RIO DE JANEIRO, BRAZIL – September should be decisive for Covid-19 vaccines. The pace of research is accelerating. Of the more than 100 vaccines in development, nine are in phase 3 testing, when a vaccine is being studied in a trial with tens of thousands of people worldwide. It is the last step required for a vaccine to be considered safe to be administered to the population.
The first test results are expected in October, according to the companies and laboratories involved in the research. Among them are the vaccine developed by the American laboratory Pfizer together with the German company BioNTech, and the vaccine from Oxford University, UK, with the pharmaceutical company AstraZeneca.
Phase 3 tests began in July, including voluntary patients in Brazil. In addition to the two vaccines against the coronavirus, the results of the tests by the Chinese laboratories Sinovac, CanSino, and Sinopharm, and a vaccine developed by the American biotechnology company Moderna are also expected. The companies also initiated the vaccine’s phase 3 tests in July.
However, once the results are published, this does not mean the vaccines will be ready to be administered immediately. The data need to be first assessed by each country’s health authorities and the vaccines need to be approved for administration. Then the production stage commences. Therefore, at best, vaccination should start in November or December.
The expectations are positive. Stephen Hahn, the head of the Food and Drug Administration (FDA) – the US regulatory agency in charge of approval – said in an interview with the Financial Times that he is willing to expedite approval of the vaccine if the result is positive.
He said the agency can issue an “emergency authorization for use” of the vaccine before a full review of the research results. He said this may occur before the US presidential election in early November.
In Brazil, there are two final tests in progress. One of them with the Chinese Sinovac vaccine, which has been administered since July in controlled groups in their country of origin. Here, the phase 3 tests continue with 2,000 volunteers in partnership with the Butantan Institute. Another 9,000 volunteers will be included in the results throughout September.
According to Dimas Covas, the director of the Butantan, the efficacy should be known until the end of the year and the aim is to begin vaccinating the population in early 2021. The governor of São Paulo, João Doria, said last week that the vaccine could be in the SUS (National Health System) in December.
Another vaccine in the advanced testing phase in Brazil, the Oxford vaccine in partnership with the pharmaceutical company AstraZeneca, should also have a decisive month for testing in September. The federal government’s plan is for 30 million doses to be delivered still this year, should everything go according to plan during September.
Source: Exame
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