China aprova vacina da sinovac contra covid-19 em uso de emergência
A China aprovou no final de agosto a vacina contra o coronavírus da fabricante Sinovac para uso emergencial em profissionais de saúde, sujeitos a maior risco para contaminação da Covid-19.
Chamada de CoronaVac, a vacina chinesa está em fase 3 de testes clínicos, inclusive sendo testada com cerca de 9.000 voluntários no Brasil. O governo de São Paulo fez um acordo com a farmacêutica Sinovac para transferência de tecnologia e produção da vacina junto com o Instituto Butantan no país.
A informação sobre a aprovação na China foi divulgada no último dia 28 de agosto pela agência de notícias Reuters em Pequim, que ouviu uma fonte próxima à farmacêutica.
Os resultados das fases 1 e 2 da vacina já mostraram bons resultados, com uma proteção acima de 97% após 28 dias. Foram avaliadas 148 pessoas entre 18 e 59 anos na fase 1 e mais 600 pessoas na fase 2. Os efeitos adversos reportados foram brandos. Não houve nenhum efeito colateral grave que pudesse indicar uma possível falha na segurança da vacina.
O estudo randomizado e duplo-cego contou com duas doses do imunizante, uma no primeiro dia de testes e outra 14 dias após. A quantidade de anticorpos no organismo foi medida 14 dias após cada dose.
Uma boa notícia é que a vacina induziu à produção de anticorpos neutralizantes, cuja função é justamente impedir a entrada do vírus nas células, sugerindo que a vacina pode ser eficaz em conter a infecção, não apenas o desenvolvimento da doença.

Os autores, no entanto, afirmam ser necessário aguardar os resultados da fase 3 para ter certeza da eficácia do imunizante.
A CoronaVac é feita a partir de vírus inativados. A ideia é modificar o Sars-CoV-2 tornando-o não infectante. Os cientistas inserem o coronavírus em células Vero —linhagem de células comumente utilizadas em culturas microbiológicas, sintetizadas a partir de células isoladas dos rins de uma espécie de macaco na década de 60 e usadas até hoje— para multiplica-lo em laboratório. A partir daí, o vírus é inativado e incorporado na vacina.
A produção de vacina com o vírus total inativado é semelhante à utilizada para a produção da vacina da raiva. Esse tipo de vacina, porém, necessita de grandes testes de segurança. A fase 3 que está em andamento no Brasil deve prosseguir por, no mínimo, seis meses.
Segundo o diretor do Instituto Butantan Dimas Tadeu Covas, caso os resultados da fase 3 sejam favoráveis a intenção é começar a vacinação já em janeiro.

O Butantan, que pretende produzir 120 milhões de doses até 2021, enfrentará um obstáculo logístico: a CoronaVac necessitade duas doses para imunização. Ou seja, o total produzido poderá atender 60 milhões de pessoas, menos de 1/3 da população do país.
Além da Sinovac, outras duas grandes farmacêuticas chinesas já possuem vacinas com uso restrito aprovado. A primeira a receber a aprovação foi a CanSino em julho, cuja vacina, feita a partir de adenovírus, tecnologia similar à da vacina da Oxford e AstraZeneca, foi aprovada para uso em militares no país.
A vacina da CanSino está atualmente desenvolvendo a fase 3 de ensaios clínicos na Arábia Saudita.
A gigante farmacêutica estatal Sinopharm, por meio do Grupo Nacional Chinês de Biotecnologia (CNBG, na sigla em inglês), também anunciou que teve autorização para o uso emergencial de uma de suas candidatas à vacina contra o coronavírus em estudo, segundo divulgou em redes sociais no último domingo (30).

A CNBG tem duas candidatas à vacina em fase 3 de ensaios, mas não divulgou qual das duas teve o uso aprovado.
Segundoa agência Xinhua, o governo chinês tem aprovado vacinas para uso emergencial como medida de bloquear possíveis novos surtos de Covid-19 durante o outono e inverno. O governo, no entanto, não divulgou maiores informações sobre como essas vacinações ocorrerão e a quantidade de pessoas a ser vacinada.
Fonte: Ana Bottallo
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