How do vaccines get licensed in the UK?

What is a vaccine?

Vaccinations are safe and effective ways of protecting people against infectious diseases. When we become infected by a pathogen, our body responds by building cells that are able to target and kill that specific pathogen. Vaccines mimic an infection and trick the body into building these cells. The cells remain in the body for a long time and are ready to react to that infection in the future.

Vaccines come in many different forms. Some contain weakened forms of the germs whilst others contain proteins that are found on the germ. Novel COVID19 vaccines contain mRNA which hijacks machinery in the cell to make viral proteins. The immune system then recognises these proteins as foreign and a threat to the body and makes the specialised cells to target them.

How does a vaccine licensed in the UK?

Vaccinations undergo extensive testing prior to being licensed in UK. Clinical trials of any medications are subject to peer review. Peer review is when other professionals critically analyse the methods and results of a study. Results are also independently reviewed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). Once approved by these independent bodies, the company will be issued a license to bring the vaccine to market.

The license will detail who can receive the vaccine, how many doses are needed and how far apart they need to be taken. It will also specify any side effects.

Once a license is granted it will be available in the private market. The ‘Joint Committee on Vaccination and Immunisation’ will then review clinical trials and modelled data to determine the best way to make the vaccine available to the public.

Why do vaccines need a license?

Licensing is only approved for vaccines that have undergone rigorous testing in the clinical trial space.

Summary

Prior to licensing, vaccines undergo several stages of clinical trials. Teams who develop vaccines then publish their findings and these results are subject to peer review from other experts and stake holders in the field. Independent bodies also review evidence to ensure vaccines are effective and safe.