2021 BQ Journal Vol 42 - 31

Early Release

among persons with underlying medical conditions. Ten hospitalizations due to COVID-19 were documented; nine in the
placebo group and one in the vaccine group (9). Preliminary
data suggest that the Moderna COVID-19 vaccine might also
provide some protection against asymptomatic SARS-CoV-2
infection (7). Among vaccine recipients, reactogenicity symptoms, defined as solicited local injection site or systemic adverse
reactions during the 7 days after vaccination, were frequent
but mostly mild to moderate. Systemic adverse reactions were
more commonly reported after the second dose than after
the first dose and were more frequent and severe in persons
aged 18-64 years than in those aged ≥65 years. Most local and
systemic adverse reactions occurred within the first 1-2 days
after vaccine receipt and resolved in a median of 2-3 days.
Severe local or systemic adverse reactions (grade ≥3 reactions¶)
occurred more commonly in vaccine recipients than in placebo
recipients (21.6% versus 4.4%). Among vaccine recipients,
9.1% reported a grade ≥3 local injection site reaction, and
16.5% reported a grade ≥3 systemic adverse reaction. The
frequency of serious adverse events** observed was low in both
the vaccine (1.0%) and placebo (1.0%) recipients and without meaningful imbalances for specific serious adverse events
between the two groups (8). No specific safety concerns were
identified in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection.
A detailed summary of safety data, including information on
reactogenicity, is available at https://www.cdc.gov/vaccines/
covid-19/info-by-product/moderna/reactogenicity.html.
From the GRADE evidence assessment, the level of certainty
for the benefits of the Moderna COVID-19 vaccine was type 1
(high certainty) for the prevention of symptomatic COVID-19.
Evidence was type 2 (moderate certainty) for the estimate of
prevention of COVID-19-associated hospitalization and
type 4 (very low certainty) for the estimates of prevention of
asymptomatic SARS-CoV-2 infection and all-cause death.
Data on COVID-19-associated hospitalizations and deaths
are limited at this time; however, a vaccine that effectively
prevents symptomatic infection is expected to also prevent
associated hospitalizations and deaths. Regarding certainty of
evidence related to possible harms after vaccination, evidence
was type 2 (moderate certainty) for the estimate of serious
adverse events and type 1 (high certainty) for the estimate
of reactogenicity. Data reviewed within the EtR Framework
supported the use of the Moderna COVID-19 vaccine. ACIP

determined that COVID-19 is a major public health problem
and that use of the Moderna COVID-19 vaccine is a reasonable and efficient allocation of resources. Whereas there might
be uncertainty about how all populations value the vaccine, it
was determined that for most populations, the desirable effects
outweigh the undesirable effects, making the vaccine acceptable
to implementation stakeholders. In addition, implementation
of administration of the Moderna COVID-19 vaccine is feasible. Although the vaccine requires a freezer (-20oC [-4oF])
for long-term storage, it is stable at refrigerator temperatures
(2-8oC [35-46oF]) for up to 30 days after thawing. This
characteristic will facilitate feasibility of administration of the
Moderna COVID-19 vaccine in most community settings,
once supply allows. Advancing health equity, however, will
require efforts to identify and reduce access-related barriers to
vaccination, as well as engagement with community organizations and leaders among groups who experience disproportionate COVID-19-related morbidity and mortality, and to
expand access to clear and accurate information on COVID-19
vaccines (10). The GRADE evidence profile and supporting
evidence for the EtR Framework are available at https://www.
cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-vaccine.
html and https://www.cdc.gov/vaccines/acip/recs/grade/
covid-19-moderna-etr.html.
Before vaccination, the EUA Fact Sheet (11) should be
provided to recipients and caregivers. Providers should counsel
Moderna COVID-19 vaccine recipients about expected local
and systemic reactogenicity. The Moderna COVID-19 vaccine
is not interchangeable with other COVID-19 vaccine products;
the safety and efficacy of a mixed-product series have not been
evaluated. ACIP does not state a product preference; a person
may receive any recommended COVID-19 vaccine series.
However, persons should complete the series with the same
COVID-19 product they received for the first dose. Additional
clinical considerations, including details of administration and
use in special populations (e.g., persons who are pregnant,
immunocompromised or who have a history of severe allergic reactions) are available at https://www.cdc.gov/vaccines/
covid-19/info-by-product/clinical-considerations.html. The
interim recommendation and clinical considerations are based
on use of the Moderna COVID-19 vaccine under an EUA and
might change as more evidence becomes available. ACIP will
continue to review additional data as they become available;
updates to recommendations or clinical considerations will be
posted on the ACIP website (3).

Grade 3 reactions are defined as use of a prescription pain reliever or those
preventing daily activity, fever (temperature 102.1-104.0oF [39-40oC]);
grade 4 reactions are defined as those that require emergency department visit
or hospitalization, temperature >104oF (40oC).
** Serious adverse events are defined as any untoward medical occurrence that results
in death, is life-threatening, requires inpatient hospitalization or prolongation of
existing hospitalization, or results in persistent disability/incapacity.

Reporting of Vaccine Adverse Events

Adverse events that occur in a recipient after receipt of
COVID-19 vaccine should be reported to the Vaccine Adverse
Events Reporting System (VAERS). FDA requires that

MMWR / December 20, 2020 / Vol. 69

Diagnostics I Pharmaceuticals I DxRx Solutions I Continuing Education I News
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A Henry Schein Publication

https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-vaccine.html https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-vaccine.html https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-etr.html https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-etr.html https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

2021 BQ Journal Vol 42

Table of Contents for the Digital Edition of 2021 BQ Journal Vol 42