Sunday, October 17

Ten Reasons We Got Covid-19 Vaccines So Fast Without “Cutting Expenses” | Coronavirus


TThe speed with which effective Covid-19 vaccines have reached authorization has caused surprise. Compared to previous vaccines, the process has been very quick and naturally people wonder how it could have happened without some kind of commitment to standards and care. Explaining it all simply as a result of the wonders of the latest scientific advances seems vague. So how has it really happened? Actually, there are at least 10 reasons: some have to do with good planning, some with good science, and some simply with good luck.

1. Plans for a pandemic were already underway

Long before the Covid-19 crisis, there was an awareness that a pandemic of some kind was likely to occur in the next few years and plans had already been made to address it. Governments, international organizations and foundations have been pooling resources. The International Coalition for Outbreak Preparedness Innovations (CEPI) launched in 2017, and when Covid-19 arrived, they were ready. Furthermore, several companies and academic institutions, notably BioNTech, Moderna and the University of Oxford, had also been working on new technologies capable of generating vaccines from the genetic codes of infectious pathogens and cancers, and testing them for several years.

2. China identified a new coronavirus early on

Professor Yong-Zhen Zhang of Fudan University, Shanghai, and his colleagues in China quickly obtained material from an early case of Covid-19 and identified a new coronavirus. They elucidated the genetic sequence of the RNA in the virus very quickly and made the information public. That was the starting gun for vaccine production. The fact that RNA vaccine and viral vector platforms only needed the nucleotide sequence of the virus (the genetic code used by all living things, from viruses to whales, to reproduce; in fact, a series of of letters you could send as a text message), and not a sample of the actual virus, allowed design and manufacturing to happen very quickly.

3. Substantial funding was awarded immediately

Vaccine developers had access to substantial and immediate funding. Raising money to develop new vaccines typically takes time: either you have to persuade grant funding agencies or charities and their advisers, who are often your competitors, that your ideas are sound or, if you are a business, you must persuade your own directors or outside funders to invest. With the health and economic costs of the pandemic so great, donors allowed all plausible options, while CEPI was also ready to back the most promising proposals immediately.

Four. The clinical trials process was accelerated

The process of drafting clinical trial protocols and obtaining the necessary approvals to carry them out was streamlined. This generally evolves very slowly – ethics committees and regulators must include them in long lines of proposals. But this time the investigators were working and meeting around the clock and additional staff were recruited. The committees received requests, prioritized them and made decisions generally within 24 hours. They all redoubled their efforts to prioritize these studies.

5. Vaccine trials started immediately

Experienced vaccine teams were able to quickly conduct Covid-19 vaccine trials. In the UK, there were already four centers ready to start the Oxford vaccine study immediately and through the National Institute for Health Research, which coordinates all clinical trials conducted by the NHS, an additional 14 sites were identified and they were set for the broader phase. 2-3 studies that followed.

6. Research data was collected electronically

Information technology was readily available and used. Clinical trials have been slow to adopt electronic recording and data collection methods for fear of failure. Paper records are solid, familiar objects that everyone can see and believe, but they are time consuming and prone to errors. Where other sectors have gone, research has finally followed. When you buy a plane ticket, you do it online and the form does not allow you to make mistakes or omit important information before completing a purchase. These characteristics are also vital for data collection, and for the three to five years leading up to this pandemic, research trials have shifted to this approach, with data collected directly on computers and tablets in the clinic. Errors and omissions are rare. The information is immediately available for analysis even while it is being collected.

7. The studies attracted large numbers of volunteers

There is massive public support and commitment to these studies. Many people wanted to participate and help. Vaccine trials typically take weeks or months to recruit, but for these studies, with the help of the speed of information from media, social media, and the ability of subjects to instantly register interest online, it was possible to identify willing volunteers in just a few hours. Without the participants, the studies could not be done.

8. Trials have yielded quick results

In order to obtain results, it is necessary that there are cases of disease. Even at all this speed, large-scale testing only started towards the end or after the first wave of Covid-19 cases in most countries. While the low rates of illness during the summer in many places were great news for our health, sanity, and the economy, they actually made testing difficult. If there are a large number of people who have been given the vaccine or the control injections, to know if the vaccine works, it is necessary that there are cases of Covid-19. Expect most of the cases to be between the controls. But if no one gets sick, they don’t realize it. The arrival of the second wave is a huge public health challenge, but it has allowed these trials to show results quickly.

9. The first vaccines worked well

It is much faster to get a result with a vaccine that works well than with one that works only weakly. Even a vaccine that only prevents a small proportion of cases could be useful in the context of a pandemic, but it takes more time to find out if there really is a weaker effect. If a vaccine were 100% effective (there is no such vaccine, but just for the sake of argument), then you may only need about 20 cases of disease in your study, which would occur among controls, to be almost certain that the vaccine caused the imbalance of 20 sick controls and no vaccinated patients. But if the vaccine were moderately effective, 20 cases would not be enough. Seven cases in vaccine recipients and 13 in controls could be due to protection induced by the vaccine, but it could also be a fluke and a vaccine that has no effect. I would like many more cases, for example 70 to 130, to be more sure of your result. But getting 10 times more cases would take much longer. The fact that the first vaccines worked well has made it much quicker to be much more certain of the strength of their protective effects.

10. The regulation was carried out while the studies were being carried out. continuous

Through the use of “continuous review,” a completely different approach to regulatory approval was taken this time. Typically, all test results and data are prepared in a bulk package after studies are completed, a process that takes months. The entire batch is then presented to regulators, which are the agencies that grant licenses for drugs and vaccines, and then they begin their review, another process that takes months. This time, the data was provided to regulatory agencies as it was generated and reviewed while the studies were ongoing. When the final results came in, those were the only results left to review. The whole process took months, but the last steps only took days.

Authorization is not the end of this “rapid vaccine” story. The launch and administration of vaccines began almost immediately. That is not normal either. No sensible company would start making vaccines until it knew it would definitely be allowed to sell it, but this time the manufacturing was done at risk and in advance. If the vaccines had failed, all the ready-made doses should have been thrown away. Fortunately, that has not happened.

There are more vaccines in the works and we have more to learn about the ones that have arrived; Much more information about safety and side effects will accumulate as they are administered to much larger numbers. But the fact that we are now in a position to begin protecting the vulnerable and highly exposed by immunization is the result of foresight, hard work and a few strokes of luck.


www.theguardian.com

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