❝It is true that the vaccines were approved in a relatively short period but we need to consider:
This is the first time in history where the collective work of the world (in its research centres, universities, industry etc) was focused on a single virus vaccine
The funding and financial support was also exceptional
Coronavirus is not a “new virus”. It is a version of the coronavirus family (of which we’ve already had two epidemics — SARS in 2002 and MERS in 2012) and the current coronavirus has at least 80 per cent similarity (in the amino acid sequencing) with those two viruses. There were was a lot of work on those viruses which was used in producing the current vaccines
In the environment of a global pandemic, the number of people enrolled in Phase 3 of our vaccines trials was enormous (more than 40,000 for Pfizer), something which needed years to collect in the ordinary times.❞
— Associate Professor Ahmad Alrubaie, senior gastroenterologist at the faculty of medicine at UNSW, manager of Iraqi Australasian Medical Association which lead the “Corona Vaccination Campaign”.
There is also a good article on Medical News Today concerning how the COVID-19 vaccines were developed and produced and approved so quickly.
To understand this, it's necessary to have a rough idea of how long most vaccines take from woe to go. 10-15 years is usual. But that does not mean that it's a safety requirement for the process to take that long; rather, it means that the various stages, practically and logistically speaking, take that long. Is it possible to shorten that timeframe safely? Of course it is, and I'll summarise how and why. I'll use spoiler tags to avoid long slabs of text.
This all takes place well before there are answers. The pathogen against which a vaccine is desired has to be known, and its point of access recognised. There's a lot of work here to come up with possible antigens (fighters against the virus), and it's this stage which has research scientists come up with possible solutions. Significant funding is required on purely speculative research which might possibly in the future have an application. You can imagine just how hard it is to get funding, or sufficient funding to move forward. A lot of time is wasted at this stage just trying to get the funding or continue the research with insufficient funding. Obviously the more resources that are available here, the more likely it is that this stage will move more quickly than the usual 1-2 years.
❝Researchers were not starting from scratch when they learned about SARS-CoV-2, the virus that causes COVID-19.
SARS-CoV-2 is a member of the coronavirus family. According to the National Institute of Allergy and Infectious Diseases, there are hundreds of coronaviruses — including four that can cause the common cold, as well as the coronaviruses that sparked the SARS, or severe acute respiratory syndrome, epidemic in 2002 and the emergence of MERS, or Middle East respiratory syndrome, in 2012.
Dr. Eric J. Yager, an associate professor of microbiology at Albany College of Pharmacy and Health Sciences in Albany, NY, told MNT that scientists have been studying coronaviruses for over 50 years. This meant scientists had existing data on the structure, genome, and life cycle of this type of virus.
Dr. Yager explained, “Research on these viruses established the importance of the viral spike (S) protein in viral attachment, fusion, and entry, and identified the S proteins as a target for the development of antibody therapies and vaccines.” He continued:
“Early efforts by scientists at Oxford University to create an adenovirus-based vaccine against MERS provided the necessary experimental experience and groundwork to develop an adenovirus vaccine for COVID-19.”
Dr. Yager said that thanks to advances in genomic sequencing, researchers successfully uncovered the viral sequence of SARS-CoV-2 in January 2020 — roughly 10 days after the first reported pneumonia cases in Wuhan, China. The ability to fast-track research and clinical trials was a direct result of this worldwide cooperation.❞
The cost of this stage is enormous. Most vaccine research requires lobbying for money, and governments and the private sector need to be convinced that it's worth the investment. With COVID-19 ravaging the world, many governments flung themselves into a huge global combined effort to share data, pool resources, and invest in as many vaccine lines of research as looked reasonably promising.
Because of this, the Exploratory Stage took very little time. We were off and running in a heartbeat, and this involved no compromise of safety.
This is the stage where most vaccines fail. They simply won't produce the required response in vitro. Again, because of the huge cost of funding, this stage usually takes another 1-2 years, but there is no clinical reason why it should. Production method needs to be shown, lab reports need to be given. There is also the potential to cut down the timeframe drastically by fast-tracking approval for the next stage. It's not because of safety concerns that the applications and approvals take so long; it's because paperwork can sit on a back-burner, and there are various priorities by governments involved in granting approvals, with only so much in the way of funding that can be allocated. Bluntly, that's all RED TAPE. Because of the desperate need for a vaccine in this pandemic, relevant government departments were on their A-game and didn't delay or procrastinate. For the vaccines that showed good immune response in tissues or cells or animals, where a safe starting dose and method of delivery for the next stage (human trials) could be established, approvals were given. This testing pre-clinical stage was able to occur in a matter of months.
Typical cost for the initial research and pre-clinical trials - as much as $68 million. Going faster means even more money - but obviously fewer unnecessary delays.
