Oxford vaccine study suspended in UK after ‘serious adverse effect’ in patient | Vaccine

Anvisa said in a statement: “The decision to interrupt the studies was made by the laboratory, which communicated to the participating countries. Anvisa has already received the message and will wait for more information to be officially sent.” The agency is responsible for authorizing the tests in Brazil.

In response to G1, AstraZeneca in Brazil reported that it is verifying the facts to prepare a position.

The Oxford / AstraZeneca vaccine is the Ministry of Health’s commitment to immunize the population. In total, Brazil plans to disburse R $ 1.9 billion for this vaccine, R $ 1.3 billion for payments to AstraZeneca, R $ 522.1 million for vaccine production in Fiocruz / Bio-Manguinhos and R $ 95.6 million for absorption of the technology by Fiocruz.

The acting Minister of Health, Eduardo Pazuello, even said on Tuesday that he plans the vaccination campaign against Covid-19 for January 2021.

Rede D’Or, responsible for testing the Oxford vaccine in Rio de Janeiro, told the G1 You are reviewing the information posted by the North American website. The Oswaldo Cruz Foundation said it has not been officially informed about the matter and that it should not speak out for the time being. Unifesp, which is responsible for testing the vaccine in São Paulo, also said it had not received a statement on the matter.

Citing British pharmaceutical sources, STAT reported that phase 3 clinical trials have been suspended, but that this would be a “routine move” made to ensure the safety and integrity of the tests.

AstraZeneca in the UK also said in a statement sent to CNBC that this move is “routine and occurs whenever there is a possibility of unexplained illness appearing during testing.”

“[Isso é feito] while we investigate the cause, making sure to maintain the integrity of the evidence. In large-scale trials, diseases will show up, but they need to be independently assessed to control them safely. ”

The Oxford vaccine is in trial phase 3, the latest in several countries, including Brazil. Under British regulation, if all goes well after this stage, immunization goes to licensing when the UK or European government regulatory agencies review the trial data. At this stage, they make sure that the vaccine has the necessary efficacy and level of safety.

Steps to produce a vaccine

It takes time to produce a vaccine. The fastest developed so far was the mumps vaccine, which took about four years to be licensed and distributed to the population.

Before starting the tests in volunteers, immunization goes through several phases of preclinical experimentation (in the laboratory and with guinea pigs). Only after its safety and efficacy have been evaluated do human trials begin, the so-called clinical phase, which are three:

• Phase 1: is a preliminary evaluation of the safety of the immunizer, performed with a small number of healthy adult volunteers who are closely monitored. It is at this time that the type of response that the immunizer produces in the body is understood. It is applied to dozens of participants in the experiment.
• Phase 2: In the second phase, the clinical study is expanded and has hundreds of volunteers. The vaccine is given to people with characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In this phase the safety of the vaccine, immunogenicity (or protective capacity), the dose and how it should be administered are evaluated.
• Phase 3: Large-scale trial (with thousands of people) that should provide a definitive evaluation of its efficacy and safety in larger populations. In addition, designed to predict adverse events and ensure the durability of protection. Only after this phase can a medical history be taken.