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**Hugh** · 21-10-2021, 14:58

First it was

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There were no clinical trials that was a stage that was removed there is nothing but computer modelling

Now it's

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Those trials were far below the usual standards

So, according to you, those trials that never happened were below the usual standards?

There is a very simple answer to your question about

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How do you explain it happening in a year or are we saying pharmaceutical companies took years previously for the fun of it corners were cut in the research and development to get it out of the door?

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How have vaccines for COVID-19 been developed so fast?
Vaccine development is normally a long and expensive process because of delays caused by applying for funding, ethical approval, recruiting volunteers, negotiating with manufacturers and scaling up production. In the emergency state of the COVID-19 pandemic the scientists, doctors, ethics approval boards, manufacturers and regulatory agencies have all come together to work harder and faster.

Has the speed of developing vaccines for COVID-19 compromised safety?
No. All the standard safety procedures have been followed during clinical trials on vaccines for COVID-19 and the rigorous regulatory processes have been fully completed as for any other vaccine or medicine.

Before any vaccine can be given to the population it must go through rigorous testing. Like all medicines, vaccines undergo extensive clinical trials, where they are administered and monitored in groups of volunteers. In the UK, the results of the trials are then assessed by the Medicines and Healthcare products Regulatory Agency (MHRA).

No medicine can ever be completely risk-free or 100% effective. However, strong licencing processes and safety tests ensure that the health benefits of medicines being given through the NHS greatly outweigh any risks.

https://www.immunology.org/coronavir...developed-fast

Also

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When scientists began seeking a vaccine for the SARS-CoV-2 coronavirus in early 2020, they were careful not to promise quick success. The fastest any vaccine had previously been developed, from viral sampling to approval, was four years, for mumps in the 1960s. To hope for one even by the summer of 2021 seemed highly optimistic.

But by the start of December, the developers of several vaccines had announced excellent results in large trials, with more showing promise. And on 2 December, a vaccine made by drug giant Pfizer with German biotech firm BioNTech, became the first fully-tested immunization to be approved for emergency use.

That speed of advance “challenges our whole paradigm of what is possible in vaccine development”, says Natalie Dean, a biostatistician at the University of Florida in Gainesville. It’s tempting to hope that other vaccines might now be made on a comparable timescale. These are sorely needed: diseases such as malaria, tuberculosis and pneumonia together kill millions of people a year, and researchers anticipate further lethal pandemics, too.

The COVID-19 experience will almost certainly change the future of vaccine science, says Dan Barouch, director of the Center for Virology and Vaccine Research at Harvard Medical School in Boston, Massachusetts. “It shows how fast vaccine development can proceed when there is a true global emergency and sufficient resources,” he says. New ways of making vaccines, such as by using messenger RNA (mRNA), have been validated by the COVID-19 response, he adds. “It has shown that the development process can be accelerated substantially without compromising on safety.”

The world was able to develop COVID-19 vaccines so quickly because of years of previous research on related viruses and faster ways to manufacture vaccines, enormous funding that allowed firms to run multiple trials in parallel, and regulators moving more quickly than normal. Some of those factors might translate to other vaccine efforts, particularly speedier manufacturing platforms.

But there’s no guarantee. To repeat such rapid success will require similar massive funding for development, which is likely to come only if there is a comparable sense of social and political urgency. It will depend, too, on the nature of the pathogen. With SARS-CoV-2, a virus that mutates relatively slowly and that happens to belong to a well-studied family, scientists might — strange as it sounds — have got lucky.

https://www.nature.com/articles/d41586-020-03626-1

Think of it as the way military technology advanced quickly during WW2.

Hope this clarifies things for you.

---------- Post added at 14:58 ---------- Previous post was at 14:45 ----------

This link gives more detail on how the timescale was shortened.

https://www.sciencenews.org/article/...elopment-speed

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By comparing the new vaccines with earlier drugs that have used the same tech under more traditional research timelines, it is possible to calculate approximately how much time got chopped off the development process once shots were ready to go into arms: roughly four years. Here’s how.

