2021 BQ Journal Vol 42 - 28

Early Release

recipients. Among vaccine recipients, reactogenicity symptoms,
defined as solicited local injection site or systemic reactions during the 7 days after vaccination, were frequent and mostly mild
to moderate. Systemic adverse reactions were more commonly
reported after the second dose than after the first dose and were
generally more frequent and severe in persons aged 18-55 years
than in those aged >55 years. Systemic adverse reactions had a
median onset of 1-2 days after vaccine receipt and resolved in
a median of 1 day. Severe local and systemic adverse reactions
(grade ≥3, defined as interfering with daily activity) occurred
more commonly in vaccine recipients than in placebo recipients.
Among vaccine recipients, 8.8% reported any grade ≥3 reaction;
the most common symptoms were fatigue (4.2%), headache
(2.4%), muscle pain (1.8%), chills (1.7%), and injection site
pain (1.4%). Generally, grade ≥3 reactions were more commonly
reported after the second dose than after the first dose and were
less prevalent in older than in younger participants. Serious
adverse events¶ were observed in a similar proportion of vaccine
(0.6%) and placebo (0.5%) recipients and encompassed medical
events occurring at a frequency similar to that within the general
population (6). 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-bymanufacturer/pfizer/reactogenicity.html.
From the GRADE evidence assessment, the level of certainty for
the benefits of the Pfizer-BioNTech COVID-19 vaccine was type 1
(high certainty) for the prevention of symptomatic COVID-19.
Evidence was type 3 (low certainty) for the estimate of prevention of COVID-19-associated hospitalization and type 4 (very
low certainty) for the estimate of prevention of death. Data on
hospitalizations and deaths are limited at this time, but a vaccine
that effectively prevents symptomatic infection is expected to also
prevent hospitalizations and deaths. Regarding potential harms
after vaccination, evidence was type 2 (moderate certainty) for
serious adverse events and type 1 (high certainty) for reactogenicity. No data were available to assess the efficacy for prevention
of asymptomatic SARS-CoV-2 infection. Data reviewed within
the EtR Framework supported the use of the Pfizer-BioNTech
COVID-19 vaccine. ACIP determined that COVID-19 is a
major public health problem and that use of the Pfizer-BioNTech
COVID-19 vaccine is a reasonable and efficient allocation
of resources. Whereas there might be uncertainty in how all
populations value the vaccine, it was determined that for most
populations, the desirable effects outweigh the undesirable effects.
The vaccine is probably acceptable to implementation stakeholders

and feasible to implement in spite of difficult ultracold-chain
storage and requirements for handling and administration. These
requirements could limit the availability of the Pfizer-BioNTech
COVID-19 vaccine to some populations thereby negatively
impacting health equity. Therefore, efforts should be made to overcome these challenges and advance health equity. The GRADE
evidence profile and EtR supporting evidence are available at
https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizerbiontech-vaccine.html and https://www.cdc.gov/vaccines/acip/
recs/grade/covid-19-pfizer-biontech-etr.html.
Before vaccination, the EUA Fact Sheet should be provided to recipients and caregivers. Providers should counsel
Pfizer-BioNTech COVID-19 vaccine recipients about expected
systemic and local reactogenicity. Additional clinical considerations, including details of administration and use in special
populations (e.g., persons who are pregnant or immunocompromised or who have severe allergies) are available at https://www.
cdc.gov/vaccines/covid-19/info-by-manufacturer/pfizer/clinicalconsiderations.html. Additional studies of safety and effectiveness are planned after authorization and will be important to
inform future ACIP recommendations as well as increase public
confidence in the COVID-19 vaccination program. The interim
recommendation and clinical considerations are based on use of
the Pfizer-BioNTech 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 (https://www.cdc.gov/vaccines/
hcp/acip-recs/vacc-specific/covid-19.html).

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 vaccination providers report vaccination administration errors, serious
adverse events, cases of multisystem inflammatory syndrome, and
cases of COVID-19 that result in hospitalization or death after
administration of COVID-19 vaccine under EUA. Reporting is
encouraged for any clinically significant adverse event, whether or
not it is clear that a vaccine caused the adverse event. Information
on how to submit a report to VAERS is available at https://vaers.
hhs.gov/index.html or 1-800-822-7967. In addition, CDC has
developed a new, voluntary smartphone-based tool, v-safe, that
uses text messaging and web surveys to provide near real-time
health check-ins after patients receive COVID-19 vaccination.
The CDC/v-safe call center follows up on reports to v-safe that
indicate a medically significant health impact to collect additional
information for completion of a VAERS report. Information on
v-safe is available at https://www.cdc.gov/vsafe.

¶ 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.

MMWR / December 13, 2020 / Vol. 69

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2021 BQ Journal Vol 42

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