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THE Ministry of Health announced on Thursday 8, the payment of the first installment of the initiative Covax installation, in the value of R $ 830 million, out of a total of R $ 2.5 billion. The program, of which Brazil is part, is a global alliance that aims to accelerate the development of vaccines against COVID-19 and make an equitable distribution. The immunizations acquired from Covax will be added to another production agreement and, according to the ministry’s forecast, the country must have 140 million doses in the first half of next year.
Through Covax, Brazil should receive doses for 10% of the Brazilian population by the end of the first half of next year, which is equivalent to about 20 million people; in the case of vaccines that require two doses, this would represent 40 million doses. The other 100 million will come from the agreement with the AstraZeneca Laboratory, which the immunizer develops in association with Oxford University.
“An advance of R $ 830 million was made (à Covax installation), which happened between yesterday (Wednesday) is today (Thursday). Then, in accordance with the contractual conditions, the rest of the payment will be made when one of the laboratories is defined, ”said the executive secretary of the portfolio, Elcio Franco.
He also noted that Brazil has adhered to the Covax option in which the country can choose which vaccine from the portfolio will immunize the population when it is available. These are the nine initiatives that make up the Covax Facility portfolio: Inovio, Moderna, Curevac, ThemisMerk, Oxford / AstraZeneca, Novavax, Queensland University, Clover and the University of Hong Kong.
“There were two options to enter, one with a slightly lower value, but with a higher risk and to be awarded one of the vaccines indicated by Covax Facility. To which Brazil adhered was option two, in which we will be able to choose which of these vaccines (will come to brazil). This will bring us security for the population, since only the vaccine approved by Anvisa will be made available to the Brazilian population, ”explained Elcio Franco.
In the ministry’s accounts, the percentage of 10% of the Brazilian population to be immunized with the Covax vaccine was defined considering three groups, those of people over 80 (4.4 million), people with morbidity (10.7 million ). million) and healthcare workers (5 million). The federal government also reinforced that the forecast to begin immunizing the population continues for the first quarter of 2021, considering the forecast, monitoring and production scale that is being drawn, but recalled that “there is a possibility of delay.” In addition, he recalled that the vaccination strategy plan is under study and should be launched between November and December.
The follow-up of the vaccinated will be done through the CPF
During the press conference, the Ministry of Health announced that it is investing in the modernization of the Information System of the National Immunization Program to meet the registration needs of the campaign against covid-19. And the mandatory CPF registration of vaccinated people is already provided for in this system.
“Unlike other campaigns, this campaign will require the identification of the citizen, through the use of the CPF. It is very important that everyone contributes to this proper registration. This registry will allow a constant monitoring of adverse events, all communication systems will be connected ”, said Jacson Venâncio de Barros, director of the IT Department of SUS.
Also according to Barros, the unified registration and identification will allow the country to have the “national digital vaccination card so dreamed of” and the vaccination certificate will be available in PDF with validation QRCode, and may be issued by the citizen at any time.
The change of procedures in Anvisa aims to speed up the review
The general manager of Medicines and Biological Products of Anvisa, Gustavo Mendes, also reported that the National Health Surveillance Agency (Anvisa) carried out a administrative innovation in procedures review of the vaccine registry to “optimize processes” and try to reduce the time to review the data, which today is up to 60 days.
“Traditionally, a complete vaccine dossier is expected, that is, it is necessary to generate all the data to request a later registration. But we know we need to rethink these flows, we need to speed things up, but in a careful and technical way. Therefore, we have established this procedure which is called Continuous Submission. As security, efficiency, quality data is generated, these data are shared with Anvisa, which begins to review it, identifying for researchers, for companies if there is any need for clarification. most, ”Mendes said.
In addition, the manager said that traditionally the 70% effectiveness criterion is used for the approval of a vaccine, but that in the case of pandemic situations “it is possible to make this percentage more flexible, which may be lower, from 50% for covid-19.
“We are talking about 50% as the criteria for the approval of the covid vaccine, because that 50% is based on an international discussion. Since the pandemic began, regulatory agencies have already known that due to the impact of the virus, the damage caused by the virus and the lack of therapeutic alternatives, 50% efficiency already represents a huge gain for public health ”. He even clarified that making it more flexible does not mean giving up the effectiveness of the vaccine. “This is a minimum requirement,” he said.
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