The safety of key new crown vaccine projects in the UK remains the focus
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Last Update: 2020-12-03
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Source: Internet
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Author: User
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Xinhua Zhang Jiawei
The candidate new crown vaccine developed by the Oxford University team is the fastest-growing new crown vaccine project in the United Kingdom and a key support vaccine project for the British government. But the project's co-pilot, AstraZeneta Pharmaceuticals, has announced that it has decided to suspend vaccinations in all clinical trials and start a standard assessment process because of "suspected serious adverse reactions" to the vaccine. Will the event affect the progress of the new crown vaccine programme in the UK?new crown vaccine, called AZD1222, was developed by oxford University's Jenner Institute in collaboration with the Oxford Vaccine Group. Oxford University launched clinical trials of vaccines in late April, and has since reached an agreement with AstraZeneta to work in-depth on the global development and distribution of the vaccine candidate to ensure that the vaccine can complete phases of clinical trials and start mass production more quickly.
is the fastest-growing vaccine project in the UK. The British government has high hopes for it, not only by providing financial support, but also by making regulatory changes to make vaccine validation and approval more efficient, and the government has even booked large quantities of the vaccine in advance. Health Secretary Michael Hancock said the vaccine was "most likely" to be used in early 2021.Professor Sarah Gilbert of Oxford University, one of the lead scholars on the
project, told Xinhua a few months ago that ideally, the team would be able to get results from Phase 3 clinical trials by the autumn, but "this is the best case, very ambitious time, and there may be changes in between".Astrain said in an official statement: "As part of the ongoing randomized, controlled global trial of AstraZeneta and Oxford's new crown vaccine, we have initiated a standard assessment process and actively suspended vaccinations in all clinical trials to allow an independent
to assess safety data for a single disease event that cannot yet be explained." The incident took place in a Phase 3 clinical trial in the UK. The
also said it was "routine" to suspend trials and conduct investigations when "unseplainable illnesses" appeared in the trials.
, director of vaccine programs at the Wellcome Trust, agrees. "It's the right thing to do to suspend this trial during the investigation, which is a normal procedure that often occurs in vaccine clinical trials," he said. He added that the vaccine is a product that needs to be rigorously tested and regulated, and that "the new crown vaccine should not be an exception."
assali promised in a statement on August 31st that it would develop the AZD1222 vaccine with the highest safety standards.According to previous presentations by Oxford University, the vaccine candidate is a adenovirus vector vaccine, a more mature type of vaccine, and because of its characteristics, does not cause persistent infection in people who are vaccinated, which also gives the vaccine better safety for children, the elderly and people with other diseases themselves.
However, Gilbert has previously said: "The first problem with vaccine development is that there is currently no certified vaccine for all types of coronavirus, so researchers don't know how much immune response is needed to vaccinate people to get real protection." We won't know until clinical trials on vaccine effectiveness are complete.
The Oxford University team reported in the British medical journal The Lancet on July 20 that preliminary results were obtained in clinical trials of the new coronavirus vaccine, which induces a strong immune response from the body's immune system, showing good safety without serious side effects, and that some subjects had minor side effects after vaccination. But the vaccine's effectiveness needs to be further tested in larger clinical trials.
Before AstraZeneta announced the suspension of the candidate, the vaccine had started Phase 3 clinical trials in the United States, as well as in the United Kingdom, Brazil and South Africa, and was scheduled to start clinical trials in Japan and Russia, where up to 50,000 subjects are expected to be recruited worldwide.
, however, some experts point out that from past experience in vaccine development and use, sometimes some people may not be entirely to blame for the vaccine itself. Professor Stephen Evans, of the University of London's School of Hygiene and Tropical Medicine, gave the example of a young woman in the UK who died in 2009 after being vaccinated against HPV, which was quickly sealed, but later findings suggested that the woman's death was actually linked to a rare malignant tumour in her chest, not a vaccine.
Regarding the Oxford team's candidate for the new crown vaccine, Evans said: "It is too early to speculate on whether the vaccine caused adverse reactions in the subjects, and even if it is concluded that the event may have been caused by the vaccine, there are other factors involved, which does not necessarily mean that the vaccine is completely unavailable." "
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