Question Number: 304
PDR Number: SQ22-000680
Date Submitted: 21/11/2022
Department or Body: Department of Health
Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) that have been shown to reduce vaccine response to 2 doses of mRNA vaccine include mycophenolate mofetil, leflunomide, and methotrexate. The Australian Technical Advisory Group on Immunisation (ATAGI) recommends a 3rd primary dose of COVID-19 vaccine for people on these immunosuppressive therapies. ATAGI recognises that a substantial proportion of vaccinated individuals among some groups with severe immunocompromise show no immune response or a suboptimal response to COVID-19 vaccine, and that this is likely to place them at ongoing increased risk of SARS-CoV-2 infection despite vaccination. ATAGI considers it important to offer a 3rd primary dose to provide a higher level of protection for these individuals, aiming to attain a level as close as possible to that seen in healthy individuals. Provision of a 3rd dose to severely immunocompromised individuals does not guarantee equivalent protection to immunocompetent individuals, therefore ongoing risk mitigation measures are warranted. Individuals who currently are not severely immunocompromised, but who will commence significant immunosuppressive therapy two weeks or more after their 2 nd dose do not require a 3rd dose, as it can be expected that an adequate response to two primary doses will be achieved. COVID-19 vaccines are recommended for people who are immunocompromised. There are no specific safety concerns relating to immunocompromise for people receiving Pfizer, Moderna, AstraZeneca or Novavax COVID-19 vaccines. Pfizer, Moderna and Novavax are not live vaccines. AstraZeneca contains a virus which cannot replicate or spread to other cells. t does not behave like a live vaccine and cannot cause infection. There is no reason to expect any higher risk of safety issues with Pfizer, Moderna, AstraZeneca or Novavax in people with immunocompromise. As of February 2022, over 10 billion doses of COVID-19 vaccines have been administered worldwide, and people with immunocompromise have been given vaccines as a priority group in many countries. To date, no safety issues specific to people with immunocompromise have been identified with any COVID-19 vaccine. Further information can be found at: o www.health.gov.au/resources/publications/atagi-recommendations-on-the-useof-a-third-primary-dose-of-covid-19-vaccine-in-individuals-who-are-severelyimmunocompromised o www.health.gov.au/resources/publications/atagi-provider-guide-to-covid-19- vaccination-of-people-with-immunocompromise o www.health.gov.au/resources/publications/atagi-covid-19-vaccination-shareddecision-making-guide-for-people-with-immunocompromise?language=en
