The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised another clinical trial of a vaccine against COVID-19 in Germany.
The intensive preliminary scientific advice of the medicines developer CureVac, and the prioritisation of the regulatory activities at the Paul-Ehrlich-Institut for vaccines and biomedicines against COVID-19 have made it possible to complete the authorisation procedure within nine working days.
The authorisation is the result of a careful assessment of the risk/benefit profile of the vaccine candidate. Clinical trials of vaccine candidates in humans are an important milestone on the road to the marketing authorisation of safe and efficacious vaccines against COVID-19 for the population in Germany as well as other countries.
The safest method of containing the SARS-CoV-2 pandemic is the world-wide provision of safe and efficacious COVID-19 vaccines. After the pre-clinical development, first clinical trials – the first use of the vaccine candidate in humans – aim at determining the general tolerability of vaccine candidates and to find out whether a specific immune response is created against the pathogen.
The Paul-Ehrlich-Institut, which is responsible for the authorisation of clinical trials as well as the assessment and the marketing authorisation of vaccines in Germany supports the development of COVID-19 vaccines with top priority. It provides advice in the development of vaccines and biomedicines against COVID-19 at an early stage, thus helping to prevent regulatory pitfalls and to accelerate processes without sacrificing a careful examination.
The vaccine candidate of the Biotechnology Company CureVac with office at Tübingen, Germany, is an RNA vaccine which contains the genetic information for the construction of the so-called spike protein of the SARS-CoV-2 pathogen in the form of ribonucleic acid (RNA). The clinical trial is a trial of Phase 1 with altogether 168 healthy volunteers, of whom 144 will be vaccinated. In this process, the dose is increased step-by-step to identify the general safety and tolerability and a dose suitable to induce an immune response with antibodies specifically targeted against SARS-CoV-2 in humans.
As per 9 June 2020, according to the World Health Organisation (WHO), this is the 11th authorised clinical trial word-wide for a preventive specific COVID-19 vaccine candidate in humans and the second of that kind in Germany. The increasing number of clinical trials for COVID-19 vaccine products, world-wide is an important step towards making such products available, while assuring that they are also safe and efficacious.
The Paul-Ehrlich-Institut is certain that additional clinical trials for COVID-19 vaccine candidates will start in Germany in the next few months. Combating the pandemic will require more than one vaccine product in order to ascertain sufficient supplies.
Background of the RNA vaccine
RNA vaccines contain segments of the genome of the viruses. These consist of the blueprint for the entire surface protein of the SARS-CoV-2 pathogen or a part thereof. An excipient is added to the RNA (LNP; lipid nanoparticle), which causes this genetic information to enter some body cells of the vaccinee following the vaccination.
There, the RNA (just like the genetic information of the body cell itself) is read, and the appropriate surface structures (proteins) of the virus are produced. Thus, while, in the case of many conventional vaccines, the antigen itself is produced, in the case of the RNA vaccine, the genetic information is injected enabling the body itself to produce the antigen.
The immune system reacts to the proteins (antigens) thus created by developing specific defence substances, including antibodies. If the vaccinee comes into contact with the SARS-CoV-2 pathogen at a later stage, the immune system will recognise the surface structure. The immune system can thus defend itself against the virus in a targeted manner and prevent the COVID-19 disease or at least the course of the disease.
Where can I get information about a participation in the clinical trial of the COVID-19 vaccine?