TOKYO -- With a lack of clinical trials and safety confirmation, Japan's health ministry may label pregnant woman as a high-risk group needing "careful consideration" before Pfizer's coronavirus vaccine as the ministry moves closer to approving the product within days after a special committee meeting scheduled as early as Feb. 12.
In December 2020, the U.S. pharmaceutical giant applied for approval of the drug with the Ministry of Health, Labor and Welfare using data on its final stage clinical trials that over 40,000 people in the United States and elsewhere took part in. The company then submitted an additional report on Jan. 29 on the results of initial trials conducted in Japan. This means that the health ministry has all the data necessary for screening the product.
In the screening process, the scope of demographics subject to vaccination and other matters will be decided. Regarding expectant mothers -- a group excluded from Pfizer's testing -- the U.S. Center for Disease Control and Prevention (CDC) states that the vaccine's potential risks to the pregnant person and her fetus "are unknown," but expectant mothers who are "part of a group recommended to receive the COVID-19 vaccine, such as health care personnel, may choose to be vaccinated."
However, some studies have shown that pregnant women have higher risks of developing severe symptoms if they get infected with the coronavirus.
Based on such circumstances, a source close to the Japanese government said it would be hard to exclude pregnant women from subjects eligible for vaccination, considering a balance between their risks of developing severe COVID-19 cases and the vaccine's safety against expectant mothers. The government therefore is unlikely to label pregnant people as "having contraindications" to the vaccine, which will blanketly make a group of people ineligible to receive immunization, but rather categorize them as having higher risks than other groups, and in need of careful consideration.
The Japan Society of Obstetrics and Gynecology and other related organizations have requested the government not to exclude expectant mothers from vaccination, and recommends that such women avoid getting vaccinated during the first trimester when the embryo's organs develop and receive vaccination at medical institutions that are able to take care of the pregnant woman and her fetus, such as an OB-GYN. The health ministry's special committee may discuss the matter at its planned meeting.
In European countries and the United States where vaccination rollouts have already begun, cases of anaphylactic reactions to the vaccine have been reported. The CDC has warned that those who have experienced severe allergic reactions from Pfizer's other types of vaccine or from the vaccine's ingredients should not receive vaccination. Japan's health ministry is also considering listing the vaccine as contraindicated for those who have experienced such allergic reactions.
With regard to immunization for young children in Japan, those aged 16 and older will subject to vaccination, as is the case in the U.S. and other countries, as not many cases of vaccination among young children have been reported.
The Japanese government has concluded a contract with Pfizer to receive 144 million doses of the vaccine, enough for 72 million people as one person is supposed to receive it twice, by the end of 2021. It plans to start the rollout first with medical professionals after the approval.
(Japanese original by Ai Yokota, Lifestyle and Medical News Department)