The mRNA Vaccine

Dr. Mel Herbert reviews the new MRNA Vaccine and explains why it is not as good as you have been lead to believe.

Brad L. -

Any data on previous use of this genetically manipulated material in respect to safety in humans relative to mutational consequences vs standard vaccination approaches?

Ian L. -

Moderna not -70C
Can store in Fridge
Different Tech

Mel H. -

Ian yes - I uploaded the wrong file it should say -7oC - which is like a standard freezer - will get corrected this am. Brad - long term safety of mRNA vaccines...we don't know - I believe this is the first commercially available mRNA vaccine. If you want to hear some actual experts on this and other COVID topics the "This Week in Virology" podcast is excellent!

Kate F. -

I was also wondering about the safety, particularly longer term. Presuming they offer this first to healthcare workers, it would be helpful to have more information to make an informed decision on whether to take it. Maybe EmRap could do a segment?

Would you take it Mel?

Mel H. -

I have an expert coming on the show soon. Long term safety we will have to see. Would I take it...yes if called into the clinical areas again I would. COVID and long COVID is a known bad thing, in the vaccine trials no significant bad things seen yet. It is possible side effects could show up later, but on measure if I was in a high risk group, I would take it. Health care workers on the frontline are high risk.

Victor A. -

Mel, I love your work but I dont think any of your points about their purported results are “gotchas”

Mel H. -

Victor - maybe gotcha is too much, but just trying to make sure people understand there is still a lot of work to do and data to see. We haven't see a published paper on this yet, so I just want to be clear we need to dive into the data before we get too far ahead of ourselves, but it is looking good...

Sean R. -

Regarding Mel's mRNA update, i'm a bit confused:
43,000 covid neg people get vaccine (placebo or actual)

7 days after 2nd dose ask who has sx c/w covid

Find 94

Break that down into who got vaccine and who got placebo

(But 100% of the 94 have mild sx in the first place, that’s how they identified them)

And if you got the actual vaccine you were 90% likely to not have mild sx? but they all had mild sx because that's how they were identified

what am i missing? obviously something!!! lol


Mels Reply:

As best I can work out Sean R that is right. They identified by symptoms 170 people that also proved to have positive test - and in that group 95% where from the placebo arm. But this is why it is hard to put together without the published paper:

This is from the study protocol but it is not that illuminating, I heard a talk by one of the investigators and that (above) is how he explained it:

Phase 2/3 is event-driven. Under the assumption of a true VE rate of ≥60%, after the second
dose of investigational product, a target of 164 primary-endpoint cases of confirmed
COVID-19 due to SARS-CoV-2 occurring at least 7 days following the second dose of the
primary series of the candidate vaccine will be sufficient to provide 90% power to conclude
true VE >30% with high probability. The total number of participants enrolled in Phase 2/3
may vary depending on the incidence of COVID-19 at the time of the enrollment, the true
underlying VE, and a potential early stop for efficacy or futility.

Amelia R. -

Our work discussion yesterday was around this supposition/question. There may be a number of front line workers who have been exposed to the virus but were never symptomatic so haven't been tested. If this was enough of an exposure to trigger an immune response, is there a risk of this vaccine triggering the overactive immune response (like we're already seeing in some COVID patients)? Should people get an Ab test prior to the vaccine to see where they are? Did they do any pre-testing of patients in the studies?


AR I am not sure - they tried to EXCLUDE people with suspected or known COVID-19 infection.

From the protocol:

Exclusion: Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT
result was not available) or microbiological (based on COVID-19 symptoms/signs and a
positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.

Matt P. -

1. Sounds like this could set up for a large denominator of negative patients in the vaccine group 2/2 AE of the vaccine causing viral-like syndrome. Will be interesting when the data comes out.

2. Embryonic stem cell use in the development will be objectionable for
some patients.

Matt P. -

For clarification on point 2, I meant to be commenting generally on some of these vaccines. I do not know the specifics on this particular one in regard to embryonic stem cell use.

Zebulon W. -

Any new research for 2021 showing whether there is reduction in transmission and not just reduction in symptoms for the vaccines?

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