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Pharmaceutical company AstraZeneca suspended end-stage testing of its Covid-19 vaccine candidate after a suspected “serious adverse reaction” in a study participant. The vaccine, which is developed in partnership with the University of Oxford, is being tested in Brazil and other countries. In a note sent to Twitter, Anvisa confirmed the interruption of the tests.
“The Astra Zeneca laboratory announced the stoppage of its global study for the Covid-19 vaccine. The decision was made by the laboratory itself, which communicated its decision to the participating countries. Anvisa has already received the suspension message sent by the laboratory, since Brazil is one of the countries in the world that participates in the global study. The Agency is waiting for more information to be sent on the reasons for the suspension to analyze the data and comment officially, ”Anvisa stated in a note. HE Twitter also looked for the AstraZeneca and awaits positioning.
Infectious disease specialist Julio Croda, from the Oswaldo Cruz Foundation (Fiocruz), told CNN Brazil that the foundation received information about “a serious adverse event in a patient from the United Kingdom, possibly associated with a neurological condition.” He also pointed out that the study will be delayed and warned the population that “there is no forecast to start vaccination.”
À NBC, a AstraZeneca sent the following statement: “Our standard review process has been activated and we have voluntarily paused vaccination to allow for review of safety data by an independent committee. This is a routine action that should happen whenever there is a possible unexplained illness in one of the evidence, while investigated, ensuring that the integrity of the evidence is maintained. “
The company also told the US broadcaster: “In large studies, diseases will appear by chance, but they need to be independently reviewed to verify this carefully. We are working to speed up the review of a single event to minimize any potential impact on The timing of the study. We are committed to the safety of our participants and to the highest standards of conduct in our tests. “
The Brazilian government has already agreed to a protocol of intent that provides for the availability of 30 million doses by the end of the year and is concluding negotiations for the payment and signing of a final agreement that will also include the transfer of technology for national production, which must be perform Fiocruz.
The AstraZeneca and Oxford candidate uses a chimpanzee adenovirus to present the spike protein to the immune system, used by the Sars-CoV-2 coronavirus to attack human cells.
If the vaccine is shown to be effective, the Ministry of Health’s forecast is to initially produce 100 million doses from imported supplies. The total production of the vaccine in the scientific-technical unit of Bio-Manguinhos, in Rio, should start from April 2021.
Nine major vaccine developers in the United States and Europe today pledged to maintain safety and efficacy standards for their experimental vaccines despite the urgency of containing the coronavirus pandemic.
The companies, including AstraZeneca, Pfizer Inc PFE.N and GlaxoSmithKline GSK.L, issued what they called a “historic compromise” after growing concern that safety standards could be sidelined in the face of political pressure. for a vaccine to be approved.
The companies said they will “maintain the integrity of the scientific process while working towards possible global regulatory conclusions and approvals for the first covid-19 vaccines.”
The other signatories were Johnson & Johnson JNJ.N, Merck & Co MRK.N, Moderna Inc MRNA.O, Novavax Inc NVAX.O, Sanofi SASY.PA and BioNTech 22UAy.F.
Non-Brazil delay
Julio Croda, who is also a researcher at Fiocruz (Oswaldo Cruz Foundation), told CNN today that the coronavirus vaccine trial tested by the foundation in Brazil and developed by AstraZeneca should be delayed after an “adverse reaction” in a patient in the UK. .
“It is necessary to investigate whether this feat is directly related to the vaccine and to better understand this process. It is good to alert the entire population that there is no prognosis to start vaccination. We need to have the results of effectiveness, but mainly of safety, “he said.
According to the infectologist, the investigation process must be thorough to understand how serious the event is and whether it may be related to the vaccine or not. The tests are carried out randomly, that is, it is unknown during the process who took the vaccine or the placebo, and it will be necessary to consider this “blinding” to identify which group the patient who presented the reaction belongs to.
“Initially, it will open the blindness for that specific patient, it will be verified if she took the vaccine or the placebo, and it will verify if there is some type of causal, temporary relationship in the condition that she presented,” explained Croda.
Fiocruz will now wait for the results of this survey to understand what the next steps will be to test the vaccine.
Pazuello talks about vaccination in January
The interim Minister of Health, Eduardo Pazuello, said today that the forecast is to start vaccinating the Brazilian population against covid-19 in January 2021.
In a ministerial meeting at the Planalto Palace, Pazuello answered the question of the girl youtuber Esther, appointed by President Jair Bolsonaro (without a party) to question his assistants, in a relaxed tone, during part of the meeting.
“Are you going to have a vaccine for everyone and medicine, or not?” The girl asked, repeating a question dictated by the president. “This is the plan. We are making contacts with those who manufacture the vaccine and the forecast is that it will reach us in January. In January we begin to vaccinate everyone,” Pazuello responded.
HE Twitter He sought out the Health Ministry after the disclosure of the testing break, but did not get a return until the report was released.
With information from Reuters, Agência Estado and Ansa
