Oxford vaccine emergency suspension
Today, bad news came from the vaccine.
The Oxford University vaccine locked by the Australian government has currently suspended research and development trials. The pharmaceutical company AstraZeneca believes that the trial may cause unpredictable side effects on subjects.
The vaccine jointly developed by Oxford University and AstraZeneca (hereinafter referred to as Oxford vaccine) is considered by the WHO as one of the most promising vaccines in the world, and it is also one of the nine vaccines currently in phase III trials worldwide.
At present, the vaccine has entered the final stage of clinical trials-a large-scale clinical trial involving XNUMX people participated.
The Oxford University vaccine research team began working on the development of a new crown vaccine in January 2020, and launched a clinical phase I/II trial in the UK in late April. The performance has been good during clinical phase I/II trials.
The Morrison government has also selected this one among many vaccines around the world and has signed a purchase agreement for Australians. It was originally planned to be provided to Australians for free early next year.
However, it seems that this plan cannot be completed on time.
According to the "Daily Mail", in the Phase III trial of this Oxford vaccine, one subject experienced "serious side effects."
Serious side effects (serious adverse reactions) refer to conditions that require hospitalization, life-threatening, or death, and these conditions are suspected to be related to the vaccine.
The specific side effects have not yet been disclosed. But relevant people told the media that the subject who had side effects is hopeful of recovery.
In fact, the suspension of vaccine trials has occurred from time to time, but this vaccine is considered by many countries and organizations to be the most potential vaccine, so the news is unavoidably disappointing.
Australian Prime Minister Morrison just announced on Monday that the federal government has spent 17 billion Australian dollars to lock in two vaccine manufacturing agreements (the Oxford vaccine and the vaccine developed by the University of Queensland in Australia).
It can be seen that Australia originally had great expectations for this vaccine.
Image source: ABC NEWS
AstraZeneca's stock price fell by 8% within a few hours after the announcement.
University of Queensland Vaccine
The other vaccine that Morrison locked in was developed by a team at the University of Queensland, and this vaccine is in the first phase of clinical trials.
Although not as fast as the Oxford University vaccine, it is still stable so far.
Volunteers in the experimental group will receive two doses of vaccine every four weeks, and the control group will receive a placebo. Subsequently, the researchers will conduct blood tests on the volunteers and follow-up observations for up to 12 months.
Professor Paul Young, co-leader of the vaccine project at the University of Queensland, said that the first human trial was to evaluate the safety of the vaccine and the immune response generated by the vaccine in a group of healthy volunteers.
So far, early preclinical tests have shown that the vaccine has the ability to produce high levels of antibodies, and these antibodies can neutralize the new coronavirus.
Professor Young said: "We expect to get preliminary results in about three months. If everything goes well, we can enter the next stage of vaccine development as soon as possible. This will be a larger-scale trial for people of different age groups to ensure The vaccine is fully effective."
9 major pharmaceutical companies issued rare statements
Just a few hours before the suspension of the AstraZeneca Oxford vaccine was announced, a rare event happened in the medical industry.
Pharmaceutical companies including AstraZeneca, Johnson & Johnson, Pfizer, GlaxoSmithKline, Moderna, Novavax and Sanofi made a "historical commitment" in a joint statement.
(9 companies participating in the statement)
These nine companies jointly swear to maintain the integrity of the scientific process in the process of reporting and approving the first new crown vaccine to global regulatory agencies.
The joint declaration of several major companies is an unusual move.
And behind this may be related to the "politicization of vaccines."
Politicians around the world are discussing what actions need to be taken to quickly curb the spread of this deadly disease and promote global business development and economic recovery.
The vaccine has become a "life-saving straw." Including Australia, when to resume international travel depends largely on vaccines.
But some countries have taken it too quickly.
The head of the US Federal Food and Drug Administration (FDA) said last month that as long as officials are convinced that the benefits of the new crown pneumonia vaccine outweigh the disadvantages, the normal approval process can be bypassed.
This is a dangerous signal and also triggered a warning from the World Health Organization.
Researchers around the world have yet to come up with large-scale trial data to show the actual infection of participants. Russia approved a vaccine last month without sufficient trials.
Ugur Sahin, one of the signatories of the joint statement and the CEO of Pfizer's partner BioNTech in Germany, said: "We want everyone to know that under the current circumstances, we are not willing to compromise on safety and effectiveness."
He added: "There are still many people who are skeptical and think that some development steps can be omitted."
For example, the Trump administration hopes to speed up the process to introduce a vaccine before the November election, which has also caused controversy.
According to this statement, the nine companies promised to comply with the established guidance from professional regulatory agencies such as the FDA.
According to the statement, apart from other regulatory obstacles, the approval of a vaccine must also be based on large-scale, diverse clinical trials, some of which will be injected with substitutes, and participants in the trial must know which group they belong to.
Ugur Sahin added that there must be a 95% statistical certainty, which is higher in some cases, that is, a positive interpretation of the efficacy is not just from random changes, but reflects the basic working mechanism of the compound.
Polls show that fierce competition in vaccine research and development has intensified people's concerns about the safety of vaccination.
We all want to hear the good news as soon as possible, but sometimes we can’t reach it quickly.
Vaccines should not be a weapon of politicians—it saves lives, not power.