About CureVac’s activities regarding an mRNA based vaccine against COVID-19
In the following, we will inform you about our development and manufacturing activities regarding an mRNA based vaccine against the novel coronavirus. This page includes:
- Information about coronaviruses in general,
- Information on CureVac’s activities regarding an mRNA based vaccine against COVID-19,
- Frequently asked questions about our vaccine activities (FAQ),
- Quotations from three members of our Board of Management,
- Our press releases as well as
- Different pictures.
We are proud being part of the international efforts to protect people worldwide from the novel coronavirus. We are aware of our global responsibility and want to use our specific know how and technological potential to support the fight against the current health emergency.
(We will update this page regularly; the latest update was on May 14, 2020)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On January 7, 2020, the novel coronavirus SARS-CoV-2 was identified as the cause of pneumonia cases in Wuhan City, Hubei Province of China, and numerous other cases have since then been found in almost every country around the globe.
For more information about the coronavirus as well as the current situation, please consult the following national and international organizations and public authorities:
CureVac’s activities regarding an mRNA based vaccine against COVID-19
The COVID-19 pandemic poses one of the greatest challenges humankind has faced in the past century. Developing vaccines is the most cost-effective way to save lives and to neutralize the grave threat posed by deadly virus. At CureVac, we aim to leverage our unique technology to provide life-saving solutions for people and patients worldwide. Our prophylactic vaccines represent a novel technology, which can enable production of safe, efficacious and cost-effective vaccines for a range of infectious diseases.
Therefore, we are currently developing a vaccine against the coronavirus based on our mRNA technology that is especially suitable to provide a rapid response to this viral outbreak situation. All our internal efforts are focused on this challenge with the goal to reach, help and protect people all over the globe: We declared COVID-19 our core project.
- CureVac's technology and mRNA platform are specifically suitable to rapidly provide an answer to a viral outbreak situation like this.
- We engaged in the prophylactic vaccine area since 2007.
- We have already worked on coronavirus/MERS in 2017.
- We have achieved positive Rabies data, which means immunization at a very low dose.
- We have the capability to manufacture mRNA based vaccines in a huge scale.
- We are in discussions with health authorities as well as institutions and organizations regarding the development, production and clinical process of a coronavirus vaccine, e.g. Coalition for Epidemic Preparedness Innovations (CEPI) and Bill and Melinda Gates Foundation (BMGF).
About our mRNA technology
With our mRNA technology, we instruct the human body to activate its own defense mechanism. To that, we use the natural messenger substance mRNA that contains the construction manual needed to produce proteins. We program this messenger substance with the information about one protein of the coronavirus and inject it into the human body. The body recognizes the protein produced by our cells as something unknown and activates its immune cells to produce antibodies and T-cells against it. In this way, we imitate the natural viral infection and activate the endogenous defense system.
Please check out our mode of action video for more information on how our technology works.
Timeline of CureVac’s activities regarding a coronavirus vaccine
(as of May 14, 2020)
Early January 2020:
- CureVac started the program when the sequence of the novel coronavirus was published.
End of January 2020:
- CureVac and CEPI extend their cooperation to develop a vaccine against the coronavirus. The cooperation includes an additional initial funding of up to $8.3 million by CEPI for the accelerated vaccine development, manufacturing and clinical tests.
- CureVac has selected the most suitable vaccine candidates from several constructs based on quality criteria and bio logical activity.
- In parallel, the company is coordinating the development of its program with the German Paul Ehrlich Institute (PEI) for accelerated clinical development of these vaccine candidates. Furthermore, CureVac is in discussions with other European health authorities.
- Two primary study centers have already been identified and are in preparation for the clinical trials.
- The European Commission offered up to €80 million of financial support to CureVac to scale up the development and production of a vaccine against the coronavirus in Europe.
Mid of May 2020:
- CureVac announced positive pre-clinical results at a low dose for its lead vaccine candidate against the novel Coronavirus (SARS-CoV-2): Coronavirus lead vaccine candidate has generated high level of virus neutralizing titers after two 2 microgram dose vaccinations in pre-clinical experiments.
Early summer 2020:
- CureVac expects to start the clinical trial Phase 1/2a in June 2020.
- Depending on the data of Phase 1/2a study, CureVac expects to start the next clinical trial phase with a significant number of participants.
Frequently asked questions about our vaccine activities (FAQ)
What are the requirements for the development and production of a coronavirus vaccine?
The basis is our 20 years of know how in mRNA technology. Our mRNA based platform allows us to react fast and flexible on such outbreaks. We also have the manufacturing capabilities to produce a vaccine in a significant amount of doses. Furthermore, clinical tests and the regulatory approval process are important steps on the way of a coronavirus vaccine.
