Guidelines for COVID-19 vaccination of pregnant women and women wishing to become pregnant in Japan

In Japan, from February 19, 2021, prior vaccination of COVID-19 vaccine (BNT162b2) will be started for medical staffs (10,000 or more subjects) at the National Hospital Organization's medical center. This prior vaccination is considered a Phase 4 clinical trial. Therefore, every day, the subject (COVID-19 vaccinated person) must record health care such as temperature and physical condition and report it to the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan Ministry of Health, Labor and Welfare. This phase 4 study will examine the safety and efficacy of COVID-19 vaccination (BNT162b2) in Japanese.

In a report dated January 27, 2021, the Japanese Society of Obstetrics and Gynecology Infectious Diseases and the Japanese Society of Obstetrics and Gynecology recommend the following for COVID-19 vaccination of pregnant women and women wishing to become pregnant:

1. As of February 2021, the mid- to long-term adverse reactions of COVID-19 vaccination in pregnant women and the safety of the fetus and offspring have not been established.

2. Pregnant women are not excluded from the subjects for COVID-19 vaccination in light of the current spread of COVID-19 infection. When pregnant women wish to be injected with COVID-19 vaccination, doctors must explain to pregnant women before vaccination that long-term adverse reactions to COVID-19 vaccination have not been identified and that safety for fetuses and offspring has not been established. The doctor should inject the COVID-19 vaccination with the consent of the pregnant woman, and then follow up the pregnant woman in the hospital for 30 minutes. Until the organogenesis period (up to 12 weeks gestation), pregnant women will not be injected with COVID-19 vaccination. Pregnant women inject with COVID-19 vaccination at obstetrics and gynecology medical facilities where maternal and infant management can be managed, and it is necessary to confirm the fetal heartbeat by ultrasonography before and after COVID-19 vaccination.

3. COVID-19 vaccination is considered for pregnant women as healthcare workers at high risk of SARS-CoV-2 infection and women with underlying diseases such as obesity and diabetes at risk of aggravation.

4. To prevent SARS-CoV-2 transmission at home, pregnant women's partners should consider COVID-19 vaccination.

5. Women wishing to become pregnant are preferably received with COVID-19 vaccination before becoming pregnant. (The COVID-19 vaccine is not a live vaccine, so long-term contraception is not required after vaccination.)

Pregnant women and those wishing to become pregnant should consult with an obstetrician / gynecologist regarding COVID-19 vaccination.

がん医療専門ドクター/癌ゲノム医療/新興感染症　　                              JAMA Published on February 14. 2021. by Kyoto@Takuma H