COVID-19 Vaccine Clinical Trials-Study-Moderna-94.5% efficiency
A phase-3 randomized study on 18 years and older population
Two injections are given, 28 days apart, and this vaccine should be able to prevent COVID-19, essentially vaccines are for this purpose only
This is an mRNA vaccine as well just like the one discovered by Pfizer
All the vaccines are developed to prevent severe symptoms of the virus, but we are not sure if they are exposed to COVID to test the efficacy of the same
The sample population have no known COVID already but are at risk, and this is a placebo-controlled blind study
Participants are tracked for 24 months via their blood samples, weekly surveillance is rigorously completed for this drug study
30,000 participants have enrolled in this study and would be receiving a 1:1 placebo or the drug, so technically only 15,000 would have received the actual vaccine shot
Randomization will be done in a manner, where at-risk patients receive a shot and > 65 years participants also receive one, so that drug efficacy is known across all age groups
The vaccine contains this: The mRNA-1273 IP is an LNP dispersion of an mRNA encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available): the proprietary ionizable lipid SM-102; cholesterol; 1,2-distearoyl-snglycero-3 phosphocholine (DSPC); and 1 monomethoxypolyethyleneglycol-2,3-dimyristylglycerol with polyethylene glycol of average molecular weight 2000 (PEG2000- DMG)
This is a rapid response vaccine platform based on a messenger RNA delivery system, this type has been used to develop vaccines for Zika, Influenza virus
There is also a theoretical risk of active vaccination causing a paradoxical increase in the risk of disease
Non-child bearing females and childbearing females with a negative pregnancy test and adult males, all of them in the ages of 18+ are part of this study
Moderna vaccine is to be stored between 2–8 C, which is higher than that of Pfizer vaccine
If the participants contract the virus during or after the vaccine, they will be studied if they are developing any severe symptoms of the virus
Oral thermometers and rulers will be provided to all, and pulse oximeters and other medicinal supplies will be furnished by the study sponsor
Blood sampling volumes, Adverse Effect diaries, visits, telemedicine consultations are all planned as part of the vaccine efficacy study
FDA is ready to approve 50+% efficacy, Pfizer reporting 95% and Moderna reporting 94.5%, both are likely to get approved for human use
These vaccines are developed after studying the genetic code of the virus, and messenger RNA producing the spike protein
Since children have been not included in the study, they are less likely to get vaccinated post-approval- Only the Pfizer study included children
First responders, essential workers, teachers, old people at risk, and young adults who have existing conditions, are likely to get vaccinated first post the FDA approval
Pfizer and Moderna both use mRNA vaccine platform, the first of which will be when they get approved, in general cold inactivated virus is used as a vaccine, but these vaccines, instruct our body to place spike protein cells on top of the virus layer and teaching our immune system to ward off the bad guy
Typically a virus infection offers better immunity than the vaccine, but tetanus and HPV vaccine offer better protection than contracting it
Reference: https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
