Submission by Moderna: variant-adapted Covid-19 vaccine in the EU approval process
06.07.2023 12:52
Subject to approval, the adapted vaccine is planned to be made available for the vaccination season in autumn/winter 2023. The company expects a future with a permanently circulating coronavirus in Germany as well as a high need for prevention among people over 60 years of age as well as people with certain age-independent previous illnesses, immunocompromised people and contact persons. [1]
Moderna, Inc., has announced the submission of its monovalent vaccine adapted to the XBB.1.5 variant of the SARS-CoV-2 virus to the European Medicines Agency (EMA). By adapting to the dominant XBB variant [2], Moderna is following the recommendations of the regulatory authorities EMA and FDA (Federal Drug and Food Administration) as well as those of the World Health Organization (WHO). [3,4,5] “Experts expect that Covid-19 will be endemic, i.e. occur regularly in waves,” [6] explains Dr. Gerald Wiegand, Managing Director of Moderna Germany. “It is therefore important that the risk of a serious course of the disease is reduced, especially for risk groups [1]. The vaccine from Moderna, adapted to the XBB.1.5 variant, is intended to protect you accordingly, subject to approval.” Wiegand continued: “You can probably compare SARS-CoV-2 with the influenza viruses. Here, the vaccine composition is adjusted annually by the WHO to the currently circulating influenza viruses. As SARS-CoV-2 mutates, this could cause the composition of all Covid-19 vaccines to change from year to year. “Vaccinating once a year, preferably in autumn, will be our new normal and is recommended by the Standing Vaccination Commission [1] for certain groups of people.”
“Living with the virus” – what does that mean?
“The WHO literally speaks of an established and permanent health problem [7] that Covid-19 now represents,” explains Dr. Alfred von Krempelhuber, Medical Director of Moderna Germany. “So Covid-19 is not over. Accordingly, older people and people at risk of a serious course of the disease in particular should check their vaccination status regularly with their doctor and consider an annual booster vaccination." Von Krempelhuber added that it is still important for everyone to be vigilant against Covid-19. to stay 19: “Since a SARS-CoV-2 infection also has long-term consequences such as long Covid. The latest STIKO recommendations1 include an annual Covid-19 booster vaccination “preferably with a variant-adapted mRNA vaccine” for people over 60, people with previous illnesses, residents of care facilities and medical staff who are direct patients or residents :internal contact and family members as well as people in close contact with immunocompromised people. [1] The Covid-19 vaccination was included in the general STIKO vaccination recommendations for 2023. [1]
Who should be vaccinated with the variant-adapted vaccine?
The latest STIKO recommendations1 include an annual Covid-19 booster vaccination “preferably with a variant-adapted mRNA vaccine” for people over 60, people with previous illnesses, residents of care facilities and medical staff who are direct patients or residents :internal contact and family members as well as people in close contact with immunocompromised people. [1] The Covid-19 vaccination was included in the general STIKO vaccination recommendations for 2023. [1]
When will the variant-adapted Covid-19 vaccine be available?
Regarding the availability of the variant-adapted vaccine, Wiegand says: “We plan that the adapted mRNA vaccine from Moderna will be available in time for the local vaccination season in the fall, subject to its approval.”
credentials
1. Robert Koch Institute. Epidemiological Bulletin 4/2023. Implementation of the COVID-19 vaccination in the general recommendations of STIKO 2023. Available online at:
https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2023/21/Art_01.html. Last accessed on June 9th, 2023.
2. World Health Organization (WHO). Tracking SARS-CoV-2 variants. Available online at: https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/. Last accessed on June 9th, 2023.
3. European Center for Disease Prevention and Control (ECDC). ECDC-EMA statement on updating COVID-19 vaccines composition for new SARS-CoV-2 virus variants. Available online at: https://www.ecdc.europa.eu/en/news-events/ecdc-ema-statement-updating-covid-19-vaccines-composition-new-sars-cov-2-virus-variants. Last accessed on June 15, 2023.
4. European Medicines Agency (EMA). Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants. Available online at: https://www.ema.europa.eu/en/news/global-regulators-agree-way-forward-adapt-covid-19-vaccines-emerging-variants. Last accessed on June 9th, 2023.
5. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. Available online at: https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines. Last accessed on June 26, 2023.
6. DocCheck Flexikon. Endemic. Available online at: https://flexikon.doccheck.com/de/Endemie. Last accessed on June 9th, 2023.
7. World Health Organization (WHO). Statement on the fifteenth meeting of the IHR (2005) Emergency Committee on the COVID-19 pandemic. Available online at: https://www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency- committee-regarding-the-coronavirus-disease-(covid-19)-pandemic. Last accessed on June 9th, 2023.