COVID-19, Booster & Monkey Pox

· Who is eligible for the Pfizer-BioNTech (Pfizer) COVID-19 Vaccine offered?

This formulation of the Pfizer COVID-19 vaccine is for those ages 12 years and above.

· How is the vaccine given?

The vaccine will be given as an injection into the muscle, usually your deltoid (shoulder) muscle.

· How many shots do I need to be protected?

For the primary series, which means you’ve never received a COVID-19 vaccine before, you will need 2 doses, at least 3 weeks apart. A third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

· Is the Pfizer vaccine FDA-approved?

The Pfizer COVID-19 vaccine that MD Now offers is FDA-approved for ages 16 and older in the U.S., and Emergency Use Authorized for ages 12-15. The Pfizer COVID-19 vaccine remains Emergency Use Authorization (EUA) approved for ages 5-15. The Pfizer vaccine we offer at our clinics is for ages 12 and above.

· Who should not get the Pfizer vaccine?

Individuals should not get this vaccine if they’ve had a severe allergic reaction after a previous dose of this vaccine or had a severe allergic reaction to any ingredient of this vaccine.

· What medical conditions do you need to warn your provider about before you get this vaccine?

· If you have any allergies

· If you have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

· If you have a fever

· If you have a bleeding disorder or are on a blood thinner

· If you are immunocompromised or are on a medicine that affects the immune system

· If you are pregnant, plan to become pregnant, or are breastfeeding

· If you have received another COVID-19 vaccine

· If you have ever fainted in association with an injection

· Does this vaccine have side effects?

There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination. The signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness. If you are ever experiencing a severe allergic reaction, you or someone should call 9-1-1 or go to the nearest hospital.

Additional side effects that have been reported with the vaccine include: severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine.

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects that do not go away.

· What is myocarditis and pericarditis?

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine: chest pain, shortness of breath, or you are feeling a fast-beating, fluttering, or pounding heart.

· What Is Emergency Use Authorization?

According to the FDA, “During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”

· What if I am immunocompromised?

According to the Emergency Use Authorization, individuals with moderately or severely immunocompromising conditions may receive an additional primary dose of vaccine 28 days after their second primary series dose. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate.​​​​​​​

· Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY®?

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® ( COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.

Of note, individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.

· Will the vaccine give me COVID-19?

No. The vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

· What are the ingredients in the vaccine?

The vaccine in the gray cap includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, and sucrose.

· Is there preservative in the vaccine?

No, the vaccine does not contain preservative.

· Are the components of the vaccine vial made with latex?

The vial stoppers are not made with natural rubber latex.

· Was the COVID-19 vaccine studied in diverse populations?

Yes, Pfizer has ensured that underrepresented populations participate in all their studies by recruiting people who fully represent the racial and ethnic diversity of their communities.

· Where can I learn more?

For more information about COVID-19 vaccination, please visit the CDC website.

· What should I do if I experience a side effect of the vaccine?

You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.

· Do I need a booster dose?

A booster shot is strongly encouraged to increase your immunity and decrease your risk of serious COVID-related illness and hospitalization.

A single booster dose of the vaccine may be administered to individuals 12 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose.

A single booster dose of the Pfizer vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older.

· Does Prestige Medical Research Clinic offer the second booster shot?

Yes, the clinic offers the second booster dose of the Pfizer-BioNTech COVID-19 Vaccine for those who are eligible to receive it.

· Who is eligible for the second booster dose?

The second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may also be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.