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Chinese company Sinopharm’s COVID-19 vaccine was studied last year in adult volunteers residing in China, the United Arab Emirates, Argentina, Bahrain, Egypt, Morocco, Pakistan and Peru, and it has been shown to provide protection to reduce the risk of complications. and death if people were exposed to coronavirus infection. In addition, after three phases of clinical trials, it turned out to be a safe vaccine. Last May, it received the endorsement of the World Health Organization. Now the results of the application of the Sinopharm vaccine in children and adolescents were known, and the scientists who conducted the study claim that “it is safe and well tolerated in all dose levels tested in girls, boys and adolescents aged 3 to 17 ”.
The results of the study of the inactivated vaccine Sinopharm have been published by the specialized journal Lancet Infectious Diseases. The study was led by ShengLi Xia of the China Center for Disease Control and Prevention in Henan, China.
Although coronavirus infection usually causes milder symptoms in children and adolescents, Scientists have estimated that this group of the population can also acquire the virus and infect other people. In other words, children and adolescents also play a key role in the transmission of the coronavirus.. To do this, they performed the phase 1 and 2 trial and assessed the safety and ability to induce immunity – that is, immunogenicity – of the vaccine in participants aged 3 to 17 years.
They performed a randomized, double-blind, phase 1/2 controlled trial at the Liangyuan District Center for Disease Control and Prevention in Shangqiu City, Henan, China. In phases 1 and 2, healthy participants were stratified by age (3-5 years, 6-12 years, or 13-17 years) and dose group. People with a history of coronavirus infection were excluded.
Between August 14 and September 24 of last year, 445 participants were selected and 288 eligible participants were randomly assigned to the vaccine or phase 1 control. In phase 2, 810 participants were selected and 720 eligible participants were randomly assigned to the vaccine or control.
The most common side effect at the application site was pain in the arm after the vaccine was injected. In addition, fever has been reported as another common side effect. Most of the effects were mild to moderate.
“The inactivated COVID-19 vaccine ‘BBIBP-CorV’ is safe and well tolerated at all dose levels tested in participants aged 3 to 17 years,” wrote the researchers who studied it. BBIBP is the official name of the Sinopharm vaccine. Scientists also explained that the vaccine elicited robust humoral immune responses against infection after two doses.
“Our results support the use of a 4 milligram dose and a two-dose regimen in phase 3 trials in the population under 18 years of age to further test its safety and protective efficacy against COVID- 19 “, they added. The study was carried out with funding from various programs of institutions in China.
On July 20, based on the results published yesterday in the specialist magazine, the Chinese regulatory authority authorized the emergency use of the Sinopharm COVID-19 vaccine in young people aged 3 to 17 years, after initial clinical phases and intermediaries. testing will show that it is safe and can trigger a strong immune response in this age group. The approval was granted by the Council of State’s Joint Prevention and Control Mechanism, created to deal with the COVID-19 pandemic.
In that country, the Sinopharm inoculant was the second COVID-19 vaccine available for children and adolescents. In June, the Sinovac Biotech vaccine was licensed for emergency use in young people.
Following the vaccine clearance, Zhang Yuntao, chief scientist and vice president of Sinopharm’s China National Biotechnology Group, in an interview with China National Radio, said: at 17, then those aged 6 to 12 years and those from 3 to 5 years, to guarantee safety ”.
In Argentina, on February 21, the Nation’s Health Ministry issued a resolution authorizing the use of the Sinopharm vaccine in adults. In Argentina, adolescents with risk factors are already vaccinated with Moderna inoculant from the United States. At the beginning of September, the head of the ministry, Carla Vizzotti, declared about the application of vaccines in adolescents: “We are thinking of the following: September, the month of the second doses; October, the vaccination of adolescents and from November to assess whether we are able to think about strengthening very specific sectors ”.
The official said shipments will take place in October, November and December to complete by the end of the year the 20 million doses purchased from Pfizer / BioNTech companies, which have already started distribution this week. “With this, the start of vaccination in 17-year-old adolescents will be defined, and in October vaccination will be staggered between 12 and 17 years”, or about 5 million people. As for those under 12, “there are still no vaccines authorized in Argentina”. He clarified that “there are few countries” which vaccinate children from the age of 3 and revealed that two of them, the United Arab Emirates and China, which produce Sinopharm, have already “been asked to information in order to have news soon “.
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