DOCTORS ' LOUNGE
DOCTORS ' LOUNGE
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Just as soon as I read that it was
possible to apply for SARS-CoV-2 vaccine trials , I did . I hunted online for weeks . In May , I filled out a general National Institutes of Health ( NIH ) application , but was told I was too old for Phase 1 trials . On July 8 , I read that the NIH was establishing a clearinghouse for all trials , the COVID-19 Prevention Trials Network ( COVPN ). This was bound up with “ Operation Warp Speed ” and based out of Seattle , Atlanta , Durham , North Carolina and Los Angeles . I filled out a general “ I am interested ” application and waited for news . I was envious of the young .
Back in early August , I applied for the University of Louisville ’ s trial with Dr . Julio Ramirez , Ruth Carrico , DNP and Forrest Arnold , DO but feared I was too old and / or too retired , since an email from the Greater Louisville Medical Society said the study was designed for health care workers , and I am currently exposed only through my husband . This one is a Johnson & Johnson / Janssen Ensemble trial and as of Veterans ’ Day , UofL asked the on-file applicants to step right up and sign in now for the go-live Phase 3 study , the details of which they ’ d learned from the investigators ’ online forum of Nov 10 . The University of Kentucky , along with Norton Healthcare and Baptist Health Lexington , are recruiting community volunteers for the Ensemble trial - which I learned belatedly , via the local National Public Radio story , and had to scramble to urge my friends and family here to consider joining .
30 LOUISVILLE MEDICINE
VACCINE ENVY AUTHOR Mary Barry , MD
Ignorantly , after my initial NIH rejection I had assumed that the study at Cincinnati Children ’ s was for younger people . Only one half of it was though , for the Phase 1 and 2 trials . Robert Frenck , MD , Director of the NIH-funded Vaccine and Treatment Evaluation Unit , leads this study . This site is using the German / Pfizer vaccine that made headlines the week of Nov . 8 for its stated 90 % efficacy in an initial safety committee evaluation of Phase 3 data ( 44,000 patients , only nine of the 94 cases had been in the active , not placebo arm ). Their Phase 3 enrolled patients up to the age of 85 . The COVPN site will give you a list of all trials that are currently enrolling in every state .
The Pfizer trials are not part of “ Operation Warp Speed ” and possibly will finish the entire FDA vaccine approval process , but Pfizer is feeling the heat from Moderna , the other M-RNA type vaccine , to be first in distribution . Billions of dollars of potential profit ( and I like to think lives , too ) are at stake . The FDA may crack under pressure . However , these vaccines require ultra-cold freezers that may be up to $ 20,000 each . How many failing-as-it-is rural hospitals can afford such freezers ? How fast can we make enough to go around ? The new medical arms race might involve freezing capacity , or transport capacity . How many trucks are needed to carry ultra-cold freezers around ? How many generators are needed to back up the ultra cold freezers ?
In August , I followed a random news bite to the Vanderbilt Moderna vaccine trial but did not get in fast enough since only 1,000 volunteers were requested . My beloved homie Dr . Diane Schneider ( we spent med school and residency joined at the hip ) had made it into the Moderna trial in San Diego and reported with hope that 24 hours after a dose , she felt like hell for three days . We were encouraged .
On Sept . 6 , I was checking the NIH sites and lo and behold , Indiana University was planning to open its trial and I emailed them stat . On Sept . 7 , they contacted me and after multiple questionnaires , I was accepted and had my first visit the day after Election Day . I was soul-weary and anxious politically , but thrilled to be there per-