Friday, 17 June 2022

MEDIA ADVISORY

Statements on current and updated COVID-19 vaccines

The Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) and the World Health Organization (WHO), with the support if its Strategic Advisory Group of Experts (SAGE) on Immunization, have today each issued statements on updated COVID-19 vaccines. 

TAG-CO-VAC, an independent group of experts that periodically reviews the evidence and analyses the implications of emerging variants of concern (VOC) on the performance of COVID-19 vaccines, has published a statement on the composition of current COVID-19 vaccines.

To complement the TAG-CO-VAC statement, the WHO has explained the decision-making considerations for the use of variant updated COVID-19 vaccines, with the support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its COVID-19 Vaccines Working Group.

In summary:

• Both statements reiterate that current COVID-19 vaccines, which are based on the ancestral strain (or index virus) of SARS-CoV-2, continue to exhibit strong protection against severe disease and death across all virus variants seen to date.  Achieving high coverage rates with the primary series and booster doses in the highest and high priority-use groups in every country remains the priority.
• As we look forward, continued virus evolution is expected, resulting in the emergence of new variants.
• The TAG-CO-VAC advises that including Omicron in a modified vaccine composition and administered as a booster dose is expected to broaden immunity while retaining protection against severe disease and death. 
• WHO emergency use listing of a vaccine product with a modified composition or its approval by a stringent regulatory authority will allow SAGE to provide policy recommendations for its use.

TAG-CO-VAC INTERIM STATEMENT ON THE COMPOSITION OF CURRENT COVID-19 VACCINES

TAG-CO-VAC, in its statement, advises that the inclusion of Omicron, as the most antigenically distinct SARS-CoV-2 variant of concern, in an updated vaccine composition may be beneficial.  Such a product, if available, would be best administered as a booster dose to those who have already received a COVID-19 vaccination primary series. 

The full text of the statement can be accessed here: https://www.who.int/news/item/17-06-2022-interim-statement-on--the-composition-of-current-COVID-19-vaccines

Key messages of the TAG-CO-VAC statement:

• The primary goal of COVID-19 vaccination is to reduce hospitalization, severe disease and death, and to protect health systems. The use of currently licensed vaccines based on the index virus (i.e. the virus that was identified from the first cases of COVID-19 in December 2019) confers high levels of protection against severe disease outcomes for all variants, including Omicron with a booster dose.
• There has been continuous and substantial virus evolution since SARS-CoV-2 emerged in late 2019, and it is likely that this evolution will continue, resulting in the emergence of new variants, particularly those with changes in the spike protein. The trajectory of SARS-CoV-2 evolution remains uncertain, and the characteristics of future variants cannot yet be predicted.
• Given these uncertainties, it may be prudent to pursue an additional objective of COVID-19 vaccination of achieving broader immunity against circulating and emerging variants while retaining protection against severe disease and death.
• Available data indicate that the inclusion of Omicron, as the most antigenically distinct SARS-CoV-2 Variant of Concern, in an updated vaccine composition may be beneficial if administered as a booster dose to those who have already received a COVID-19 vaccination primary series.

INTERIM STATEMENT ON DECISION-MAKING CONSIDERATIONS FOR THE USE OF VARIANT ADAPTED COVID-19 VACCINES

In its interim statement, the WHO SAGE Secretariat reflects the current understanding of variants of concern and variant-updated vaccines and highlights the gaps in evidence and potential implications for vaccination strategies.  Different use-case scenarios for an Omicron-updated vaccine will be considered once such a vaccine has received WHO emergency use listing or emergency use authorization by a stringent regulatory authority, and as per its mandate to provide policy recommendations.  

The full statement is available here: https://www.who.int/news/item/17-06-2022-interim-statement-on-decision-making-considerations-for-the-use-of-variant-updated-covid-19-vaccines

Key messages of the WHO SAGE Secretariat statement:

• Current COVID-19 vaccines, which are based on the ancestral strain of the SARS-CoV-2 virus, continue to exhibit strong protection against severe disease and death across all virus variants seen to date.  Achieving high coverage rates with the primary series and first booster doses in the highest and high priority-use groups in every country remains the priority.
• However, the emergence of variants of concerns has resulted in a rapid decline of the protection against symptomatic illness.  There is therefore a need to assess whether variant-updated COVID-19 vaccines, especially to Omicron, would improve vaccine performance.  Such vaccines should aim to provide even greater and more durable protection against severe disease and death, and broader protection against future variants that may be even more antigenically distant to the index virus.
• Variant-updated vaccines are under clinical development and will in due course be assessed by regulatory authorities.  Once these vaccines have received WHO emergency use authorization or approval by a stringent national regulatory authority, they will be considered by SAGE for policy recommendations.  Policy recommendations will address different use-case scenarios for Omicron-updated vaccines and include consideration of programmatic aspects. 
• The full public health benefit of variant-updated vaccines and their value proposition over current vaccines can only be quantified once vaccine effectiveness data have been obtained.

Notes to editor:

What is TAG-CO-VAC?

The Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) is an independent group of experts that periodically reviews the evidence and analyses the implications of emerging variants of concern (VOCs) on the performance of COVID-19 vaccines.  Subsequently, TAG-CO-VAC may recommend to WHO adaptations of vaccine composition from a global public health perspective and guided by the principles of equitable access.  Further information: https://www.who.int/groups/technical-advisory-group-on-covid-19-vaccine-composition-(tag-co-vac)

What is SAGE?

The Strategic Advisory Group of Experts (SAGE) on Immunization is the principal advisory group to WHO for vaccines and immunization.  It 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.  SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases. 

SAGE assesses evidence on safety, efficacy, effectiveness, impact and programmatic suitability, considering both individual and public health impact.  SAGE Interim recommendations for EUL products provide guidance for national vaccination policy makers.  These recommendations are updated as additional evidence becomes available and as there are changes to the epidemiology of disease and the availability of additional vaccines and other disease control interventions. Further information: https://www.whoint/immunization/policy/sage/en/

What is a SAGE “interim statement”?

SAGE Interim Statements summarize the available body of evidence on a topic of contemporary debate, outlining the key considerations and research gaps to guide policymakers. Interim Statements summarize the current state of ongoing research and do not constitute a change in policy recommendations. 

Media contacts:
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