Moderna: mRNA-1273 vaccine is safe and effective in children aged 6-11
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Moderna: mRNA-1273 vaccine is safe and effective in children aged 6-11 years, and can induce a strong neutralizing antibody response!
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Moderna: mRNA-1273 vaccine is safe and effective in children aged 6-11 years, and can induce a strong neutralizing antibody response!
Moderna recently announced the positive interim data of KidCOVE Phase 2/3 Study (NCT04796896).
The study is evaluating Moderna COVID-19 Vaccine (mRNA-1273), a COVID-19 mRNA vaccine product, among children from 6 to 12 years old. Interim analysis showed that at a dose level of 50μg, 2 doses of mRNA-1273 had good safety and produced a strong neutralizing antibody response.
This is the first result of a key study from a population of children aged 6 to under 12. Moderna plans to submit these data to the US FDA, EU EMA and other global regulatory agencies in the near future.
KidCOVE is a randomized, observer-blind, placebo-controlled extended study designed to evaluate the safety, tolerability, responsiveness, and effectiveness of 2 doses of mRNA-1273 (28 days apart) in healthy children.
The study population was divided into 3 age groups (6 to <12 years old, 2 to <6 years old, and 6 months to <2 years old). This time, Moderna reported the interim analysis data of people aged 6 to under 12 years old.
The cohort enrolled 4753 children aged 6 to under 12 years old. In this trial, the response in children was compared with that of young adults in the Phase 3 COVE study.
The SARS-CoV-2 neutralizing antibody geometric mean ratio (GMR) was 1.5 (95% Cl: 1.3, 1.8), and the serum response The rate was 99.3%, and the difference was 0.6% (95% CI: -2.8, 2.8%).
These results show that one month after the second dose of vaccination, this group of children developed a strong immune response, reaching the common primary immunogenicity endpoint of children 6 to 12 years old in the KidCOVE study.
mRNA-1273 is generally well tolerated, and its safety and tolerability are basically the same as the Phase 3 COVE study in adolescents and adults. The severity of most adverse events was mild or moderate. The most common adverse events were fatigue, headache, fever and pain at the injection site.
Currently, safety data is increasing, and the research continues to be monitored by the independent safety monitoring committee. All subjects will be monitored for 12 months after the second injection to assess long-term protection and safety.
Depending on the ongoing data collection, these data may change. Moderna plans to submit data from the KidCOVE study to peer-reviewed publications for publication.
In the KidCOVE study, the enrollment of children from 6 to 12 years old has been completed, but children from 6 months to under 6 years old will continue to be enrolled. Moderna has enrolled approximately 5,700 children in the United States and Canada to participate in the trial.
Stéphane Bancel, Chief Executive Officer of Moderna, said: Moderna is encouraged by the immunogenicity and safety of mRNA-1273 in children aged 6 to 12 years old, and is pleased that the study has reached its main immunogenicity endpoint.
Moderna looks forward to submitting applications to global regulatory agencies and continues to work to do its part to vaccinate adults and children of all ages to help end the COVID-19 pandemic.
Moderna COVID-19 Vaccine (mRNA-1273) is an mRNA vaccine that can prevent COVID-19 through active immunization.
The vaccine can encode a fusion of the new coronavirus (SARS-CoV-2) spike protein (S protein) Former stable form. mRNA-1273 targets the S protein, which is the key to the virus infecting host cells. It is also the target for the development of severe acute respiratory syndrome (SARS) coronavirus vaccines and Middle East respiratory syndrome (MERS) coronavirus vaccines in the past.
It is worth mentioning that it only took 63 days for mRNA-1273 from sequence selection to phase I clinical immunization.
In the United States, Moderna COVID-19 Vaccine was granted emergency use authorization (EUA) by the FDA on December 18, 2020: it is used for group immunization of adults aged 18 and over to prevent COVID-19.
Just recently, the US FDA granted Moderna COVID-19 Vaccine (mRNA-1273) an emergency use authorization (EUA) for a 50μg booster needle:
(1) for people aged 65 and over;
(2) for people aged 18-64 with high People at risk of severe COVID-19;
(3) People aged 18-64 who are frequently exposed to SARS-CoV-2 in institutions or occupations.
The booster shot should be vaccinated at least 6 months after the completion of the primary immunization (2 doses of vaccine).
In addition, the FDA also authorizes the use of Moderna COVID-19 Vaccine (mRNA-1273) single-dose booster after completion of other authorized or approved COVID-19 vaccine primary immunizations.
Original Source: Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age
Moderna: mRNA-1273 vaccine is safe and effective in children aged 6-11 years, and can induce a strong neutralizing antibody response!
(source:internet, reference only)
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