Saudi FM calls Indian, Pakistani counterparts to discuss developments    Al Hilal thrash Gwangju to reach AFC Champions League Elite semi-finals    Saudi Arabia cracks down on fraudulent Hajj campaigns, urges pilgrims to use official channels    Nammos Amala Resort to open soon with Saudi-Greek designs    Saudi Arabia completes 674 Vision 2030 initiatives, achieves 93% of KPIs as ninth-year milestone marked    Literature Commission inaugurates Saudi Pavilion at Muscat Book Fair    Saudi Minister of Culture holds talks with his Costa Rican counterpart in Jeddah    Alkhorayef praises advancements in Al-Kharj food industries sector    MHRSD: 80% of recruitment offices are non-compliant with regulations    At least 50 Palestinians killed in Israeli strikes across Gaza    Teenage girl killed in French school stabbing attack    Trump claims meeting with China after Beijing denies any trade negotiations    GACA chief chairs 16th meeting of the Steering Committee on aviation's strategy    Saudi Theater Commission launches its Work and Learn Project in UK    The season has begun — and one comment shook us all    Jennifer Lopez dazzles in Jeddah with a Formula 1 performance    Saudi Arabia open to expanded 64-team World Cup in 2034, says sports minister    Average life expectancy in Saudi Arabia rises to78.8 years    Film Commission launches 'Cinema' initiative to enhance content    Famed Philippine film star Nora Aunor dies at 71    Pakistani star's Bollywood return excites fans and riles far right    Veteran Bollywood actor Manoj Kumar dies at 87    Bollywood actress vindicated over boyfriend's death after media hounding    Grand Mufti rules against posting prayers and preaching in mosques on social media    Exotic Taif Roses Simulation Performed at Taif Rose Festival    Asian shares mixed Tuesday    Weather Forecast for Tuesday    Saudi Tourism Authority Participates in Arabian Travel Market Exhibition in Dubai    Minister of Industry Announces 50 Investment Opportunities Worth over SAR 96 Billion in Machinery, Equipment Sector    HRH Crown Prince Offers Condolences to Crown Prince of Kuwait on Death of Sheikh Fawaz Salman Abdullah Al-Ali Al-Malek Al-Sabah    HRH Crown Prince Congratulates Santiago Peña on Winning Presidential Election in Paraguay    SDAIA Launches 1st Phase of 'Elevate Program' to Train 1,000 Women on Data, AI    41 Saudi Citizens and 171 Others from Brotherly and Friendly Countries Arrive in Saudi Arabia from Sudan    Saudi Arabia Hosts 1st Meeting of Arab Authorities Controlling Medicines    General Directorate of Narcotics Control Foils Attempt to Smuggle over 5 Million Amphetamine Pills    NAVI Javelins Crowned as Champions of Women's Counter-Strike: Global Offensive (CS:GO) Competitions    Saudi Karate Team Wins Four Medals in World Youth League Championship    Third Edition of FIFA Forward Program Kicks off in Riyadh    Evacuated from Sudan, 187 Nationals from Several Countries Arrive in Jeddah    SPA Documents Thajjud Prayer at Prophet's Mosque in Madinah    SFDA Recommends to Test Blood Sugar at Home Two or Three Hours after Meals    SFDA Offers Various Recommendations for Safe Food Frying    SFDA Provides Five Tips for Using Home Blood Pressure Monitor    SFDA: Instant Soup Contains Large Amounts of Salt    Mawani: New shipping service to connect Jubail Commercial Port to 11 global ports    Custodian of the Two Holy Mosques Delivers Speech to Pilgrims, Citizens, Residents and Muslims around the World    Sheikh Al-Issa in Arafah's Sermon: Allaah Blessed You by Making It Easy for You to Carry out This Obligation. Thus, Ensure Following the Guidance of Your Prophet    Custodian of the Two Holy Mosques addresses citizens and all Muslims on the occasion of the Holy month of Ramadan    







Thank you for reporting!
This image will be automatically disabled when it gets reported by several people.



Pfizer says coronavirus vaccine is 100% effective in kids ages 12 to 15
Published in The Saudi Gazette on 31 - 03 - 2021

Clinical trial results of Pfizer/BioNTech's COVID-19 vaccine showed its efficacy is 100 percent and it is well tolerated in youths ages 12 to 15, the manufacturer said on Wednesday.
Pfizer/BioNTech plans to submit the data to the US Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine.
In a Phase 3 trial of 2,260 participants ages 12 to 15 in the US, the vaccine elicited strong antibody responses one month after the second dose — exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer reported. The vaccine is currently authorized in the US for emergency use in people 16 and older.
Researchers observed 18 COVID-19 cases among the 1,129 participants who were given a placebo, and none among the 1,131 volunteers who got the vaccine. The data has yet to be peer reviewed.
Pfizer/BioNTech added that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. Common side effects include pain at the injection site, fatigue and fever. The participants will be monitored for protection and safety for two years after their second dose.
Those comparisons to the older population are important because researchers are building off of the knowledge they gained in the adult trials.
Researchers can define a number of antibodies that are a correlate of the protection seen in adults, and then look for that level of antibodies in pediatric participants to know that the vaccine is providing protection. That's why the COVID-19 vaccine trials in children and adolescents have generally required fewer volunteers than the adult trials.
"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Pfizer CEO Albert Bourla.
"We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."
Dr. William Gruber, Pfizer's senior vice president of vaccine clinical research and development also noted last week that the vaccine could be ready for this age group by the upcoming school year.
A return to the classroom isn't the only factor at play. Health experts have emphasized the importance of protecting as many people as possible through vaccination, as more infectious COVID-19 variants continue to spread throughout the nation.
"We all long for a normal life. This is especially true for our children," said BioNTech CEO Ugur Sahin. "The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant."
Pfizer recently told CNN that the safety demonstrated in this adolescent trial helped the company make the decision to begin testing its vaccine in younger children.
A separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched last week, when the first children ages 5 to 11 received a shot. Pfizer/BioNTech plans to begin dosing 2 to 5-year-olds next week and work its way down to participants ages 6 months to 2 years. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.
Moderna is also testing its vaccine in adolescents and children, in two clinical trials of children ages 12 to 17 and those ages 6 months to 11 years.
Experts anticipate Covid-19 vaccines won't be available for children 11 and younger in time for the upcoming school year. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said those younger children may have to wait until the first quarter of 2022.
Dr. Buddy Creech, director of Vanderbilt University's Vaccine Research Program and an investigator in Moderna's pediatric trials, estimates a COVID-19 vaccine could be available for high-risk kids 12 and older by July or August, but likely won't be available for children 11 and younger until November or December, at the earliest. — Courtesy CNN


Clic here to read the story from its source.