COVID: more on the Moderna vaccine

there was some important feedback i got regarding the post on the Moderna vaccine (see http://gmodestmedblogs.blogspot.com/2020/05/covid-new-vaccine-trial.html ):
  1. i did come across as being rather strident. i was very concerned about the early release of insufficient data for us to really evaluate the vaccine. and, not having enough data is in some ways worse than not having anything. more questions, more uncertainty, more inability to answer questions raised by the study for concerned patients/staff.
  2. but i do strongly believe that the only way out of Covid-19 is to have an effective vaccine. and this one may be it... there will be expanded studies, as noted below
  3. i was also naive to the process of the publication of results. Anna Wald made the following comments that put the Moderna press release in perspective and indicated that what Moderna did was in fact required:

The company is legally required to put out the data in the public once it is known and shared with pretty much anyone.  They had to submit the data to the FDA for phase 2 and 3 studies, so they would not be able to have it remain confidential.   So they can’t wait till publication – and you really would not want to publish the first 8 cases in peer reviewed literature. Thus they provided what they had to the public as required. 

 

For this phase 1 trial, they are enrolling 105 in various age strata, so that is actually a pretty big phase 1 study.   The  participants are healthy adults, 18-99.  Here is a bit more data about it https://clinicaltrials.gov/ct2/show/NCT04283461?term=vaccine&cond=COVID&cntry=US&draw=2&rank=1.


in fact, the trial was started and enrolled in record time, and longer term data are not yet available. 

4. Jon Pincus sent me an email stemming from an NPR segment (https://www.npr.org/2020/05/19/858977817/china-leads-the-worldwide-race-to-develop-a-covid-19-vaccine ). per Jon:
I would add that the number of currently available, approved mRNA vaccines is 0. And I believe the total number of people who have received mRNA vaccines is about 3,000 so we know very little about the safety of these new vaccines.  Hopefully this technology is a new way to rapidly develop safe and effective vaccines with rapidly scaled up production but as you point out it’s way to early to even get a safety signal from this vaccine or even mRNA vaccines in general

he included a reference (see https://www.nature.com/articles/s41541-020-0159-8 ): which notes that mRNA vaccines comprise a new technology, easier expression of complex proteins that are otherwise difficult to generate, easier ability to express potent monoclonal antibodies, and signifcant rapidity to manufacture in large quantity, though "assuming that mRNA vaccines will be proven clinically efficacious and safe". but as they also note, mRNA constructs are a work in progress that will undoubtedly be improved and optimized over time. and that "early-phase clinical trials need to be designed in a way to appropriately capture the inflammatory component intrinsic to all mRNA vaccines, given that several intracellular innate immune response sensors are activated by RNA" (??a concern for Covid-19??)


as a general statement: i really appreciate getting feedback, and i am very happy to pass it on, with or without personal acknowledgement (i would not include your email address, and will not include your name unless you give me permission to)


geoff

 

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geoff

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