AstraZeneca Covid-19 vaccine study put on hold

[sri_india]

 

 

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K. 

[sri_india]

large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

 

Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold.

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

[sri_india]

Deeni meedha chala hopes undeee

[Pitta]

[RunRaajaRun123]

1 minute ago, sri_india said:

Deeni meedha chala hopes undeee

Hold pettaru antey chala severe reaction ayyi undali

[Picheshwar]

2 minutes ago, sri_india said:

Deeni meedha chala hopes undeee

[sri_india]

Just now, RunRaajaRun123 said:

Hold pettaru antey chala severe reaction ayyi undali

@TRUMP emo Oct kalla vaccine annadu .... but situation chusthy different gaa undi .... ippudu USA companies nundi emi news vosthadoo 

[RunRaajaRun123]

Just now, sri_india said:

@TRUMP emo Oct kalla vaccine annadu .... but situation chusthy different gaa undi .... ippudu USA companies nundi emi news vosthadoo 

Who ever take the vaccine in first couple of months will be Human Guinea Pigs, people will wait for few months before taking the shot.

[sri_india]

1 minute ago, RunRaajaRun123 said:

Who ever take the vaccine in first couple of months will be Human Guinea Pigs, people will wait for few months before taking the shot.

neenu trial ki register ayya through kaiser 

[Spartan]

Assam.

[reality]

Trump ga adhi nora mora arey

[Spartan]

3 minutes ago, sri_india said:

neenu trial ki register ayya through kaiser 

how to register @sri_india

[sri_india]

Just now, Spartan said:

how to register @sri_india

Kaiser vadu email chesadu bro ,  final gaa ikkada register kavali https://www.covidvaccinestudy.com/

 

 

[sri_india]

now this is the only option ani @TRUMP chepadu 

 

[snoww]

Mana Indian vaccines updates enti