FDA approves the plan… Vaccination is permitted only for adults in the US
(Jennycha Reuters = Yonhap News) The U.S. Centers for Disease Control and Prevention (CDC) finally approved the vaccination of a new coronavirus infection (Corona 19) by Johnson & Johnson (J&J), a local pharmaceutical company, on the 28th of last month (local time). This is a follow-up to the U.S. Food and Drug Administration (FDA) approving the emergency use of the J&J vaccine the day before. As a result, the United States has secured the third Corona 19 vaccine after Pfizer-Bioentech and Modena. The photo shows the Corona 19 vaccine and syringe placed in front of the Johnson & Johnson logo. [email protected]
(Seoul = Yonhap News) Reporter Lee Young-seop = Johnson & Johnson (J&J) plans to conduct a clinical trial of a novel coronavirus infection (Corona 19) vaccine for infants, including newborns, and pregnant women, the New York Times (NYT) said last month 28 Reported on the day (local time).
J&J recently applied to the Food and Drug Administration (FDA) for urgent use of its vaccine and submitted a plan to expand such clinical trials. The plan was approved by Member Oper Levy of the Vaccine and Biological Products Advisory Committee (VRBPAC), an FDA advisory body.
Levy explained, “J&J did not provide a lot of specific information about the clinical expansion plan, but it was clear that it was conducting research on the immunity of COVID-19 in children and pregnant women.”
Janssen Bioentech, an affiliate that produces J&J vaccines, also confirmed to NYT that it would expand clinical trials for children.
The FDA and the Centers for Disease Control and Prevention (CDC) have approved the J&J vaccine for adults over 18 years of age.
According to the proposal submitted by J&J to the FDA, first, the vaccine will be tested on children and adolescents aged 12 to 18 years old, and immediately after that, the test subjects will be expanded to all under the age of 18.
After that, it plans to conduct clinical trials for pregnant women and newborns, as well as immunocompromised people.
Pfizer-Bioentech and Moderna, which were licensed to use vaccines for adults in the U.S. prior to J&J, are also currently conducting clinical trials for children and adolescents 12 years of age or older, NYT said.
J&J’s vaccine was developed using’Adenovirus’, a common cold virus, unlike Pfizer/Moder or vaccines manufactured using messenger ribonucleic acid (mRNA).
The same adenovirus vaccine, the Ebola vaccine, is now safely vaccinated against 1-year-old infants, and another adenovirus vaccine, the respiratory syncytial virus (RSV) vaccine, is also safely vaccinated into newborns, NYT explained.
Levy said that so far, about 200,000 people have been vaccinated against adenovirus, but there have been no serious safety issues, and this history was mentioned at the FDA advisory committee meeting.
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2021/03/01 16:47 sent