March 2, 2021

SAGE recommendations on the Moderna mRNA−1273 vaccine against COVID−19

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World Health Organization

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) issued interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19.

The recommendations have been agreed at the SAGE extraordinary meeting held on 21 January and are based on the evidence summarized in the Background document on mRNA-1273 vaccine (Moderna) against COVID-19 and the Background paper on Covid-19 disease and vaccines.

Summary of the recommendations:

  • Based on current evidence, SAGE recommends the administration of two doses (100 µg, 0.5 ml each) with an interval of 28 days between doses. SAGE recommends at present that, if judged necessary due to exceptional circumstances of COVID-19 disease burden in a country, the interval between doses may be extended to 42 days. The evidence for this is not strong, but this was the longest interval in the primary analyses of the Phase 3 trial; the great majority received the second dose after a shorter interval. SAGE does not recommend halving the dose.
  • SAGE recommends that the vaccine should be administered only in settings where anaphylaxis can be treated. SAGE provided specific recommendations on the narrow limits of exclusion of vaccination and on the post-vaccination observation period as well as the management, monitoring and reporting of any safety events.
  • SAGE recognized the importance of vaccination of pregnant women, especially given the priority for protection of health workers, of whom a large proportion globally are women. WHO recommends not to use mRNA-1273 vaccine in pregnancy, unless the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks, such as in health workers at high risk of exposure and pregnant women with comorbidities placing them in a high-risk group for severe COVID-19.
  • SAGE acknowledged lack of data on the safety of the vaccine in lactating women but given the mechanism of action of the vaccine, considered it unlikely to pose a risk.  SAGE recommends that a lactating woman who is part of a group recommended for vaccination, e.g. health workers, should be offered vaccination.
  • SAGE recommends that COVID-19 vaccination be offered regardless of a person’s history of symptomatic or asymptomatic SARS-CoV-2 infection.  Available data currently indicate that symptomatic reinfection within 6 months after an initial infection is rare. Thus, in the context of limited vaccine supply, persons with PCR-documented SARS-CoV-2 infection in the preceding 6 months may choose to delay vaccination until near the end of this time period.
  • As noted in the WHO Prioritization Roadmap, SAGE reemphasized that national programmes should take specific steps to identify groups disproportionately affected by COVID-19 and those who face health inequities due to social or structural inequities in order to address barriers to vaccination and achieve equitable access to vaccination.
  • In the current period of very limited vaccine supply, preferential vaccination of international travelers would counter the principle of equity.  Because of this and the lack of evidence that vaccination reduces the risk of transmission, SAGE currently does not recommend COVID-19 vaccination of travelers (unless they are also part of a high-risk group identified in the WHO Prioritization Roadmap).

More information:

The Strategic Advisory Group of Experts (SAGE) on Immunization is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions.  

A SAGE Working Group on COVID-19 Vaccines was established in June 2020 and consists of 26 experts who have been considering all aspects that would inform policy recommendations, including values, ethics, clinical trial data, and programmatic considerations. 

SAGE has undertaken a 3-step process to provide guidance for overall COVID-19 vaccination programme strategy as well as vaccine-specific recommendations: a Values Framework for Allocation and Prioritization of COVID-19 vaccination was issued in September 2020 and a Prioritization Roadmap for Prioritizing Uses of COVID-19 Vaccines in the Context of Limited Supply in October 2020; on 5 January, SAGE provided its first product-specificinterim recommendation for COVID-19 vaccine use for the Pfizer BioNTech BNT162b2 mRNA vaccine.

For more information, visit https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/working-groups

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