Information about Covid-19 Vaccine: Indications and Contraindications

Contraindications & Precautions – From CDC

 

Contraindications

CDC considers a history of the following to be a contraindication to vaccination with COVID-19 vaccines:

  • Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
  • Immediate allergic reaction of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine

Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine.  PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur.

People with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna).

However, people with a contraindication to mRNA COVID-19 vaccines may be able to receive Janssen COVID-19 vaccine, and vice versa, provided certain measures are taken (see “precautions” below).

Known polysorbate allergy is no longer a contraindication to mRNA vaccination; however, known polysorbate allergy is a contraindication to Janssen COVID-19 vaccine and thus, a precaution to mRNA COVID-19 vaccination.

  • Healthcare professionals should attempt to determine whether reactions reported following vaccination are consistent with immediate allergic reactions versus other types of reactions commonly observed following vaccination, such as a vasovagal reaction or post-vaccination side effects (Appendix D). This will help determine which patients have a contraindication to vaccination, including to the second dose of an mRNA COVID-19 vaccine.

 

Precautions

Most people deemed to have a precaution to a COVID-19 vaccine at the time of their vaccination appointment can and should be administered vaccine.

CDC considers a history of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies, i.e., “allergy shots”]) as a precaution but not a contraindication to vaccination. People with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains multiple components, one or more of which is a component of a COVID-19 vaccine, have a precaution to vaccination with that COVID-19 vaccine, even if it is unknown which component elicited the allergic reaction.

People with a contraindication to one type of the currently authorized COVID-19 vaccines (e.g., mRNA) have a precaution to the other (e.g., Janssen viral vector). However, because of potential cross-reactive hypersensitivity between ingredients in mRNA and Janssen COVID-19 vaccines, consultation with an allergist-immunologist should be considered to help determine if the patient can safely receive vaccination. 

The following considerations can be used to help the vaccination provider conduct a risk assessment for vaccination in individuals with a precaution to vaccination:

  • Risk of exposure to SARS-CoV-2 (e.g., because of residence in a congregate setting such as a long-term care facility, occupation)
  • Risk of severe disease or death due to COVID-19 (e.g., because of age, underlying medical conditions)
  • The unknown risk of anaphylaxis (including fatal anaphylaxis) following COVID-19 vaccination in a person with a history of an immediate allergic reaction to other vaccines or injectable therapies
  • Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis. Note, for people with a contraindication to another type of COVID-19 vaccines (e.g., mRNA vaccines), vaccination with another type (e.g., Janssen viral vector vaccine) should only be undertaken in an appropriate setting under the supervision of a healthcare professional experienced in the management of severe allergic reactions.

 

Neither contraindications nor precautions to COVID-19 vaccination

  • Allergic reactions (including severe allergic reactions) not related to vaccines (COVID-19 or other vaccines) or injectable therapies, such as allergic reactions related to food, pet, venom, or environmental allergies, or allergies to oral medications (including the oral equivalents of injectable medications), are not a contraindication or precaution to COVID-19 vaccination.
  • The vial stoppers of COVID-19 vaccines are not made with natural rubber latex, and there is no contraindication or precaution to vaccination for people with a latex allergy.
  • In addition, because the COVID-19 vaccines do not contain eggs or gelatin, people with allergies to these substances do not have a contraindication or precaution to vaccination.

Delayed-onset local reactions have been reported after mRNA vaccination in some individuals beginning a few days through the second week after the first dose and are sometimes quite large. People with only a delayed-onset local reaction (e.g., erythema, induration, pruritus) around the injection site area after the first vaccine dose do not have a contraindication or precaution to the second dose. These individuals should receive the second dose using the same vaccine product as the first dose at the recommended interval, preferably in the opposite arm.

