An Australian vaccine that “infected” people with HIV

By the end of 2020, hopes for curbing COVID-19 were already being seen: BioNTech and Pfizer’S mRNA vaccines were approved in countries such as the US, Canada and the UK, Moderna’s mRNA vaccine received FDA emergency use authorization, and China began vaccinating key populations…

But there was a strange message on the horizon.
On December 11, local time, a new candidate for a champions league candidate vaccine in Australia in Ⅰ prompted a HIV positive subjects in clinical trials.
The government has urgently halted trials of the vaccine and cancelled orders for 51 million doses [1].

Why does this happen with Australian vaccines?
Who is leading the study?

10 million dollars. That’s it?
The ‘Miao’, named V451, was developed by The University of Queensland in collaboration with CSL, one of Australia’s leading biotechnology companies.

In a June 5 announcement, the University of Queensland detailed the details of its collaboration with CSL: The technology to develop the vaccine was developed by Professor Paul Young, Associate Professor Keith Chappell and Dr Dan Watson;
MF59, a proprietary adjuvant manufactured by CSL’s vaccine company Seqirus, will be used in the clinical trials [2].

Adjuvants are substances that, together with or pre-injected into the body, can enhance the immune response to an antigen or alter the type of immune response.
Recombinant protein vaccines do not elicit a strong immune response in humans, so adjuvants are needed to enhance the vaccine’s effectiveness.

If clinical trials are successful, the vaccine will be in place by 2021, and mass production will begin at the CSL biotech manufacturing facility in Melbourne.
CSL will also strive to find other subcontractors around the world to increase production and expand usage areas [2].

Who is CSL, which can produce both immune adjuvant and energy generation and distribution, and provide a one-stop service for the University of Queensland?

The HISTORY of CSL goes back a hundred years.
CSL’s predecessor, The Commonwealth Serum Laboratories, was founded in 1916 during World War I.
Since then, the Federal serum Laboratory has provided insulin and penicillin to Australians, as well as vaccines against influenza, polio and other infectious diseases [3].
CSL was privatised in 1994, renamed CSL Limited, and listed on the Australian Stock Exchange (ASX) in June of that year.

In the new millennium, CSL became the acquisition monster, and through continuous expansion, established its advantages in blood products and flu vaccines.

Part of the acquisition cases of CLS, which was sorted out by the headlight team [4]-[10]

CLS has operations centers in 35 countries and regions around the world, employing more than 1,700 research and development personnel.
CSL also plans to further expand its market in immunology, neurology, blood products, respiratory diseases and other fields [11].
In 2019, CSL ranks 25th among pharmaceutical companies in the world in terms of total revenue [12].
According to its 2019 annual report, CSL2019 revenue totaled $8.539 billion and net profit reached $1.919 billion.
CSL currently has a market capitalisation of about $130bn.

Back to CSL in collaboration with the University of Queensland for COVID-19 vaccine development.
Since the announcement, clinical trials of the vaccine have gone well.

The first dose of V451 was administered on 13 July [13].

On 7 September, CSL signed an agreement with the Australian government to supply 51 million doses of the University of Queensland vaccine [14].

On 26 September, the University of Queensland team announced that its vaccine, combined with MF59 adjuvant from Seqirus (a vaccine company owned by CSL), had elicited a strong immune response in mice.

The Queensland Minister of Innovation stated that this was a major milestone for vaccine development in Queensland and deserved the government’s funding of us $10 million for this project [15].

But the bubble burst in December when the Australian government announced it was cancelling its contract with CSL after vaccine subjects tested POSITIVE for HIV.

How did the COVID-19 vaccine make people infected with HIV?

It starts with the technology route chosen by the University of Queensland.

With wonderful materials, make a rare good clamp
There are several routes for the development of COVID-19 vaccines.
The lab at the University of Queensland is developing the recombinant COVID-19 vaccine.
Here, we need to briefly understand the development of recombinant protein vaccines.

Recombinant protein vaccines, in which fusion proteins, a key protein used by viruses to invade cells, are isolated and given to the immune system for recognition, create targeted antibodies.

If the human body can be compared to a city, then novel coronavirus is the “siege ladder” to break through a city wall.
The recombinant protein vaccine, in which scientists give samples of the “siege ladder” to the immune system for analysis and make corresponding antibodies, is equivalent to training soldiers in advance to dismantle the “siege ladder”.

The principle doesn’t sound complicated, but people have a hard time doing it in practice.

Once the fusion protein of the virus is extracted, its protein structure changes.
The structure of the protein changes, making antibodies against the protein less effective.
Keeping the fusion protein extracted from the virus stable is thus a tricky problem.

