Implementation of a vaccine for SARS-CoV-2 – legal analysis

by Anastazja Niedzielska-Pitera

27 May 2020

Dozens of research teams around the globe are working on a vaccine for coronavirus. Several pharmaceutical companies, e.g. Pfizer and Moderna, have already started tests on people. But before the vaccine is placed on the market it must meet some special requirements laid down in pharmaceutical laws.

Procedure overview

Work on a vaccine starts with laboratory (preclinical) studies. First, they are conducted on cells and tissues followed by tests on animals. The research rules in Poland are set out e.g. in the Laboratory Diagnostics Act. Positive results allow researchers to proceed to carry out tests on humans. However, they first need to obtain approval from a competent bioethical commission. The expert commission assesses, among other things, risks and protection guarantees for the test participants.

Clinical trials are divided into three phases with the number of volunteer-participants increasing with every phase (up to a few thousand). The aim of the tests on humans is to determine the safety level, immunological reaction, i.e. the ability to trigger a reaction of the immunological system, and efficacy of the vaccine. Standards for clinical trials are laid down e.g. in the Physician Profession Act, the Pharmaceutical Act, and the EU regulation on clinical trials on medicinal products for human use.

Administrative proceedings

Once the clinical trials are over, the responsible party starts a procedure for regulatory approval of the vaccine to be able to place it on the market. To this end, it submits the application plus all research documentation to the competent regulatory agency. In Poland, it is named the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych). In the European Union it is the European Medicines Agency. In the course of the procedure, a team of experts checks, above all, the safety and quality of the vaccine. If it meets the detailed requirements for medicinal products, they may issue the approval for marketing the vaccine. There are a few competing registration procedures, but the verification process standards are similar. Detailed rules are set out in the EU regulation laying down Community procedures for the authorisation and supervision of medicinal products for human use and in the Polish Pharmaceutical Act.

Timeframe

The time between the start of lab research and the vaccine approval for market use is usually several years. With most vaccines the preclinical studies take 2–5 years and clinical trials take about 6 years. Administrative proceedings may last up to 240 days but the regulatory approval usually takes a bit less. With the coronavirus vaccine, some research teams have already completed the lab tests and started clinical trails (the Jenner Institute, Moderna Therapeutics, Pfizer) thus cutting that phase short to several months. We do not know how long the tests on humans will take but researchers claim that they may able to get the job done by the end of 2020. The later regulatory procedure may be cut short considerably, especially as the law sets no minimum time limits.

The work on a vaccine for SARS-CoV-2 has been intensified in an unprecedented way. This will most certainly speed up the authorisation procedure. Regulatory agencies will definitely prioritize applications related to the coronavirus vaccines. This, however, does not mean that the requirements for any party or for the much-awaited vaccine will be relaxed. Quite the opposite. The breakneck speed of research will necessitate a greater scrutiny over the product safety and a more careful risk assessment of the vaccine shots on the general population. We must not forget that vaccines are special-purpose medicinal products which contain biologically active materials and are monitored extra carefully.