Observation periods following vaccination

CDC recommends the following observation periods after COVID-19 vaccination:

  • 30 minutes:
    • History of an immediate allergic reaction of any severity to a vaccine or injectable therapy
    • People with a contraindication to a different type of COVID-19 vaccine (for example, people with a contraindication to mRNA COVID-19 vaccines who receive Janssen viral vector vaccine should be observed for 30 minutes following Janssen vaccination).
    • History of anaphylaxis due to any cause
  • 15 minutes: All other people

Contraindications & Precautions – Sinopharm Vaccine

There is very scare information regarding Sinopharm (Whole Virus Vaccine) vaccine compared to the US/Europe manufactured mRNA vaccine 

WHO – LINK Re Sinopharm

‘https://www.who.int/news-room/feature-stories/detail/the-sinopharm-covid-19-vaccine-what-you-need-to-know

Epidemiology UNIT, MoH Sri Lanka

Contraindications:

1. Individuals who are allergic to any component of this product (including excipients Disodium hydrogen phosphate, Sodium chloride, Sodium dihydrogen phosphate, Aluminium hydroxide).

2. Immediate or delayed onset allergic /anaphylactic reactions after a previous dose of the SARS-CoV-2 (Vero Cell), Inactivated Vaccine.

3. Patients with uncontrolled epilepsy or other progressive nervous system diseases, with a history of Guillain-Barre syndrome and any adverse nervous system reaction occurred after a previous dose of the same vaccine product.

4. Pregnant and lactating women lactation (lactation is considered only for the initial 6 months after delivery) [not done clinical trials so far for adequate evidence).

5. <18 years (not done clinical trials so far)

Special Warnings and Precautions for Use

1. Intravascular injection is strictly prohibited. There is no safety and efficacy data of the vaccine after subcutaneous and intradermal injection.

2. Use with caution in patients with acute diseases, acute onset of chronic diseases, severe chronic diseases, allergies and fever – advised to get clinician advise if necessary.

3. Use with caution in patients who have diabetes and those with a history or family history of convulsions, epilepsy, encephalopathy or mental illness.

4. Use with caution in patients who have decrease in platelets or clotting disorders (e.g. clotting factor deficiency, coagulopathy, platelet disorders) because of the risk of bleeding which may occur during intramuscular administration of the vaccine. Need to get specialized opinion if need of the disease condition.

5. Use with caution in patients with impaired immune function (such as malignant tumor, nephrotic syndrome, AIDS patients, etc.) because the safety and efficacy data are not available, and such population should be vaccinated on an individual basis.

6. People injected with immunoglobulin should be vaccinated with this product at least 1 month apart, so as not to affect the immune efficacy.

7. The concomitant clinical trials on this vaccine in combination with other vaccines have not yet been conducted. Consult a physician for advice if other vaccines have to be immunized at the same time.

 


Gulf News – Sinopharm COVID-19 vaccine: All you need to know

https://gulfnews.com/special-reports/sinopharm-covid-19-vaccine-all-you-need-to-know-1.1613923087408

 

Bankok hospital

What are contraindications to Sinopharm COVID-19 vaccine?

Answer: Sinopharm COVID-19 vaccine is not recommended for:

  • Anyone who developed serious allergic reactions from previous vaccination with Sinopharm COVID-19 vaccine.
  • Anyone who is allergic to any vaccine components.
  • People aged below 18.
  • Pregnant women. Sinopharm COVID-19 vaccine might be considered only if vaccine benefits outweigh the potential risks.
  • People who have fever or body temperature is greater than 38.5 ‘C.

Q: What are possible side effects caused by Sinopharm COVID-19 vaccine?

Answer: Common side effected caused by Sinopharm COVID-19 vaccine are:

  • Pain, swelling, redness at the injection site. Cold compress can be applied to alleviate pain.
  • Weakness or fatigue
  • Headache
  • Muscle pain or malaise
  • Fever or chills
  • Nausea

These side effects usually happen within a day or two of getting the vaccine. They are normal signs that your body is building up protection. These symptoms should subside and go away within a few days. In case that headache or fever exhibits, paracetamol can be taken as directed if no allergy history.

Nonetheless, if symptoms worsen or severe allergic reactions develop, e.g. skin rash, urticarial, breathing difficulty, abdominal pain and diarrhea, immediate medical assistance must be sought.


Q: Can people infected with COVID-19 be vaccinated with Sinopharm COVID-19 vaccine?

