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35 Novavax COVID-19 Vaccine Nuvaxovid, Covovax, NVX-CoV2373 in Pregnancy

NOVAVAX:
NUVAXOVID,
COVOVAX, NVX-
COV2373
Characteristics of COVID-19
Vaccines in Relation to Pregnancy
and Lactation

The information provided below is

for readers based in the United
States of America. Readers
outside of the United States of
America should seek the
information from local sources.

Nuvaxovid, Covovax, or NVX-CoV2373, is

more commonly known as the Novavax
vaccine and has recently been approved
for emergency use in protecting against
COVID-19 by the World Health
Organization (WHO).

As of January 19, 2022, the vaccine is being

administered in a growing number of
countries, in-cluding Austria, Belgium,
Bulgaria, Croatia, Cyprus, Denmark,
Estonia, Finland, France, Germa-ny,
Greece, Hungary, Iceland, India, Indonesia,
Ireland, Italy, Latvia, Liechtenstein,
Lithuania, Luxembourg, Malta,
Netherlands, Norway, Philippines, Poland,
Portugal, Republic of Korea, Romania,
Slovakia, Slovenia, Spain, and Sweden.

As of late January 2022, emergency use

authorization of the Novavax vaccine also
appears likely in various other countries,
including the United Kingdom, Australia,
Canada, the United States, New Zealand,
Singapore, and the United Arab Emirates.

Currently, the Novavax COVID-19 vaccine is

approved for use in people of age 18 years
and older; clinical trials are advancing in
children ages 12-17.

There are a number of different versions of

the Novavax vaccines, meaning that the
version(s) of the vaccine approved and
available may differ by country.

Novavax is an American biotechnology

company that is based in Gaithersburg,
Maryland. Cur-rently, Novavax is
collaborating with the Serum Institute of
India on the production and manu-
facturing of the NVX-CoV2373 vaccine.

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How The Novavax Vaccine Works
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NVX-CoV2373 is what scientists call a

protein subunit vaccine and is made of
tiny units known as protein nanoparticles.

The protein molecules of these

nanoparticles are genetically engineered
and attached to a sub-stance called an
adjuvant (adjuvants are molecules that,
when combined with protein molecules,
help produce a stronger immune
response in people receiving the vaccine).

The specific adjuvant used in the Novavax

vaccine is called a Matrix-M1 adjuvant.

In the case of the COVID-19 virus, the

specific protein interest is the spike (S)
glycoprotein (the protein that gives SARS-
CoV2 - the virus that causes COVID-19 - the
crown-like, or corona ap-pearance when
examined under an electron microscope).

There is no virus in the Novavax vaccine.

The business end of the vaccine is merely
the S glyco-protein attached to the Matrix-
M1 adjuvant.

While the SARS-CoV2 virus uses the S

glycoprotein to infect body cells, the S
glycoprotein of the Novavax vaccine is
locked into a particular shape that
prevents it from acting like the S gly-
coprotein of actual virus particles; this
means that the vaccine cannot harm
body cells.

What the Novavax vaccine can do, and is

designed to do, is to stimulate the
immune system to respond the same way
that it would upon detecting initial
infection by the SARS-CoV2 virus. This
response stimulates immune system
production of special immune cells and
special antibod-ies that attach to S
glycoprotein.

Interestingly, genetically engineering and

attaching a protein to an adjuvant isn’t a
new concept. Scientists have used this
process to successfully create other
vaccines, including the HEPLISAV-B
vaccine (to protect against hepatitis B and
the Shingrix zoster vaccine (to prevent
shingles).

How The Novavax Vaccine Is

Administered

The Novavax vaccine is administered

intramuscularly and injected into the
deltoid muscle of your shoulder.

