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SMALL THREAD: With the news now of the Pfizer/BioNTech approval in the UK, here a paper summarising an early dose-escalation trial assessing safety, but also immunogenicity (ability to induce an immune response). https://www.nejm.org/doi/full/10.1056/NEJMoa2027906
I have no idea when the Phase 3 data dump is going to happen, so I want to capitalise on the current interest and say a few things that occur to me looking at this recent report in NEJM.
There were two candidates under investigation, BNT162b1/2, which encode either a secreted or membrane-bound form of the SARS-CoV-2 spike protein.
This could be informative for future strategies to try these two options. I only see minor differences in the data on first pass.
This could be informative for future strategies to try these two options. I only see minor differences in the data on first pass.
Importantly, this study assessed immunogenicity in two broad age bands, including older individuals >65 years of age (who can be tougher to vaccinate).
It was a small study at this stage with 195 participants, divided into 13 groups.
So, to the safety...
It was a small study at this stage with 195 participants, divided into 13 groups.
So, to the safety...
This figure shows local reactions to the two candidates. Nothing between them IMO. Seems that the majority of people will experience 'minor' pain at the injection site. No major redness, maybe swelling at second dose. Placebo clean, as you would hope. ;)
Probably worth telling those receiving one of these vaccines that it will likely hurt a bit for a day or two afterwards, but this is really minor stuff.
Looks like BNT162b2 is slightly more mild?
Looks like BNT162b2 is slightly more mild?
Here "systemic effects", like fever and chills, after the first and second dose. Fever was rare. Fatigue seems to be similar in both vaccinated and placebo after first dose, but increases with the second dose. Chills are common, dose proportional and absent in placebo (i.e. real)
These data suggest that you will likely experience some degree of 'the chills', some fatigue, but it will be minor, and less a problem with increasing age (just a trend).
Just a boring, normal, thalidomide-free vaccine so far (sorry, couldn't resist).
Just a boring, normal, thalidomide-free vaccine so far (sorry, couldn't resist).
Here the immunogenicity, as measured by antibody response. On the right we see "HCS" which stands for healthy convalescent serum, i.e. antibodies measured in serum from patients recovered from the natural infection.
What really leaps out at me from this data are two things:
1) In young adults, the vaccines both induce significantly stronger antibody titers compared to natural infection.
And more important:
2) In older age groups, you HAVE to go back for the second jab.
1) In young adults, the vaccines both induce significantly stronger antibody titers compared to natural infection.
And more important:
2) In older age groups, you HAVE to go back for the second jab.
You also have to go back for the second dose if you're your, don't get it twisted. ;)
The arrows represent when the dose is administered. You can see on d21, when the second dose is administered, the antibody response in >65 years is not high enough that we can be sure of the protection level with a single dose.
There will be more data on this from the bigger trials and the picture may change, but from this data, if your mum & dad say "nah I don't fancy the second one" you poke'm in the ribs and tell them to sort it out immediately.
That's an order.
That's an order.
I hope that the larger trials will discuss T cell responses, but considering a humoral response of this magnitude, cellular responses are taking place.
Remember, the primary goal of this was SAFETY. If you don't have that, you don't have much.
Remember, the primary goal of this was SAFETY. If you don't have that, you don't have much.
