Vaccines and medicines against COVID-19
The COVID-19 disease has spread to most parts of the world. COVID-19 is caused by a novel type of virus, SARS-CoV-2, which belongs to the so-called coronavirus family. Worldwide, clinical trials are currently testing new and old medicines that could perhaps be used against the disease.
As soon as a company believes it is ready to have a vaccine or medicine approved for treatment, it must submit documentation on the medicine’s efficacy and safety to the drug regulatory authorities.
In the case of medicines for the treatment of infectious diseases, this is handled by the EU under the so-called centralised procedure. This means that the documentation must be submitted to the European Medicines Agency, EMA, which assesses the vaccine or medicine on behalf of all EU member states. If the EMA recommends approval, the European Commission subsequently issues a marketing authorisation in all EU member states.
It normally takes about 10 years from the idea of a new medicine to it being authorised and made available to consumers. But in the context of COVID-19, this process is expected to take about on to two years.
A medicine or a vaccine for SARS-CoV-2 can only be authorised for use in the wider public if there is strong and sufficient documentation on the product’s efficacy and safety from major, scientific trials enrolling thousands of human beings in so-called phase 3 clinical trials.
The EMA has initiated an emergency plan one of the aims being to reduce the review times considerably so that a COVID-19 vaccine can be approved faster without compromising on the strict requirements for documentation of efficacy and safety.
This can take place through the granting of a conditional authorisation, which implies that a vaccine can be approved before the availability of long-term data on effects and possible side effects from completed phase 3 trials – i.e. normally after two to three years – if the benefits of making a vaccine available to people faster outweigh the risks inherent in the fact that the amount of available data will be less compared to a normal authorisation procedure.
If a conditional authorisation is granted, it will therefore be based on documentation of efficacy and side effects from ten thousands of voluntary trial subjects and on the basis of an assessment of known and potential effects and side effects.
Under a conditional authorisation, the vaccine manufacturer is obliged to submit further data to the EMA on an ongoing basis. A conditional authorisation is granted for one year and is subject to annual renewal. When the authorities have received all the agreed documentation, the conditional authorisation can be changed to an actual marketing authorisation.
Ongoing assessment of documentation
When vaccines or medicines are needed in particularly acute situations like COVID-19, the documentation is assessed on an ongoing basis or according to a so-called rolling review, which means that the pharmaceutical companies submit their data to the EMA for assessment as soon as they become available.
This means that the procedure can be completed in about 70 days compared to normally 210 days because the companies do not wait for all tests to have finished before submitting their data. The assessments are carried out continuously by a group of experts and in close dialogue with the health services in the countries affected by the virus outbreak. After marketing of the vaccine, a close follow-up procedure will be established to monitor potential side effects.
The authorities subject the data to an extremely thorough assessment. The purpose is to ensure that at the time when a conditional authorisation is granted, there is sufficient certainty that the benefits outweigh any side effects. In this extraordinary COVID-19 situation, it is a particularly aggravating circumstance that the disease is global, that it increasingly appears to cause severe courses of the disease and long-term side effects for some patients and that our health service is seriously impacted by it.
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