Topics Held the Pharmaceutical Manufacturers Association of Japan (PMAJ) Media Forum. The theme is "What is a Vaccine? -In the Corona Disaster, Learn About Vaccines Once More-"
On February 9, 2021, the "Pharmaceutical Cooperative Media Forum" was held at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo). The topic of this year's forum was "What is a Vaccine? -Under the theme of "What is a Vaccine? - Learning about Vaccines Once More in the Wake of the Corona Disaster," Dr. Nobuhiko Okabe, Director of the Kawasaki City Institute of Health and Safety, gave a lecture on the topic. More than 60 journalists attended the event at the venue and via webcast (19 attended at the venue and 44 watched the webcast). A summary of the lecture is as follows.
Scene of the forum
Origins of Vaccination in Japan
Edward Jenner developed the cowpox vaccination method in 1796. In Japan, about 50 years later, the cowpox vaccination method was implemented by Narabayashi Soken, the official physician of the Saga Clan. Later, in 1858, the Otamagaike Smallpox Center was established in the birthplace of the current University of Tokyo School of Medicine, and in 1909, the Smallpox Law was enacted. These developments have led to the current Immunization Law. There is no doubt that vaccines are an important weapon in the fight against infectious diseases. However, vaccines can sometimes cause serious adverse reactions, even if there is only a small probability of such reactions. In the past, vaccinations have resulted in class action lawsuits, with the government being held responsible. This has led to the basic idea that vaccinations in Japan should not be given in groups, but should be given to each individual with a thorough preliminary examination and with respect for the individual.
Kawasaki Institute of Health and Safety
Director Mr. Nobuhiko Okabe
Purpose of Vaccination
The purpose of vaccination is to prevent infectious diseases, but its significance goes beyond that. Rubella, for example, is a relatively mild infectious disease. However, if the infection occurs early in pregnancy, it can infect the fetus and cause postnatal disabilities. In other words, vaccination has the purpose of not only preventing individual infection but also protecting the health of the next generation. The more widespread the prevention of each individual, the more we can protect society as a whole. Vaccination against the explosion of infectious diseases has crisis management implications.
New coronavirus vaccine
A vaccine for the new coronavirus has been commercialized, and vaccination has begun among healthcare workers. Recently, we have received many questions such as "How long will this vaccine be effective? However, it has only been about one year since the outbreak of the novel coronavirus began. While the natural course of the disease is still not well understood, there are many things we do not know, such as how long the artificially acquired immunity will last. However, this should not just cause anxiety. At this point, I think it is a good idea to think of it as "keep immunity for a few months to a year, and then think about the next move. Perhaps annual vaccinations like the flu may be necessary, or perhaps vaccinations every few years may be sufficient. We will have to wait and see what happens in the future.
There are two main types of vaccines: live vaccines and inactivated vaccines. Live vaccines, also called attenuated vaccines, are inoculations of the pathogen itself with weakened infectivity. Inactivated vaccines are inoculated with pathogens that have lost their infectivity (also called dead vaccines) or with antigenic parts (proteins) of the pathogens. Both of these vaccines require the cultivation of large quantities of viruses and other pathogens themselves, and therefore take time to develop and manufacture. Vaccine development against novel coronaviruses is underway using various methods ( Fig. 1 ). For example, DNA and mRNA vaccines, for which some genetic information is extracted from the virus and used as a vaccine, are available. However, because genes are unstable, a method called a viral vector vaccine, in which a portion of the genetic information of the novel coronavirus is placed in another virus and inoculated as a vaccine, has also been developed. While these vaccines have the advantage of being developed quickly and can be mass-produced quickly, there is no denying that they have a poor track record and are not well experienced.
Figure 1: New coronavirus vaccines under development
Source: Materials from the Subcommittee on Countermeasures to Combat New Coronavirus Infections
Adverse reactions and adverse events
Vaccinations have the potential for adverse reactions. Although the term "adverse reaction" may be more familiar to the general public, the term "adverse reaction" is used for vaccines. The term "adverse event" has also become more common recently ( Figure 2 ). Adverse events and adverse reactions are terms used not only for vaccines, but also for drugs, surgery, and other medical procedures in general.