Answer: For COVID-19 patients who have been treated with monoclonal antibodies or convalescent plasma therapy in the hospital, Sinopharm COVID-19 vaccine administration can be considered at least 90 days after receiving COVID-19 treatment. For COVID-19 patients who did not receive monoclonal antibodies or convalescent plasma therapy, Sinopharm COVID-19 vaccine can be administered once SARS-CoV-2 RT-PCT test shows negative result (not detected) for at least 1 month. In this case, only single dose of Sinopharm COVID-19 vaccine is required.


Q: Can Sinopharm COVID-19 vaccine be used interchangeably with other COVID-19 vaccines?

Answer: Due to a lack of firm clinical evidence in efficacy and safety, COVID-19 vaccines should not be used interchangeably. The first dose and second dose should be the same vaccine. However, if severe allergic reactions develop after the first dose

 

 

 

Common questions about Covid-19 vaccination

Summary of the three USA Vaccines

summary-interim-clinical-considerations-poster

 

COVID-19 vaccination and SARS-CoV-2 infection

 

Vaccinating people with a known COVID-19 exposure or during COVID-19 outbreaks

 

Considerations for vaccination of people with certain underlying medical conditions

 

Considerations involving pregnancy, lactation, and fertility

 

Vaccination of children and adolescents


CDC
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

Summary page
https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations-poster.pdf

 

 

All about Sinopharm Vaccine

WHO

‘https://www.who.int/news-room/feature-stories/detail/the-sinopharm-covid-19-vaccine-what-you-need-to-know

Gulf News

https://gulfnews.com/special-reports/sinopharm-covid-19-vaccine-all-you-need-to-know-1.1613923087408


Bankok hospital

What are contraindications to Sinopharm COVID-19 vaccine?

Answer: Sinopharm COVID-19 vaccine is not recommended for: 

  • Anyone who developed serious allergic reactions from previous vaccination with Sinopharm COVID-19 vaccine. 
  • Anyone who is allergic to any vaccine components.
  • People aged below 18.
  • Pregnant women. Sinopharm COVID-19 vaccine might be considered only if vaccine benefits outweigh the potential risks.
  • People who have fever or body temperature is greater than 38.5 ‘C.

Q: What are possible side effects caused by Sinopharm COVID-19 vaccine?

Answer: Common side effected caused by Sinopharm COVID-19 vaccine are: 

  • Pain, swelling, redness at the injection site. Cold compress can be applied to alleviate pain. 
  • Weakness or fatigue 
  • Headache 
  • Muscle pain or malaise 
  • Fever or chills 
  • Nausea 

These side effects usually happen within a day or two of getting the vaccine. They are normal signs that your body is building up protection. These symptoms should subside and go away within a few days. In case that headache or fever exhibits, paracetamol can be taken as directed if no allergy history. 

Nonetheless, if symptoms worsen or severe allergic reactions develop, e.g. skin rash, urticarial, breathing difficulty, abdominal pain and diarrhea, immediate medical assistance must be sought. 


Q: Can people infected with COVID-19 be vaccinated with Sinopharm COVID-19 vaccine?

Answer: For COVID-19 patients who have been treated with monoclonal antibodies or convalescent plasma therapy in the hospital, Sinopharm COVID-19 vaccine administration can be considered at least 90 days after receiving COVID-19 treatment. For COVID-19 patients who did not receive monoclonal antibodies or convalescent plasma therapy, Sinopharm COVID-19 vaccine can be administered once SARS-CoV-2 RT-PCT test shows negative result (not detected) for at least 1 month. In this case, only single dose of Sinopharm COVID-19 vaccine is required.


Q: Can Sinopharm COVID-19 vaccine be used interchangeably with other COVID-19 vaccines?

Answer: Due to a lack of firm clinical evidence in efficacy and safety, COVID-19 vaccines should not be used interchangeably. The first dose and second dose should be the same vaccine. However, if severe allergic reactions develop after the first dose

 

 

 

CDC
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

Summary page
https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations-poster.pdf

Contraindications and precautions

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