The ongoing COVID-19 pandemic warrants accelerated efforts to test vaccine candidates. A study recently published by the specialized scientific medium The Lancet aimed to evaluate the safety in immunogenicity of an inactivated vaccine candidate for severe acute respiratory syndrome coronavirus 2 BBIBP-CorV, in humans.
The randomized, double-blind, placebo-controlled sample showed that in SARS-CoV-2, the inactivated vaccine, BBIBP-CorV, was safe and well tolerated among healthy individuals at all doses tested in all groups: 18 to 59 years and over 60 years. According to the task undertaken by the group led by Shengli Xia from the Henan Provincial Center for Disease Control and Prevention of the city of Henan in China, “a robust humoral immune response was observed in all vaccine recipients.”
In the document they specify that only mild adverse reactions were detected, with no severe conditions in any age category.
“This is the first stage of an inactivated SARS-CoV-2 vaccine tested in human participants, the researchers say.” There is potential for next steps, “they add.
Since the first cases of SARS-CoV-2 were detected in Wuhan, China, the virus has swept across the world. In the absence of any vaccine licensed to protect against SARS-CoV-2, Accelerated efforts to obtain ongoing COVID-19 pandemic clearances is an operation against the clock.
Eligible participants were healthy individuals between 18-80 years old.For phase 1, they separated 192 participants (mean age 53.7 years) who, in turn, were divided into two groups: 18 to 59 years and more than 60 years, for randomly receive the BBIBP-CorV vaccine or placebo in two doses on days 0 and 28 via intramuscular injection.
For phase 2, participants aged 18 to 59 years were randomly assigned to receive an intramuscular injection of the vaccine or placebo on days 0 and 14, 0 and 21, or 0 and 28.
Researchers indicate that BBIBP-CorV vaccine, given as a two-dose immunization, is safe and well-tolerated at doses across both age groups. A robust humoral immune response was observed among all beneficiaries.
All adverse reactions were mild or moderate, with no serious complications reported in the subsequent 28 days. In both age groups, antibody neutralizing titers were higher at day 42 among those who were vaccinated than among the placebo recipients.
During phase 2, an adverse reaction was detected within the first 7 days among 76 of 336 people who received the vaccine. The rest of the adverse reactions were mild or moderate in severity. The most common systemic reaction was fever.
The neutralization ranges on day 28 were significantly higher among those who received 4μg on day 0 and again on day 14, 21, or 28 than among those who received just the single 8μg on day 0.
The working group of this study assures that in their opinion “BBIBP-CorV vaccine has been shown to be safe, tolerable, and immunogenetic among healthy adults, if they were younger than 60 even more”.
“Immunization with BBIBP-CorV results in the rapid induction of immune responses against SARS-CoV-2, and would have value in preventing or limiting the COVID-19 pandemic,” they cite in the scientific paper.
Interpretation of the results of this study is limited by the short duration of follow-up. Another limitation is the lack of safety and immunogenicity tests in children and adolescents.. Although it was part of the original plan for this trial, testing will not begin in people under 18 years of age until the full analysis of the adult groups is completed.
“We found that the inactivated SARS-CoV-2 BBIBP-CorV vaccine is tolerable and immunogenic in healthy people. Rapid humoral responses against SARS-CoV-2 were observed from day 4 after the first inoculation and 100% seroconversion was found in all participants on day 42. On days 0 and 21 and days 0 and 28, the two immunization schedules elicited a higher amount of neutralizing antibody titers than the schedule on days 0 and 14 and the single immunization schedule. There is the possibility of further investigation of this inactivated vaccine for the control and prevention of COVID-19. Ongoing phase 1/2 and phase 3 trials will provide further information on the safety and immunogenicity, dose and immunization schedule of BBIBP-CorV, ”they concluded.
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