Covaxgate

{{Short description| Vaccine controversy in Brazil}}

{{Use dmy dates|date=January 2025}}{{Use Oxford spelling|date = January 2025}}

{{Update|date=May 2022|reason=Results of the investigation and further implications in 2021 and into 2022.}}

{{Infobox event

| title =

| image = Covaxin.jpg

| caption = Ampoule of Covaxin

| native_name = Caso Covaxin

| native_name_lang = Portuguese

| timezone = UTC−3

| duration = {{Time interval|2021-06-16|show=ymd}}

| date = {{end date and age|2021|06|16|df=y}}

| venue =

| location = Brazil

| also_known_as = Covaxgate

| type = Alleged overbilling of 20 million doses of Covaxin vaccine by members of the Brazilian government

| cause =

| motive =

| participants =

| outcome =

| verdict =

| convictions =

}}

The Case Covaxin, also known as Covaxgate, refers to an investigation made by the Brazilian Federal Public Ministry (MPF), held on 16 June 2021, which found evidence of irregularities in the purchase of 20 million doses by the Ministry of Health of the Indian vaccine Covaxin, with the value of the vaccines 1000% higher than initially foreseen.{{Cite web |date=2021-07-06 |title=Caso Covaxin: Senadora aponta falsificação em documento usado pelo governo Bolsonaro |url=https://jc.ne10.uol.com.br/politica/2021/07/12618225-caso-covaxin-senadora-aponta-falsificacao-em-documento-usado-pelo-governo-bolsonaro.html |accessdate=2021-07-08 |language=pt-br}}{{Cite web |date=2021-06-28 |title=Randolfe promete novos documentos para provar a corrupção do Covaxgate |url=https://www.diariodocentrodomundo.com.br/essencial/randolfe-promete-novos-documentos-para-provar-a-corrupcao-do-covaxgate/ |accessdate=2021-07-08 |language=pt-br}}{{Cite web |author=Caroline Oliveira |date=2021-06-29 |title=Caso Covaxin: o que se sabe até agora? |url=https://www.brasildefato.com.br/2021/06/29/caso-covaxin-o-que-se-sabe-ate-agora |accessdate=2021-07-08 |language=pt-br}}{{Cite web|url=https://www.cnnbrasil.com.br/politica/2021/06/22/documentos-apontam-que-governo-comprou-vacina-indiana-por-valor-1000-maior|title=Documentos apontam que governo comprou vacina indiana por valor 1000% maior|date=2021-06-22|accessdate=2021-07-08|author1=Rachel Vargas |author2=Gustavo Uribe}}

The Prosecutor General of the Republic has also asked to investigate whether President Jair Bolsonaro committed the crime of misfeasance, for allegedly failing to report to investigative bodies evidence of corruption in the negotiations to purchase the vaccine.{{Cite web|url=https://www.redebrasilatual.com.br/politica/2021/07/pgr-investigacao-bolsonaro-prevaricacao-covaxin/|title=PGR pede investigação sobre prevaricação de Bolsonaro na compra da Covaxin|date=2021-07-02|accessdate=2021-07-08|language=pt-br}}

Investigation

An investigation by the Federal Public Ministry (MPF), conducted on 16 June 2021, found evidence of irregularities in the purchase of 20 million doses of the vaccine through the pharmaceutical company Precisa Medicamentos, with the value of the vaccines 1000% higher than the initial value shown initially by Bharat Biotech six months earlier.{{Cite web |last=Globo |first=Agência O. |url=https://ultimosegundo.ig.com.br/politica/2021-06-24/entenda-cronologia-compra-superfaturada-corrupcao-covaxin-governo-bolsonaro.html |title=Entenda a cronologia da compra superfaturada da Covaxin pelo Governo Bolsonaro |date=2021-06-24 |accessdate=2021-06-27 |website=iG |language=pt-BR}} On 29 June, the contract for the purchase of the vaccine was suspended by the Ministry of Health after "controversies".{{Cite web |url=https://www.cnnbrasil.com.br/saude/2021/06/29/ministrio-da-saude-vai-suspender-hoje-contrato-da-covaxin |title=Ministério da Saúde suspende contrato de compra da vacina Covaxin |accessdate=2021-06-29 |website=CNN Brasil |language=pt-BR}}

=Miranda brothers=

{{Main|COVID-19 CPI}}

File:CPIPANDEMIA - Comissão Parlamentar de Inquérito da Pandemia (51157522716).jpg on 4 May 2021]]

