Houston, December 17th – The advisory group of the U.S. Food and Drug Administration (FDA) held a meeting on the 17th to vote for the approval of the emergency use of the second coronavirus vaccine for people aged 18 and above. The vaccine was developed by Modena Biotechnology in cooperation with the National Institute of Allergy and Infectious Diseases.
According to the Associated Press, members of FDA advisory groups such as the U.S. Advisory Committee on Vaccines and Related Biological Products (VRBPAC) and the Center for the Evaluation and Research of Biological Products (CBER) discussed the safety and efficacy of the vaccine on the 17th, and discussed the “vaccine for people aged 18 and above. “Know whether the benefits outweigh the risk of vaccination” to vote. The result of the vote showed 20 votes in favor, 0 against and 1 abstention.
Michael Curilla, an expert at the National Institutes of Health (NIH), abstained in the vote, saying that the full authorization for people aged 18 and above is too broad.
An analysis released by the FDA recently confirmed the results of a trial disclosed by Modena in November: the effectiveness of the coronavirus vaccine is 96% for people aged 18 to 65 and 86% for people aged 65 and above in preventing COVID-19 infection. The report said that the subjects who were vaccinated did not have serious health problems.
The report said that the coronavirus vaccine was given in two shots at intervals of 28 days, and there was evidence that the first injection began to protect the human body. The report emphasizes that the possibility of the vaccine causing Bell’s paralysis cannot be ruled out. Bell’s paralysis is a unilateral nerve paralysis of unknown cause, and the affected side of the eye cannot be closed.
The report said that most of the subjects had symptoms of soreness, fatigue and headache at the injection site after vaccination. Severe allergic reactions rarely occur.
It is worth noting that a medical staff in Alaska recently developed severe allergic reactions such as shortness of breath after being vaccinated with the first approved coronavirus vaccine. The vaccine was jointly developed by Pfizer Pharmaceutical Co., Ltd. and the German biotechnology company. It was authorized by the FDA for emergency use on the 11th and began to be sent to the states of the United States on the 13th. Priority vaccination includes front-line medical staff and long-term residents of nursing homes.
U.S. officials have previously said that once both vaccines are approved, they are expected to provide 40 million doses of COVID-19 by the end of 2020, enough to vaccinate 20 million people.
At present, the number of COVID-19 infections, hospitalizations and deaths in the United States have climbed to new highs. As of the evening of the 17th Eastern Time, the cumulative number of confirmed coronavirus cases in the United States exceeded 17.19 million, and the cumulative death toll exceeded 310,000.