A spokesman for the Kovid-19 vaccine race, AstraZeneca, said in a statement that the company’s “standard review process prevented vaccination to review safety data.”
It was not immediately clear who held the trial, although it is possible that it was voluntarily placed by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it occurred was also not immediately known, although the participant is expected to recover, according to a person familiar with the case.
The spokeswoman described the stagnation as “a routine action that occurs whenever a test has a potentially unexplained disease, while examining it, while ensuring that we test the integrity of the test Maintain. ” The spokesperson also said that the company is “working to expedite the review of the single incident to minimize any potential impact on the trial timeline.”
A person familiar with the development said the researchers said the test was excluded from “an abundance of caution”. Another person familiar with the matter, who also spoke on condition of anonymity, said the discovery is also having an impact on other AstraZeneca vaccine trials – as well as clinical trials being carried out by other vaccine manufacturers. Too.
Clinical holds are not uncommon, and it is unclear how long AstraZeneca can last. But the progress of the company’s litigation – and all Kovid-19 vaccines in development – is being closely watched given the need for new methods to curb the global epidemic. There are currently Nine vaccine candidates in Phase 3 trials. AstraZeneca’s first phase 3 is the Kovid-19 vaccine trial known.
Researchers running other tests are now combing through reviewed databases and looking for similar cases of adverse reactions A so-called Data and Security Monitoring Board, another person said.
AstraZeneca only began testing its Phase 3 in the US in late August. According to a government registry, the US is currently undergoing trials at 62 sites across the country, although some have not yet begun enrollment of participants. Phase 2/3 trials were first undertaken in the UK, Brazil and South Africa.
There are many different reactions that may qualify as suspected severe adverse reactions, symptoms that require hospitalization, life-threatening illness, and even death. It was also not immediately clear which clinical trial caused the adverse reaction, although there is an obvious possibility Phase 2/3 trial in progress Uk
While it is still unclear how severe and rare an adverse event can be, this finding may affect how quickly efficacy data will be available from the UK trial. Those data are To seek an emergency use authority for the vaccine from the US Food and Drug Administration is considered an integral part of any bid – and jeopardizes President Trump’s efforts to fast-track a vaccine before the November election .
One step 1/2 Study published in July It was reported that 60% of the 1,000 participants experienced side effects of the vaccine. All side effects, including fever, headache, muscle pain, and injection site reactions, were considered mild or moderate. All side effects reported during the study also decreased.
The vaccine – known as AZD1222 – uses an adenovirus that carries the gene for one of the proteins in SARS-Cov-2, the virus that causes Kovid-19. Adenoviruses are designed to induce the immune system to produce a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus.
Phase 3 trials in the US aim to enroll around 30,000 participants at 80 sites in the country Released last week From the National Institutes of Health.
It was not immediately clear what steps were being taken at study sites across the US in response to the catch. Clinical studies in ongoing studies often involve recruiting new participants and dosing existing ones, unless continuing dosing is deemed to be in the interest of participant safety.
In AstraZeneca’s statement, the company’s spokesperson said that “large trials would coincidentally have the disease, but it should be reviewed independently to be carefully examined.” The spokesperson also stated that the company is “committed to the safety of our participants and the highest standards of conduct in our trials.”