And if you factor that into the data we have, it is likely that those who did not experience these effects have been more careful than those who did. If so, that means that the ~95% efficacy is actually even higher.
It depends. There are vaccines which are a single protein so those will probably have very similar risks. Vaccines run the gamut from attenuated virus vaccines to single antigens, so it is hard to generalize.
When I consider expert advice outside my areas of expertise I will often look at what the expert is risking. With such a high profile vaccine there are a lot of careers on the line and a lot of stock prices at risk. The experts really, really want to get this one right. Could they get it wrong in the end? Yeah, they could, but I will take the advice of a well motivated expert over a wild guess any day.
My point has nothing to do with it being a single protein. Itās about the delivery system. Expressing a single protein using an adenovirus, no matter how the adenoviral vector has been crippled, would have, in principle, greater risk.
Iām also in the Pfizer trial. I had zero effects, not even a sore arm, so Iām guessing I got the placebo. I was hoping for noticeable effects so Iād know for sure!
When I went to the first trial visit, I asked what would happen with the placebo group when they get EUA. The nurse didnāt know the answer to that. She had heard that they might vaccinate the placebo group, but she told me that if they didnāt, just go get an antibody test and Iād know. I havenāt done that yet, since it will be a while before Iām offered a vaccine.
Another follow up question. I heard today that the current vaccines are not tested or approved for children. Given the risks are so low, what would require additional testing specific to children?
Iāve since heard from other people who have asked recently (like within the last week or two) that they plan to unblind the placebo group and vaccinate them, and that the vaccines to do this have been/are being distributed to trial sites. Multiple people have said thatās the answer they got when they asked (this is in a facebook group of verified trial participants).
The trials started for age range 18-(I think)85, and theyāve been dropping it down in 2-year increments every so often. Pfizer is down to either 12 or 10 years at this point, and they will continue dropping them down as the trial goes on. My understanding is that this is the standard procedure in trials like this, and isnāt related to any specific risks or lack thereof.
Iāve heard rumors of that as well, just nothing official. Hopefully Iāll get a call or email from the trial center soon.
I got an email several weeks ago asking for kids ages 16-17 to participate. I asked my 16 year old son if he wanted to do it, but he said no.
I wonder how difficult the children trials are. I donāt think my kids would be fans of the blood work involved, if they do it the same way as the adult trial. I didnāt enjoy the blood work myself. That first time, they had to stick me a couple times, with 3 nurses attempting to find my veins.
I would think that a child-specific study would have lower priority based on lower risk.
Doing that eliminates the negative control for detecting long-term side effects. Itās a difficult ethical decision.
Absolutely. And under normal circumstances would seem to preclude doing it. The current vaccine development and testing system is designed to deal with things that have been with us for a long time, not once-in-a-century emergencies. The Moderna vaccine was developed back in January, just TWO days after the genome sequence of the virus was made public. Two days later, 95% effective vaccine. Here we are in December and we MIGHT be able to start distributing that vaccine a year after it was first made.
Obviously the priority after years and years of horrifically unethical and extremely dangerous ātreatmentsā is safety and efficacy, but there must be a way to do this faster in response to genuine emergencies. Imagine the lives saved if we could have started vaccinating last spring, at the height of the first wave, instead of next spring, after what is already, in December, a terrible winter. This did not have to be the case. But here we are. Ask me, put out the fire first, then deal with any water damage.
And yet even with the year of testing, ~40% of people in the US have been primed by pseudoscientific antivaxxers and say they wonāt take it.
I think this is a bit harsh. People are being asked to take the vaccine, that has not passed through normal levels of testing. They are told the risk is low, and certainly lower than taking it, and to trust the experts.
However there is very little information available (at a level your average person can understand) to explain why the risk low. Iām not sure why more effort (by public health or relevant authorities) isnāt put into countering the antivaxer message by explaining the mechanics of the testing process the the vaccines have gone through, and why itās highly unlikely the vaccine could cause other problems.
A ātrust us, we are the expertsā message isnāt enough.
I see all kinds of scientists and public health people making tremendous effort to communicate with the public daily on social media.
Just because the feds (and other institutions) have failed immensely doesnāt mean plenty of people arenāt trying to get information out.
First off, Iām from Canada, so Iām not making any comment on the US situation. Overall I think our Public Health officials and governments have done a good job of handling the whole Covid-19 situation.
I also know that many scientists and individuals are also trying to communicate with the public
However, I still find, that is very hard to find clear information on why the vaccines, and particularly why mRNA vaccines are low risk, given we are bypassing typical long term testing protocols.
Is this the case? What other testing is normally done?
My understanding, is that typically longer term trials are done before new vaccines are release to the public.
COVID-19 Vaccine Research and Development
See the following article, and particularly the usual duration of clinical trials shown in Figure 1.
Also itās interesting to note the following paragraph (second from the bottom) which contradicts the view expressed by many of you on mRNA vaccines
" Vaccines developed using traditional techniques have a history of safe use, while innovative techniques such as genetic vaccines do not. As such, safety testing of innovative vaccines could require more regulatory stringency. On 8 September 2020, the Chief Operating Officers of nine major vaccine developers issued a pledge not to submit any vaccine candidate for regulatory approval unless all ethical and scientific standards have been met."
Again, Iām not questioning the safety of the vaccines or whether we should take them, just how well the reasons for their safety has been communicated in a way that is clear to the general public.
They have been through phase 1, 2, and 3 double blind trials with tens of thousands of people in the phase 3 trials. One reason theyāre able to get the trial done quicker (besides all hands being focused on just this) is that there is so much community spread that it didnāt take long to get the number of positive cases they needed to determine efficacy. If youāre doing a vaccine for a disease thatās only active in a small part of the world or that is active but isnāt at pandemic status, it might take years to get the right number of infections. The vaccines that trial after these first ones roll out will probably take longer, since it will be harder for them to get enough positive cases.
Also, the trials are still going on for the full 2 years. They just have EUA because this is a pandemic. The risk of disease is so much higher than the risk of vaccine after vaccinating tens of thousands of people. They will continue the phase 3 trial, and beyond that they still do regular safety monitoring that they do for all vaccines.
My IG feed is mostly scientists doing just that. There are several good ones, and I cannot imagine how exasperated they are at the DMs they get. Iām exasperated after just dealing with a couple antivax friends.
No, it does not at all. I have been very, very careful to qualify my opinions with āin principle,ā because in principle, the innovation itself circumvents most known vaccine side effects.