Butantan says he is providing vaccine data requested by Anvisa; check out what they are – Prime Time Zone

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On Twitter, Governor João Doria asked for a “sense of urgency” for the Agency to release CoronaVac

SUAMY BEYDOUN / AGIF – PHOTOGRAPHY AGENCY / ESTADÃO CONTENT – 12/30/2020Butantan provided a detailed explanation of the data requested by Anvisa on CoronaVac

O Butantan Institute informed, on the morning of this Sunday, 10, that it is providing all the necessary documents for the CoronaVac, potential vaccine against a Covid-19 produced in partnership with the Chinese laboratory Sinovac, have the registration for emergency use granted by Health Surveillance Agency (Anvisa). According to the Institute, this should not change the schedule. “The fact that Anvisa requests more information, which is being promptly attended to by Butantan, does not affect the term foreseen for authorization to use the immunobiological product.”

“Requests for new documents or more information are absolutely common in processes like these. This Saturday, 9, the Butantan Institute held two meetings with the agency and is available to provide all requested complementary data ”, the note adds. Fur Twitter, the governor of São Paulo, João Doria, took a position on the request of the regulatory body. “Anvisa needs a sense of urgency to release the Butantan vaccine. Rites of science must be respected, but we must remember that Brazil loses about a thousand lives / day to Covid-19. With the release of Anvisa, millions of vaccines that are already ready can save lives. ”

What is missing?

Butantan provided a detailed explanation of the data that were requested by Anvisa on CoronaVac – and that will be presented by the Institute. Understand:

1. Critical demographic and baseline characteristics of the study population: are the basic data with the characteristics of all volunteers tested, such as age, sex, race, weight and body mass index of the participants. Data on other important characteristics are also needed, for example, kidney or liver function and comorbidities such as hypertension, diabetes, obesity. Such data must be presented in a complete form for both those who received the vaccine and those who received a placebo. The data are essential to allow comparison between treated groups.

2. Study results by “intention-to-treat” (ITT) population: involves a more complex and detailed cut of the population that would be the target of vaccination. For the analysis of the results of clinical studies, two basic populations are defined: the first is defined by the “intention-to-treat” (ITT) that includes all participants regardless of protocol violations and losses from follow-up; the second, called “per-protocol” (PP), is a subset of the first, and includes only participants who completed the study according to the protocol criteria, excluding all those who had any deviations.

3. Data on the disposition of the participants, with clear accounting: means having the exact numbers about volunteers, doses received and number of volunteers who completed the study in each group. That is, in the group that took the vaccine and in the group that took the placebo. It is the data about how many volunteers received the vaccine, how many took a placebo and how many completed the two doses of vaccination. This data also includes information on how many volunteers were monitored for the period planned in the study and an explanation of volunteers who did not complete the study in detail. It also includes an explanation for all interruptions, grouped by treatment and main reason (loss of follow-up, adverse event, poor compliance, etc.).

4. Description of protocol deviations: is the detail about anything done differently than what was in the research protocol or that was not programmed. It includes, for example, information about the interval between the first and the second dose of the vaccine (or placebo). These deviations must have an impact classification for the study, that is, how much they can impact the final result.

5. List of participants with protocol deviations: it is the detailed list of patients who had some kind of protocol deviation (for example, how many participants took only one dose, how many had a greater or lesser interval between doses, etc.), for each research center that participated in the study.

6. Immunogenicity data from the phase 3 study: it is the evaluation that checks the antibodies generated by the vaccine and how long these antibodies remain in the research participants.