AstraZeneca, in partnership with the University of Oxford, has halted its Phase 3 trials of a vaccine after a “standard review process” found a “potentially unexplained illness in one of the trials,” according to a statement obtained by the outlet on September 8.
The participant is located in the United Kingdom, STAT indicated.
AstraZeneca initiated its Phase 3 trial in the United States on August 31, according to an online news release.
— Rebecca Robbins (@RebeccaDRobbins) September 8, 2020
Although AstraZeneca did not disclose any details surrounding the participant or their adverse reaction, it indicated that it is “working to expedite the review of the single event to minimize any potential impact on the trial timeline,” according to STAT News.
It also emphasized that the pause was initiated by the company, the outlet continued.
STAT reported that the participant is expected to recover, citing “an individual familiar with the matter.”
While a total of nine potential vaccines are in Phase 3 Trials, AstraZeneca’s is the first to one to have been put on pause, the outlet added.
Here’s what you need to know about AstraZeneca’s potential vaccine:
Last Month, AstraZeneca Began Recruiting 30,000 People in the U.S.
At the heart of our core values is to “follow the science” and we are committed to adhere to the highest scientific and clinical standards as we research a potential #COVID19 vaccine. @Sanofi will you join us as #WeStandWithScience? https://t.co/uEaOpNBba8 pic.twitter.com/WgJestzs3D
— AstraZeneca (@AstraZeneca) September 8, 2020
According to The Los Angeles Times, AstraZeneca began recruiting in 30,000 Americans last month “for its largest study of the vaccine.”
AstraZeneca announced in an August 31 news release that it was aiming to enroll up to 30,000 adults over 18 “to assess safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19.”
AstraZeneca Vice President Mene Pangalos said in the online release:
“We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
The release indicated that participants will randomly receive either two doses of the vaccine or two doses of a saline control, four weeks apart. The trial will then determine the efficacy of the vaccine, as well as its safety, the release continued.
STAT added that the U.S. trial is being dispersed throughout 62 sites across the nation.
The U.S. trial is also being funded by the Biomedical Advanced Development Authority and the National Institute of Allergy and Infectious Diseases, the company announced online.
Many Have Taken to Social Media to Demand More Answers
Since news of the hold broke on September 8, many have taken to social media to demand more answers surrounding the pause and adverse reaction.
As of early Wednesday morning, AstraZeneca was trending on Twitter with many calling on the company to dispel certain rumors circulating online.
Below are some of the responses:
.@AstraZeneca needs to IMMEDIATELY DISCLOSE exactly what is going on with their coronavirus vaccine trial. We're getting word that the "unexpected adverse reaction in a participant" is a female hospitalized with transverse myelitis that includes loss of use of her hands & feet.
— Toby Rogers PhD, MPP (@uTobian) September 9, 2020
Astrazeneca pauses vaccine trial after unexplained illness in one of their volunteers. The vaccine was believed to be the safest.
This race between the east & the West to be the first to produce a vaccine will end in tears 🙆
— Gerald™ (@CappyGerald) September 9, 2020
Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had a suspected adverse reaction in the UK. The outcome of vaccine trials is being closely watched around the world. https://t.co/zIkh6lI16y pic.twitter.com/pQIX4XohFW
— Health Business (@HealthBizKE) September 9, 2020
How about report all adverse reactions to vaccines?
'Phase 3 trials for the coronavirus vaccine being developed by Oxford University and AstraZeneca have been placed on a hold after a 'serious adverse event' was reported in a participant in the UK.'https://t.co/UIj1XeRShR
— Charlotte Gracias (@Charlotte3003G) September 9, 2020