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On November 17, Sinovac Biotech said in a statement that its CoronaVac COVID-19 Inactivated Vaccine developed by Sinovac Life Sciences (Sinovac LS) has produced a rapid immune response against SARS-CoV-2. Although the experimental vaccine produced fewer antibodies than in people who had recovered from a respiratory illness. Although they are still in the middle stage of trials, the scientists said the vaccine was adequately safe and effective in providing immunization. The findings were published in The Lancet, and the trials involved more than 700 volunteers.
“Our findings show that CoronaVac is able to induce a rapid antibody response within 4 weeks of immunization by administering two doses of the vaccine at a 14-day interval,” said Zhu Fengcai, one of the authors of the paper. In addition, he added, “we imagine this makes the vaccine appropriate for emergency use during the pandemic.” China’s Sinovac is in the stage of Part III clinical trials in Indonesia, Brazil and Turkey. CoronaVac is one of three experimental COVID-19 vaccines being produced by China. Gang Zeng, a Sinovac researcher stated that the Sinovac vaccine can be stored at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 ° -46 ° F), while the Pfizer vaccine needed storage below -70. degrees Celsius. “This would offer some advantages for distribution to regions where access to refrigeration is a challenge,” Zeng said in the study.
Previously, Sinovac had stopped the CoronaVac phase III clinical trial sponsored by the Butantan Institute in Brazil due to a reported serious adverse event (SAE) in one of the participants. However, the company submitted a report from the Data and Security Monitoring Board (DSMB) to Anvisa. After evaluating the data, Anvisa made a very timely decision to resume the clinical investigation. “Suspension and resumption of such studies are common in clinical research. A suspension does not necessarily mean that the product under investigation has any quality, safety or efficacy problems,” Anvisa said.
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Sinovac has published a clarification on the interruption of the phase III trial of its COVID-19 vaccine in Brazil. The head of its Brazilian partner the Butantan Institute believes that this serious adverse event (SAE) is not related to the vaccine.
– Spokesperson Spokesman’s Office (@MFA_China) November 10, 2020
Sinovac will continue to communicate with Brazil on this matter.
– Spokesperson Spokesman’s Office (@MFA_China) November 10, 2020
Double blind, placebo controlled
China’s “CoronaVac” was also approved by the National Medical Products Administration (NMPA) for a clinical trial in adolescents and children. The randomized, double-blind, placebo-controlled phase I / II clinical trial was conducted in adolescents between 3 and 17 years of age and was approved by the Ethics Committee of the Hebei Provincial CDC. Volunteers were given low dose (300 IU / dose) and medium dose (600 IU / dose) with two-dose immunization at 28-day intervals.
Meanwhile, the company’s CoronaVac Phase I / II clinical trials in adults (18 to 59 years old) and elderly volunteers (60 years and older) were conducted in Jiangsu and Hebei provinces, China. . “No serious adverse events related to the vaccine were reported. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable safety and immunogenicity of CoronaVac, ”the company announced.
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