Over the years, researchers have developed ways to stabilize fusion proteins.
However, these methods are all complicated and immature, which cannot be applied in large-scale practice.
In this context, researchers at the University of Queensland have developed a “molecular clamp technique” :

There are many types of viruses.
The fusion protein fragments of some viruses can produce extremely stable structures on their own, and the fusion proteins possessed by different viruses are very similar.
Thus, embedding a stable fusion protein fragment ona novel Coronavirus may enable the fusion protein extracted from the novel Coronavirus to remain stable (equivalent to clamping the fusion protein with a pair of pliers), a technique known as “molecular pliers”.

Fusion protein stabilized by molecular clamp Source: Official website of the University of Queensland [16]

Researchers from the University of Queensland have found that part of the HIV virus fusion protein GP41 can generate a stable helix structure, which is suitable for “molecular clamp” to fix the novel Coronavirus fusion protein [17].

But surprisingly, the immune system reacts to both proteins at once, creating two antibodies: novel Coronavirus antibody and HIV antibody.

CSL said in a statement on December 11 that the subjects had been fully informed of the situation prior to the vaccination and that subsequent tests had confirmed that the subjects were indeed infected with HIV.
In other words, subjects who received the V451 vaccine had a false positive for HIV.

Interestingly, CSL also claims, somewhat unconvincingly, that both CSL and the University of Queensland believe that health care providers need to make changes to accepted HIV testing methods [18].

CSL statement on HIV positive v451 vaccine source: Australian Stock Exchange (ASX)

But such clinical trial results are bound to fail regulatory and medical ethics, and CSL and the Australian government have agreed not to carry out further clinical trials of the vaccine.

A wave of vaccine development
According to the statistics of Datamenti, a guhusk data News project, 237 COVID-19 vaccines have been developed in more than 100 countries and regions [19].
The news that the university of Queensland and CSL were terminating their vaccine development did not cause much of a stir.
After all, there are far too many COVID-19 vaccines under development.
The failed vaccine was just a tiny spray in that wave.

However, the headlight team further calculated that nearly a third of these vaccine development projects involve various universities and research institutes.

In addition to the COVID-19 vaccine developed by the University of Queensland and CSL, the Recombinant adenovirus vector vaccine developed by the University of Oxford and AstraZeneca, the recombinant protein COVID-19 vaccine developed by Flinders University and Vaxine Pty, and the nucleic acid vaccine developed by Tongji University and China CDC and Micro Biology…

It is not just ivory tower LABS that are choosing to lean against the trees and collaborate with vaccine giants to develop vaccines.
BioNTech, for example, has teamed up with Pfizer, and the vaccine is already available in the UK, THE US and elsewhere.

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

These institutions may have cutting-edge technology ideas but lack experience in managing clinical trials, let alone producing them.
They need to draw on the vast experience and resources of the vaccine giants in registering, producing and distributing drugs.
Therefore, it is natural for the two to jointly develop COVID-19 vaccine [20].

Such co-operation is not without its problems.
It was a long way from the laboratory to the workshop of the pharmaceutical factory.
The more partners there are, the more difficult it is to collaborate.
Any delay on either side could lead to further delays in the introduction of a vaccine.

The failure of the university of Queensland to develop a vaccine with CSL partly reflects a lack of communication between the two sides.
Why the fuss about the vaccine in the first place, when scientists knew it might make people test POSITIVE for HIV?

The headlamp team also pointed out in an article in November that the development of recombinant adenovirus vaccine between The Chinese Academy of Military Sciences and Tianjin Conchino did not go well, and the reason why they got up early and caught up with the late gathering was that the production capacity of Conchino had problems [21].

The end of the
COVID-19 is something of an opportunity for research institutions and drug companies.

The molecular clamp technology at Queensland University and The mRNA vaccine preparation technology from Modena are all being used in clinical trials for the first time during the COVID-19 outbreak.
Whether it fails or succeeds, COVID-19 has actually accelerated the transformation of a number of cutting-edge biomedical technologies.

The COVID-19 epidemic will continue, and those failed and terminated studies bear witness to efforts to overcome this once-in-a-century epidemic.
Thanks to these efforts, it looks like humans will be a little further away from COVID-19 by 2021.

Australia’s biotech giant will not go home empty-handed.

After announcing the cancellation of the University of Queensland’s vaccine order with 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 from Astrazeneca will still be produced by CSL [23].

“From the first day of the outbreak, all these scientists started working feverishly in the lab, and no one stopped.
In a desperate situation — the most desperate they had ever experienced — most of them lowered their standards of acceptance of evidence and approached it with hope and optimism.
[24]”

In the Great Flu, John Barry, a famous American writer, described the scientists during the 1918 Spanish flu.
Now, scientists are back to the rhythm of history.

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