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Australia I had a hard time getting a sufficient dose of Pfizer To meet the growing demand of Australians for COVID-19 vaccination.

Australia Production of AstraZeneca doses after March, But this is vaccine The risk of coagulation is small but serious and is no longer recommended for people under the age of 60.

Currently, the research team at Monash University Professor of Pharmaceutical Biology Colin PoutonWants to develop a new mRNA vaccine that works on the same principle as the Pfizer vaccine and can be manufactured locally.

So how does the vaccine work? What hurdles do researchers need to overcome to achieve that? And when will it be available?

It is based on existing technology

Prior to COVID, researchers developed mRNA vaccines against a variety of viruses and diseases and tested the technology in mice. After the pandemic, they set out to develop an mRNA vaccine against COVID-19, centered on skill and technology.

The vaccine is an mRNA vaccine similar to that by Pfizer or Modana. These vaccines encourage your body to produce viral spike proteins. Immune system Make antibodies against.

However, the Monash mRNA vaccine is applied to cells A small part of the spike protein, “Receptor binding domain“, This is the most important part that allows the virus to invade our cells.

Receptor binding domain, or Peplomer tipIs also a rapidly changing part to form different variants of concern. Targeting this part directly makes sense to get the most variant-specific response.

How does the mRNA vaccine work again?

The MRNA vaccine acts as an indicator, instructing cells to make specific proteins. When these proteins are foreign to our body, our immune system recognizes them and initiates an immune response. Over time, immunological memory develops. That is, when a virus is encountered, the immune system removes the virus.

Researchers began modeling the vaccine from the original strain of the virus first discovered in Wuhan. But then I adjusted the sequence to model the first beta shot found in South Africa. This adjustment was partly due to neutralizing antibodies from patients infected with the Wuhan strain. Less effective against beta..

The current crop of the approved COVID vaccine provides adequate protection from the first discovered Alpha variant in the United Kingdom and the first discovered Delta variant in India. However, beta variants are good at evading immunity from vaccines, so once vaccine protection begins to weaken, they are more likely to surge than most other variants.

For these reasons, the clinical need for beta mutant vaccines is increasing.

This rapid adjustment of the sequence shows how flexible mRNA technology is. It is easy to reorder the vaccines and adapt them to new variants of the emerging virus, which may emerge in the future. This ability to quickly alter sequences is similar to that of DNA vaccines such as AstraZeneca, but more difficult with traditional protein-based vaccines.

Like all other mRNA vaccines, RNA is broken down in the body in a day or so. Vaccines do not stay in your body for long periods of time. When you learn how your immune system responds to short bursts of protein your body makes, you gain immunity. A second RNA vaccine enhances immunological memory.

The group has tested the vaccine in mice and states that the results are truly promising.

Based on these preclinical results, the Victorian Government has awarded the project A $ 5 million.Money came out of A $ 50 Million Research Fund Assigned to support the development of local mRNA vaccines.

A $ 5 million will help pay European manufacturers to produce sufficient amounts of mRNA for Phase 1 trials. The material is then shipped to Australia via ultra-low temperature storage, allowing local companies to package RNA into “lipid nanoparticles” and allow mRNA to enter human cells.

What is the next step?

Phase 1 trials to confirm that the vaccine is safe in humans October or November of this year, Initially includes 150 volunteers.

If the vaccine passes this trial, it will move to Phase 2 and 3 trials that require tens of thousands of participants. The main purpose of these late-stage trials is to see if the vaccine can reduce the severity of COVID-19 disease, while at the same time ensuring that it is still safe.

These late-stage trials can be completed more quickly if (unfortunately) conducted in areas with high community infections. One of the reasons for the immediate approval of the Pfizer and Modana vaccines is that they have been tested in countries where the virus is endemic. If this vaccine moves to Phase 2 and Phase 3 trials, Australia hopes that the infection will not spread. As a result, the team may need to involve international partners and recruit international participants.

However, there may be alternative indicators to measure how well the vaccine is working. Researchers can look at the blood of research volunteers to see how many and what types of antibodies they are producing. It can act as a proxy for measuring effectiveness. However, it is not clear whether the Australian drug regulator, Therapeutic Goods Agency, will approve the vaccine without a traditional exposure model.

The team will also compare the mRNA vaccine directly with Pfizer and compare it side-by-side to see how stable it is and how well it induces antibodies to the virus.

So when can we put it in our arms? The time it takes for the entire series of trials is unknown, but it probably won’t take a couple of years. The vaccine may not pass Phase 1 or 2 trials, but this is less likely because the methodology is similar to the safe Pfizer and Moderna vaccines.

Why you need an Australian vaccine

This is an important step in the production of mRNA vaccines and the development of Australian sovereign capacity. Australia’s RNA biotechnology sector under development as a whole.. Booster shots are likely to be needed over the next few years, so local manufacturing capabilities need to be developed.

We sincerely hope that it will succeed, but even if it does not, we are building a pipeline for the development of terrestrial mRNA vaccines.

In addition, mRNA vaccines are the new gold standard and next-generation vaccine technology. There is growing debate about the potential of local mRNA vaccines as pandemics and new viruses are likely to increase in the future.

I don’t know how much the federal government paid for the Pfizer and Moderna vaccines, but it could be much more expensive than making them here. If we could make it cheaper ourselves, we would really have an advantage.

Ask a pediatrician: How does the COVID-19 vaccine work and is it safe for teens?

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