Why Australian COVID-19 vaccine caused HIV positive?

Why Australian COVID-19 vaccine caused HIV positive? At the end of 2020, people have already seen the hope of curbing the new coronavirus pneumonia: BioNTech and Pfizer’s mRNA vaccines have been approved in the United States, Canada, and the United Kingdom, and Moderna’s mRNA vaccines have won the FDA Emergency use authorization, China began to vaccinate key populations…

But a strange news appeared from Australia. Recently, a candidate COVID-19 vaccine candidate in Australia caused HIV-positive subjects in a phase I clinical trial. The government urgently halted the trial of the vaccine and cancelled the order for 51 million doses of the vaccine [1].

Why is the vaccine in Australia like this? Who is leading this research?

$10 million research project

The “seed” that caused the subject to become HIV-positive was named v451, which was jointly developed by The University of Queensland and CSL, a well-known Australian biotechnology company.

In an announcement on June 5, the University of Queensland disclosed details of its cooperation with CSL: The technology for developing vaccines was developed by Professor Paul Young, Associate Professor Keith Chapel and Dr. Dan Watson from the University of Queensland. Development; in clinical trials, the proprietary adjuvant MF59 manufactured by Seqirus, a vaccine company under CSL, will be used [2].

Adjuvants refer to those auxiliary substances that can be injected into the body together with the antigen or can enhance the body’s immune response to the antigen or change the type of immune response. The immune response caused by the recombinant protein vaccine in the human body is not strong enough, so it is necessary to introduce an adjuvant to enhance the effect of the vaccine.

If the clinical trial is successful, the vaccine will be in place in 2021, and mass production will first be carried out at the CSL biotechnology manufacturing plant in Melbourne. CSL will also work hard to find other subcontracted manufacturers worldwide to increase production and expand the use of areas [2].

What is the sacred part of CSL, which can produce immune adjuvants and energy production and distribution, and provide one-stop service for the University of Queensland?

The history of CSL can be traced back to one hundred years ago. In 1916, the predecessor of CSL, the Federal Serological Laboratory
(The Commonwealth Serum Laboratories) was established during the First World War. Since then, the Federal Serological Laboratory has provided Australians with insulin, penicillin, and vaccines against influenza, polio and other infectious diseases [3]. In 1994, the former federal CSL was privatized, renamed CSL Limited, and listed on the Australian Securities Exchange (ASX) in June of that year.

Entering the new millennium, CSL became the incarnation of the acquisition of Crazy Demons, and through continuous expansion, it established its own advantages in blood products and flu vaccines.

CLS has established operation centers in 35 countries and regions around the world, with more than 1,700 R&D personnel. CSL also plans to further expand its market in immunology, neurology, blood products, respiratory diseases and other fields [11]. In 2019, CSL’s total revenue scale ranked 25th among the world’s pharmaceutical companies[12]. The 2019 annual report shows that CSL’s total revenue in 2019 reached US$8.539 billion and net profit reached US$1.919 billion. At present, the total market value of CSL is around US$130 billion.

Back to the COVID-19 vaccine research and development of CSL and the University of Queensland. After the announcement of the cooperation, clinical trials of the vaccine are progressing smoothly.

• July 13, v451 received the first injection [13].
• September 7, CSL and the Australian government signed a supply agreement for 51 million doses of the University of Queensland vaccine [14].
• September 26, the team at the University of Queensland announced that the combination of its vaccine and Seqirus (a vaccine company under CSL) MF59 adjuvant triggered a strong immune response in mouse experiments.

The Minister of Innovation of Queensland State stated that this is a major milestone in Queensland’s vaccine research and development. It is worthwhile for the government to provide US$10 million in funding for this project [15].

But the bubble finally broke in December-the vaccine subjects tested positive for HIV, and the Australian government announced the cancellation of the contract with CSL.

How did the COVID vaccine infect the vaccinators with HIV? This starts with the technical route chosen by the University of Queensland.

Use wonderful materials to make outstanding products

There are multiple technical routes for the development of the COVID-19 vaccine. What the University of Queensland’s laboratory is doing is the development of a recombinant protein COVID-19 vaccine. Here, we need to briefly understand the development principles of recombinant protein vaccines.

Recombinant protein vaccine means that the fusion protein, the key protein used by the virus to invade cells, is separately extracted and handed over to the immune system for recognition, thereby producing targeted antibodies.

If the human body is compared to a city, then the fusion protein is the “siege ladder” used by the COVID-19 virus to break through the city wall. The recombinant protein vaccine means that the scientists hand the samples of this “siege ladder” to the immune system for analysis and let it generate corresponding antibodies, which is equivalent to training “soldiers” in advance to dismantle the “siege ladder”.

The principle does not sound complicated, but people have encountered difficulties in the actual operation.

Once the virus fusion protein is extracted, its protein structure will change. The structure of the protein has changed, and the effectiveness of antibodies produced against the protein at this time is greatly reduced. Therefore, keeping the fusion protein extracted from the virus stable has become a thorny problem.

