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On October 29, the US Food and Drug Administration (the US Food and Drug Administration, FDA) granted Pfizer/BioNTech the emergency use authorization for the new crown vaccine for children aged 5 to 11
.
This authorization is based on the FDA's complete evaluation of the data, including the opinions of an external expert advisory committee.
FDA states :
FDA declaration Effectiveness: The immune response of children aged 5 to 11 is comparable to that of people aged 16 to 25
.
In addition, the vaccine is 90.
Safety: The vaccine safety study included approximately 3,100 vaccinated children between the ages of 5 and 11, and no serious side effects were found
.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet next week to discuss further clinical recommendations
.
FDA Acting Commissioner Dr.
Janet Woodcock said: “As a mother and a doctor, I know that parents, home care workers, school staff and children have been waiting for today’s authorization
.
Vaccinating young children has taken us away from normal life.
The vaccination plan of Pfizer/BioNTech's new crown vaccine for children aged 5 to 11 years is as follows: The main immunization program consists of two injections, separated by 3 weeks, with a dose of 10mg per injection, which is lower than the vaccination dose (30mg) for people 12 years and older.
.
In the United States, the number of children aged 5 to 11 suffering from the new crown accounts for 39% of the number of patients under 18 years of age
.
According to CDC data, about 8,300 children aged 5 to 11 were admitted to the hospital for treatment with the new crown
Dr.
Peter Marks, director of the FDA Center for Biologics Evaluation and Research (CBER), mentioned: “FDA is committed to making decisions guided by science trusted by the public and the healthcare community
.
We are authorizing this authorization Relevant safety, effectiveness, and production data are full of confidence
The FDA has determined that the vaccine meets the criteria for emergency use authorization
.
According to all available scientific evidence, the benefits of Pfizer/BioNTech's new crown vaccine for people over 5 years of age outweigh the risks
Effectiveness evaluation
Effectiveness evaluation The data supporting the validity of this emergency use authorization is based on an RCT being conducted in the United States, Finland, Poland and Spain, which has included approximately 4,700 children between the ages of 5 and 11
.
Children in the intervention group were vaccinated with two doses of Pfizer/BioNTech's new crown vaccine, each containing 10 mg of mRNA
The FDA also conducted a preliminary analysis of cases infected with the new crown 7 days after the second injection, and the study included subjects who had not been infected with the new crown before the vaccination
.
There were 3 infections among 1305 people in the vaccinated group and 16 infections among 663 people in the placebo group; the vaccine's effectiveness in preventing new crowns was 90.
Safety assessment
Safety assessment The safety data supporting this emergency use authorization includes an ongoing study that has included 4,638 children aged 5 to 11 years (3,100 in the vaccine group; 1,538 in the placebo group)
.
In this trial, a total of 1444 vaccinators were followed up for safety, at least 2 months after the second shot
.
Common side effects in clinical trials include pain at the injection site (sore arm), redness and swelling, fatigue, headache, muscle/joint pain, chills, fever, swollen lymph nodes, nausea, and loss of appetite
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More children have side effects after the second shot than after the first shot
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Side effects are generally mild to moderate, occurring within two days after vaccination, and most of them disappear within one to two days
.
The FDA and CDC safety monitoring systems have previously found that after vaccination with Pfizer/BioNTech’s new crown vaccine, the risk of myocarditis and pericarditis is increased, especially after the second injection, males aged 12 to 17 are at the highest risk
.
Therefore, the FDA uses the model to conduct risk-benefit assessments
.
(Risk: number of potential myocarditis cases, hospitalizations, ICU admissions, and deaths; benefit: how many new coronary cases, hospitalizations, ICU admissions, and new coronary deaths will be prevented by the vaccine)
.
The FDA model predicts that for children aged 5-11, the benefits of the vaccine will outweigh the risks
.
Continuous safety monitoring
Continuous safety monitoring Pfizer has updated its vaccine safety monitoring plan to assess myocarditis, pericarditis and other adverse events that may be related to the vaccine
.
In addition, the FDA and CDC have established multiple systems to continuously monitor the safety of the new crown vaccine and quickly discover and investigate potential safety issues
.
The plan stipulates that Pfizer and medical staff providing vaccination services must report any serious adverse events, multi-system inflammatory syndrome, and hospitalization or death due to COVID-19 infection
.
Medical staff must also report all vaccination errors to the Vaccine Adverse Event Reporting System (VAERS) so that Pfizer can submit relevant information to the FDA through a monthly safety report
.
