<COVID-19>Proposal on the COVID-19 Vaccination
February 19, 2021
Japan Federation of Bar Associations
The Japan Federation of Bar Associations compiled its “Proposal on the COVID-19 Vaccination” dated February 19, 2021, and submitted it on February 22 to the Minister of State (who is in charge of promoting the COVID-19 vaccination); the Minister of Health, Labour, and Welfare; the official representatives of the respective political parties; the President of the National Governors' Association; the President of the Japan Association of City Mayors; and the Chairman of the National Association of Towns and Villages.
Executive Summary of the Proposal
The COVID-19 pandemic has caused numerous challenges in Japan involving serious human rights issues, social problems, economic consequences, and other difficulties. Accordingly, there have been widespread calls from society for solutions to the plight. The COVID-19 vaccine rollout (“the Vaccination”) was launched by the Government under such circumstances, aiming at nationwide coverage. Thus, the Vaccination has brought tremendous anticipation.
Meanwhile, the COVID-19 vaccines were not only developed in an extremely short period of time, but many of them are also novel vaccines (mRNA vaccine, DNA vaccine, etc.). Therefore, the potential for unforeseen side effects cannot be ruled out.
Additionally, as vaccination on such a large scale is an unprecedented undertaking in Japan, there are strong concerns that new human rights issues and social problems may arise. It also cannot be ruled out that adverse drug events that are beyond current medical expertise and knowledge may occur.
It is unquestionable that vaccines have historically played a vital role in protecting the lives and health of people and preventing infectious diseases. On the other hand, it is also true that vaccines have caused serious side effects: The JFBA has issued opinions and other views on ensuring the safety of drugs and redressing drug-induced harms as well as on patients’ rights including the guarantee of the right to self-determination, considering the salutary lessons learned from past adverse drug events and people’s wish for effective and safe medicines. Although the Vaccination is a strong social requirement amid the spread of the serious COVID-19 pandemic, it is urged now more than ever that the effectiveness be deliberated with composure and great importance be placed on safety. The Government should reaffirm the perspective that anti-infective measures should be used “… to ensure high-quality and appropriate medical care [for patients] … while respecting their human rights” (Preamble, Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases). Therefore, it is imperative that the Government take responsibility for predicting issues accurately throughout the entire process of the Vaccination and take action to prevent them to the fullest extent, and that it implement appropriate and rapid response measures when problems arise.
In light of these perspectives, the JFBA proposes as follows:
- Considering that the Vaccination is a process of injecting vaccines, which have been developed in an extremely short period of time, to a large number of people in the country, the Government should verify—without concentrating exclusively on the social requirement and speed—the effectiveness and safety of the vaccines from a medical viewpoint, watching closely the adverse drug events reported both in Japan and overseas, when it conducts the examination for drug approval, particularly for the Special Approval.
- The Government should exhaustively publicize the information required to decide whether to be vaccinated, such as effectiveness and safety, in a timely and appropriate manner, which includes releasing information about side effects as well as the minutes of the examination board without delay. In addition, the Government should establish a system in which the self-determination of those who are eligible for vaccination is respected, by leading the process of informed consent at the site of vaccination.
- The Government should promote an understanding that whether or not to be vaccinated ought to be determined by individual choice, and take effective measures to prevent Vaccination-related prejudice and discrimination and protect privacy.
- Given the unprecedented massive scale of the Vaccination, the Government should take on the responsibility of maintaining meticulous collaboration with respective local governments, which conduct the practical operations, while respecting their intention, and establish and develop a system to address the issues of physician shortages and other issues.
- The Government should take responsibility for the effectiveness and safety of the Vaccination and ensure that full measures are in place to respond to unpredicted side effects, etc. caused by the Vaccination. Should there be any report of adverse drug events such as side effects, the Government should assume responsibility for taking appropriate and adequate measures.