AstraZeneca’s building in Luton, Britain.
Tim Ireland | Xinhua News Agency | Getty Images
Phase three trials for AstraZeneca’s coronavirus vaccine have resumed in the U.K. after they were halted earlier this week over safety concerns, raising hope that one of the leading candidates in the global race to develop an injection which can stem the pandemic is back on track.
AstraZeneca said it received confirmation from the United Kingdom’s Medicines Health Regulatory Authority that it was safe to resume clinical trials. The company declined to disclose medical information about the pause of the trial, but indicated earlier this week that a potentially unexplained illness was under investigation.
The company said “the standard review process triggered a voluntary pause” to all global trials on Sept. 6 so that independent committees and internal regulators could review the safety data. While trials can now resume in the U.K., the status of trials elsewhere remains unclear.
“The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” AstraZeneca said in a statement.
The University of Oxford, which developed the vaccine in partnership with AstraZeneca, said Saturday that some 18,000 people have so far received the vaccination in trials.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” Oxford said in a statement.
STAT News reported earlier this week that AstraZeneca’s CEO Pascal Soriot said during a private conference call that the “potentially unexplained illness” occurred in a woman in the U.K. who displayed neurological symptoms consistent with a spinal inflammatory disorder called transverse myelitis. The call was set up by investment bank J.P. Morgan, STAT reported.
On the same call, Soriot also confirmed that AstraZeneca’s clinical trials had been halted once before in July after a participant experienced neurological symptoms, but the illness was found to be unrelated to the experimental vaccine.
AstraZeneca’s potential coronavirus vaccine, called AZD1222, is among the frontrunners in the race toward a safe and effective vaccine that could put a dent in the global pandemic. The company launched its late-stage trials at the end of August. It’s one of at least three vaccine candidates, along with Pfizer‘s and Moderna‘s, in late-stage trials.
Officials from the World Health Organization have previous hailed AstraZeneca’s vaccine candidate as one of the most promising currently in development. On Thursday, WHO Chief Scientist Dr. Soumya Swaminathan said there’s no need to be “overly discouraged” by the news of the pause of the trial, adding that “these things happen.”
“I think this is a good … perhaps a wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those,” she said.
The United States has invested more than $10 billion in six efforts to bring a coronavirus vaccine to market. On May 21, the U.S. announced it would invest $1.2 billion in AstraZeneca’s effort in exchange for at least 300 million doses if the candidate proves safe and effective enough.
U.S. to test run Covid vaccine distribution networks as it awaits FDA clearance in ‘just a few weeks’
Biden team receives Operation Warp Speed briefing after weeks of delays
WASHINGTON — President-elect Joe Biden‘s transition team has been briefed on America’s response to the Covid-19 pandemic, Health and Human Services Secretary Alex Azar told reporters Tuesday.
Azar said that on Monday evening Rear Adm. Erica Schwartz, the official leading the transition planning effort, briefed the Biden team on Operation Warp Speed, which aims to get a coronavirus vaccine to the public in record time.
“We are immediately getting them all of the pre-prepared transition briefing materials,” Azar said.
“We will ensure coordinated briefings with them to ensure they’re getting whatever information that they feel they need,” Azar said, adding that the “transition planning and execution will be professional, cooperative and collaborative.”
The Biden transition team did not immediately respond to CNBC’s request for comment.
The move ends weeks of delays in the formal handover of power from President Donald Trump to the Biden administration in the wake of the U.S. presidential election. Trump has not conceded the election to Biden.
The U.S. is grappling with a dramatic resurgence of coronavirus cases as major holidays approach. Thus far, the nation has recorded at least 257,991 Covid-19 related deaths, according to data compiled by Johns Hopkins University.
The Trump administration has been criticized as not doing enough to control the spread of the deadly disease.
Last week, Pfizer and its partner BioNTech applied for an emergency use authorization from the Food and Drug Administration for their Covid-19 vaccine. The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been scheduled for early December.
Pfizer announced on July 22 that the U.S. agreed to buy 100 million doses of its vaccine for up to $1.95 billion. The agreement, which is part of Operation Warp Speed, allows the U.S. to acquire an additional 500 million vaccine doses.