On Friday, 25 June 2021, Congressman Luis Miranda (DEM-DF) and his brother, Luis Ricardo Miranda, a civil servant at the Ministry of Health, were heard at the COVID-19 CPI.{{cite web |url=https://www.cnnbrasil.com.br/politica/2021/06/26/em-4-pontos-entenda-o-caso-da-covaxin-e-dos-irmaos-miranda |title=Em 4 pontos, entenda o caso da Covaxin e dos irmãos Miranda |date=2021-06-25 |accessdate=2021-07-01 |website=CNN Brasil|language=pt-br}} The Miranda brothers said that the contract for the purchase of the Indian vaccine Covaxin was agenda. During testimony, Ricardo Miranda refuted Onyx Lorenzoni's accusations.{{Cite web |url=https://www.terra.com.br/noticias/brasil/politica/miranda-informacoes-contradizem-governo-sem-corrupcao,3ac76939a935f0424a4afdf3dc6ee548rd5mm4p7.html |title=Miranda: informações contradizem "governo sem corrupção" |accessdate=2021-07-01 |website=Terra |language=pt-BR}} After suspecting corruption in the Covaxin purchase, the congressman and the civil servant claim that they would have met with President Bolsonaro.{{Cite web |last=Povo |first=Correio do |url=https://www.correiodopovo.com.br/not%C3%ADcias/pol%C3%ADtica/irm%C3%A3os-miranda-relatam-%C3%A0-cpi-press%C3%A3o-e-suspeitas-de-corrup%C3%A7%C3%A3o-na-compra-da-covaxin-1.643861 |title=Irmãos Miranda relatam à CPI pressão e suspeitas de corrupção na compra da Covaxin |accessdate=2021-07-01 |website=Correio do Povo |date=25 June 2021 |language=pt-br}}

=Brazilian Supreme Court=

On 2 July 2021, the Prosecutor General of the Republic asked the Supreme Federal Court to open an inquiry to investigate Bolsonaro for the possible crime of misfeasance in the Covaxin vaccine overbilling case, in a development of the investigations carried out by the COVID-19 CPI.{{Cite web |url=https://g1.globo.com/politica/noticia/2021/07/02/pgr-pede-abertura-de-inquerito-para-investigar-bolsonaro-por-prevaricacao-no-caso-covaxin.ghtml |title=PGR pede abertura de inquérito para investigar Bolsonaro por prevaricação no caso Covaxin |work=G1 |date=2021-06-19 |accessdate=2021-06-19|language=pt-br}}

Search and seizure warrants

By determination of the STF minister Dias Toffoli and appreciated by the COVID-19 CPI, the Federal Police searched the headquarters of Precisa Medicamentos in São Paulo. The vaccine contract, already cancelled, is also investigated by the Federal Audit Court and the Federal Public Prosecutor's Office.{{cite web|url=https://g1.globo.com/sp/sao-paulo/noticia/2021/09/17/pf-faz-operacao-em-sede-da-precisa-medicamentos-em-sp-empresa-que-entrou-na-mira-da-cpi-da-covid.ghtml|title= PF faz operação em sede da Precisa Medicamentos em SP, empresa que entrou na mira da CPI da COVID|work=G1|date=17 September 2021|accessdate=17 September 2021|language=pt-br}}

Covaxin

{{Main|Covaxin}}

Covaxin is a vaccine against COVID-19 produced in India by the Bharat Biotech laboratory.{{Cite web |url=https://www.bharatbiotech.com/images/press/bharat-biotech-signs-agreement-with-precisa-medicamentos-for-supply-of-covaxin-to-brazil.pdf |title=Bharat Biotech signs agreement with Precisa Medicamentos for supply of 'COVAXIN™' to Brazil |accessdate=2025-02-02 |publisher=Bharat Biotech |language=en }} In January 2021, Precisa Med signed a contract with Bharat Biotech to supply Covaxin in Brazil.{{Cite journal |url=https://www.livemint.com/news/india/bharat-biotech-inks-pact-with-precisa-med-to-supply-covaxin-to-brazil-11610456928074.html |title=Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil |date=2021-01-12 |website=mint}}

It was one of the first to be used in the world for emergency vaccination and would be one of the vaccines applied by Brazil, where it would be produced in partnership with Precisa Medicamentos, and the Ministry of Health estimated to use it in February 2021.{{Cite web |url=https://www.gov.br/saude/pt-br/assuntos/noticias/ministerio-da-saude-negocia-na-proxima-sexta-feira-5-aquisicao-de-30-milhoes-de-doses-das-vacinas-sputinik-v-e-covaxin-1 |title=Ministério da Saúde negocia na próxima sexta-feira (5) aquisição de 30 milhões de doses das vacinas Sputinik V e Covaxin |accessdate=2021-02-04 |website=Ministério da Saúde |language=pt-br}}{{Cite web |url=https://www.uol.com.br/vivabem/reuters/2021/02/03/laboratorio-anuncia-testagem-da-covaxin-no-brasil-em-parceria-com-eisntein.htm |title=Laboratório anuncia testes da Covaxin no Brasil em parceria com Einstein |accessdate=2021-02-04 |website=www.uol.com.br |language=pt-br}} On 5 February 2021, the National Health Surveillance Agency (Anvisa) announced that it had received an application to study the vaccine in Brazil.{{Cite web |url=https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-recebe-pedido-de-estudo-da-vacina-covaxin-no-brasil |title=Anvisa recebe pedido de estudo da vacina Covaxin no Brasil |date=2021-02-05|accessdate=2021-02-05 |website=Agência Nacional de Vigilância Sanitária |language=pt-br}}

