For NUVAXOVID® Recipients and Caregivers
This brochure contains information to help you understand the risks and benefits of NUVAXOVID®,
which you or your caregiver may receive.
Please use this brochure in addition to the information provided by your local municipality.
NUVAXOVID®: NUVAXOVID COVID-19 Vaccine, Adjuvanted＊This brochure is for NUVAXOVID® recipients and the contents are based on Japanese law and the approved matters of NUVAXOVID ® in Japan. While every
effort is made to ensure the accuracy of translation, Takeda Pharmaceutical Company Limited assumes no liability for damage or loss caused by any error,inaccuracy, or misunderstanding with regard to this translation. If you have any questions about the notice or your treatment, please consult with your doctor.

NUVAXOVID® is a vaccine that may prevent COVID-19.
Immunization schedule is as follows:
Primary Series

12 yrs of age& older

1stDoseBooster shot

12 yrs of age& older

12 yrs of age& older
3weeks

2ndDose6months▶ NUVAXOVID® is administered as a primary seriesof 2 doses that are given 3 weeks apart.
▶ If it has been over 3 weeks since you havereceived your 1 st dose, please schedule your2nd dose vaccination immediately.

3rdDose12 yrs of age& older
6months

4thDose6months▶ The booster shot is administered at least
6 months after the previous vaccination.

You should continue to take basic infection prevention measures (wear masks,
avoid the three Cs[closed places, crowded places, close-contact settings],
wash hands, have coughing manners) even after you have received the vaccine.
As NUVAXOVID® may cause side effects (fever, tiredness, pain etc), you shouldmake plans of the day of and the day after your vaccination accordingly.
If you have received 1st dose of NUVAXOVID®, you should receive a 2nd dose of NUVAXOVID® tocomplete the vaccination series.
Please schedule your 2nd dose vaccination with your local municipality or vaccinating doctor.
2nd dose Vaccination Date:YYYYMMDD

2nd dose Vaccination Location:

AMPM

Please schedule your 2nd dose vaccination at the time of your 1st dose vaccination.
Make sure to write down or make a note on your cell phone of your 2nd dose vaccination schedule.

IMPORTANT SAFETY INFORMATIONBEFORE you receive NUVAXOVID®
What you should mention to your vaccinating doctor
BEFORE you receive NUVAXOVID®

Please checkthe □ boxes

People who cannot receive the vaccine:This vaccine cannot be administered to people to whom any of the following circumstances
apply. If you think any of the following circumstances apply to you, be sure to inform the doctor
during the pre-vaccination consultation.
□ People with obvious symptoms of fever＊1□ People suffering from serious acute illness□ People with a history of severe hypersensitivity＊2 to any of the ingredients of this vaccine□ People who have another condition making it inappropriate for them to receive the vaccine＊1： An obvious symptom of fever is usually defined as a temperature of 37.5°C or higher. However, this standard
does not necessarily apply if fever has been diagnosed in comparison to normal body temperature, even if
the temperature reading is below 37.5°C.
＊2： Anaphylaxis and multiple symptoms suggestive of anaphylaxis, including generalized skin and mucous
membrane symptoms, wheezing, dyspnea, tachycardia, hypotension, etc.

People who need to be cautious about getting vaccinated:

Those to whom any of the following circumstances apply should be cautious about receiving
this vaccine. If you think any of the following circumstances apply to you, be sure to informthe doctor during the pre-vaccination consultation.
□ People on anticoagulant therapy, people with thrombocytopenia or coagulation disorders□ People who have been diagnosed with immunodeficiency in the past, or people whohave close relatives with congenital immunodeficiency□ People with underlying medical conditions such as heart, kidney, liver or blood disorders,
or developmental disorders□ People who, after receiving vaccines in the past, have experienced symptoms indicativeof an allergy, such as fever or generalized rash, within two days of vaccination□ People who have experienced convulsions in the past
□ People who may be allergic to the ingredients of this vaccine
If you are pregnant, may be pregnant, or are breast-feeding, be sure to inform the doctor
during the pre-vaccination consultation.

