Published 19:17 IST, September 10th 2020
COVID-19 vaccine: AstraZeneca CEO says 2020 approval 'on cards' despite trial pause
CEO said in live-streamed address that while it is unclear how long COVID-19 trial will be paused in response to adverse illness, 2020 approval was on cards.
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After AstraZeneca paused its COVID-19 vaccine candidate over the “potentially unexplained” illness of a UK volunteer, the company has now said that it aims to speed the manufacture of the vaccine and make it available as early as the 2020 year-end. AstraZeneca’s chief executive Pascal Soriot held a live-streamed address with local UK health news outlet Tortoise, saying, that the firm still aims to have a vaccine by the end of this year, or early next year. The CEO said in a virtual live-streamed address that while it is unclear how long the trial will be paused in response to a recent adverse illness, 2020 approval was still “on the cards”.
This morning at the #TortoiseG7bn Summit, Pascal Soriot, @AstraZeneca's CEO: https://t.co/pfA9vvoJnD pic.twitter.com/Q4YL5YeQuj
— tortoise (@tortoise) September 10, 2020
AstraZeneca's potential vaccine candidate was in late-stage Phase 3 human trials. The company enrolled over 30,000 volunteers, including in Brazil and South America but the illness from its vaccine AZD1222 was reported in a UK participant, the pharmaceutical agency revealed in a statement. The pause in vaccine and its adverse impact was first reported by the health news site STAT, and the National Foundation For Infectious Diseases, UK shared about the implication of pause on other vaccines.
“This is 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 firm said in a press release.
The company added, “In large clinical trials, illnesses will happen by chance and must be independently reviewed.”
How does @AstraZeneca trial pause affect other #COVID-19 #vaccines? Analysts weigh in via @FiercePharma https://t.co/O9gw6G291H pic.twitter.com/XIdeHnjtWA
— NFID (@NFIDvaccines) September 10, 2020
Director of UK scientific research charity the Wellcome Trust, Jeremy Farrar, said in an address on a radio interview that there were often pauses in vaccine trials, adding, that it indicated the importance of conducting vaccine trials properly. He said that the pause showed that the company was into a rush to make a vaccine but a clinically safe vaccine with independent oversight and the involvement of the regulators and experts. In the end, the vaccine has to be safe and of course effective for absolute public trust, he said.
AstraZeneca’s Chief Executive Officer, Pascal Soriot, said that the vaccine’s temporary pause “is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts”.
'Transverse myelitis' speculated
Meanwhile, the firm AstraZeneca has not revealed the nature of the adverse reaction and its cause. This, in turn, has led to public angst as some doctors in the medical fraternity speculated that the woman administered with the vaccine showed transverse myelitis while others speculated the neurological or spinal cord problems. According to UK media reports, AstraZeneca could resume dosing subjects early next week, however, the timings were outside the company’s decision as the experts needed to review the case to ascertain if the vaccine is implicated.
“We don’t know if it’s transverse myelitis. We don’t know what the final diagnosis is,” the CEO said at the live-streamed press conference. The company is expected to make a full evaluation of its AZD1222 vaccine as even a small risk of transverse myelitis could pose a problem, the CEO indicated.
.@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
19:18 IST, September 10th 2020