided rules and regulations for the member countries which they have to abide by to curb the emergency situation. It is evident that even after a century of development and advancement in health and technology we are unable to cope with the current epidemic diseases and hence, our attention on health policies is the need of the hour.
B. Human Trials
The outbreak of coronavirus has led to adverse conditions in one of the most developed nations like the U.S.A, Canada, etc. The imposition of lockdown in most of the countries to nullify the spread of covid-19 has resulted in an economic crisis. Social Distancing and Sanitisation measures recommended by the Center for Disease Control (CDC) has become the new normal in every country. Therefore, to mitigate the current situation the rigorous process of vaccination testing and global standards have undergone frantic pace to accomplish clinical trials. The stages required while testing and analyzing the vaccines are as follows:
Stage 1: Exploratory phase
Laboratories conduct research on non-human subjects in order to understand the characterization of a pathogen and to determine what antigen could stimulate a powerful immune response. The Crowe lab of the VI4 and Vanderbilt University Medical Center have researched antibodies that neutralize the SARS Cov-2 by a viral membrane called a spike. Spike is an effective antigen to fight against the virus and to build strong immune responses. If the vaccine shows results in animal subjects the companies are required to submit an Investigation New Drug (IND) application in order to give detailed knowledge about the vaccine before experimenting it on human subjects.
Stage 2: Clinical phase
There is a three phase clinical study to ensure the safety of human participants in this process. Phase I, II and III of the clinical trial involves less than a hundred participants(Phase I) to around thousands of individuals (Phase II) who are dosed in a controlled fashion to determine the efficacy and efficiency of the vaccine. The researchers study and critically evaluate the human subjects identifying the effects of the vaccine on a large population.
Stage 3: Approval
After a detailed successful clinical trial and submission of the data to the Federal Drug Administration (FDA). The organization reviews the data conducting a risk/benefit assessment to determine if it is viable to distribute the vaccine in public. Vaccine Adverse Event Reporting System (VAERS) looks into the effects after the distribution is done to the general population. If there are any adverse effects of it then it is reported to the organization.
Stage 4: Research & Development
Considering the current Covid-19 situation, it is pertinent to note that, time is of the essence. With millions of people dying everyday the burden on the healthcare system is round the clock due to which all over the world the research laboratories are working day and night to identify the vaccine for Covid-19 and to produce it within a reasonable time frame. Moreover, the funds required in the research and development of these vaccines is yet another challenging issue. According to the National Institute of Health, millions of dollars and public resources were invested in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) to develop a research strategy for the speedy development of treatments and vaccines. Other organizations that assisted in the speedy operation of the production of doses and funding are, Operation Warps Speed (OWS) and Biomedical Advanced Research and Development Authority (BARDA) wherein, additional funding to eliminate inefficiencies and for manufacturing 300 million doses by January 2021.
C. Distribution Process & Funding
The vaccination process has been challenging for pharmaceutical companies to invest billions of dollars in R&D with only a 6% market entry probability for the vaccine. There have been several trials conducted by the researchers for vaccine candidates from Pfizer and BionTech, Astrazeneca, Novavax, Johnson and Johnson, Inovio, Moderna and Gilead. Gilead product Remdesivir has gained significant attention due to its speedy response to the treatment of covid-19. After the advent of vaccines for Covid-19 manufacturing of the vaccine will be a hurdle that needs to be taken care of. Many countries are working round the clock to look into this matter and have come up with strategies for the manufacturing and distribution of the vaccination. In India, vaccines developed by Bharat Biotech, Serum Institute and Pfizer are under consideration in India's drug regulator. The government is putting their efforts into strategizing the distribution, refrigeration and manufacturing of the vaccine not only for India but for the other COVAX countries who are in need of help. India has always extended hands to nations who require help with the covid-19 situation. The vaccination will first be provided to those most susceptible to the coronavirus, including the healthcare workers.
Therefore, the demand and supply chain has to be regulated with an eventual increase in the production of the vaccines. The rate of production will gradually increase with a large number of pharmaceutical industries joining hands in this challenging situation.
D. Emergency Approvals
The world is under the radar of a deadly virus which has increased recklessness amongst the healthcare authorities, government and the public at large. These times are tough and all are working towards normalizing the current situation. There are Pharma companies that have applied for emergency approvals for the distribution of the vaccine. Pfizer sought emergency approval for the sale and distribution of the vaccine of coronavirus in India. Serum Institute’s Covishield is yet another vaccination under the emergency use authorization. India's first mRNA vaccine is also under approval mode as asserted by the Central Government of India. Another challenging factor would be the trust amongst the public to take the vaccination.
