That’s a lot of i’s and a lot of t’s
These vaccine data packages are huge. Just huge. So much bigger than a typical drug or vaccine filing. Aduhelm (someone else mentioned above) Phase 3 data included 3,285 patients. Pfizer’s vaccine Phase 3 trials were close to 50,000 participants.
Perhaps, just perhaps, the process need to be reviewed and brought kicking and screaming into the 21st century. This will, most likely, happen again, and when companies like Moderna can design a vaccine in two days (once the dna sequence of the virus is available), it seems like the approval process needs to adjust to new technologies. Maybe we can start with articulating just what “dotting the i’s and crossing the t’s” means?
1 Like
The process is still gated by the time it takes to do the trials.
Of course, now the question is, will there have to be an extensive approval process if a company with an existing approved COVID-19 vaccine makes a version of the vaccine tuned for a variant, like how influenza vaccines are made for new influenza variants each year?
2 Likes
All of the developmental guidance for industry and review process details are publicly available on FDA’s website. I am sure there are opportunities for improvement, but most likely take governmental $$$ being allocated from elsewhere.
And since it’s publicly available that must mean that it’s the best possible way to handle new technologies?
As the government struggles to process tax filings and passport applications with their outdated computers and IT infrastructure, I guess an efficient vaccine approval process may be asking a little much.
Page include R0 estimates for some variants. Higher R0 means that the percentage immune needed for herd immunity is higher.
| Variant | R0 |
|---|---|
| Ancestral | 2.4-2.6 |
| B.1 ? | 3 |
| B.1.1.7 Alpha | 4-5 |
| B.1.617.2 Delta | 5-8 |
3 Likes
Adding to the above table, and adding measles for comparison:
| Variant | R0 | % immune for herd immunity |
|---|---|---|
| Ancestral | 2.4-2.6 | 58-62% |
| B.1 ? | 3 | 67% |
| B.1.1.7 Alpha | 4-5 | 75-80% |
| B.1.617.2 Delta | 5-8 | 80-88% |
| Measles | 18 | 94% |
See Maths in a minute: "R nought" and herd immunity | plus.maths.org for a description on calculating herd immunity from R0.
1 Like
adding Measles really puts things into perscpective. It has a much higher RO but yet it is mostly considered wiped out in this country (with the exception of occasional outbreaks.) Makes you think that long term COVID elimination is very possible.
1 Like
According to Dr. Fauci, polio and smallpox would still be around if we had as much misinformation about their vaccines as we have about COVID vaccines. Smallpox has R0 around 5 and polio slightly higher.
1 Like
One question that there still seems to be little or no information about: do vaccinated people who get breakthrough infections get long haul problems?
1 Like
That’s what I want to know too.
Can vaccinated people get long Covid? Doctors say risk is 'very, very small' indicates that physicians treating COVID-19 patients are anecdotally saying that long haul COVID-19 is rare in breakthrough cases (unlike in unvaccinated cases), but large scale research using the VA database is not yet finished.
In other words, what little information there is suggest that vaccination is probably highly helpful at preventing long haul COVID-19, but it is best to exercise some caution in the absence of completed research on the topic (unfortunately, this seems to be a mostly neglected area of COVID-19 research).
1 Like
This is an interesting spin. Saying that vaccinated people getting Asymptomatic Delta would be a better alternative than a 3rd booster in terms of protection. This only works where you have a high incidence of vaccinate compliance though.
1 Like
Has anyone seen information anywhere on what vaccines were given to the folks with the severe breakthrough cases, those who were hospitalized or died? I’m sure it’s been tracked. Not sure that’s something they would share, but they should.
1 Like
Post deleted
Thanks for that link, those are some good findings! But, they are likely not applicable to the larger population as Diana Berrent states:
With acknowledgement that this was not a poll of random people so is not meant for all elements of the data to be able to be extrapolated to the public at large)
1 Like
My understanding was that R naught isn’t a constant for a particular disease or variant but is influenced by many factors including human behaviors. These higher values have happened during a time of ever decreasing masking, distancing etc. so maybe reinstating some restrictions can improve the situation and change that value?
Unfortunately, the numbers given in that Twitter thread seem to be inconsistent with themselves, even beyond the issue of how the survey was done. For example, compare posts 7 and 8 in the Twitter thread. Post 7 says that 20/697 (2.87%) Moderna vaccine recipients surveyed had breakthrough symptomatic cases, while post 8 says that 7/18 (39%) has breakthrough symptomatic cases that led to long Covid. Why isn’t the numerator in post 7 the same as the denominator in post 8? For J&J (with 127 recipients total), the numbers listed make even less sense, since post 7 says that 13/115 (11.3%) had breakthrough symptomatic cases while post 8 says that 13/127 (10%) had breakthrough symptomatic cases that led to long Covid.
Also, the thread’s numbers are hardly optimistic in terms of avoiding long Covid if you actually do get a breakthrough case after the Pfizer or Moderna vaccine (ignoring the wildly-inconsistent-with-itself J&J numbers). But than, as noted, that could be related to the self-selection bias among those answering the survey.
1 Like
Can’t believe anyone on cc would give credence to a so-called survey on twitter. As any AP student should know, self-reported anecdotes are essentially worthless.
2 Likes