What do you mean with vaccine platform technology?
The term “vaccine platform technology” broadly refers to a system that uses the same basic components as a backbone, but can be easily adapted for use against different pathogens by inserting new sequences.
When could CureVac deliver a coronavirus vaccine?
We are planning to start with first clinical trials in June 2020. If the data are favorable, we could go soon into the next clinical study with several thousand of participants in autumn 2020. Besides the data, it depends strongly on the regulatory authorities when a vaccine could be available on the market.
What is the difference of your vaccine approach in contrast to “traditional” vaccine development?
Traditional vaccine approaches administer live or inactivated pathogens or use recombinant protein to generate an immune response. However, the mRNA vaccine candidate delivers mRNA into a cell of the vaccine, instructing it to produce a specific protein or antigen (i.e., a foreign substance that induces an immune response). The induced immune response is directed against the encoded protective antigen. To prevent degradation of the mRNA and improve vaccine effectiveness, the mRNA is also encapsulated in a protective shell.
Where are you currently in the development process?
We are working intensively and with high speed on the development of a vaccine. We already have selected the best vaccine candidates from several constructs and have seen first positive effects in in-vivo tests. We expect to have a vaccine candidate ready for clinical studies in June 2020.
Which criteria have been important for the selection of the best vaccine candidates?
Quality criteria, tolerability and biological activity have been important for the selection of the best vaccine candidates.
Why could the phase 1 rabies data be relevant for the development of a coronavirus vaccine?
In that trial, we investigate a rabies vaccine that was produced via the same platform, as we will use for the coronavirus. We can therefore assume that the immune responses and the safety information we gather via that study are indicative for what will happen in the clinical study on the coronavirus. Notably we saw that our platform has the potential to stimulate an immune response with a low dose vaccine, which would allow us, after further development, to produce more vaccine doses overall to be able to protect a larger part of the population.
Did you already decide where you will conduct the clinical studies?
Two primary study sites in Europe have been identified and engaged.
When do you expect to have first data from your clinical studies?
We expect to have initial immunogenicity and safety results within a few weeks of trial start in late summer.
How many doses of coronavirus vaccine can you produce?
Based on the low dosing of our rabies vaccine in humans, we have the capacity to produce up to several hundred million doses of bulk RNA material per annum with our current GMP III facility. Beyond that, we are planning to put a new GMP IV suite into operation within two years where we can produce one billion or more doses per year.
Quotations from three members of our Board of Management
Dr. Franz-Werner Haas, acting Chief Executive Officer and Chief Operating Officer of CureVac:
“We are working intensively and with high speed on the development of a vaccine against the coronavirus and we have already selected the best vaccine candidates from several constructs based on quality criteria, tolerability and biological activity. Therefore, we are optimistic to have a vaccine candidate ready for clinical studies Phase 1/2a in June 2020 to test its safe and efficacious use in humans. If these data are good as well as with the consent of the authorities, we could immediately start a larger trial.”
Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac:
“Nature has invented mechanisms to activate our immune system against infectious diseases. With our unique messenger RNA technology, we mimic nature and give our body the information how to fight against the virus. The combination of mRNA science, disease understanding, formulation and production expertise make CureVac a unique player to fight against any infectious disease, no matter whether they are seasonal or pandemic.”
Dr. Florian von der Mülbe, Chief Production Officer of CureVac:
“Thanks to our existing industrial-scale, GMP-compliant production facility in Tübingen, we will be able to produce material for up to several hundred million doses of our mRNA based vaccines. A new production unit, which we plan to complete in the next two years, will enable us to manufacture material for several billion vaccine doses per year.”
Our press releases
Please find all our published press releases here.
Check out our media library for images and videos.
About CureVac AG
CureVac is a leading clinical stage biotechnology company in the field of messenger RNA (mRNA) technology with 20 years of expertise in developing and optimizing this versatile molecule for medical purposes. The principle of CureVac's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. The company applies its technologies for the development of cancer therapies, antibody therapies, the treatment of rare diseases, and prophylactic vaccines. CureVac has received significant investments, amongst others from dievini Hopp BioTech holding and the Bill & Melinda Gates Foundation. CureVac has also entered into collaborations with multinational corporations and organizations, including Boehringer Ingelheim, Eli Lilly & Co, Genmab, CRISPR Therapeutics, the Bill & Melinda Gates Foundation, CEPI and others. CureVac is headquartered in Tübingen, Germany with sites in Frankfurt and Boston, USA.
CureVac Media Contact
Head of Corporate Communications
+49 (0)7071 9883-1577