{"id":545711,"date":"2025-04-15T17:40:37","date_gmt":"2025-04-15T20:40:37","guid":{"rendered":"https:\/\/revistapesquisa.fapesp.br\/?p=545711"},"modified":"2025-04-15T17:40:37","modified_gmt":"2025-04-15T20:40:37","slug":"butantan-vaccine-candidate-reduces-the-risk-of-severe-dengue-fever-by-89","status":"publish","type":"post","link":"https:\/\/revistapesquisa.fapesp.br\/en\/butantan-vaccine-candidate-reduces-the-risk-of-severe-dengue-fever-by-89\/","title":{"rendered":"Butantan vaccine candidate reduces the risk of severe dengue fever by 89%"},"content":{"rendered":"
\"\"

Renato Rodrigues\u2009\/\u2009Butantan Institute Communication<\/span>Technician performs a visual inspection of the batch of Butantan DVRenato Rodrigues\u2009\/\u2009Butantan Institute Communication<\/span><\/p><\/div>\n

A single dose of just 0.5 milliliters (mL) of the candidate vaccine against dengue from the Butantan Institute, Butantan DV, provided lasting and elevated protection against the disease. It reduced the risk of people presenting symptoms (mild, moderate, or severe) of dengue by an average of 67.3%, even long after its administration\u2014on average, 3.7 years.<\/p>\n

Presented in an article published in August in the journal The Lancet Infectious Diseases<\/em><\/a>, this level of protection is slightly lower than that observed in a study published in February in The New England Journal of Medicine<\/em><\/a> (see<\/em> Pesquisa FAPESP issue n\u00b0 324<\/em><\/a>). In that study, the overall protection of the Butantan DV vaccine was 79.6%, but measured two years after administration. Now, with almost double the time, immunity has fallen a little but remains significant.<\/p>\n

The new and most important data revealed now is that the vaccine provides elevated protection against the most worrying cases. It reduced the risk of those vaccinated developing severe dengue or dengue with warning signs by 89%, once exposed to the virus. Produced with an attenuated version of four varieties (serotypes) of the dengue virus, the Butantan-DV offered an average protection of 64.6% to those from 2 to 6 years of age, 70.6% for those 7 to 17 years of age, and 72.8% for those 18 to 59 years of age. It had an overall efficacy of 75.8% against dengue serotype 1 and 59.7% against serotype 2. Infections by serotypes 3 and 4 were not detected during the monitoring phase, concluded before the epidemic this year, and, for now, the level of protection provided by the vaccine against these two varieties of the virus is unknown.<\/p>\n

\u201cThe peak of protection occurs during the first year of vaccination, after which a drop in the production of antibodies is normal. We will continue to monitor the data, but as of now, they suggest that it is not necessary to adopt a booster dose,\u201d explains Fernanda Boulos, medical director of the Butantan Institute and coordinator of the clinical trials with Butantan DV, the initial development of which had funding from FAPESP.<\/p>\n

In the tests, 10,259 people were selected to receive the vaccine, while 5,947 were administered an inactive compound (placebo). Neither the physicians nor the participants knew who was receiving what. The frequency of adverse events was greater among those who took Butantan-DV (53%) than among those who received the placebo injection (45.6%), generally local pain, fever, and red spots on the body. Meanwhile, the rate of severe adverse events was similar in the two groups: 6.2% in the first and 6.6% in the second.<\/p>\n

\u201cThe vaccine remained highly effective and had solid safety data,\u201d affirms physician and virologist Maur\u00edcio Nogueira, of the School of Medicine of Rio Preto (FAMERP), lead author of the article in The Lancet Infectious Diseases<\/em> and coordinator of one of the test centers. \u201cWe cannot afford to have a vaccine that is more or less safe,\u201d he says.<\/p>\n

According to Boulos, the new data are being submitted to the Brazilian Health Regulatory Agency (ANVISA), responsible for approving drugs and foods in the country, and the patent application for the vaccine has already been filed. The process of scaling up production and evaluating the quality of the vaccine is now underway. \u201cOnce this phase is complete, we will be able to calculate our production capacity better,\u201d affirms the researcher. \u201cIf everything goes well, we hope that approval by ANVISA is granted in the first half of next year,\u201d she says.<\/p>\n

In January this year, the Brazilian Ministry of Health included the first vaccine against dengue, Qdenga, into Brazil\u2019s public healthcare system (SUS). Manufactured by the Japanese laboratory Takeda, the vaccine is aimed at children aged 10 to 14.<\/p>\n

The story above was published with the title “Protection against severe dengue<\/strong>” in issue 343 of September\/2024.<\/p>\n

Scientific articles
\n<\/strong>NOGUEIRA, M. L. et al<\/em>. Efficacy and safety of Butantan-DV in participants aged 2\u201359 years through an extended follow-up: Results from a double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil<\/a>. The Lancet Infectious Diseases<\/strong>. Aug. 5, 2024.
\nKALLAS, E. G. et al<\/em>. Live, attenuated, tetravalent Butantan-Dengue Vaccine in children and adults<\/a>. The New England Journal of Medicine<\/strong>. Feb. 1, 2024.<\/p>\n","protected":false},"excerpt":{"rendered":"The compound proved safe and prevented 67.3% of those immunized from developing symptoms of the disease","protected":false},"author":16,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[159],"tags":[242,232,260],"coauthors":[105],"class_list":["post-545711","post","type-post","status-publish","format-standard","hentry","category-science","tag-immunology","tag-pharmacology","tag-public-health","keywords-vaccine"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/545711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=545711"}],"version-history":[{"count":5,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/545711\/revisions"}],"predecessor-version":[{"id":549231,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/545711\/revisions\/549231"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=545711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=545711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=545711"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=545711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}