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Many experts talk about the suspension of the new crown vaccine: no similar problem was found in China

via:CnBeta     time:2020/9/13 11:06:18     readed:961

Several academicians and experts expressed their views on the suspension of clinical trials of the new crown vaccine.AstraZeneca, a leading multinational drug company, took the initiative on September 8 to suspend its new crown vaccine clinical trial with Oxford University because a British volunteer was found to have unexplained diseases. According to the latest news on the evening of September 12, the Oxford vaccine team said that the previously suspended independent review process of clinical trials of the new crown vaccine had been completed and that the trial would be restarted in the UK, as recommended by the Independent Safety Review Commission and the MHRA of British regulators.

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The trial has begun again, but discussions about the suspension of phase three clinical phases have not stopped. On September 12, the first Dawan vaccine summit on the theme of "Vaccine Innovation and Public Health" was held in Shenzhen. At a one-day conference, several academicians and experts expressed their views on the suspension of clinical trials.

No Oxford-like vaccine problem found in China

Li Yingli, chief reviewer of the Department of Biological products Clinical Department of the Drug Review Center of the State Drug Administration, said in an interview with the news that the Drug Review Center asked the new crown vaccine R & D enterprises to report daily safety. At present, China's vaccine research has not found similar problems as Oxford vaccine.

Regarding another much-watched vaccine ADE( the antibody-dependent enhancement effect, the phenomenon that the virus increases the ability of the antibody to infect host cells for some reason), Li Yingli said that the vaccine currently under study has not found anything ADE ," if it happens, stop ."

Safety is a top priority in clinical trial design, especially for new vaccines, such as nucleic acid vaccines and sentinel subjects.

She also mentioned that in the later confirmatory clinical trial phase, the design of immune persistence and protective persistence should also be considered ," we hope to get data on one year persistence ".

Professor Li Yingli told the news that it was not possible to determine the immune persistence of the vaccine, but from the point of view of the drug review department, he hoped that the immune durability of the new crown vaccine would reach one year.

When the domestic new crown vaccine was approved, Li Yingli did not directly reply to the news, but she said she hoped to be approved as soon as possible.

Patients in the Oxford vaccine trial are only individual cases and need further evaluation

The volunteer who led to the global suspension of the third phase of the AstraZeneca vaccine trial was a British woman with neurological symptoms consistent with a rare and severe myelitis —— transverse myelitis, AstraZeneca CEO Pascal Soriot told a private conference call with investors on Wednesday morning.

In an interview with the chinese academy of sciences academician and director of the institute of immunology at tsinghua university, dong chen said :" this is not a very good understanding of the matter from immunology. It's just a case. It needs further assessment of what's going on and why there's strange reactions ."

At the vaccine summit, many experts also expressed their views on the suspension.

Scene Map of the First Bay Area Vaccine Summit

On the morning of September 12 morning of September 12, Gao Fu, a member of the Chinese Academy of Sciences and director of the Chinese CDC, referred to the suspension of clinical trials of the Oxford University-Aslicon New Crown vaccine, which he stressed was only a case in point.

On the agenda on the afternoon of September 12, Zhu Feng, chief physician of the Jiangsu CDC, mentioned the suspension in his speech on the theme of "promoting vaccine evaluation innovation and helping disease prevention and control ". According to his personal understanding, it may be the chimpanzee carrier, and the dose may also be related.

During his presentation, Zhu Fengcai summarized the possible reasons for the failure of four vaccine clinical trials. One was the factors of the vaccine itself, including whether the vaccine strain matched the epidemic strain, the choice of antigen, dosage form, dosage and needle number; the other was the factors between vaccine and target population, such as ADE phenomenon; third, the influence of population infection and infection characteristics, such as immune escape; fourth, the methods and indicators of preclinical and clinical evaluation, such as animal models and suitability.

Vaccine safety is a top priority

Since the new crown epidemic, because of the lack of special treatment drugs, preventive vaccines are expected, the World Health Organization official data show that there are more than 30 candidates for the new crown vaccine clinical trials, including the third phase of clinical vaccines.

At home, Chinese medicine group Chinese biology, Fosun medicine and other aspects of the production, pricing, logistics and other aspects of the new crown vaccine began to cooperate layout, the commercialization of the new crown vaccine seems to have been put on the agenda, but it can not be ignored, as a new vaccine, to ensure safety and effectiveness is the most basic.

At the vaccine conference, the Dawan vaccine summit expert group issued a "accelerated vaccine innovation to enhance the ability to prevent and control infectious diseases ," which said :" to ensure safety and evidence to promote a more reasonable range of vaccine use, so that all suitable people, including people in special health conditions, can enjoy vaccine protection fairly and maximize vaccine value ."

The oxford vaccine team, announcing the resumption of clinical trials, also stressed that "we are committed to ensuring the safety of participants and the highest standards of conduct in our study and will continue to monitor safety closely ."

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