An update on the regulatory submission for AstraZeneca’s COVID-19 vaccine in Switzerland

AstraZeneca has decided not to pursue the marketing authorisation for its COVID-19 vaccine in Switzerland. This decision is based on Swissmedic’s requirement to restrict the indication to people 50 years and above.

Since AstraZeneca started rolling submissions for marketing authorisation of the vaccine in Switzerland in October 2020, the company has been in close communication with the regulator and has continuously provided the requested study results and other pertinent information and documents.

The vaccine has been shown to have a favourable reactogenicity profile and is generally well tolerated in adults 18 years and above.1.2.3.4 It has been shown to be effective against all severities of COVID-19, across current variants of concern and all adult age groups, from clinical trials in up to 60,000 participants5 and in over 7.5 million people in a real world study.6 Incidents of an extremely rare blood disorder, thrombosis with thrombocytopenia syndrome (TTS) have been reported in a small number of people who have received the vaccine (2.3 events per million after second dose compared with 8.1 events per million after the first dose). There are established treatment protocols for the optimal management of TTS.7,8,9,10,11

AstraZeneca's COVID-19 vaccine has been granted a conditional marketing authorisation or emergency use in more than 80 countries across six continents. More than 1.7 billion doses have been released for supply to over 170 countries worldwide, including more than 100 countries through the COVAX Facility, and it has already helped save tens of thousands of lives and prevented hundreds of thousands of hospitalisations.
 

AstraZeneca COVID-19 vaccine, formerly AZD1222

The AstraZeneca COVID-19 vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

 

References

1. EMEA report, 11 May 2021: COVID-19 vaccine safety update – Vaxzevria : https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-vaxzevria-previously-covid-19-vaccine-astrazeneca-11-may-2021_en.pdf [Accessed: 24 May 2021]

2. Burn, E et al, Thrombosis and thrombocytopenia after vaccination against and infection with SARS-CoV-2: a population-based cohort analysis. Available at: https://www.medrxiv.org/content/10.1101/2021.07.29.21261348v1 [Accessed August 2021]

3. Burn, E et al, Thromboembolic Events and Thrombosis With Thrombocytopenia After COVID-19 Infection and Vaccination in Catalonia, Spain. Available at SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3886421 [Accessed July 2021]

4. Laporte JR et al. Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study. Preprint. https://www.medrxiv.org/content/10.1101/2021.07.23.21261036v1 Posted July 27. [Accessed August 2021]

5. AstraZeneca PLC. COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials. [Online]. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/covid-19-vaccine-astrazeneca-confirms-protection-against-severe-disease-hospitalisation-and-death-in-the-primary-analysis-of-phase-iii-trials.html [Last accessed: October 2021].

6. Bernal, J., et al. (2021) Early effectiveness of COVID-19 vaccination with BNT162b2 mRNA vaccine and ChAdOx1 adenovirus vector vaccine on symptomatic disease, hospitalisations and mortality in older adults in England. Pre-print: https://www.medrxiv.org/content/10.1101/2021.03.01.21252652v1  [Last accessed October 2021]

7. British Society for Haematology. Guidance produced by the Expert Haematology Panel (EHP) focussed on Vaccine induced Thrombosis and Thrombocytopenia (VITT). [Online] Available at: https://b-s-h.org.uk/about-us/news/guidance-produced-by-the-expert-haematology-panel-ehp-focussed-on-vaccine-induced-thrombosis-and-thrombocytopenia-vitt/ [Accessed July 6, 2021]

8. American Society of Hematology. Thrombosis with Thrombocytopenia Syndrome (also termed Vaccine-induced Thrombotic Thrombocytopenia). [Online] Availble at: https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia [Accessed July 6, 2021]

9. P. Bhuyan et al. Thrombosis with thrombocytopenia after second AZD1222 dose: a global safety database analysis of rare cases. Lancet. Available at: https://doi.org/10.1016/PII. Accessed July 2021.

10. NICE. COVID-19 rapid guideline: vaccine-induced immune thrombocytopenia and thrombosis (VITT). Available at: https://urldefense.com/v3/__https://www.nice.org.uk/guidance/ng200/resources/fully-accessible-version-of-the-guideline-pdf-pdf-51036811744__;!!Gajz09w!V72l1GN-_6bCjnLi7XVFEyZ18bc1rWznliHbmrBnQYf0Yw3yXHCfkugP21nFsFmUey1sZfB66pEM6Q$ Last accessed July 2021.

11. United Nations. Guidelines: Diagnosis and Management of Thrombosis with Thrombocytopenia Syndrome (TTS) following Adenovirus Vectored COVID-19 Vaccinations. Available at https://www.un.org/sites/un2.un.org/files/coronavirus_vipitguidance.pdf. Accessed August 2021.

 

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

AstraZeneca in Switzerland

AstraZeneca has 120 employees who are responsible for coordinating business operations in Switzerland. Our site in Baar is also the headquarters of the Europe & Canada Commercial Regional Team and the Europe & International Oncology Team, which employ a further 60 staff in Switzerland. Our primary therapeutic areas are Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. To meet our climate goals ahead of schedule, we are working tirelessly to further reduce CO2 emissions and waste. As part of our Ambition Zero Carbon strategy, we are transitioning to a carbon-free business operation by taking steps to reduce and ultimately eliminate greenhouse gas emissions. In 2021, AstraZeneca Switzerland was recognized by its employees for the fourth time as an outstanding employer and was awarded the external “Great place to work®” certification.

Find out more: astrazeneca.ch


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AstraZeneca Switzerland Media Department

Tel. +41 (0) 41 725 75 75; angelika.maerz@astrazeneca.com 
Dr. Angelika März, Corporate Affairs Lead


CH-5311, 11/2021