These are the human trials, starting out by limiting the trials to perhaps 20-40 participants, because it's important to test safety and efficacy and side-effects on healthy volunteers. With the huge funding thrown at the vaccine candidates that made it to the clinical trials stage, there was nothing in the way of conducting the stage I trials and ascertaining the required information needed for the next stage. And... there were thousands upon thousands of willing volunteers eager to play their part in providing a solution.
(Remember the "molecular clamping" vaccine being developed by University of Queensland? This is where the trials had to stop because the technology resulted in the volunteers returning a false test result for HIV (making it seem as though they were HIV-positive, when they were not) when one particular pathology test for HIV was used. Even though the volunteers were NOT harmed in any way, the false readings posed a potential problem because healthy people could be misdiagnosed as HIV-positive. UoQ will continue to develop their clamping research because it was actually efficacious... but it's going to take longer for them to get there. They need to use a different gene segment for the clamp.)
There is no reason why stage II and III human trials can't be run concurrently. In fact, this is often done with vaccine development. Larger cohorts of volunteers are used, including both sexes, various demographics, various ages, with various underlying health conditions. The purpose of these stages is to see if issues crop up in a larger group, because adverse effects might only be seen in 1 in 10,000, for instance.
These are also the stages to determine how effective and efficacious the vaccine is with a greater pool of results. Rigorous standards of safety are maintained.
By this stage, the cost is huge - hundreds of millions of dollars, and it's only by this stage that one would even know that the investment is going to pay off in terms of an effective vaccine.
While the safety data and trial results are being assessed by the authorising bodies involved, the raw materials have been sourced and the manufacturing process begun. In fact, I understand that Pfizer, for instance, was already producing the vaccine before clinical trials were concluded, taking the risk of enormous production costs because this would speed things up. If the trials had failed, that would mean a lot of money had been spent without a good result; thankfully, the trials did not fail and valuable time was saved, because production and batch testing are not as quick as 1-2-3.
All vaccines are going to be monitored in the real world, because it's after their use in the "wild" that additional information will become available that isn't possible to see in clinical trials. The side effects of the very rare clotting event in the AstraZeneca vaccine is one such adverse side-effect, but it's now known and can be diagnosed and treated much more effectively. The risk of that adverse effect is very very small, particularly in comparison with the risks of COVID-19. Further developing of that vaccine may well eradicate that risk, but there's little doubt that mRNA vaccines are well-poised to be as future-proof as possible against COVID-19, with fast ability to tweak the vaccine against future strains.
In short, no steps were hastened with regard to safety data or rigorous testing. The only things that were ditched were:
unnecessary procrastinating by government bodies
delays due to lack of funding
delays due to lack of research resources
delays due to lack of information
delays due to lack of thousands of volunteers for stage III trials
delays due to lack of production and resource requirements.
There was no seeking of grants or lobbying for investment. The world has been and continues to be desperate for vaccines, because global vaccination is the only way - the ONLY way - to reduce spread of this disease to make it clinically manageable. Some research is looking and has been looking at treatment research, and that's also being heavily funded. To manage COVID-19, we really need both - vaccination for prevention, and medical interventions for treatment (primarily to treat patients who develop more severe symptoms requiring hospitalisation, and to prevent deaths). There will also be ongoing research into longCOVID - why some people develop those longer-term symptoms with poorer health outcomes, and how this can be prevented or treated.
I hope that helps to explain why we should not think that the fast development/production of COVID-19 vaccines are any less safe than other vaccines.
NOTE: China has not released relevant data for their two main approved vaccines. Russia, on the other hand, has released the relevant information for their Sputnik vaccine, and certainly in phase III trials the efficacy and effectiveness were good. We always have to bear in mind that in the wild, these numbers can change... and don't forget that Delta changes things.
I applaud you for your ability to provide REAL learning and education and not some ad-hoc link to some obscure website run by conspiracy nuts.
Some folk just don’t get it! You can give them all the available knowledge in the world, yet they still won’t get it!
All these internet experts who’ve never stepped foot inside a laboratory, nor worked with covid patients, nor even seen anyone with covid, or know anyone who has died from covid…. yet THEY know better 😐
SO, thank you Countessalmirena….. THANK YOU.♥️
To all the nay-sayers….
I’M FULLY VACCINATED. YOU’RE WELCOME! 😊
********* *********** *********** ************ ************ *********** *********** Be Kind To Nurses.... They Stop The Doctors From Killing You.
A vaccine is proven safe through the assessing / testing process that takes that long via the assessing / testing process that is usually taken. There are books on this.
Cosmologically speaking we are all little more than a bacterial film on a soft rock hurtling through an unimaginable void. Don't take it all too seriously.
