Need for Speed: Coronavirus

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With the unemployment rate having risen by 0.4% in the last three months, with businesses scrambling for turnover and education being hindered for young people across the UK, it is evident that we must have a vaccine as soon as possible. The challenge in all of this, though, is the urgency. The vaccine development process has been compressed by taking steps that would usually be linear and conducting them in parallel. Examples of this would be scaling up manufacturing while vaccines are still in their trial phases. CSL: a company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions, are currently working at dangerous speeds to produce these vaccines on a large scale. The manufacturing of the UQ vaccine, a recombinant protein vaccine, is not something new to CSL. The scale of production required, while immense, is well within their capacity. CSL estimates it can produce 100 million doses of a Covid-19 vaccine by the end of next year. Half will go to Australia and the remaining will be distributed to developing nations in a deal with the Coalition for Epidemic Preparedness Innovations – a global organisation for equitable distribution of vaccinations.

The way the vaccine is produced can be simplified to a few steps: Scientists start with the Covid-19 genetic sequence. UQ create a new DNA sequence – combining the COVID-19 spike protein with molecular clamp technology. The DNA is inserted into mammalian cells. Mammalian cells grow and produce litres of clamped protein in large bioreactors at CSL Behring. Purification and testing of clamped protein. Combination with Seqirus MF59® adjuvant, helping stimulate the immune system and reduce the amount of antigen needed for each vaccine.

Manufacturing a vaccine at trial stage is quite rare, mainly due to the risks of making such a huge investment in an unproven vaccine. Vaccine manufacturing usually does not begin until later, after phase three, due to the financial wager the companies will have to make and the time put into the entire process. So, a very likely possibility is money and time is being put into producing something that does not technically work. For this particular situation, none of the key steps in producing a vaccine have been neglected. The majority of the “speeding up” comes from reducing the time in between clinical trials which is often the most significant reason for time delays in the development of vaccines.

Other vaccines being researched include “NVX-CoV2373” by Novavax. Novavax have bioengineered the virus’s spike proteins which help invade cells but do not cause the replication or symptoms of COVID-19. These spike proteins are combined with a compound that stimulates immune cells to provoke an immune response. The vaccine is administered in two doses, three weeks apart. On the 2nd of September in the New England Journal of Medicine, it was confirmed to be safe and found to produced antibodies at a greater magnitude than among those who have recovered from COVID-19. In late September this was launched in its phase three trial in the United Kingdom where it was tested among ten thousand people of different categories – with and without underlying conditions.

“JNJ-78436735” by Johnson and Johnson is another vaccine currently being developed. This multinational company specialising in healthcare is developing an adenovector vaccine which utilises a piece of DNA from the Sars-CoV-2 by incorporating it into a genetically engineered common cold which won’t replicate inside the body. The process for this vaccine builds upon the technology previously used for the Ebola vaccine and candidates for Zika virus and HIV. The British science journal “Nature” contained a study of the vaccine in their July issue, showing the vaccine-elicited neutralising antibodies in monkeys and was close to achieving complete protection in just one dose. Towards the end of September, they announced the launch of a phase three ensemble trial with sixty thousand participants in several nations to evaluate all aspects of the vaccine. This included the safety of the vaccine, how effective it is and other factors which are necessary to be tested. However, in early October it was announced theses trials will be postponed due to unexpected complications with a trial member.

“mRNA-1273” by Moderna Therapeutics: this vaccine functions by injecting snippets of a virus’s genetic material, mRNA, into human cells. They create viral proteins that mimic the coronavirus, creating recognition in the immune system. Certainly, a very avant-garde technique, this technology has never been licensed for any disease. If successful, it would be the first mRNA vaccine approved for human use. This vaccine requires two doses, four weeks apart. On the 27th of July, Moderna stated it had started the third phase of its clinical trials, even as it continues to monitor phase two results. Initial findings from phase one have shown that healthy subjects, from the youth to the elderly, produced coronavirus antibodies and a reaction from T cells. Phase three will test the vaccine in 30,000 participants located in the US. Moderna is noted to apparently be on track to deliver at least 500 million doses per year beginning in 2021, thanks in part to the cooperation of a Swiss corporation that will allow it to manufacture up to one billion doses a year. In September, however, the New York Times was reported to have received information from the chief executive of Moderna that it was unlikely the vaccine would be widely available in the first half of 2021.

Hopefully CSL, or any company for that matter, are successful in their endeavours and can distribute this vaccine across nations so we can battle this virus sooner.