Like all medicines, vaccines are developed, tested and licensed in accordance with current regulatory guidelines and legal requirements, taking into account scientific guidelines. The aim is to provide a high-quality, effective and, above all, safe vaccine.
Vaccine development
The development and research of a vaccine candidate in the laboratory takes about two to five years. First, the pathogen is analyzed and tested to determine which components of the virus the human immune system reacts to and can build up protection (antibodies). This is followed by vaccine development and small-scale manufacturing for further vaccine testing in animals and humans.
In preclinical vaccine development, cell cultures (in vitro, z.B. The immunogenicity (ability of the antigen to induce immunization), efficacy and safety of the vaccine are tested in animal studies (in vivo). Only after extensive research and proof that the vaccine can be produced in good quality and meets all the high requirements is the vaccine tested in clinical trials on volunteers who have been informed of all possible risks. This also takes about two to five years to develop.
Clinical trials
The responsible national authorities and ethics committees ensure that all studies are scientifically sound and ethically correct. Clinical trials prior to vaccine approval can be divided into three phases.
Phase I: As a rule, between 20 and 100 healthy volunteers are involved in order to test whether the vaccine triggers the expected reactions on the basis of laboratory tests (immunogenicity). First and foremost, safety and tolerability are tested.
Phase II: Studies in several hundred volunteers provide information on the best possible vaccine dosage for optimal protection, the side effect profile and the number of vaccinations needed for the best possible vaccination regimen.
Phase III: In the final phase, the vaccine is given to a few thousand (in the case of COVID-19 vaccines, several 10.000) volunteer subjects tested in the target population. It shows how effective the vaccine is compared to a control group (z. B. placebo) protects against the disease and what side effects, if any, may occur and with what frequency.
Approval of vaccines
A regulatory approval process is generally a prerequisite for a vaccine to be marketed. Approval means: testing of a vaccine for quality, efficacy and safety based on data submitted by the applicant. In the EU, the approval process for COVID-19 vaccines is coordinated by the European Medicines Agency (EMA). The national drug authorities are involved in the technical review process.
The applicant submits registration documents for regulatory review according to clearly defined guidelines. These include u.a. regulatory information, manufacturing data, preclinical and clinical data, current literature, and information on planned long-term post-approval surveillance. In addition to the vaccine antigen, the "actual active ingredient," all other ingredients of a vaccine are also evaluated. The European Pharmacopoeia, which has the character of law, defines these ingredients including their permissible limit values.
A vaccine is approved if the risk-benefit ratio is positive, i.e. the benefits outweigh the risks. The "standard" approval process itself can take up to two years to complete.
If the vaccine meets all scientific and regulatory requirements and its benefits outweigh its risks, the EMA’s expert panel (consisting of representatives from the EU member states plus Norway and Iceland) recommends approval of the vaccine to the European Commission, which then grants marketing authorization. This is valid for all EU countries, national approval is no longer required.
In addition, a batch release by an officially appointed medicines control laboratory is required in Austria (OMCL – Offical Medicines Control Laboratory of AGES). A batch is a quantity of a vaccine produced in the course of a uniform manufacturing process. Any drug control laboratory in the EU or. in the European Economic Area (EEA) and Switzerland, if it meets the legal requirements, a batch release for vaccines can be carried out. The certificates of release must then be distributed throughout the EU or. be recognized throughout the EEA and Switzerland. Manufacturers can decide for themselves to which drug control laboratory they submit their vaccine for a batch release.
COVID-19 vaccines
The development and approval process for COVID-19 vaccines is being accelerated due to the severe impact of this pandemic. Extensive existing knowledge about coronaviruses and vaccine development is incorporated into the process.
To accelerate development, companies and research institutions commit significantly more human and financial resources in less time than traditional development processes. Where possible, and subject to strict safety requirements, study phases are also conducted in parallel. In addition, manufacturers are expanding their production facilities at a much earlier stage of vaccine development than usual to ensure that large quantities of vaccine are available quickly after licensure.
In addition, the European Medicines Agency (EMA) offers accelerated scientific advice to vaccine developers to keep development focused and on target.
Standard vaccine development
Accelerated inoculation development