Development of COVID-19 vaccines
Candidate vaccines must undergo extensive testing
Several biotechnology companies, global vaccine manufacturers and other organisations such as CEPI (Coalition for Epidemic Preparedness Innovation) and BARDA (Biomedical Advanced Research and Development Authority) are developing vaccines against COVID-19 disease. There is a wide range of candidate vaccines based on different vaccine models.
The WHO is closely monitoring these efforts and is working with international pharmaceutical authorities to guide the selection, prioritisation and selection of candidates globally. Any vaccines given priority for full development must undergo a variety of studies, including animal studies and clinical trials on humans. In phase 1, safety is tested in a few people, followed by safety and efficacy in gradually larger groups in phases 2 and 3. European and Norwegian pharmaceutical authorities are reviewing and approving further development between each phase, and deciding whether to approve relevant vaccine candidates for use in the population. We expect this to happen in the autumn 2021 at the earliest.
New production methods
Some of the vaccines under development use vaccine models that are not yet approved for human use. Development can start quickly in the initial phase, but new challenges can arise that delay development.
Safety and efficacy must be documented
Documenting the safety and efficacy of a new candidate vaccine through human testing is imperative for a vaccine intended for the entire population. The benefit of vaccination should outweigh any potential risk of side effects. For some infections, antibodies produced after vaccination may exacerbate the disease when the vaccinated person is exposed to those infections. This will be closely monitored during testing of the candidate vaccines. It is crucial to show that this risk is not present in the vaccines selected for full development.
Prioritisation - demand will exceed supply
Establishing sufficient production capacity is a demanding but important process. This will be particularly demanding for vaccines based on new models, but even for vaccines based on known principles, it will take time to build up the capacity to produce sufficient quantities of vaccine. In many countries, national authorities and private actors have joined forces to share the financial risk and to develop sufficient production capacity.
WHO currently estimates that the vaccine production for extensive use can begin at the earliest in 12-18 months, i.e. in autumn 2021. After this, there must be strict prioritisation. Prioritised groups are likely to be healthcare personnel and defined risk groups, but consideration will be given based on the status of the outbreak and which geographical areas need the vaccine most at the time.
Norway is in negotiations to participate in a procurement collaboration within the EU to ensure the possibility of buying vaccine doses for the Norwegian population. Meanwhile, Norway is also working to ensure the fair distribution of available vaccine doses to low- and middle-income countries.