Space/Science — HabitableZone

Space/Science » in reply to Opinion on the Pfizer vaccine trial

An earlier post on the topic

Here is what he had to say on the vaccine Prior to it's release:

Some Thoughts on Vaccines:
It is likely that we shall see the rollout of a vaccine for covid-19 in the next few weeks. Because I’ve had some experience in pharmaceutical development, some of my friends have asked for my opinion about the advisability of taking a new vaccine. I should note up front that I do not have the credentials to give medical advice of any kind. Neither do I have the clinical trials data that would enable me to offer any statistical opinion on the safety or efficacy of any of the vaccine candidates under consideration. That said, I can point out some of the issues we will all face as we roll up our sleeves.
Vaccines have been around for quite a while and are well understood by the scientific community. Historically, there have been two kinds of vaccines for viral diseases. Killed virus vaccines, (like the familiar flu vaccine) are made by culturing and killing huge quantities of virus. When these dead virus particles are injected into patients their immune systems recognize them as foreign material. The body responds to some portion of the foreign protein by generating an antibody response to that protein. If the body happens to choose a protein molecule that is vital to the survival of live viruses in the environment the patient will become resistant to any infectious agent that includes that molecule.
Live virus vaccines (like those sugar cubes laced with the Sabine vaccine for polio that we all took in grade school) expose patients to a weakened variety of the virus that can induce a mild infection. A normal patient will mount an immune response that will fend off not only the weakened virus but also the more virulent strain. This type of vaccine has the advantage of spreading the weakened infection to contacts of the patient. Just as the virulent virus spreads by social contact, so the weakened strain spreads to untreated subjects and gives them the same level of immunity. However, there is also the small risk that some rare individuals will develop the full disease as a result of the treatment.
There has been speculation for several years that a better immune response could be induced by injecting only a selected portion of the viral protein material. This would allow scientists to choose what fragment would trigger the response. A variant of that strategy is to inject synthesized Messenger RNA which would induce the subject’s own cells to produce a portion of the viral protein coat. This would trick the immune system into responding to the exact protein that is believed to be essential to the functioning of the virulent virus. Further, this approach would allow a vaccine to be engineered as soon as the genetic code of the virus has been identified. While an exciting theory, this strategy has never actually been used to develop a vaccine for human use before. Several of the vaccine candidates currently being developed for covid-19 (including the Pfizer and Moderna versions) are of this new type.
Are vaccines risk free? No medical intervention is without risk! The decision to undergo a medical intervention is ALWAYS an exercise in risk/benefit analysis. Clinical trials exist to quantify the probability of bad outcomes as well as the probability of good outcomes. This is done by using carefully controlled experiments involving several thousand volunteer subjects over an extended period of time. There is the rub. There has been no shortage of volunteers and no lack of incentive. There has been insufficient time for the normal process to be completed. This one will have some risk and that risk can not at this time be properly quantified. We are going to have to make some guesses.
Whenever it is believed that a developmental drug is needed for emergency use before it has been given final FDA approval one can request an Emergency Use Authorization. This is an exception to the normal New Drug Approval process. It is usually temporary and usually restricted as to scope. The approval will be based on the seriousness of the threat posed by the disease and the likely risk imposed by shortchanging the safety testing process. There are some data points that can make this an educated guess rather than a shot in the dark.
(1) The vaccines (at least the ones being considered at this writing) are NOT made from actual covid-19 virus. There is NO chance the vaccine will directly cause the disease.
(2) The most likely time for adverse events to show up in vaccine trials is in the first few days after treatment. While long term follow-up is normal, it is less important in the safety analysis of vaccine trials.
(3) Both of the vaccine candidates have been tested on about half the optimal number of phase 3 subjects and no catastrophic adverse events have been detected. While one might desire more subjects, it is possible to say that a HIGH probability of serious adverse events can be ruled out.
(4) It appears that the worst possible outcome of the treatment is far less objectionable than the worst outcome of the virus.
I wish we had more data and I wish we had more time to study these data. However, it looks like we are heading into a very grim phase of the pandemic and there appears to be no will to invoke the marginally successful public health measures that might buy us more time. It seems to me that until the number of mobile morgues parked behind the vaccination sites is greater than the number parked behind the hospital, I’ll opt for the vaccination.

Log in or register to post.

The whole thread (10 posts)

Related discussions