The initial Novavax vaccination schedule

included two injections given 21-days
English
apart.
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15/02/23 12.35 Novavax COVID-19 Vaccine Nuvaxovid, Covovax, NVX-CoV2373 in Pregnancy

However, and since people who have

received other COVID-19 vaccines have
been receiving a third booster shot,
vaccinations beginning with two shots of
the Novavax vaccine will now be
considered up to date with a third shot.
The third shot could be either another
Novavax shot, or a shot of one of the
mRNA vaccines (Pfizer-BioNTech,
Moderna).

Furthermore, people who received two

shots of a different COVID-19 vaccine (or
one shot of the Janssen vaccine) will likely
be able to receive Novavax as the third
shot. Eventually, Novavax will also be
available to those who are ready for a
fourth shot.

In other words, the Novavax vaccine is

likely to soon be an accepted option within
the mix and match framework of current
COVID-19 vaccines.

Effectiveness And Safety Of The Novavax

Vaccine

Large scale studies in the United

Kingdom, the United States, and Mexico
have demonstrated that the Novavax
vaccine effectively prevents the
development of COVID symptoms in over
90 percent of COVID-19 cases that would
normally occur in unvaccinated people
exposed to cer-tain SARS-CoV2 variants
(including the variants that dominated the
pandemic prior to the surge of the
Omicron variant).

When evaluating effectiveness in

preventing the severe kind of COVID-19
that leads to admis-sion to an intensive
care unit (ICU), the effectiveness of the
Novavax vaccine was close to 100 percent.

Considering this, scientists expect that the

Novavax vaccine, like the other approved
COVID-19 vaccines, will be extremely
effective in preventing severe disease and
death.

Pregnancy and Lactation Issues

The World Health Organization

recommends vaccination in pregnant
women “when the benefits of vaccination
to the pregnant woman outweigh the
potential risks”. Currently, the benefits of
COVID-19 vaccination far outweigh
potential risks, both in pregnancy and
lactation.

The only exceptions to this

recommendation are in rare cases of
people who previously haveEnglish
suf-fered
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allergic reactions to ingredients in the

vaccine, such as polyethylene glycol.

Specific to the NVX-CoV2373, studies that

have included pregnant women have
demonstrated acceptable safety profiles
for nanoparticle/Matrix-M1 used in the
creation of the Novavax vac-cine.

Adverse Effects Associated With The

Novavax Vaccine

Undesirable or adverse effects of the

Novavax vaccine commonly occur at the
injection site and include pain, redness,
and swelling. Like other COVID-19 vaccines,
common effects felt throughout the body
include tiredness, headache, chills, fever,
nausea, and muscle aches.

Pregnancy and Lactation Positions by

Country for the Novavax Vaccine (Covovax)

WHO What You Need to Know

References

Formica N, Mallory R, Albert G, Robinson

M, Plested JS, Cho I, Robertson A,
Dubovsky F, Glenn GM; 2019nCoV-101
Study Group. Different dose regimens of a
SARS-CoV-2 recombinant spike protein
vaccine (NVX-CoV2373) in younger and
older adults: A phase 2 randomized
placebo-controlled trial. PLoS Med. 2021
Oct 1;18(10):e1003769. doi:
10.1371/journal.pmed.1003769. PMID:
34597298; PMCID: PMC8486115.

Heath PT, Galiza EP, Baxter DN, et al.;

2019nCoV-302 Study Group. Safety and
Efficacy of NVX-CoV2373 Covid-19 Vaccine.
N Engl J Med. 2021 Sep 23;385(13):1172-1183.
doi: 10.1056/NEJMoa2107659. Epub 2021
Jun 30. PMID: 34192426; PMCID:
PMC8262625.

Novavax. Novavax COVID-19 Vaccine

Demonstrates 90% Overall Efficacy and
100% Protection Against Moderate and
Severe Disease in PREVENT-19 Phase 3
Trial. Accessed January 19, 2022

Novavax. All Updates On Our COVID-19

Vaccine Effort. Accessed January 19, 2022

World Health Organization. COVID-19

vaccines side effects and safety. Accessed
January 19, 2022

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