Human: I can understand your approach. I agree that it's generally a good idea to ask questions and even do some research on issues of great import to us.
I especially note this thought you expressed as a reason for your wait-and-see approach:
"Given how new it [the vaccine] is, how fast it was brought forth, the waving of all usual protocols..."
I have noticed that this is one of the main arguments frequently brought forth re the CV vaccine. It seems that many people miss the fact that with this vaccine, because of the urgency due to the pandemic, phases of development were being carried out "in parallel". Previously, vaccines and medicines have been developed slowly over a period of years. There are good reasons for this, including methods, regulations, industry competition, the length of trials, available facilities, speed of production, cost to developers and manufacturers, distribution considerations, as well as caution about issues of liability.
I have read and listened to many experts in various science- and medicine-related fields as they address the oft-repeated hesitation or objection to the COVID-19 vaccine that arises due to the unprecedented speed with which the vaccine was developed and distributed. In this case, fast action has resulted in questions of safety.
Here is an article that presents a discussion between science and medicine experts about some of the questions and objections (it's long but instructive):
https://www.nytimes.com/interactive/2020/06/09/magazine/covid-vaccine.htmlExcerpts re considerations, approach and speed:
"For Covid-19, developers are talking about performing as many steps in parallel as possible, as opposed to sequentially. For example, multiple vaccine manufacturers are willing to take enormous financial risks — planning for large-scale manufacturing up front, even before knowing whether the vaccine works or not.
NG says: "steps in parallel" - that's what I referred to above. That until the emergence of the COVID-19 emergency, vaccine development was a slow process for reasons outlined in this and other articles.
"I think we definitely need to be thinking about the scale-up and manufacturing issues [while going through initial steps instead of waiting for each phase of development to be completed].
"So in speeding up the vaccine-development process, we have three things going for us: We have cleaner and likely safer technologies to create vaccines; we know the viral proteins that are likely to raise a good immune response; and we know how to measure that immune response with much greater accuracy in humans that have been given a test dose of the vaccine. All of these we hope will accelerate the Phase 1 safety trials
NG says: "Speeding up the vaccine-development process" - that was the entire objective and all parties involved cooperated to find a new approach to development, with speed but also safety as main goals.
"...with all the challenges regarding developing, testing, manufacturing and distributing a safe and effective vaccine — no matter how much effort so many scientists and companies put on the problem — it could still take years or even longer. This is why it’s so important to have additional efforts ongoing in parallel to try to fight back against this pandemic.
NG says: Again, "in parallel" - that is, not doing one step at a time but as many steps as possible simultaneously in a massive effort to shrink the time it would take to come up with a safe, effective vaccine.
"From what I’ve been able to see, there is unusual urgency and cooperation among scientists in this effort.
"It’s remarkable, in terms of the collaboration across disciplines and research institutions and sectors and borders. There’s been more openness and sharing than I’ve seen in past crises like Ebola or Zika or H1N1. Regulatory authorities around the world are coming together in ways that are very, very important to reduce barriers and to make sure that they’re bringing the best possible science to bear on decision making, trying to identify what are the critical questions that have to be asked and answered, what kind of study designs and preclinical work is going to be necessary, so that you don’t have companies facing different regulatory authorities with different standards and requests and approaches, so that the hard questions can be more effectively addressed through bringing together the best minds, wherever they are.
"I’ve never seen this before, either. Our C.D.C. permit to receive the virus, which is classified as a biosafety Level 3 agent, was approved in less than two days. We received at least two material-transfer agreements, which have to be signed by a number of institutional officials and sometimes lawyers, in a matter of hours. Both of those processes have taken much longer, sometimes weeks, in the past. This is just one sign of administrators and scientists collaborating with each other and acting extra efficiently to facilitate the science.
"From a research perspective, I have never seen such collaborative spirit, such open sharing of materials, data, protocols, thoughts and ideas among academic groups, industry groups, government groups and the clinicians on the front lines.
"I’ve seen unprecedented collaboration from all forces. I can get on the phone and call my counterpart, Mikael Dolsten, at Pfizer, and his first question is, “Well, what can we do to help?” Whether it’s scientists in academia, whether it’s people at biotech and pharma companies, whether it’s the doctors and health care workers who are at the epicenter at hospitals like Mount Sinai or Columbia in New York City, whether it’s the F.D.A. — we are all coming together, and things are happening at unprecedented rates because we realize that we have a common enemy."
NG: All these excerpts illustrate the changes in approach needed in order for all the associated parties to move more quickly than had ever occurred before, and in cooperation with each other rather than as competitors.
I think this amply explains how the CV vaccine could be developed at supersonic speed and why experts of all types, all around the world, agree that it is safe. I know they likely can't predict what may occur in future but to date millions of vaccinations have been done around the world and I haven't heard of alarming severe reactions. The way these things go, the most severe reactions occur close to the time the dose is administered. I would be totally shocked if someone had a significant reaction a year post-vaccination.
The key concept in vaccine development has been "in parallel". Instead of doing one step at a time, a laborious pace (i.e., slow as hell) they did vaccine trials, for instance, simultaneously, instead of separately which takes much more time. As well as compressing the time for many other steps. I hope the discussion in the article explains this well for readers and makes sense of some of the more major concerns.