Please consult with your vaccinating doctor if :□ You feel different than usual or do not feel well
□ You feel anxious about vaccines,needles or pain
□ You have allergies, food allergies or have had allergic reaction to medication□ You have fear of vaccines

2

IMPORTANT SAFETY INFORMATIONAFTER you receive NUVAXOVID®
Please stay at the facility where you received the vaccine for
15-30 minutes after vaccination.
There is a remote chance that NUVAXOVID® could cause severe shock or anaphylaxis
within a few minutes to 30 minutes after vaccination.
Also, vagal response may be triggerred by pain or anxiety from the vaccination.
For this reason, please sit on a chair with a back and relax for 15-30 minutes at theplace where you received your vaccine.
Please notify your vaccinating doctor or nurse immediately if you experience any
concerning symptoms or any of the following symptoms:
Signs of shock or anaphylaxis reaction:
Cold sweating, lightheadedness
Turning paleFeelings of having a fast-beating, difficulty breathing
Itching, bad rash all over your bodyDizziness, fainting
Scratchy throat
Cold feet and hands
Signs of vagal response:
Dizziness on standing up

Turning pale (sometime fainting)

Please be sure to take basic infection prevention measures while waiting:▶Wear a mask

▶Keep social distance▶Refrain from talking

If you feel any of the conditions mentioned above or notice any concerning symptoms
after you leave the vaccination site, please contact your vaccinating doctor or yourfamily doctor.
Side effects on the back page of this brochure may occur. If you experience high fever orconvulsion, please seek medical care immediately.
Please keep the injected area clean.
Although bathing on the day of vaccination is not a problem, please do not rub the injectedarea.
Please refrain from strenuous exercise on the day of your vaccination.
You should continue to take basic infection prevention measures (wear masks, avoid thethree Cs[closed places, crowded places, close-contact settings], wash hands, havecoughing manners) even after you have received the vaccine as the effectivenessagainst transmission is unknown.
2Q & AQ1
A1

What is NUVAXOVID®?
NUVAXOVID® contains a recombinant form of the SARS-CoV-2 spike protein. This spike protein is a foreign
object to our body thus, when we receive the vaccine, our immune system is activated to attack
and remove this spike protein. NUVAXOVID® also contains ingredients that support the immune system.
By receiving the vaccine, we can protect our body from being infected with the COVID-19 virus.

Q2 Why do we need a booster shot?
A2

Even after you have received the primary series (1 st and 2 nd dose) of the vaccine, you may still be
infected with the COVID-19 virus. There are many reasons for this but decrease in the antibody
level with time is considered as one. A booster shot after primary series gives your immune system
additional strength.
Please visit the Ministry of Health, Labor and Welfare website (https://www.mhlw.go.jp/stf/covid-19/booster.html)
for more information.

infection prevention measures after we
Q3 Do we still need to takereceive NUVAXOVID®?
A3NUVAXOVID® may prevent COVID-19 but we still do not know how the vaccine may help prevent thespread of COVID-19 from vaccine recipients to others. While vaccination is still in progress, there will
be a crowd of vaccine recipients and non-vaccine recipients in the society. Thus, we would like to ask
you to continue to take infection prevention measures such as avoid the 3 Cs (closed places, crowdedplaces, close-contact settings), wear a mask, wash hands with soap and use alcohol sanitizers.

Q4 What do need to be aware of before and after we receive NUVAXOVID®?
A4Before you receive NUVAXOVID®:Please be sure to receive the vaccine when you are in good condition. Please notify your vaccinating
doctor if you have any concerns regarding your condition, have had allergic reaction to medication in thepast, have food allergies or allergies, feel anxious about needles or pain, have fear of vaccines.
After you receive NUVAXOVID®:
There is a remote chance that you may faint due to anxiety or pain with the vaccination. To avoid fallig
down (sometimes people who faint can fall down and hurt themselves), please be sure to be seated forabout 30 minutes after the vaccination. In addition, the vaccine may cause severe allergic reaction suchas shock or anaphylaxis. Please make sure to wait at the facility for a while as this makes it possible torespond to any sudden onset of side effects.

