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CDC's Interim Clinical Considerations Updated Last Month to Reflect mRNA Vaccine Preference

CDC's Interim Clinical Considerations Updated Last Month to Reflect mRNA Vaccine Preference

Wednesday, January 5, 2022

On December 17, 2021, the Centers for Disease Control and Prevention (CDC) updated their Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. The update reflects the recent guidance for the preference of mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna) in most situations for the primary and booster vaccination.

Based on an updated risk-benefit analysis, use of mRNA COVID-19 vaccines is preferred over the Janssen COVID-19 vaccine for all vaccine-eligible persons. Vaccine providers should start the two-dose mRNA COVID-19 vaccine series even if there is uncertainty about how the patient will receive their second dose; setting alone should not be a reason to offer the Janssen COVID-19 vaccine. However, the Janssen COVID-19 Vaccine may be offered in some situations as described below:

  • When there is a contraindication to mRNA COVID-19 vaccines (e.g., severe allergic reaction after a previous dose or to a component of an mRNA COVID-19 vaccine).
  • When a person would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
  • When a person wants to receive the Janssen COVID-19 vaccine despite the safety concerns identified.

All persons who elect to receive a Janssen COVID-19 vaccine booster should be counseled about the risk and symptoms of thrombosis with thrombocytopenia syndrome (TTS) that could occur after vaccination (typically within 2 weeks after receipt), and the need to seek immediate medical care should such symptoms develop at any time. This guidance applies to both the primary and booster doses of Janssen COVID-19 Vaccine. People should seek medical attention immediately if they develop any of the following symptoms:

  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain
  • Severe or persistent headaches or blurred vision
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection

There are no data on the safety of administering a booster dose of either the Janssen COVID-19 Vaccine or an mRNA COVID-19 vaccine to people who had TTS following the first dose. It is contraindicated to administer Janssen COVID-19 Vaccine to persons with a history of TTS following receipt of the Janssen COVID-19 Vaccine or any other adenovirus vector-based COVID-19 vaccines (e.g., AstraZeneca’s COVID-19 Vaccine, which is not authorized or approved in the United States). These people should receive a dose of an mRNA COVID-19 vaccine as a booster at least 2 months (8 weeks) following their dose of the Janssen COVID-19 Vaccine and after their clinical condition has stabilized. Prior to booster vaccination, a conversation between the patient and their clinical team, including a hematologist or other specialists, may assist with decisions about using an mRNA COVID-19 vaccine as a booster and the timing of the booster vaccination.

Key points from the interim clinical considerations:

  • For all persons aged 18 years and older it is preferred to receive an mRNA COVID-19 vaccine (Pfizer or Moderna) over the Janssen COVID-19 Vaccine for primary and booster vaccination.
    • However, recipients of an mRNA vaccine primary series aged 18 years and older who are unable to receive an mRNA booster dose can be offered a Janssen vaccine booster dose at least 6 months later, after discussion of the benefits and risks.
  • Persons aged 18 years and older who received Janssen primary vaccination should preferably receive an mRNA vaccine dose at least 2 months (8 weeks) later. 
  • Although mRNA vaccines are preferentially recommended in most situations compared to Janssen COVID-19 vaccine, the Janssen COVID-19 vaccine may be considered in some situations. See Considerations for Janssen COVID-19 Vaccine and Contraindications and precautions.
  • Offering the Janssen COVID-19 Vaccine is preferable to not providing any COVID-19 vaccine.
  • It is contraindicated to administer Janssen COVID-19 Vaccine to persons with a history of thrombosis with thrombocytopenia syndrome (TTS) following receipt of the Janssen COVID-19 Vaccine or any other adenovirus vector-based COVID-19 vaccines (e.g., AstraZeneca’s COVID-19 Vaccine, which is not authorized or approved in the United States). 
  • Persons should be counseled that mRNA vaccines are preferred over the Janssen COVID-19 Vaccine and that there is a risk of TTS following receipt of Janssen vaccine.
  • Those who elect to receive a Janssen COVID-19 Vaccine should be informed about the risk and symptoms of TTS.

Emergency Use Authorization (EUA) for mRNA Vaccines: Both mRNA COVID-19 vaccines under EUA in the U.S. were amended to reflect the FDA authorized and ACIP recommended additional dose of mRNA COVID-19 vaccine for certain immunocompromised individuals after an initial 2-dose primary series of an mRNA COVID-19 vaccine.

Use the Michigan version of the EUA, which can be found at the State of Michigan COVID-19 Vaccine Provider webpage. Vaccine Specific EUAs:

Sources:

CDC’s media statement: CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations