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AstraZeneca-University of Oxford vaccine clinical trial in Brazil, July 24, 2020 (Credit: AFP / Archives)
The Oswaldo Cruz Foundation (Fiocruz) tries to reverse a possible veto by the Indian government on the export of covid-19 vaccines developed by the pharmaceutical company AstraZeneca and the University of Oxford. The Brazilian laboratory articulates the import of 2 million prefabricated doses of this product, manufactured in a plant in India by AstraZeneca, which would allow the immunization schedule in Brazil to be brought forward to January. Fiocruz’s plan is also to produce doses, but the first batch should be ready only in February.
The intention is to seek a diplomatic solution through Itamaraty and the Ministry of Health to allow the doses to arrive, according to Fiocruz officials who are following the discussion. The laboratory must request the endorsement for the emergency use of the vaccine this week from the National Sanitary Surveillance Agency (Anvisa). Until the 15th, the plan is to request the definitive registration. Fiocruz and the agency met on Monday the 4th to finalize the details of these requests.
According to members of the federal government, the Indian veto should not delay the discussion on emergency use. Some of the authorities accompanying the debate claim to believe that the release of doses should occur even with the Indian veto, since the units would already be reserved for sale abroad.
According to a statement made on Sunday 3 by the general director of the Serum Institute of India, which manufactures the doses of AstraZeneca, Adar Poonawalla, the country will not allow exports. “We can only give (the vaccines) to the government of India at the moment,” Poonawalla said, adding that the decision was also made to avoid making the immunizer more expensive. As a result, according to him, the export of vaccines to the Covax consortium (an initiative of the World Health Organization to ensure equitable access to immunizers against covid-19) should start only in March or April.
It will not be the first diplomatic move by Brazil to launch products against the covid-19 arrested in India. In April 2020, President Jair Bolsonaro spoke with Prime Minister Narendra Modi and called for the release of the export of pharmaceutical supplies for the production of hydroxychloroquine. Bolsonaro is excited about the drug, which is not proven effective in treating the disease.
Fiocruz will continue to receive inputs
The import of 2 million prepared doses of AstraZeneca was authorized on December 31 by Anvisa. Before, Fiocruz only intended to receive the pharmaceutical input this month and complete the manufacturing of doses in Brazil, which would only be launched in February, in a first batch of 30 million units.
As it is an exceptional import, Anvisa requires that the vaccines be kept in the custody of Fiocruz until registration or emergency approval is granted. This is the same process authorized by the Butantan Institute, which claims to have 10.8 million doses of Coronavac units in storage, pending authorization for use.
The purchase of prepared doses is the main bet of the government to start vaccination on January 20, even in a restricted public. In addition, the idea is to distribute another 210.4 million doses in 2021 with pharmaceutical supplies that will reach the country, units that would serve to immunize more than 105 million people. The government invested about R $ 2 billion to buy doses and transfer technology to Fiocruz. In the national immunization plan, the government plans to apply doses of this vaccine to around 50 million Brazilians in priority groups in the first half of the year.
The lack of transparency in the disclosure of Oxford / AstraZeneca vaccine data has drawn criticism from the scientific community. A dosing error led to two product efficacy results: 62% when applied in a two full dose regimen and 90% with a half dose followed by a full dose. There are still questions about the results for people over 55 years old.
Responsible for coordinating the clinical study of the vaccine in Brazil, said Dr. Lily Yin Weckx to the Status that the first dose of the vaccine already shows about 70% effectiveness against the disease, but in a short interval. “We can still have an average efficiency of 70%. The study continues, we will have a segment year to see the persistence of protection, antibodies, security, etc. The important thing is that we have a safe and effective vaccine that can make a difference in the pandemic. That number of 60%, 70%, 80% is protection against covid disease. But if we consider serious illnesses and hospitalization, the vaccine was almost 100% preventable. Among the people who were vaccinated, none had a serious illness or were hospitalized for covid. All hospitalizations occurred in the control group, ”said the doctor.
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