Well one be an elderly healthy adult … but none with “significant disease”.
Phase II drug trials are specifically designed to test safety with elderly, children, and those who may be less healthy. The covid vaccines are unusual in that many of the vaccine trials combined phase I and II.
Since only a few companies have started phase III only recently, how do they expect to have any data before the election? Phase III is simply an expanded number of people. It takes a while to recruit all these people and it will take a while to determine if they’re safe. I guess they’ll get some data on antibody levels of some people. However, I find it hard to believe that we’ll get enough data to determine whether people were protected. They have to be exposed to the virus and be immune.
So I’m just guessing that the plan is to simply make sure people have antibodies (and maybe T cell response) and with an acceptable amount of side effects by November and they’ll say “let’s go”.
My fear is if they okay the vaccine(s) too soon, people will go about their lives thinking they’re protected. If the vaccines don’t work, we’ll have a huge surge.
I am one of those high risk folks. Back when I was under 40 and had my life before me, I might have considered being a test subject. Now that I only have 20 years left if I’m careful, no way am I going to risk being a test subject. I have already gotten my yearly flu shot, I have no intention of getting a COVID vaccine for at least a year after it is available for the general public.
28,025,181 total cases
908,000 dead
20,103,385 recovered
In the US:
6,549,475 total cases
195,239 dead
3,846,095 recovered
Yesterday’s numbers for comparison:
Pfizer and Moderna have had vaccines in phase 3 trials since the end of July. By the October 22 FDA meeting Moderna will have had phase 3 trials underway for 87 days. The protocol is two injections, 28 days apart. So the first subjects will have completed both injections more than 8 weeks before that meeting.
It is far from certain that there will be sufficient positive results before the election to warrant ending the trials and proceeding to an EUA for a vaccine. But there might be. And as Ron Klain, former Biden chief of staff, noted the manufacture and roll out of the H1N1 vaccine did not go smoothly during the 2009 swine flu epidemic. We need to make all preparations now to be ready to roll out a COVID vaccine as soon as it is approved.
Keep in mind that the H1N1 vaccine was approved in Sept 2009, about 5 months after H1N1 was recognized as a significant new strain of flu.
COVID is a coronavirus, a different family of virus than H1N1, and that may account for some differences in vaccine testing protocols. But rapid vaccine development is not new. It happens every single year for flu vaccines. And as the CDC noted in this June 2019 article there have been a lot of improvements in vaccine development since the 2009 H1N1 outbreak.
Please trust the CDC and the science. The COVID vaccine will be ready when it is ready. Not according to any politician’s timeline.
A friend of mine has a teenaged daughter who was really looking forward to going back to school. She’s an only child and has been observing lockdown religiously but misses her friends. She went back to school on Tuesday but came home today very upset because some kids (don’t know how many or what proportion) were goofing around without their masks, coughing on each other. Needless to say, she’s staying home now.
This is so hard on parents, kids, and especially teachers!
H1N1 was a flu. There is lots of experience with flu vaccines which it was really just a variation of and no reason to expect any surprises. Any SARS-CoV-2 vaccine is a completely new beast.
Ahh. That makes it a bit better. Still, that timeline seems fine for determining safety but still doesn’t seem much for determining efficacy.
28,328,097 total cases
913,918 dead
20,342,706 recovered
In the US:
6,588,163 total cases
196,328 dead
3,879,960 recovered
Yesterday’s numbers for comparison:
A variation in more ways than one. In the EU, the process of annually changing the flu vaccine “active ingredients” is classified as a Variation to a Marketing Authorisation - it’s the only example I know of where a new Marketing Authorisation Application is not required for a new active ingredient/combination of active ingredients. Variations typically address things like manufacturing process changes*, so that’s the level it’s addressed at. I assume a similar process applies in the US. I also assume it’s done that way because, for annual flu, you just have to be pragmatic - Variation = fast; new MAA = too slow.
j
(*) - I’m oversimplifying; there are many different marketing authorisation which are done by variations - I just chose a (hopefully) useful comparison.
I was looking at the criteria for one trial (that a friend has volunteered for) and in the first phase they only wanted to recruit people who were both at high risk of being exposed naturally and ALSO at low risk of having adverse effects. They had a second part of the trial where they planned to recruit people at higher risk, too. That seemed pretty reasonable to me. (look at the very long list of exclusions for phase 1)
Much better than the AstraZeneca description!
Makes sense.
But it still looks like they’d never be testing it at all on people under 18, or on anyone who’s pregnant. Would they then not be offering the vaccine to children and pregnant people?
No one is testing pregnant women but AstraZenica is testing children. Will Covid-19 vaccines be safe for children and pregnant women?
Good to hear (was not in the protocol I had found) … albeit I highly doubt the numbers will be anything large enough given the low risk of the disease in the population.
28,659,610 total cases
919,715 dead
20,585,981 recovered
In the US:
6,636,247 total cases
197,421 dead
3,917,962 recovered
Yesterday’s numbers for comparison:
Arizona USA infection rates keep going up, but death rates are going down. I really do wonder if COVID19 is doing an Andromeda Strain thing. I was in my late 20’s when suddenly having sex without condoms meant a slow and painful death of AIDS. While the doctors and scientists worked so hard to help manage AIDS, the virus helped by mutating into something that wouldn’t insta-kill its hosts.
Covid racing through a college dorm will kill fewer people than if it infected the same number at the nursing home.
??? This page clearly shows that Arizona’s infection rates have been declining steadily for about two months, with only a tiny uptick for a week or so around the beginning of September, and are currently around 20% of what they were at the beginning of July.