Anne Josephine A.

Juson Internal Medicine Level I

SLMC QC

Appraising Validity
 Were patients randomly assigned to treatment group?
o YES. On page 3 of the article it was stated that, “Participants were randomly assigned in a
1:1 ratio, through the use of a centralized interactive response technology system, to
receive vaccine or placebo.”
 Was allocation concealed?
o YES. On page 48 of the Protocol Supplementary material, it was stated that, “The
randomization will be in a blinded manner using a centralized Interactive Response
Technology (IRT), in accordance with pre-generated randomization schedules. Only the
Unblinded personnel will have controlled access to which arm the participant is randomly
assigned.”
 Were baseline characteristics similar at the start of the trial?
o YES. On page 6, table 1 shows the baseline demographic and clinical characteristics of the
study participants. The baseline characteristics between treatment and control group are
not significantly different from each other. Furthermore, as stated on page 7, column 1,
Anne Josephine A. Juson Internal Medicine Level I
SLMC QC

“Baseline demographic characteristics were balanced between the placebo group and the
mRNA-1273 vaccine group.”

 Were patients blinded to treatment assignment?

o YES. As stated on page 52 of the Protocol Supplementary material, "The investigator, study
staff, study participants, site monitors, and Sponsor personnel (or its designees) will be
blinded to the IP administered until study end". Moreover, on page 53, it is stated that “An
opaque sleeve over the syringe used for injection will maintain the blind at the time of
injection, as the doses containing mRNA-1273 will look different than placebo.”
 Were caregivers blinded to treatment assignment?
o YES. As stated on page 52 of the Protocol Supplementary material, "The investigator, study
staff, study participants, site monitors, and Sponsor personnel (or its designees) will be
blinded to the IP administered until study end". Moreover, on page 53, it is stated that “An
opaque sleeve over the syringe used for injection will maintain the blind at the time of
injection, as the doses containing mRNA-1273 will look different than placebo.”
 Were outcome assessors blinded to treatment assignment?
o YES. As stated on page 52 of the Protocol Supplementary material, "The investigator, study
staff, study participants, site monitors, and Sponsor personnel (or its designees) will be
blinded to the IP administered until study end". Moreover, on page 53, it is stated that “An
opaque sleeve over the syringe used for injection will maintain the blind at the time of
injection, as the doses containing mRNA-1273 will look different than placebo.”
 Were all patients analyzed in the groups to which they were originally randomized?
o YES. According to page 4, column 2, “Participants were evaluated in the treatment groups to
which they were assigned.” However, it is done in a modified intention-to-treat analysis.
Anne Josephine A. Juson Internal Medicine Level I
SLMC QC

 Was follow-up rate adequate?

o NO. Although, as stated in page 4, column 2, that the study has met the follow-up duration
of at least 2 months from the last (2nd) dose with an efficacy cut off date of November 21,
2020, computation of the best-case scenario and worst-case scenario showed otherwise.

TREATMENT GROUP CONTROL GROUP

n= 15,210 n= 15,210

Analyzed= 14,550 Analyzed= 14,598

Dropouts= 660 Dropouts= 612
Death=0 Death= 0

DEATHS 0/14,550 0/14,598

DROPOUTS 660 612

WORST CASE SCENARIO X TW XCW

=0 + 660/15,210 =0/15,210
= 0.0434 =0

COMPARISON X >X
TW CW

BEST CASE SCENARIO XTB XCB

=0/15,210 =0 + 612/15,210
=0 = 0.0402

COMPARISON X <X
TB CW

The best-case scenario shows fewer bad events for treatment, while the worst-case scenario shows
more bad events for treatment. Therefore, there were too many drop-outs in this study.