Q5 What if I have had allergic reaction to other vaccines, medication,
food or makeup in the past?
A5Please consult with your family doctor or write down in your screening questionnaire and notify yourvaccinating doctor at the pre-vaccination consultation (Please write down everything that have causedallergic reactions).

Q6 What if I am or may be pregnant?
A6

Please discuss your options with your doctor and receive the vaccine only if you have determined thatthe benefits of the vaccination outweighs the risks.

For NUVAXOVID® Recipients and Caregivers

Q7 What if I am breastfeeding?
A7

Please discuss your options with your doctor and take into account the benefits of the vaccination andbreastfeeding and consider whether to continue or discontinue breastfeeding. We do not know how
much of the ingredients or the antibody to the ingredients of the vaccine will transfer into breastmilk.

Q8 Can children or infants receive NUVAXOVID®?
A8People aged 12 years and older may receive this vaccine for both primary series and booster dose.
Efficacy and safety of primary series and booster dose for people under 12 years of age are not yet clear.

stQ9 What if it has been over 3 weeks since I have received the 1 doseof the primary series?

A9Please schedule your 2nd dose vaccination as soon as possible.

Q10 What are the risks of NUVAXOVID®?
A10There is a chance that this vaccine may cause side effects. If you experience any concerning symptoms
or feel different than usual, please seek medical attention right away. In case of health damage
resulting from the COVID-19 vaccine, relief benefits (such as medical expenses, disability pension
benefits etc.) are available under the Immunization Act. Please consult with the municipality where you
reside in regard to the procedures required for the application.

Q11 Where can I find more information on COVID-19 and COVID-19vaccines?
A11Please visit the Ministry of Health, Labor and Welfare website(https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000164708_00079.html) for more information.
Also contact your local municipality for details of the COVID-19 vaccination.

Q12 Should teenagers and people in the twenties, especially men notreceive the vaccine as there is a higher risk of myocarditis andpericarditis?
A12It has been reported that the COVID-19 vaccines used in Japan may prevent COVID-19 and severe
COVID-19. As there is an increase in the number of COVID-19 cases among younger people inJapan as in the rest of the world, we would like to ask you to consider receiving the vaccine.
However, it is your decision whether you receive the vaccine or not. Please be sure to understandthe benefits and risks of the vaccine in making your decision.

For NUVAXOVID® Recipients and Caregivers

Side Effects that may occur after you receive NUVAXOVID®
Injection site reactions:
It has been reported that 60% of the 1st dose vaccine recipients, and 80% of the 2nd
and 3rd dose vaccine recipients have experienced some kind of injection site reactions.
Symptoms vary but may include the following:
pain/tenderness, swelling, redness of the injected area

General side effects:
It has been reported that 50% of the 1st dose vaccine recipients, and 70% of the 2nd
and 3rd dose vaccine recipients have experienced some kind of general side effects.
Symptoms vary but may include the following:
headache, vomiting (nausea), tiredness, fatigue, muscle pain, joint pain, handand feet pain, shivering, fever
Symptoms may be severe after the 2nd or 3rd vaccination. Most symptoms go away
after 1-3days after vaccination however if you experience high fever or convulsions,please contact your healthcare provider.
Symptoms occur mostly after 1-2 days after vaccination but sometimes occur after 7
days after vaccination. Symptoms tend to occur more in younger (vs. older) people
and female (vs. male).

These may not be all the possible side effects of NUVAXOVID®.
You should monitor your health conditions at least for a few days after vaccination.
If you notice any concerning symptoms, please ask your family doctor for medicaladvice.

＊In the case of health damage resulting from the COVID-19 vaccine, relief benefits(such as medical expenses,
disability pension benefits) are available under the Immunization Act. Please consult with the municipality where
you reside in regard to the procedures required for application.

Medical Institution

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