Wednesday, September 09, 2020

Covid vaccine studies tested in Brazil are suspended.

Drugmaker AstraZeneca has suspended the final stage tests of its covid-19 vaccine candidate after a suspected "serious adverse reaction" in a study participant. The information was confirmed to uol. The vaccine, which is developed in partnership with the University of Oxford, is tested in Brazil and other countries.
"As part of the randomized controlled trials of the ongoing Oxford coronavirus vaccine, our standard review procedure was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee. This is a routine action that should happen whenever a potential unexpected adverse reaction is identified in one of the clinical trials while it is investigated, ensuring the integrity of the studies is maintained," the statement said.
"In large trials, adverse events happen at random, but should be reviewed independently to verify this carefully. We are working to accelerate the review of a single event to minimize any potential impact on the test schedule. We are committed to the safety of our participants and the highest standards of conduct in our tests," he adds.
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 awaits the sending of more information on the reasons for the suspension to analyze the data and officially comment", declares Anvisa.
The Ministry of Health issued a note to the UOL reinforcing its commitment to ensure "a safe and effective vaccine in quantity for the Brazilian population. The government also reported the pause in the study indicates that "there will be no inclusion, at this time, of new participants", but that the more than 18,000 that have already been included continue to be studied.
According to the NYT, a study volunteer had transverse myelitis, which is an inflammation of the spinal cord often triggered by viral infections. However, as the newspaper points out, it is not possible to identify so far whether the inflammation is directly related to the AstraZeneca vaccine. The company has not yet confirmed which reaction interrupted the studies.
Infectologist Julio Croda of the Oswaldo Cruz Foundation (Fiocruz) told CNN Brazil that the foundation received information of a "serious adverse event in a PATIENT in the United Kingdom, possibly associated with a neurological condition." He also pointed out that the study will delay and warned the population that "there is no provision to start vaccination."
The Brazilian government has already agreed 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 to national production, which should be conducted Fiocruz.
The AstraZeneca and Oxford candidate uses a chimpanzee adenovirus to present the spike protein, used by the Sars-CoV-2 coronavirus, to harm human cells.
If the vaccine has its proven efficacy, the Ministry of Health's forecast is to initially produce 100 million doses from imported inputs. The full production of the vaccine in the Bio-Manguinhos technical-scientific unit in Rio should begin from April 2021.
Nine major vaccine developers from the United States and Europe today promised to maintain safety and efficacy standards for their experimental vaccines despite the urgency to contain the coronavirus pandemic.
Companies, including AstraZeneca, Pfizer Inc PFE. N and GlaxoSmithKline GSK. L, issued what they called a "historic compromise" after growing concerns that safety standards could be set aside in the face of political pressure for a vaccine to be approved.
The companies said they would "maintain the integrity of the scientific process as they work toward potential global regulatory findings and approvals for the first covid-19 vaccines."
The other signatories were Johnson & Johnson JNJ. N, a Merck & Co MRK. N, a Moderna Inc MRNA. O, a Novavax Inc NVAX. O, a Sanofi SASY. PA and BioNTech 22UAy.F.
UOL - 09/09/2020 News Item translated automatically
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