The drugmaker intends to finalize the FDA license application by the end of 2022; Testing of adolescents to include the age group has also already begun in Brazil
the vaccine against chikungunya produced by the French pharmaceutical company Valneva, in collaboration with Butantane Institute, showed the persistence of antibodies after one year of single dose vaccination in clinical trial participants. The test was carried out after the good responses of the phase 3 study, which verified the immunogenicity and safety of the vaccine.
The test dedicated to verifying this antibody persistence was carried out with a subgroup of 363 people over the age of 18 followed for at least 5 years to verify persistence after a single dose.
“We are thrilled that these twelve-month data align with what we saw in our previous reading from month 6 post-vaccination and bolster the chances of a long-lasting antibody response to our chikungunya vaccine candidate.” Dr. Juan Carlos Giaramillo.
The observed result was also positive in people over the age of 65, who maintained similar antibody counts as young adults. The response confirms the continuation of the result of the 96% response rate reported in the following six months vaccination🇧🇷 Monitoring should continue annually.
In Brazil, tests on adolescents have already begun under the coordination of the Butantan Institute. Healthy young people between the ages of 12 and 17 were invited to participate in the study and, with parental approval, will receive the immunization in a single dose, which will also be monitored over a period of 6 to 12 months .
The research intends to recruit 750 adolescents in seven research centers in Brazil.
By the end of this year, Valneva expects to finalize the submission of its Biologics License Applications (BLA) to the US Food and Drug Administration (FDA)., the US federal health agency that regulates pharmaceuticals. The process is an immunizer eligibility inquiry.
Cases of Chikungunya in Brazil
According to the Epidemiological Bulletin of Ministry of HealthAs of September this year, there were 162,407 probable cases of chikungunya in Brazil, an 89.4 percent increase over the same period in 2021. The region North East it had the highest incidence with 243.7 cases per 100,000 population.
Symptoms of the disease include high fever, joint and muscle pain, headache, nausea, skin rashes, and chronic arthralgia. Despite its low mortality, Chikungunya has a high morbidity rate mainly affecting endemic areas such as Brazil.
In 2022 alone, 64 deaths from disease have already been recorded in the country, of which 30 in the State of Ceara🇧🇷 Another 45 death cases are under investigation.
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Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
