COVID-19 vaccines Q&A continued. READ THE PREVIOUS Q&A here
Q3) We are told it takes 10-20 years to produce a vaccine. How come this vaccine has been developed in just one year ? Have they not cut corners? (A very controversial but important question).
Answer:
It is not true that vaccine development takes X or Y number of years. There is no stipulated time frame for this. What people quote is the average time for previous developments. The standard mode of measuring and monitoring drug development is by PHASES which are not necessarily time-bound.
Drugs/vaccines HAVE to be trialed through three phases to get approval and then through one post-authorization/Marketing phase making it four phases in all. And these must be in humans. Before this, the development process must have started in a laboratory and the developers must have proven in cells in test tubes that the drug works. From the lab, they must try the drug/vaccine in animals: First in lower animals such as mice and next in higher animals such as monkeys. At all these levels, safety is strictly monitored. If the results are favorable, the data is taken to an independent regulatory authority for approval and authorization to conduct trials in human beings. These bodies are non-political and very independent. They vary in professional backgrounds(from lawyers to sociologists to pastors, ethicists etc) and are constituted on country to country basis. This is not the function of the WHO as people have claimed.
In human trials, Phase 1 is mainly to look at the safety of the drug/vaccine. Being the first time the drug is to be administered to a human being, it involves just a few people. If they develop no adverse reactions, the data is again submitted for approval to progress to phase 2. In phase 2, many more people are involved(a few hundreds). This is to confirm safety in a larger population. While confirming safety, preliminary data to determine whether or not the vaccine works is collected at this stage as well. So as you can see, even before manufacturers think about efficacy, safety is thoroughly examined. NO MATTER HOW POTENT A DRUG IS, IT CANNOT AND WILL NOT PASS A TRIAL IF IT IS FOUND TO BE UNSAFE. There have been so many examples of drugs/vaccines which though gave good results in animal studies, never got unto the market because they failed safety checks. In fact many more drugs fail trials than those which pass.
In phase 3, the drug is trialed for confirmation of efficacy in very large groups of people. The Pfeizer Vaccine trials involved 42,000 human beings in different countries. The Oxford Vaccine trials target 60,000 human beings of which 23,000 were involved in the preliminary data released in November. The Russian Sputnik 5 Vaccine was trialed in over 20,000 human beings. It is not a 5-man family and friends joke 😀. If found to be efficacious, the data is sent country to country for authorization and use. Again, it is up to every country to look at the data and examine the product to decide whether or not it will accept it. It cannot be forced and there is no universal body, granting universally binding authorization. Not even the WHO. Phase 4 involves longterm follow up after the drug gets on the market. This is where longterm side effects and interactions are usually identified. It is done after the drug gets onto the market and not during the earlier phases. So the argument that longterm side effects of the Covid vaccines should be identified before use really doesn’t hold. For all the drugs/vaccines you know of, this is only done in phase 4 just as is being done with Covid vaccines. No matter how long phase 2 or 3 trials take, individual participants are only involved for a specific period of follow-up time and discharged for new participants to be recruited so the focus at that stage is not to identify long term side effects. Most trials only follow up on participants for up for a year. This is the standard method by which things are done. It was the same for paracetamol and is the same for the Covid vaccines.
So having understood this process, what happened with Covid vaccines? How were all these achieved within a year ?
The vaccines went through these same processes. None was skipped. In fact, on a personal level, I have been involved in Phase 2 and 3 trials for two Covid vaccines and do confirm that there were no skips. You can also read up the data for the various trials. They are available on pubmed.
1. A lot of money has been sunk into Covid vaccine research and development because of the urgency. On top of the pre-existent infrastructure and pharmaceutical costs, the American government pumped in excess of over 9 billion US dollars into this project. The Oxford-AstraZeneca Vaccine is estimated to have cost the UK government over £700 million. Money has always been a major delay factor in drug/vaccine development. So with the money available, it shouldn’t be difficult to see how things would be accelerated.
2. Existent Technologies:
Of all the COVID vaccines rolled out, NONE so far is based on any new technology. They are all based on pre-existent vaccine platforms which were developed and used for other vaccines. So it was NOT a start from scratch. It was a build up which meant safety profiles had already been established and time for development of new platforms had been cut. As far back as 2016 when I started working on vaccines for my PhD, I used at least three of these platforms for my work. For instance, the oxford Covid Vaccine is based on the design of a meningitis vaccine the same group developed many years ago. The Pfeizer Vaccine is based on a technology developed by a German company against cancer. So it was just a matter of tweaking these products to fit COVID-19. And that definitely wasn’t going to take forever
3. As explained in question Q2, the COVID-19 virus did not seem too immunologically complex to deal with. Finding a vaccine target was quite straightforward. So again, time was saved here. (You can read the details on this in the previous post)
4. Cooperation:
With the priority given to Covid because of how it affected nations, authorization bodies gave it so much attention and suspended work on almost everything else to focus on Covid therapeutics and so in some cases, the bodies worked hand in hand with pharmaceutical/research bodies and governments and were actively involved in the monitoring of the data as the trials progressed rather than the usual practice of waiting for the trial data to be sent to them to compete for attention with other trials. Again, this saved the world time
5. Availability and willingness of people to participate in trials:
Working on the trials, one of the things I have come to appreciate so much is humanity. People were willing to sacrifice to participate in these trials for no financial rewards. Nobody was paid for any of the large trials but because Covid had become a worldwide issue, it didn’t take too long to gather 42,000 people for trials as Pfeizer did. Imagine how much time it would have taken to achieve such numbers in ordinary times. People were willing and there were so many active infection cases to follow up on. NB: This was in Europe and America where people are generally more accepting of trials.
Again, this cut the time heavily.
So no corners were cut. Things were facilitated and as has become evident, we can achieve so much when we avert our minds to such enterprises.
References for further understanding:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
