Oxford Covid-19 Vaccine Testing Suspension: See Questions and Answers | Vaccine

1. What was the reason for the temporary suspension of the tests?
2. What was the adverse reaction of the patient?
3. Was it the first interruption of the vaccine studies?
4. When should testing be resumed?
5. What do the results of the previous test phases show about the reactions?
6. What did the Brazilian authorities say?

See the answers below:

1. What was the reason for the temporary suspension of the tests?

On Tuesday night (8), the pharmaceutical company said that the safety protocol was activated after one of the volunteers in the UK had an adverse reaction that could be related to the vaccine.

The interruption was also valid for Brazil, according to the National Sanitary Surveillance Agency (Anvisa) and the Federal University of São Paulo (Unifesp), one of the institutions responsible for the study in the country. Unifesp reported that 5,000 Brazilian volunteers have already been vaccinated.

According to AstraZeneca, the “standard review procedure” for studies was activated and vaccination was paused “voluntarily to allow review of safety data by an independent committee.” Researchers will need to investigate whether the reaction was actually related to the application of the vaccine.

2. What was the adverse reaction of the patient?

On Wednesday (9), the Reuters news agency published a position from AstraZeneca in which it reaffirms that the diagnosis of the volunteer staff is still pending and that, therefore, it is incorrect to relate the suspension of vaccine tests to a case of myelitis. transverse, an inflammatory syndrome that affects the spinal cord.

Myelitis was initially cited in a report in The New York Times on Tuesday. The same information was received by the Brazilian pulmonologist Margareth Dalholm. (Look the following video).

On Wednesday, AstraZeneca president Pascal Soriot mentioned that the volunteer had symptoms associated with myelitis, but that the diagnosis was still under investigation. The information was disseminated by “STAT”, a website specialized in health and also the first to report the pause in studies.

Still according to “STAT,” Soriot said she is a volunteer, a woman, who is improving and will likely be discharged from the hospital on Wednesday.

3. Was it the first interruption of the vaccine studies?

No. AstraZeneca reported that in July the studies were stopped due to the manifestation of neurological symptoms in one of the volunteers. After examinations and independent investigation, it was discovered that the patient had an undiagnosed condition of multiple sclerosis.

4. When should testing be resumed?

There is no forecast. Officially, experts from the independent committee are expected to investigate the symptoms, determine what actually caused the reactions, and assess whether there is a safety requirement to resume testing. The researchers will continue to follow the patients who have already participated in the studies.

However, according to a report in “The Financial Times”, testing with the vaccine could resume next week. The information was attributed to people linked to the trials, the newspaper said.

5. What do the results of the previous test phases show about the reactions?

According to preliminary results from phases 1 and 2, published on July 20, the vaccine is safe and induces an immune response in the bodies of volunteers.

In these first two stages, which were carried out simultaneously in the United Kingdom, the surveys involved 1,077 volunteers. The trials showed that the vaccine was able to induce both antibody and T cell responses up to 56 days after dosing. All side effects, such as fever, headaches, muscle aches, and injection site reactions, were rated as mild or moderate.

“Exactly the kind of immune response we were expecting,” said Andrew Pollard, a professor of pediatrics at the University of Oxford, at the time.

6. What did the Brazilian authorities say?

The National Agency for Health Surveillance (Anvisa) said that no Brazilian patients had “serious adverse events” during the Oxford vaccine trials.

“In Brazil, there are no reports of serious adverse events in volunteers,” the institution said in a statement. “Anvisa is already in contact with the AstraZeneca laboratory to access all the information and communicate with other medical authorities in the world.”

According to Anvisa, the information about the suspension arrived on Tuesday, as Brazil is one of the countries participating in the global study. She explained that the investigation must check whether the case of the British patient is related to the vaccine applied.

“The laboratory reported that the COV002 study, which is concerned with the safety and efficacy evaluation of the ChAdOx1 nCoV-19 vaccine, will be temporarily halted until the serious adverse event observed in a UK volunteer is investigated to determine its relationship with the vaccine”. said the Brazilian regulatory agency.

The Oswaldo Cruz Foundation, which is expected to produce the doses of the vaccine in the country, said that it was informed by the British laboratory and that it will monitor the results of the investigations to make an official statement.

The Ministry of Health reported that the contract for the production of the vaccine in Brazil will not change after the temporary suspension.

“Fiocruz’s contract with AstraZeneca will not undergo changes,” said Elcio Franco, executive secretary of the portfolio, at a press conference. “In addition to the memorandum of understanding, the technology order agreement has already been signed electronically between AstraZeneca, in England, and Brazil with the Oswaldo Cruz Foundation.”

“We still do not know how much the planned schedule for the development of the AstraZeneca vaccine impacts the suspension of the trial. It is necessary to wait and evaluate, ”said Franco.