South African clinical trial check… “In the range of incidence rates from other flu vaccines”
There was a case of suffering anaphylaxis, a severe allergic reaction, after receiving the vaccine for the novel coronavirus infection (Corona 19) of Johnson & Johnson (J&J).
According to Reuters and CNBC broadcasts, J&J reported to the U.S. Food and Drug Administration (FDA) Advisory Committee on Vaccine and Biological Drugs (VRBPAC) on the 26th (local time). Reported that there was.
J&J explained that one case of an allergic reaction was that a medical practitioner who participated in a South African clinical trial had an anaphylactic reaction.
It has been reported that other cases have not been specifically explained.
J&J conducted a phase 3 clinical trial on 44,000 people in the United States and South Africa.
This is the first time that an anaphylaxis reaction to the J&J Corona 19 vaccine has been reported.
Anaphylaxis is the body’s overreaction to certain drugs or foods.
It occurs within minutes or hours after vaccination, and symptoms appear throughout the body.
According to a report on the 16th of the Centers for Disease Control and Prevention (CDC), 62 out of 13.7 million vaccinations (Pfizer-Bioentech 46, Modena 16) from December 14 last year to January 13 this year. It showed an anaphylactic reaction.
The incidence rate of anaphylaxis is a level that is included in the incidence rate of anaphylaxis of influenza (flu) vaccine, CDC explained.
The J&J Corona 19 vaccine showed 72% and 64% preventive effects in the United States and South Africa, respectively, as a result of phase 3 trials.
It is less effective than Pfizer vaccine (95%) or moder vaccine (94.1%), but unlike these vaccines, expectation is high because it requires only one shot.
Moreover, the J&J vaccine clinical trial was conducted during the epidemic of mutations.
The J&J vaccine can be stored for up to 2 years in a frozen state at -20 degrees Celsius and up to 3 months in a refrigerator at 2-8 degrees Celsius, making it relatively easy to store and transport.
The FDA advisory committee recommended the J&J vaccine emergency use approval (EUA) on that day.
If the FDA accepts the recommendation, the J&J vaccine will be approved for use in the United States for the third time.
The J&J vaccine received the world’s first approval for use in Bahrain the day before.
/yunhap news
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