Fig. 2 Adverse events and adverse reactions
An adverse reaction is an apparent reaction that occurs as a result of vaccination. Examples include fever, fatigue, local redness and swelling, etc. Both adverse reactions and adverse reactions are events for which a causal relationship to medication or vaccination cannot be denied. However, it takes time to determine the causal relationship. For this reason, the term "adverse event" has come to be used to broadly cover symptoms that occur after administration of medication or vaccination, regardless of the causal relationship. In other words, the term "adverse event" is used in the sense of quickly identifying any event that occurs after medication or vaccination that is harmful to the body and quickly catching any adverse reactions or side effects that may be included in the event, so to speak, by keeping one's antennae up.
The World Health Organization (WHO) classifies adverse events into (1) reactions to vaccine components (e.g., allergic reactions), manufacturing defects, (2) procedural errors, and (3) accidental events. Accidental events are those that are obvious, such as the accidental appearance of other diseases after vaccination, but are often misidentified as adverse reactions. For example, "something that was infectious before the vaccination developed after the vaccination, resulting in a high fever and convulsions. The Ministry of Health, Labour and Welfare (MHLW) requires certain changes in health after vaccination, including adverse events, as "adverse reaction 'suspected' reports," and collects and evaluates a wide range of cases regardless of causal relationship, leading to necessary countermeasures.
What is Immunization Stress Related Reaction (ISRR)?
The WHO's Global Advisory Committee on Vaccine Safety (GACVS) has been working on the issue of adverse reactions to vaccines. Advisory Committee on Vaccine Safety (GACVS) has been discussing the new concept of immunization stress-related responses (ISRRs), and has now published a Manual The ISRR is an umbrella concept that includes a diverse spectrum of symptoms and signs observed in immunization-related stress responses . A combination of biological, psychological, and social factors can lead to a variety of reactions related to vaccination. Biological factors include age, genetic factors, low body weight, etc. Psychological factors include the psychological tendency to feel anxious about vaccination, negative past experiences with vaccines, and stress reactions. Social factors include information about vaccination from family, acquaintances, media, and others, reactions of others, and cultural beliefs. Social media is also a major influence.
Fig. 3 What is ISRR?
All healthcare professionals involved in vaccination must understand ISRR and take adequate measures to prevent ISRR There are several important points to prevent ISRR. The term "vaccine hesitancy" has recently become an issue. Vaccine hesitancy has also become an issue recently. One of the issues is how to deal with people who are hesitant to receive vaccines. In Japan, we respect the wishes of individuals and do not force vaccination on those who say "no" to vaccination. However, it is necessary to rethink the balance between the benefit of preventing disease and the risk of adverse reactions ( Fig. 4 ). If the vaccine is truly recommended, those who are unsure should be given a full and detailed explanation of why it is necessary and what can happen, including adverse reactions.
Fig. 4 Balance between benefits and adverse reactions
It is also important to improve the environment in which vaccinations are administered. It is well known that vaccination in crowded, prolonged standing, or privacy-less environments is more likely to cause ISRR. Additionally, we need to be aware of social media, which is also a social factor in ISRR.
WHO training program "Vaccination and trust
Created by WHO in 2017, the Training program called Vaccination and trust is available. It outlines how concerns about vaccination arise and how to communicate to allay those concerns.
For example, if there is an incident with a vaccination, responders should gather information immediately and communicate the results to the public as soon as possible. If there is information that has not been fully analyzed, it is not clear at this time. On the other hand, we also need to monitor the opinions of different people and see how the public perceives the results.
Undesirable events associated with vaccination may be related to a variety of factors, including ISRR, and not just the vaccine itself. In order to safely promote vaccination, it is important to "not rush," "not panic," and "not race to the numbers. It will be important to continue to deliver correct information for the public to make decisions about vaccinations.
( Yoko Shimamoto, Communications Promotion Subcommittee, Public Relations Committee)