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Pfizer clinical data: Vaccines are safe & effective for children aged 5 to 11
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Pfizer clinical data: Vaccines are safe & effective for children aged 5 to 11. Pfizer: The latest clinical data show that the vaccine is safe and effective for children aged 5 to 11
The results of Pfizer/BioNTech’s Phase 2/3 clinical trial of the COVID-19 vaccine for children aged 5 to 11 years are released. It is expected that the FDA will make a decision on the safety and effectiveness of the vaccine within three weeks.
Among them, the clinical results show that the two doses of 10 μg with an interval of 21 days are well tolerated in young children. In addition, they expect that the clinical results of the other two age groups (2-5 years old and 6 months to 2 years old) in the phase 1/2/3 trial will be announced as soon as the fourth quarter of this year.
Pfizer and BioNTech announced that their COVID-19 vaccine Comirnaty has shown good safety and a strong neutralizing antibody response in children aged 5 to 11.
The two companies said that the early results of the long-awaited Phase 2/3 clinical trial showed that the 10μg two-dose dosage regimen with an interval of 21 days was well tolerated in young children.
This dose is only one-third of the dose used in the early studies (people aged 16 to 25) who received 30μg of the vaccine.
Based on the antibody response and side effects, from the perspective of safety, tolerability and immunogenicity, the preferred dose for children aged 5 to 11 years is 10 µg.
Aggregated data from 2268 participants aged between 5 and 11 years showed that the geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody was 1,197.6 (95% confidence interval) [CI, 1106.1, 1296.6] , Showing a strong immune response one month after the second dose.
In comparison, the geometric mean titer (GMT) of neutralizing antibodies in the control group (participants aged 16 to 25 vaccinated with a two-dose 30μg regimen) was 1146.5 (95% confidence interval) [CI, 1045.5, 1257.2].
“We are eager to extend the protection provided by the vaccine to the young child population, but we need to obtain regulatory approval, especially when the Delta variant spreads and it poses a major threat to children,” said Albert Bourla, Chairman and CEO of Pfizer. “Since July, the number of young children with COVID-19 in the United States has increased by approximately 240%, which highlights the need for vaccination in public health.
These clinical trial results provide us with a solid foundation for seeking vaccine authorization for children aged 5 to 11, and we plan to urgently submit it to the FDA and other regulatory agencies. “
The two companies plan to share these clinical data with the FDA, EMA and other national drug regulatory agencies as soon as possible.
In addition, they expect that the clinical results of the other two age groups (2-5 years old and 6 months to 2 years old) in the phase 1/2/3 trial will be announced as soon as the fourth quarter of this year.
Reuters reported that senior US health officials believe that regulators can make decisions on the safety and effectiveness of the vaccine within three weeks after submitting clinical data on the vaccine.
In addition, schools are already open nationwide, and rapid approval of the vaccine will help reduce the potential surge in COVID-19 cases.
FDA Acting Commissioner Dr. Janet Woodcock said that once the FDA receives an application, its process to determine whether the vaccine is safe and effective for young children includes verifying the production process of low-concentration vaccines and research on its safety.
The FDA will review clinical data to ensure that young children’s response to the vaccine meets our expectations.
Pfizer/BioNTech’s Comirnaty is one of three COVID-19 vaccines currently in use in the United States.
Just last month, it became the first and only vaccine fully approved by the FDA to prevent COVID-19 in people 16 years and older.
In addition, since May this year, it has also been authorized by the EUA, which is suitable for people between 12 and 15 years old.
It is worth noting that last Friday, the FDA advisory panel rejected Pfizer’s plan to provide COVID-19 booster injections for most Americans, and only supports people 65 years of age and older, and those who are at high risk of serious diseases.
(source:internet, reference only)