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Phase 3 trials for the coronavirus vaccine being developed by the University of Oxford and AstraZeneca have been suspended after a ‘serious adverse event’ was reported in a participant in the UK.
Serious adverse events are suspicious reactions to vaccines or medications that require hospitalization, are fatal or life threatening.
The exact nature of the reaction was unclear, but a person familiar with the matter told Stat News that the person is expected to recover.
Trial suspensions are not uncommon, but it is a blow to global hopes that an injection will be ready in the coming months, as the AstraZeneca injection was viewed by many, including the World Health Organization, as the leading candidate for world level.
The development of the AstraZeneca vaccine and eight others in phase 3 trials are being closely followed in hopes that they can stop the coronavirus pandemic that has killed more than 894,000 people worldwide, including nearly 190,000 Americans, and cost tens of millions their jobs.
It comes after vaccine developers, including AstraZeneca, pledged not to skimp on safety and efficacy testing, despite urgent push from US President Trump for the Food and Drug Administration (FDA ) grant emergency approval to a vaccine before the November 3 election.
Phase 3 trials for the coronavirus vaccine being developed by the University of Oxford and AstraZeneca have been suspended after a ‘serious adverse event’ was reported in a participant in the UK.
“ As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process was activated and we voluntarily stopped vaccination to allow review of safety data by an independent committee. ” an AstraZeneca spokesperson told DailyMail.com.
“This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials.
‘In large trials, diseases will happen by chance, but they need to be independently reviewed to check this carefully. We are working to expedite the single event review to minimize any potential impact on the trial schedule. We are committed to the safety of our participants and to the highest standards of conduct in our tests. ‘
AstraZeneca’s candidate vaccine, known as AZD1222, is in phase 3 trials, the final stage before safety and efficacy data can be submitted to regulators for approval, at dozens of sites in the US and Worldwide.
Trials for the AstraZeneca vaccine are underway in the US, UK, Australia, Brazil (pictured), and other nations. Phase 3 testing will now pause while reviewing security data
Together with Pfizer and Moderna, AstraZeneca and its partner at the University of Oxford hoped to find out if the vaccine worked and was safe by the end of the year.
While the trials to review safety data are not necessarily damning, the pause in the AstraZeneca trial may delay long-awaited results and the completion of one of the fastest vaccine development pathways in human history.
Market confidence in the pharmaceutical giant took a hit as soon as reports surfaced about the suspension of the trial.
Shares of AstraZeneca plummeted eight percent in after-hours trading.
President Donald Trump has hinted that he thinks a vaccine could be ready before a ‘special date’, likely the November 3 election.
The company is now in mitigation mode to try to stay as close to the test completion date as possible.
AstraZeneca is “working to expedite the review of the single event to minimize any potential impact on the trial schedule,” the spokesperson told Stat News.
While any signs that may suggest possible flaws in a leading vaccine for the disease that has killed nearly 190,000 Americans is puzzling, the decision to stop a trial for safety reasons may be reassuring for some.
Hours before the trial was temporarily halted, AstraZeneca and eight other companies working on COVID-19 vaccines signed a pledge to prioritize the safety of their vaccines over rapid development.
They promised to ‘maintain the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccine.’
The promise was made in response to growing concerns that governments would pressure companies and research institutions to rush a vaccine through trials and approval processes in an effort to bolster political capital and restore normalcy amid the pandemic.
Last week, the US Centers for Disease Control and Prevention (CDC) sent instructions to state health departments to prepare for the possible arrival of one of the two coronavirus vaccines in late October.
Later, President Trump hinted at the hopeful possibility that a vaccine could be ready before a ‘special date’, prompting speculation that he was referring to the November 3 presidential election, just days after the possible line. end of October goal at CDC. Guide.
Health officials like infectious disease expert Dr. Anthony Fauci, U.S. Surgeon General Jerome Adams, and Trump’s own vaccine czar, Dr. Moncef Slaoui, were quick to assure the American public that it was possible, but unlikely, that an injection would be ready by then, and that the FDA would pay no attention to the date, but only the data, to determine when a vaccine is ready for distribution.
However, Pfizer confirmed that it hoped to have enough test data to know if its injection was safe and effective by the end of October, and would be submitted for FDA approval “immediately” thereafter.
Most experts and observers speculate that the two unnamed shots referenced in the CDC guide were from Moderna and Pfizer, not AstraZeneca.
The suspension of the trial casts even more doubts about the possibility that the company’s vaccine will be the first list for the US market.
Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, primarily by contributing funds to private companies working on vaccines, announced that AstraZeneca would receive up to $ 1.2 billion in funding for vaccine development in May.
The United States signed an agreement with AstraZeneca for 300 million doses of its injection, if the FDA gives the green light to the vaccine as safe and effective, and had set its sights on an approval date in October, which seems increasingly unlikely. .