To back up a bit first, designing the vaccines began far earlier than the jabs-in-arms stage. It began with deciphering the exact genetic makeup of SARS-CoV-2, the virus that causes COVID-19 (SN: 12/11/20). By early January 2020, that genetic blueprint was in hand and the first vaccines to test were ready just a few weeks later.

For some perspective, researchers first deciphered, or sequenced, the entire human genome over a span of almost 13 years, starting in 1990 and wrapping up in 2003 (SN: 1/17/03). Because of advances in computers, the same task now can take only hours.

Most crucially, researchers now had the genetic instructions for making the spike proteins that the virus uses to break into cells — a key ingredient for making the vaccines. Jutting out from the virus’ surface, these spike proteins make an easy target for the immune system to recognize. Researchers knew to zero in on those proteins thanks to decades of work studying coronaviruses, including two that have caused other outbreaks of human diseases — SARS and MERS. That work also identified the best form of the protein to use: a stable form just before the virus fuses with a cell it’s about to infect.

Finding a delivery system
Those instructions could then be fed directly into pre-made delivery vehicles that carry the genetic code to cells to induce an immune response. Scientists had already built these rapid, genetically based templates largely because of the ongoing battle against HIV, says Tom Denny, Chief Operating Officer of the Duke Human Vaccine Institute in Durham, N.C.

“In the last 10 to 15 years, there’ve been major teams around the world … trying to understand what needed to occur to make a protective HIV vaccine,” Denny says. Those efforts have “helped us in our battle with this current pandemic.”

Recruiting volunteers
After the first syringefuls of prospective COVID-19 vaccine emerged from the “plug-and-play” mRNA labs, years were removed from the timeline by cutting out the long stretches of pure waiting that are built into most human testing. Driven by the urgency of the pandemic, nearly half a million people in America alone had offered up their deltoids for the cause through the COVID-19 Prevention Network in a matter of months, in many cases even before the first public inklings of success, according to the American Medical Association.

For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. Based on this comparison, that’s roughly 730 days — nearly two years — saved in recruiting alone.

Getting fast results
Another, more dismal factor contributed to the scientific speed: How fast the virus spread.

Scientists can begin to calculate a vaccine’s efficacy when a sufficient number of people in the group that got a placebo rather than a vaccine have gotten infected naturally (SN: 10/4/20). If an outbreak peters out, it takes longer to reach that threshold. That’s true too if a virus naturally spreads more slowly — say a virus like HIV, herpes or human papillomavirus, or HPV, which are transmitted primarily through sex. In contrast, just breathing or talking can spread SARS-CoV-2 — and everybody does that (SN: 4/2/20).

Loosely comparing vaccine trials for COVID-19 with HPV vaccine trials offer clues to just how many days may have been lopped off the COVID-19 timeline because of the new virus’s astronomical rate of spread. The HPV trials took about 529 days, or 1.4 years, to reach a point at which efficacy could be calculated, when the placebo group got to an infection rate of 3.8 percent.

The Pfizer Phase II/III coronavirus trial, in contrast, got initial efficacy results for the first of its two doses in just 105 days, when it hit a nearly 2.4 percent infection rate in the placebo group. That’s 424 days faster than HPV. Why? Because just months into the pandemic, SARS-CoV-2 was infecting hundreds of thousands of people per day globally.

Jumping the line
There was also waiting time recouped from the U.S. Food and Drug Administration’s review process. Typically, it takes the FDA 10 months to review a new drug.

However, with the COVID-19 death toll rising, the FDA rushed all coronavirus vaccines to the front of the review lines. The Pfizer vaccine got reviewed and authorized for emergency use only 21 days after submission and the Moderna vaccine in just 19 days (SN: 12/11/20; SN: 12/18/20). Compared with a more typical 10-month wait time, that’s about another 283 days saved.

In total, that’s 1,437 days, or 3.9 years, cut off the normal timeline for a new vaccine. And that doesn’t include other time savings, such as putting the ethics reviews at the front of the line. Add that saved time to the 11 months it actually took to get the first COVID-19 vaccines and it would add up to nearly five years — remarkably close to the six years needed to test and approve patisiran.

In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. Once the companies had emergency use authorization in hand, they were ready to ship doses immediately.