BioNTech/Pfizer [1]: "This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined."
Moderna [2]: "Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate."
AstraZeneca [3]: "In this interim analysis, we have not been able to assess duration of protection, since the first trials were initiated in April, 2020, such that all disease episodes have accrued within 6 months of the first dose being administered. Further evidence will be required to determine duration of protection and the need for additional booster doses of vaccine."
Johnson & Johnson [4]: "A limitation of the trial is the relatively short follow-up, which was necessitated, as in other Covid-19 vaccine trials, by the urgent need for vaccine. The data do not suggest a waning of protection."
[1] https://www.nejm.org/doi/full/10.1056/nejmoa2034577 [2] https://www.nejm.org/doi/full/10.1056/nejmoa2035389 [3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [4] https://www.nejm.org/doi/full/10.1056/NEJMoa2101544
There is also the official reaction. Aug 18, 2021: "CDC Director Says Coronavirus Vaccines Less Effective For Delta But Still Prevent Severe Infection".
Possible all of these studies are flawed. And perhaps I'm accidentally misquoting Rachel Walensky. Given that the original trials were closed by vaccinating the control arm of the studies, not even sure where to look for credible longterm tracking of VE against infection data.
On the other hand, possibly the manufacturer original studies were flawed. Or the virus evolved, Delta, duh. These conversations are difficult to carry partly because we are supposed to take the original studies, created with (acceptable) conflict of interest as gold standard, and summarily dismiss any independent verification thereof.
https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v...
https://www.nejm.org/doi/full/10.1056/NEJMoa2114114
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410
https://www.forbes.com/sites/andrewsolender/2021/08/18/cdc-d...
UK, VE vs delta over 90 days
days VEaPCRI VEaSI
after
2nd
dose
14 85% 93%
30 83% 92%
60 80% 86%
90 75% 78%
Now the picture seems to be that vaccine effectiveness does indeed drop over time, but protection against severe disease remains pretty strong, with the possible exception of old people who tend to have a weak immune response. Most governments have reacted by recommending third shots to this group in order to further improve the protection.
I really can't see any controversy here. This is precisely the procedure one expects when a new vaccine is introduced.
It is also worth pointing out, that even without boosters the vaccines vastly outperform any medication tested against COVID so far. And they do that much cheaper and with lower side effects.
Nuance: Not mentioning that their own full application estimates saving one in a million children, under the best circumstances. See Table 14 on page 34.
The difficult ethical question: on one hand there is 1 child you may save given the information available today. On the other hand you don't know which one ahead of time, you need to inoculate 1 million children with a vaccine for which you don't have any longterm data on.
https://www.fda.gov/media/153447/download