I think this is hard news for anyone counting on vaccines from a multiplicity of sources ending the COVID-19 pandemic within the next few months. Fox Business reports that GlaxoSmithKline and Sanofi’s vaccine won’t be available until late 2021:
LONDON — Drugmakers GlaxoSmithKline and Sanofi said Friday that their potential COVID-19 vaccine won’t be ready until late next year because they need to improve the shot’s effectiveness in older people.
The companies said early trials showed the vaccine produced an “insufficient†immune response in older adults, demonstrating the need to refine the product so it protects people of all ages. London-based GSK and Paris-based Sanofi, now expect the vaccine to be available in the fourth quarter of 2021.
Both companies’ stocks declined on the news.
As of today there are 52 COVID-19 vaccines approved or in development. Of the six which have received approval, only Pfizer’s has received approval for use in humans in any Western country. The other five were developed in China or Russia.
Of the other 46, six are in Phase 3 trials. Moderna’s vaccine is the closest to gaining emergency use authorization. Of the balance of those being developed by Western companies, the closest to getting approval are from AstraZeneca, Johnson & Johnson, and Novavax.
Did you look at the stats for Pfizer and its use in older people? Sort of OK for 65-75, but over 75 the results are pretty meaningless. Interesting to see if Moderna did better job in the older age group. I had wondered if we might actually be better off starting with older people rather than health care workers but given the lack of evidence for older people it may actually be better to use in the health care workers who care for them.
Steve
What is “meaningless over 75”?
There wasn’t enough data?
The confidence bars were too wide?
Or the indicated effectiveness is below X%?
My own view (speaking as an old person) is that we shouldn’t worry about inoculating old people in nursing homes until much later in the process for three reasons:
1. They can be protected effectively by inoculating people who work in the facilities and closing them to uninoculated persons.
2. There are fewer of those than of old people in nursing homes.
3. People in nursing homes die. That will skew the results of the vaccine.
I already have problems with how COVID-19 deaths are being identified. In Illinois at any rate death for any reason of someone who has received a positive result on a COVID-19 test is a COVID-19 death.
Around 21% of the trial participants were over 65, but there were only five cases of COVID-19 for age over 75 and they all got the placebo and fifteen cases from 65-74 and all but one got the placebo.
One inference would be that the vaccine was so successful it prevented cases, but the study does not use non-cases to calculate effectiveness, presumably because we cannot know whether those who didn’t get infected were ever exposed. But I don’t think this type of study would ever be large enough to determine effectiveness in subgroups.
I agree w/ Dave on prioritizing those that come and go from nursing homes.
I’m mostly agnostic about front-line health-care workers getting priority, I think this is more of a perk we should offer to those who’ve dealt personally with care for those infected. It doesn’t seem like they are sources of spread. Talked to a nurse last night who has pre-existing conditions of concern, and she said that there’s nowhere she feels safer than on one of the COVID floors because of all of the precautions. She’s in no hurry to get vaccinated, which is fine.
I would prioritize age and speed and there are some logistical benefits to prioritizing long-term care facilities of various types.
I think there is reason to suspect that the vaccine may not be quite as effective for older people because their immune system is not as good as it once was. But apparently mRNA vaccines focus on the spike protein in the virus and are not dependent like traditional vaccines on leveraging a person’s immune response. At least that’s my rough understanding.
Speed is more important than targeting because the benefit of herd immunity is ultimately to the herd, not necessarily any individual.
I would like to have known more about who Pfizer rejected from the trials because it looks like they tried to get people with pre-existing conditions but rejected those whose conditions were not controlled. Seems like that group should be flagged with caution.
” In Illinois at any rate death for any reason of someone who has received a positive result on a COVID-19 test is a COVID-19 death.”
And with pcr cycles up in the 35+ range yielding perhaps 90% false positives the whole covid case/death counts are a circus event.
Trust the “science.” Yeah, right.
PD mostly has it. Not enough people in the study in the older age group. The results are just as likely to be a random finding as real.
“And with pcr cycles up in the 35+ range yielding perhaps 90% false positives the whole covid case/death counts are a circus event.”
A little bit of knowledge is a dangerous thing. Stick with stuff you understand. (But everything is now a conspiracy theory for you guys so nothing will stop you.)
“In Illinois at any rate death for any reason of someone who has received a positive result on a COVID-19 test is a COVID-19 death.”
Not how the CDC counts them. They take them off of the death certificates.
Steve
Pritzker’s top health care advisor has said that’s how the State of Illinois counts them. I’m not making it up; I looked it up yesterday.
I would not say the signal for over 75 is not there.
For over 65 (which includes over 75); the 95% confidence interval of effectiveness was 66% to 100%. There’s no biological process that renders a vaccine instantly ineffective at 75.
I think the efficacy for 65-75 is lower. The confidence intervals for the older group are meaningless. So if you use an efficacy of 53.2%, and you know that vaccines dont generally work as well you get older, then the issue is not that it becomes instantly ineffective at 75 but that we dont really know what is through that entire range of 75-90. There is a good chance it is well below 50% and the risk is that its a new vaccine where we dont really know the risks. Cornell outlines it.
https://garycornell.com/2020/12/09/statistics-in-the-pfizer-data-how-good-is-the-vaccine/
I think the author of that post isn’t quite looking at it right.
The interval for 65-75 is 53% to 100%. The interval for > 75 is -12 to 100%.
But combined the age groups; the analysis in the NEJM for > 65 the confidence interval is 66% to 100%.
And the point estimate for the true efficiency for > 65 isn’t very far from the point estimate for the over all population at 94%. i.e. there isn’t evidence from the study that the vaccine was less effective among the elderly.
But we know that vaccines are generally less effective as you age. You can combine the two age groups if you want, but it doesn’t tell you much about the age group of interest. Heck, eliminate all separate age groups and lump them all together. You get nice numbers but not useful for the highest risk group. But since we can separate them out and we know the numbers we know that based upon this study we actually have no idea how effective the vaccine is for older people, these results could have been due to random chance. We have to rely upon other evidence.
Steve