Japan panel OK’s J&J coronavirus vaccine

Jiji Press

14:32 JST, May 31, 2022

TOKYO (Jiji Press) — A panel of Japan’s health ministry Monday endorsed a ministry plan to give pharmaceutical approval to U.S. drugmaker Johnson & Johnson’s COVID-19 vaccine.

The ministry is expected to grant the approval soon to what will be the fifth COVID-19 vaccine that can be used in the country.

The ministry does not plan to make inoculations of the vaccine free of charge at public expense because it has already secured necessary amounts of vaccines. Japan has not signed to buy the J&J vaccine.

The J&J product is a viral vector vaccine like the one made by British drugmaker AstraZeneca PLC. It can be administered only to people aged 18 or above.

Only a single shot is necessary for the J&J vaccine unlike the previously approved vaccines, all of which require two shots at an interval of at least three to four weeks.

The government will also allow the J&J vaccine to be used as a booster shot, administered at least two months after the initial dose.

But the safety of a cross vaccination with a different vaccine has not been evaluated, according to the ministry.

Tokyo-based Janssen Pharmaceutical K.K., a unit of J&J, applied for the approval in May 2021.

Clinical trials overseas have found that the vaccine is 66% effective in preventing moderate to severe symptoms with a single shot and 75% effective with a booster shot.

Among adverse events after an initial shot, a headache was experienced by 39.0% of the surveyed people, a muscle pain by 33.2% and a fever of at least 38.0 degrees Celsius by 9.0%.

The U.S. Food and Drug Administration restricts the use of the J&J vaccine mainly to people who had allergic reactions to other COVID-19 vaccines, citing a rare risk of forming blood clots.