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What does it mean for a drug or treatment to be "FDA approved"?
Prescription drugs and medical devices for specific medical conditions have to go through an arduous approval process (showing that they work and that their benefits outweigh their risks) before getting to market. The average time it takes for a drug to hit the pharmacy is 12 years, and hundreds of millions of dollars are spent on research, development, and trials. Note that the FDA does not actually test these drugs; it simply reviews the testing processes.
FDA Approved Definition & Meaning: A Physician Explains What to Look Out For (prevention.com)
The Covid vaccines are 'authorized' and not 'FDA approved' [EUA: Emergency Use Authorization]
- Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.
Emergency Use Authorization | FDA
Which Organization(s) Selected the Specific Spike Protein The Moderna Vaccine Would Produce?
The Spike (S) proteinwas selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH,directed by Anthony Fauci.
Who Led Moderna's Phase 1 Trial?
National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, directed by Anthony Fauci.
When Did Moderna's Phase 1 Trial for it's Covid-19 vaccine begin?
Dose 1 was administered March 15, 2020.
How Long Did Moderna's Phase 1 Human Trials Last?
57 days.
Dose 1 and Dose 2 were given on Day 1 and Day 29 respectively. The particpants were monitored for 28 days following Dose 2 for anti-body development.
Here's Moderna's Summary Graphic:
COVID-19 Vaccine (mRNA-1273) (modernatx.com)
How Many People Participated in Moderna's Phase 1 Trial for it's Covid-19 vaccine?
Hopeful results from phase 1 Moderna COVID vaccine trial | CIDRAP (umn.edu)
"45 healthy participants 18 to 55 years old enrolled (volunteeered) at sites in Seattle and Emory University in Atlanta and vaccinated from Mar 16 to Apr 14." [ransomnote: One additional participant withdrew after developing vaccine-related urticaria (hives)].
Three groups of 15 participants each received two intramuscular injections 28 days apart. All subjects received one injection; and 42 received a second injection.
[ransomnote: Three groups of 15 participants each. Each group was tested for a different dosage [25, 100, or 250 micrograms (μg) of mRNA-1273]
[ransomnote: The trial, which expected to be broadened in April to include participants older than 55 years, and would go on to have 90 enrollees, but the preliminary phase 1 report only included the 45 member 18- to 55-year-old group. Useful information on the older cohort is hard to find - the group may have ended up being 90 persons. ]
PLACEHOLDER: INSERT 55+ PHASE 1 OVERVIEW HERE
What did Moderna's Phase 1 Trial Monitor?
FROM: Hopeful results from phase 1 Moderna COVID vaccine trial | CIDRAP (umn.edu)
"The researchers monitored vaccine-induced antibody activity for 29 days after the second injection as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2." [ransomnote: This should be impossible. Researchers requesting samples of live SARS-CoV-2 are still told no such samples exist]
Did Moderna's 45 Participants in their Phase 1 Trial Experience Side Effects?
FROM: Hopeful results from phase 1 Moderna COVID vaccine trial | CIDRAP (umn.edu)
"More than half of the enrollees reported chills, fatigue, headache, muscle pain, or pain at the injection site. After the first dose, mild or moderate systemic adverse events were reported by 5 enrollees (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group."
"Systemic adverse events occurred more often after the second injection and in those given the highest vaccine dose, occurring in 7 of 13 enrollees (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group. Three volunteers in the 250-μg group (21%) reported at least one severe event."
Moderna's Vaccine (mRNA-1273) Development Timeline
Placeholder: Mouse Study
Placeholder: Phase 2
Placeholder: Phase 3
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ransomnote's comment: these small volunteer studies are not used to validate viruses but are small exploratory studies used to determine if full validation studies are warranted. With EUA for Covid-19, I think the rules re validateion studies in phase 3 were bent 'significantly' to allow for 'emergency use'. I'll soon find out.
"Clinical experience and observational studies cannot and should not be used to validate intervention effects [1]. The randomised clinical superiority trial remains the mainstay of modern clinical intervention research and is needed for a valid assessment of possible causality between interventions and outcomes [1]."
Pasted from <https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-14-34>