Regular operation or market over-aggressive? AstraZeneia's New Crown Vaccine Phase III trial suspended full decryption.

On September 8th (local time), it was announced that AstraZeneca had voluntarily suspended a Phase III clinical trial of the new crown vaccine AZD1222 at dozens of clinical trial centres in the United States because of suspected serious adverse reactions by a participant in a clinical trial in the United Kingdom.
is the world's first suspended phase III clinical trial of the new crown vaccine.
as one of the world's leading candidates in the race for new vaccine research and development, AstraZeneca's move shook capital markets, with U.S. shares trading lower on Sept. 9.
Chart 1. Suspension of Phase III clinical trials affects AstraZeneta's U.S. stock price Source: Google, Zhongkang Industrial Capital Research Center The impact of this event, domestic vaccine companies Wantay Bio, Hailey Bio, Watson Bio, Hualan Bio and other stock prices have fallen, the most affected are Kantai Bio.
reason is that Contair Bio signed an agreement with AstraZeneta in August to obtain exclusive rights to the new crown vaccine AZD1222 in Chinese mainland and is responsible for research and development, production, supply and commercialization of the mainland market.
's share price doubled to 100 billion yuan, but on September 9th its market value evaporated by more than Rmb20bn.
was surprising at the start and end of the test suspension, the earliest source of the news was not AstraZeneca, but STAT, the US health news site.
company employee Rebecca Robbins claimed on Twitter that she received a so-called "statement from AstraZeneca" on Tuesday afternoon (September 8), the source of which was not clear (Figure 2).
Chart 2. STAT staff revealed that they had received a statement about AstraZeneta Source: Twitter, China Health Industry Capital Research Centre, statement: "As part of the ongoing global randomized, controlled trial of the New Coronavirus Vaccine in Oxford, our standard review process triggered a suspension of vaccinations to review safety data.
this is a routine operation that must be performed when a trial has a potentially unsealable disease, ensuring that we maintain the integrity of the trial when the disease is investigated.
in large trials, diseases occur occasionally, but must be carefully and independently examined.
we are accelerating the review of this single event to minimize the potential impact on the test timeline.
we are committed to the highest standards of implementation for the safety and testing of our participants.
's statement was later updated by the provider, stressing that "active suspension of vaccinations to allow an independent commission to review safety data" Is not uncommon for clinical trials to be suspended, but AstraZenecom's clinical trials are not common.
is being closely watched around the world in view of the urgent global need to contain the new crown outbreak.
there are currently nine candidate new crown vaccines in Clinical Phase III worldwide, and as a member of the first echelon of the research and development competition, any change will be even more remarkable.
(Figure 3) Chart 3. New Coronary Vaccines in Clinical Phase 3 Worldwide (2020.9.4) Source: WHO, China Health Industry Capital Research Center AstraZenecom Start randomized, double-blind, placebo-controlled, multi-center Phase III clinical trials in the United States at the end of August (Figure 4 red box) to assess the safety, effectiveness and immunogenicity of AZD1222 prevention of neocyclic pneumonia (COVID-19).
30,000 participants in 62 clinical trial centers across the United States, and some have not yet begun recruiting participants.
UK patients who have been suspended from the clinical trial are involved in Phase II/III clinical trials in the UK (figure 4 green box).
is unclear what U.S. clinical trial centers are doing to respond to the suspension.
ongoing clinical studies, usually involving suspension of recruitment of new participants and suspension of drug use to participants, will continue unless it is for the safety of the participants.
Chart 4. Clinical Trial Overview of the New Crown Vaccine AZD1222 Source: AstraZenecon 2020H1 Clinical Results, China Health Industrial Capital Research Center, September 9 (local time), by J.P. On an investor conference call organised by Morgan, AstraZeneca CEO Pascal revealed that the participant who triggered the suspension of Phase III clinical trials was a British woman with symptoms consistent with transverse spinal corditis, a rare and rare spinal disease.
the disease is manifested in limb paralysis below the level of spinal cord lesions, sensory loss and neurological dysfunction of the bladder, rectum, and plants, most of which occur after acute infection or vaccination.
, which oversees AstraZeneta's clinical trial data and safety section, confirmed that the participant was injected with the candidate new crown vaccine, AZD12222, rather than a placebo.
is not without precedent for the suspension of trials due to a single serious adverse event.
, especially in large-scale clinical trials, when there are tens of thousands of participants, some of whom are likely to get sick.
this case, it is necessary to carefully identify whether the disease is caused by a test drug or by other factors of the participants themselves.
conference call, Pascal also confirmed that other clinical trials had been suspended once in July because of neurological symptoms in the participants.
examination, the participant was diagnosed with multiple sclerosis, which is not thought to be related to the new coronary vaccine.
the afternoon of September 9 (UK Daylight Saving Time), AstraZeneca issued an official statement suspending clinical trials of the new crown vaccine AZD1222, in consistent with what was revealed on Twitter on September 8.
astrain put science, safety and social interests at the heart of its work," said Pascal Soriot, CHIEF executive of AstraZeneca.
this brief pause is practical evidence of adherence to these principles, even if it is a single incident at a pilot centre assessed only by the Independent Expert's Committee.
AstraZeneta, under the guidance of this committee, will determine when the trial will restart so that work can continue as soon as possible to make the vaccine widely, fairly and profit-free during the new crown outbreak."
AZD1222 safety new crown vaccine AZD1222 (ChAdOx1) in Clinical Phase I/II, commonly known as the "Oxford Vaccine", was co-invented by Oxford University and its spin-off company,Vaccitech.
the vaccine uses a vector of viruses that replicate defects, based on a weakened version of a common cold virus (adenovirus) that causes chimpanzee infections, to integrate genetic material that expresses the new coronavirus (SARS-CoV-2) spike protein.
, human cells express echithoprotein, inducing the production of corresponding antibodies.
when the new coronavirus infects the human body, the existing echizon protein antibodies will target the new coronavirus.
chimpanzee adenovirus vector has not yet been used for approved vaccines, but has been tested in experimental vaccines against other viruses, including Ebola, and can be used safely in children, the elderly and people with a history of diabetes.
Chart 5. Oxford University's New Coronary Vaccine Mechanism Signals Source: Oxford University, China Health Industry Capital Research Centre, July 2020, a Phase I/II Clinical Study on AZD1222 (NCT04324606) shows that about 60% of the 1,000 vaccinated participants experienced side effects.
all side effects, including fever, headache, muscle pain and injection site reactions, are considered mild or moderate.
all side effects also subsided during the study.
direct impact of the suspension of Phase III clinical trials in AZD1222 is that the release date of data for phase II/III clinical trials in the UK with severe adverse reactions (NCT04400838, figure 4 green box) will be delayed.
data are considered necessary to seek emergency approval for the vaccine from the FDA.
addition, the episode could jeopardize U.S. President Donald Trump's efforts to get a new vaccine on the market ahead of November's election.
Aspaska hinted in Anglico's official statement on the 9th, one of the market's concerns now is how long the test suspension will last, whether it will seriously affect research and development progress, resulting in a lag in product launch, affecting future markets.
concern of the U.S. market is whether serious adverse reactions that trigger the suspension of tests can be avoided in subsequent research and development.
reiterated that it is not uncommon for clinical trials to be suspended due to serious adverse events, but in this particular period of the new crown epidemic, the suspension of AstraZeneta's phase III trial of the new crown vaccine has affected multiple interests, both capital and politics, leading to global attention.
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