{"id":305335,"date":"2022-01-07T18:10:49","date_gmt":"2022-01-07T21:10:49","guid":{"rendered":"https:\/\/anba.com.br\/fiocruz-produzira-vacinas-100-nacionais-contra-covid-19\/"},"modified":"2022-01-07T18:15:24","modified_gmt":"2022-01-07T21:15:24","slug":"fiocruz-to-produce-covid-19-vaccines-with-brazilian-inputs","status":"publish","type":"post","link":"https:\/\/anba.com.br\/en\/fiocruz-to-produce-covid-19-vaccines-with-brazilian-inputs\/","title":{"rendered":"Fiocruz to produce COVID-19 vaccines with Brazilian inputs"},"content":{"rendered":"<p>S\u00e3o Paulo \u2013 The Brazilian National Health Surveillance Agency (ANVISA) approved the inclusion of the production of the vaccine against COVID-19 by the Oswaldo Cruz Foundation (Fiocruz) using the national Active Pharmaceutical Ingredient (API). The publication is in Resolution RE 35\/2022 of the General Management of Medicines at ANVISA, released this Friday (7) in the <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-re-n-35-de-6-de-janeiro-de-2022-372478228\" target=\"_blank\" rel=\"noopener\"><em>Brazilian Official Federal Gazette<\/em><\/a>. \u201cIn practice, the decision concludes Fiocruz\u2019s process for the country to have an all-Brazilian vaccine, with all stages of production carried out in the country,\u201d the agency informed in a statement.<\/p>\n<p>Fiocruz\u2019s vaccine against COVID-19 will be produced entirely in the country using a national API. \u201cFor this decision, Anvisa evaluated the comparability studies. These studies demonstrated when manufactured in the country, the input maintains the same performance as in the imported vaccine,\u201d added the entity.<\/p>\n<p>In May 2021, Anvisa had already made the Certification of Good Manufacturing Practices for the new input, which ensures the production line meets all the requirements for ensuring the quality of the API. Since then, Fiocruz has been carrying out the production of test batches to obtain authorization to use the national API in the COVID-19 (recombinant) vaccine.<\/p>\n<p>With the decision, this Friday (7), the transfer of technology made by Fiocruz, which started last year, was concluded. The vaccine has been approved in Brazil since January 17, 2021, and received permanent registration on March 12, 2021.<\/p>\n<p><strong>Translated by El\u00fasio Brasileiro<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The all-Brazilian vaccine against COVID-19 will be entirely produced in the country using a national API. It was approved today by ANVISA through a resolution.<\/p>\n","protected":false},"author":2315,"featured_media":305332,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[114],"tags":[27191,22644,9534,14891,26992,14156,26993,27186,17381,27187,27188,5163,18787,17870,27189,27190],"class_list":{"0":"post-305335","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-news","8":"tag-api","9":"tag-brasil-en-2","10":"tag-brazil-en","11":"tag-covid","12":"tag-covid-3-en","13":"tag-covid-19-en","14":"tag-covid-19-en-2","15":"tag-fiocruz-2-en","16":"tag-fiocruz","17":"tag-ifa-en","18":"tag-producao-en","19":"tag-production","20":"tag-vaccination","21":"tag-vaccine","22":"tag-vacina-2-en","23":"tag-vacinacao-2-en"},"wps_subtitle":"The all-Brazilian vaccine against COVID-19 will be entirely produced in the country using a national API. It was approved today by ANVISA through a resolution.","_links":{"self":[{"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/posts\/305335","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/users\/2315"}],"replies":[{"embeddable":true,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/comments?post=305335"}],"version-history":[{"count":0,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/posts\/305335\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/media\/305332"}],"wp:attachment":[{"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/media?parent=305335"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/categories?post=305335"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/anba.com.br\/en\/wp-json\/wp\/v2\/tags?post=305335"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}