On 26 February the Government of Brazil announced that it would buy 20 million doses of the Indian Covaxin vaccine.{{Cite web |url=https://pt.wikinews.org/wiki/Covid-19:_no_Brasil,_governo_assina_contrato_para_compra_de_20_milh%C3%B5es_de_doses_da_vacina_indiana_Covaxin |title=Covid-19: no Brasil, governo assina contrato para compra de 20 milhões de doses da vacina indiana Covaxin – Wikinotícias |accessdate=2021-02-28 |website=pt.wikinews.org |language=pt}}

=Sanitary risk=

On 30 March 2021, Anvisa announced that it had denied the manufacturer the Good Manufacturing Practices Certificate due to "health risk to users," having found, after an inspection of Bharat in India, "non-conformities, being three critical, 12 major and 14 minor, which together denote a significant risk to manufacturing and quality assurance of the product."{{Cite web |url=https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-publica-decisoes-sobre-pedidos-de-cbpf |title=Anvisa publica decisões sobre pedidos de CBPF |accessdate=2021-03-30 |website=Agência Nacional de Vigilância Sanitária – Anvisa |language=pt-br |archive-date=2021-03-30 |archive-url=https://web.archive.org/web/20210330152743/https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-publica-decisoes-sobre-pedidos-de-cbpf |url-status=dead }}{{Cite web |url=https://g1.globo.com/bemestar/vacina/noticia/2021/03/30/anvisa-nega-certificacao-de-boas-praticas-a-empresa-fabricante-da-covaxin-vacina-da-india-para-covid-19.ghtml |title=Anvisa nega certificação de boas práticas a empresa fabricante da Covaxin, vacina da Índia para Covid-19 |accessdate=2021-03-30 |website=G1 |date=30 March 2021 |language=pt-br}}

=Approval=

The vaccine was approved for emergency use at the end of February 2021.{{Cite journal |url=https://ourworldindata.org/covid-vaccinations |title=Coronavirus (COVID-19) Vaccinations – Statistics and Research |accessdate=2021-01-28 |journal=Our World in Data|date=5 March 2020 |last1=Ritchie |first1=Hannah |author1-link=Hannah Ritchie |last2=Mathieu |first2=Edouard |last3=Rodés-Guirao |first3=Lucas |last4=Appel |first4=Cameron |last5=Giattino |first5=Charlie |last6=Ortiz-Ospina |first6=Esteban |last7=Hasell |first7=Joe |last8=MacDonald |first8=Bobbie |last9=Beltekian |first9=Diana |last10=Roser |first10=Max |author10-link=Max Roser}}

class="wikitable"

|+ COVID-19: emergency release (January 2021)

Vacinal candidate

(developer/financier)

!Current situation

!Effectiveness

!Country of origin

!Technology

!Testing phase; number of participants

!Adverse effects

!References and notes

Covaxin or BBV152

(Bharat Biotech)

|Released for emergency use{{Cite journal |url=https://www.bbc.com/portuguese/internacional-55528472 |title=Alvo da rede privada no Brasil, vacina indiana Covaxin gera críticas por aprovação apressada |accessdate=2021-01-04 |journal=BBC News Brasil |language=pt-BR}}

|81%

|India

|Inactivated virus

|Phase 3 closed; 25,800 participants

|Common: pain at the injection site, headache, fatigue and fever

|{{Cite web |url=https://www.uol.com.br/vivabem/noticias/redacao/2021/01/22/vacina-desenvolvida-na-india-gera-resposta-imunologica-diz-estudo.htm |title=Vacina desenvolvida na Índia gera resposta imunológica, diz estudo |accessdate=2021-01-31 |website=www.uol.com.br |language=pt-br}}{{Cite journal |title=Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial |date=2021-01-21 |journal=The Lancet Infectious Diseases |last1=Ella |first1=Raches |last2=Vadrevu |first2=Krishna Mohan |doi=10.1016/S1473-3099(20)30942-7 |issn=1473-3099 |last3=Jogdand |first3=Harsh |last4=Prasad |first4=Sai |last5=Reddy |first5=Siddharth |last6=Sarangi |first6=Vamshi |last7=Ganneru |first7=Brunda |last8=Sapkal |first8=Gajanan |last9=Yadav |first9=Pragya|volume=21 |issue=5 |pages=637–646 |pmid=33485468 |pmc=7825810 }}{{Cite web |url=https://agenciabrasil.ebc.com.br/saude/noticia/2021-03/vacina-covaxin-apresenta-eficacia-de-81-diz-laboratorio-indiano |title=Vacina Covaxin apresenta eficácia de 81%, diz laboratório indiano |date=2021-03-03 |accessdate=2021-03-04 |website=Agência Brasil |language=pt-br}}

Note 1: the vaccine was released in India before data from phase 2 trials

Note 2: in Brazil it would be produced in partnership with [https://www.precisamedicamentos.com.br/ Precisa Medicamentos] {{Webarchive|url=https://web.archive.org/web/20210917185116/https://precisamedicamentos.com.br/ |date=2021-09-17 }}

See also

References