Weekly reports on side effects to be compiled

The Health, Labor and Welfare Ministry will publish weekly reports of adverse reactions to vaccination against COVID-19 in the first phase of inoculations that began Wednesday for more than 10,000 health care workers.

Large-scale feedback studies of other recipients will also be conducted later. The ministry is aiming to provide information on vaccine safety promptly so that people can get vaccinated free of anxiety.

The first phase of inoculations will use the Pfizer-BioNTech vaccine, the first COVID-19 vaccine to be approved in Japan. In principle, the vaccine is administered twice, three weeks apart.

According to product information accompanying the vaccine, 84% of recipients experienced arm pain, 63% fatigue, and 55% headaches, based on clinical trials conducted overseas and in Japan. Most of the symptoms were mild and subsided within a few days, but severe symptoms such as fever of 39 C or higher were also reported.

The health condition of all participants will be tracked in first-phase vaccinations on health care workers.

After each vaccination dose, recipients will be asked to keep a record in a diary for one week of their body temperature, and whether they experienced fatigue or felt pain at the inoculation spot. Recipients will also be asked to report any changes in their physical condition that occur after a week has elapsed.

A specialized research team will analyze the data, and the ministry will publish a report once a week. The ministry will also study the coronavirus infection rate among recipients.

For the vaccination of senior citizens and non-priority residents starting from April, the ministry will conduct a health survey by questionnaire after each dose on a total of 3 million people — 1 million for each of the three types of vaccines contracted by the government.

It will solicit participants at vaccination sites and send questionnaires via social media once every two weeks to those who have given their consent.

If cases involving serious side effects including anaphylaxis are suspected, the physician who examined the recipient will report their age, gender and other information to the government in accordance with the Immunization Law. The collected information will be analyzed by an expert committee that is reviewing cases of adverse reactions before being published as needed.

“Cases of symptoms such as swelling, soreness and fatigue will occur to some extent,” said Health Minister Norihisa Tamura after a Cabinet meeting on Tuesday. “The most important thing is to provide information on adverse reactions, including anaphylaxis [which occurs very rarely] to gain the public’s understanding.”

After the first phase of vaccinations, people aged 65 or older, nursing care facility staff and people with pre-existing conditions will be among those inoculated from April on a priority basis. Inoculations for non-priority members of the general public are expected to begin from summer or later.

Japan has signed contracts with U.S. firms Pfizer Inc. and Moderna Inc., and Britain’s AstraZeneca PLC to supply a total of 314 million vaccine doses for 157 million people. (Feb. 18)

WITHIN 4 HOURS

The government has decided to urge medical institutions to report anaphylaxis, one of the reported side effects of the novel coronavirus vaccines, if the acute and severe allergic reaction occurs within four hours after inoculation. A draft of the reporting criteria was approved by an expert panel on Monday.

Anaphylaxis is a potentially life-threatening allergic reaction that occurs shortly after medicine or food enters the body.

The incidence of anaphylaxis in the Pfizer-BioNTech vaccine, which was granted special approval by the Health, Labor and Welfare Ministry on Sunday, was five cases per 1 million doses administered overseas. Of these cases, 74% occurred within 15 minutes and 90% within 30 minutes following vaccination.

The ministry has decided to ask people who have been vaccinated to sit and wait for at least 15 minutes after receiving their shot. Those who have a history of allergies will be asked to wait for about 30 minutes. Each vaccination site will be equipped with medicine and other first aid supplies to ensure safe vaccination.

The results of a clinical trial of the Pfizer-BioNTech vaccine, conducted in Japan with a sample population of about 160 people, were released for the first time in a document that also stipulates precautions to be taken when administering the vaccine. Other side effects included arm pain, which is said to have occurred in 86% of trial participants after the first vaccination and 79% after the second vaccination. Fatigue and headache were also reported. In approving the vaccine, the ministry judged that the vaccine’s safety, in terms of the rate of side effects observed, was on par with the results of overseas clinical testing. (Feb. 17)