E. Various Authorities Governing The Programs
The Global Health Observatory i.e, World Health Organization (WHO) is responsible for regulation, assessment, licensure, control, and surveillance of biological medicinal products introduced by national regulatory authorities to overcome the infectious diseases spread across the globe. The organization sets global standards for immunization and vaccine clinical evaluation, quality, preparations etc. Also, Members of the European Parliament (MEPs) have adopted a new regulation in regard to the quick treatment of Covid-19 and its vaccination. This new regulation allows derogation from certain rules for clinical trials temporarily. In India, on the directions of the Prime Minister, a high level Group of Ministers (GOM) was constituted in order to formulate observation by reviewing, monitoring, evaluating the preparedness and measures taken regarding containing the coronavirus. The Ministry of Health and Family Welfare (MoHFW) in coordination with the central government is working on mitigating the impact of the outbreak in India. The Costa Rican government called in action with the WHO in Solidarity to create the Covid-19 Technology Access Pool (C-TAP) where the rights to technologies, data, and know-how can be shared across the globe. Also, India and Africa proposed that some of the provisions from the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) be waived so that the distribution and trade can be done easily amongst the nations in current times. Hence, the government of all the nations are working towards thriving the novel coronavirus and are finding ways to overcome and mitigate the situation for a better outcome.
In the 1918 flu pandemic, the situation was much worse than the current Covid-19 pandemic as scientific technology has mushroomed over the years. Given the current times, an intensive approach in research and development has played a key role in making a difference. The collaborations of various pharmaceutical companies, local and federal government and the public at large have helped sail the boat until now and the fight against the novel coronavirus is still on. The countries must support each other to come out of the tough situation. The C-TAP initiative is a great way to exchange the pool of knowledge and share the technologies with each other so that it can help in the quantitative production of vacations all over the world. A massive campaign to educate the public about the benefits of COVID-19 vaccination is also needed for an hour. The trust factor in the population might have been trembled due to which awareness amongst the individuals will be needed. With supporting the government on vaccination, the public must keep on taking preventive measures by following the social distancing norms, Wearing a mask and Sanitisation norms. Also, the isolation norms of 14 days must also be taken into consideration while traveling. Our safety is in our hands. But in this case, others' safety is also in our hands which makes it even more important to be cautious and follow preventive techniques. Until effective vaccines become available the nations can help each other out to flatten the curve.
Ayushi Gupta | Trainee
Sapphire & Sage Law Offices
 Nuventra Pharma Sciences, “Developing Vaccines for the Coronavirus Disease (COVID-19) Outbreak”, by Adam Dickinson, Pharm.D. & Tyler Cromer, M.P.S. March 18, 2020 (https://www.nuventra.com/resources/blog/developing-vaccines-for-the-covid-19-outbreak/)  Vanderbilt Institute Medical Centre, “Infection, Immunology and Inflammation”, by Chris Hofmann, December 1, 2020. (https://www.vumc.org/viiii/immuknow/covid-vaccine-pandemic-speed)  ibid  The History of Vaccines Educational Resource By The College of Physicians of Philadelphia, “Vaccine Development, Testing and Regulation,” (https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation) National Institute of Health, “Accelerating Covid-19 Therapeutic Interventions And Vaccines (ACTIV).”(https://www.nih.gov/research-training/medical-research-initiatives/activ)  The History of Vaccines Educational Resource By The College of Physicians of Philadelphia, “Vaccines for Pandemic Threats.” (https://ftp.historyofvaccines.org/index.php/content/articles/vaccines-pandemic-threats)  LiveMint, "How states are preparing to give covid-19 doses,” by Sangeeta Ojha, 13 Dec 2020(https://www.livemint.com/science/news/how-states-are-preparing-to-give-covid-19-vaccine-doses-11607837656448.html)  LiveMint, “Covid vaccine in India: Oxford's emergency authorisation, 1st mRNA vaccine trial to start; key updates,” by MeghnaSen,12Dec2020(https://www.livemint.com/news/india/covid-19-vaccine-in-india-emergency-authorisation-of-oxford-vaccine-1st-mrna-vaccine-trial-to-start-key-updates-11607764414614.html)  World Health Organization , “Vaccine regulation.”(https://www.who.int/immunization_standards/vaccine_regulation/en/)  Economic Times, “New regulation for faster vaccines and treatments for COVID-19 adopted by EU,” July 11, 2020.(https://health.economictimes.indiatimes.com/news/policy/new-regulation-for-faster-vaccines-and-treatments-for-covid-19-adopted-by-eu/76905955)  Library of Congress, “India’s Government Response to COVID-19 (Novel Coronavirus),” by Ruth Levush, March 19, 2020(https://blogs.loc.gov/law/2020/03/falqs-indias-government-response-to-covid-19-novel-coronavirus/)  Human Rights Watch, “Whoever Finds the Vaccine Must Share It” Strengthening Human Rights and Transparency Around Covid-19 Vaccines, October 29, 2020 (https://www.hrw.org/report/2020/10/29/whoever-finds-vaccine-must-share-it/strengthening-human-rights-and-transparency)