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

Author . . Baiziwan Wu Yanzu September 8 (local time) reported that AstraZeneca has taken the initiative to suspend a Phase III clinical trial on the new crown vaccine AZD1222 at dozens of clinical trial centers in the United States due to a suspected serious adverse reaction in a clinical trial participant 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 affected by this incident, 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 to be 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 source of the information 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 (Chart 2).
Chart 2. STAT staff revealed that they had received a statement about AstraZeneta from Twitter, China Health Industrial Capital Research Centre: "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 committee to review safety data" AstraZeneta is not uncommon, as the statement said, but AstraZenecon's clinical trial is not unusual.
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: World Health Organization, China Health Industry Capital Research Center AstraZenecom began 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.
the suspension of ongoing clinical studies, which usually involves a moratorium on the recruitment of new participants and a moratorium on the dosing of participants, unless the drug is continued for the safety of the participants.
Chart 4. Clinical Trial Profile of the New Crown Vaccine AZD1222 Source: AstraZenecon 2020H1 Clinical Results, China Health Industrial Capital Research Center, September 9th (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, AZD1222, 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, there is a need 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 a realistic evidence of adherence to these principles, even if it is a single incident at a pilot centre assessed by the Independent Expert's Committee.
AstraZeneta, under the guidance of this committee, will determine when the trial will resume 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.
after inoculation, 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 vectors have not yet been used for approved vaccines, but have been tested in experimental vaccines against other viruses, including Ebola, and can be safely used in children, the elderly and people with diabetes histories.
Chart 5. Oxford University's New Crown Vaccine Mechanism Signals Source: A Phase I/II Clinical Study on AZD1222 (NCT04324606) by Oxford University, China Health Industry Capital Research Centre, July 2020, 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.
Asperger's official statement on the 9th suggested that one of the market's concerns now is how long the test suspension will last and whether it will seriously affect research and development progress, leading to delays in the launch of products and 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 the Phase III trial of AstraZeneta vaccine has affected multiple interests, both capital and politics, leading to global attention.