Over the years, researchers have developed some methods to stabilize fusion proteins. But these methods without exception are relatively complicated and immature, and cannot be applied on a large scale. In this situation, researchers at the University of Queensland have developed “molecular tweezers technology”:

There are many types of viruses. The fusion protein fragments of some viruses can autonomously generate extremely stable structures, and the fusion proteins possessed by different viruses are similar. Therefore, building a stable fusion protein fragment into other fusion proteins may be able to keep the fusion protein extracted from the new coronavirus stable (equivalent to clamping the fusion protein with a pair of tongs). Vividly called “molecular tweezers.”

 
Fusion protein stabilized by molecular tweezers Source: University of Queensland official website [16]

Researchers at the University of Queensland found that a part of the HIV virus fusion protein gp41 can generate a stable helical structure, which is suitable as a “molecular clamp” to fix the fusion protein of the new coronavirus [17].

But what is surprising is that the immune system reacts to the two proteins at the same time and produces two antibodies: the new coronavirus antibody and the HIV virus antibody.

CSL issued a statement on December 11, stating that the subject had been fully informed of this situation before the vaccination, and subsequent tests confirmed that the subject was not really infected with the HIV virus. In other words, subjects vaccinated with v451 vaccine have false positives for HIV.

Interestingly, CSL also claimed somewhat unconvincingly that both CSL and the University of Queensland believe that healthcare institutions need to make changes to the accepted HIV testing methods [18].

However, the results of such clinical trials are doomed to fail to be recognized by the regulatory authorities and medical ethics. CSL and the Australian government have reached an agreement not to conduct follow-up clinical trials of the vaccine.

A wave under the tide of vaccine development

According to the statistics of DATAMUSE, the husk data news project, more than 100 countries and regions around the world have carried out the research and development of 237 COVID-19 vaccines [19]. The news that the University of Queensland and CSL’s vaccine research and development ceased did not cause much disturbance. After all, there are too many new coronavirus vaccines currently under development. This failed vaccine is just a tiny wave in this tide.

However, the magnifying lamp team further statistics found that nearly 1/3 of the vaccine research and development projects have various universities and research institutes.

In addition to the collaboration between the University of Queensland and CSL to develop a recombinant protein COVID-19 vaccine, the University of Oxford and AstraZeneca are cooperating to develop a recombinant adenovirus vector vaccine, Flinders University and Vaxine Pty are jointly developing a recombinant protein COVID-19 vaccine, and Tongji University is also Develop nucleic acid vaccines together with China CDC and Sri Lanka…

Not only the laboratories in the ivory tower, some small biological companies have also chosen to rely on big trees to jointly develop vaccines with vaccine giants. For example, BioNTech chose to cooperate with Pfizer, and the vaccine has already been vaccinated in the UK and the US.

The reasons behind scientific research institutes and small companies choosing to cooperate with vaccine giants are similar.

Although these institutions may have more cutting-edge technical concepts, they lack clinical trial management experience, let alone production. They need to rely on the vast experience and resources accumulated by vaccine giants in drug registration, vaccine production, distribution and sales. Therefore, it is natural for the two to jointly develop a COVID-19 vaccine [20].

Such cooperation is not without problems. There is still a long distance from the laboratory to the production workshop of the pharmaceutical factory. The more partners there are, the more difficult it is to collaborate. Any delay in any link of any party may cause the advent of the vaccine to be further delayed.

The failure of the University of Queensland and CSL to jointly develop vaccines also shows to some extent that the cooperation between the two parties lacks sufficient communication. Since scientists have long known that vaccines may make subjects detect HIV-positive, why do they have to vaccinate with a big fanfare in the first place?

The zoom lamp team also pointed out in an article in November that the reason why the research and development of the recombinant adenovirus vaccine launched by the Chinese Academy of Military Sciences and Tianjin Cansino has not progressed smoothly. It was because of Cansino. There is a problem with the production capacity [21].

At the end

For scientific research institutions and pharmaceutical companies, the COVID-19 epidemic is an opportunity to some extent.

The molecular tweezers technology of the University of Queensland and Moderna’s mRNA vaccine preparation technology are the first clinical trials applied during the COVID-19 epidemic. Whether it is failure or success, the COVID-19 epidemic has actually accelerated the transformation of a number of cutting-edge biomedical technologies.

The COVID-19 epidemic will continue, and those failed studies and terminated studies have witnessed humanity’s efforts to overcome this unprecedented epidemic. Thanks to these efforts, it seems that mankind can be farther away from the COVID-19 epidemic in 2021.

As an Australian biotech giant, he will not go home empty-handed.

After announcing the cancellation of the vaccine order between the University of Queensland and CSL, the Australian government ordered 20 million doses of AstraZeneca vaccine and 11 million doses of Novavax vaccine as alternatives [22]. The 20 million doses of vaccine from AstraZeneca will still be manufactured by CSL [23].

“From the first day of the disease outbreak, all these scientists began to work feverishly in the laboratory, and none of them stopped. In the desperate situation of desperation-this is the most desperate situation they have ever experienced. Most of them lower the standard of accepting evidence and treat it positively with hope.[24]”

The well-known American writer John Barry described scientists in the 1918 Spanish flu in this way in “The Great Influenza”. Today, scientists are back on the road following the rhythm of history

(source:yaochuanke, reference only)

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