Berks County Medical Society Medical Record Winter 2021 - 17

FDA review with expected approval by mid to late December. In
addition, Johnson and Johnson and Oxford-AstraZeneca vaccines are
in phase 3 studies with anticipated release in the US.
Both the Pfizer and Moderna vaccines use messenger RNA
vaccine technology that encodes for the spike protein found on the
surface of SARS-CoV-2. Since mRNA is fragile, the mRNA strands
are encased in lipid nanoparticles. In the body, this mRNA is taken
up by cells and translated into proteins that are recognized by the
immune system. As the immune system sees this foreign protein it
produces antibodies, from B-cells and T-cell responses against the
spike protein, that protect the recipient against subsequent infection.
The mRNA from the vaccine is eventually destroyed, leaving no
permanent trace.

HOW EFFICACIOUS ARE THE VACCINES?
The Pfizer/BioNTech/Fosum Pharma vaccine initially enrolled
43,661 participants of which 41,135 received the second dose.
Preliminary data at 60 days showed the vaccine to be 95% effective.
They observed 170 cases of COVID-19 of which 162 cases were seen
in placebo and 8 cases in the vaccine group. Of these cases, 10 were
considered severe and 9 of the 10 were seen in the placebo group.
This vaccine is a 2-dose series, 21 days apart, and requires ultra-cold
storage of -94 C storage for optimal shelf life. If the vial is thawed
under refrigeration, the dose must be used within 5 days. If thawed
at room temperature, the dose must be used within 2 hours. Pfizer
expects to produce over 1.3 billion doses for worldwide distribution
in 2021.
The side effect profile for the Pfizer vaccines includes redness/
swelling/pain at the injection site. 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%).4 More grade ≥3 reactions occurred
after the second dose and older adults had milder side effects
than younger participants. There is insufficient data to provide
conclusions in children under 16, pregnant women, and in those
with compromised immune systems. The FDA authorized the
vaccine for emergency use on December 11 and emergency use was
authorized in Great Britain on December 2. Distribution in the US
started the week of December 14th. There were 2 allergic reactions
noted during the initial vaccination of health care workers in
England. Both of these individuals had a history of serious reactions
to prior vaccines. Due to this reaction, the current recommendation
is to avoid vaccinating patients with this history.
The Moderna vaccine included 30,000 volunteers in their phase
3 study and was reported to be 94.5% effective. Ninety-five cases of
COViD-19 were reported in the volunteer group. Ninety were seen
in placebo and 5 in vaccinated population. Eleven were considered
severe disease. This vaccine is dosed 28 days apart. They project that
they will be able to supply 1 billion doses in 2021. The safety profile
for the Moderna vaccine was favorable with fatigue, muscle pain,
headache and achiness noted.

VACCINE DISTRIBUTION
As we are expecting the Pfizer vaccine to be distributed beginning
mid December, all health systems have been making plans for
storage, handling, electronic tracking, and prioritization of the initial

doses. The recommended prioritization was broken down into 3
phases based on risk factors: Phase 1 includes health care personnel,
first responders, critical workers, and high-risk individuals; Phase
2 includes health care administration, individuals with barriers to
access to care, essential workers and individuals at elevated risk; and
Phase 3 includes populations not included in phase 1 or 2.

ADDITIONAL NEWLY EUA APPROVED
TREATMENTS:
Additional Emergency Use Authorizations have been issued
to COVID-19 monoclonal antibodies. The government has
purchased and the state has distributed doses of bamlanivimab
and Regeneron (casirivimab and imdevimab) to hospital systems
based on COVID-19 impact. These 2 monoclonal antibodies have
been approved for patients over the age of 12 with risk factors for
progression to severe COVID-19 and/or hospitalization. These
risk factors include age >65, BMI >=35, chronic kidney disease,
diabetes, and immunosuppressive conditions. In addition, patients
>=55 qualify if they have at least one of the following conditions
including cardiovascular disease, hypertension, or chronic
obstructive pulmonary disease. Data has shown that the following
adverse reactions were seen: nausea 4%, diarrhea 3%, dizziness 3%,
headache 2%, pruritus 2% and vomiting 2%.
The bamlanivimab efficacy study named BLAZE-1 included 452
outpatients with mild to moderate COVID. The primary outcome
was mean change in log viral load. Secondary outcomes studied
reduction in hospitalizations from 15% in placebo and 4% in the
treatment group.
The Regeneron study included 799 non-hospitalized adults and
this group was broken down into 3 segments: 266 receiving a single
infusion of 2400 mg, 267 with 8000 mg, and 266 receiving placebo.
There was a significant decrease in hospitalizations from 9% with
placebo and 3% with Regeneron.
We are currently 9 months into the pandemic from the pandemic
declaration by the World Health Organization on March 11, 2020.
We have learned a great deal regarding how to diagnose and treat
this infection. It is encouraging that we have additional treatment
options in the form of monoclonal antibodies to help protect
COVID-19 infected patients with co-morbidities to prevent severe
infection and hospitalization.
However, the single most important step is prevention and we
are very fortunate that a vaccine has been approved and currently is
being dispensed. Health care providers and patients at risk will be
prioritized. I encourage you and your patients to receive it. By doing
this, we can help society achieve the herd-immunity threshold to
protect our community, our patients, our families, and ourselves.
1 JAMA Intern Med. doi: 10.1001/jamainternmed.2020.7976. Published
online November 24, 2020.
2 Gomes, M Individual variation in susceptibility or exposure to
SARS-CoV-2 lowers the herd immunity threshold. Posted 5/21/2020.
doi: https://doi.org/10.1101/2020.04.27.20081893
3 JAMA. 2020;324(20):2095-2096. doi:10.1001/jama.2020.20892
4 https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6950e2-H.pdf

WINTER 2021

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Berks County Medical Society Medical Record Winter 2021

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