The authorities are getting ready for fast-track approval of vaccines for coronavirus

Drug regulatory authorities around the world are supporting researchers and companies in the fast development of a vaccine for coronavirus (2019-nCoV) and are getting ready to facilitate an approval as fast as possible without compromising safety.

There is currently no vaccine for coronavirus (2019-nCoV), and no medicines have been authorised for treatment of this virus specifically. However, researchers and companies around the world are working at full speed to develop them.

“This is a new type of virus, which was identified for the first time in Wuhan in China in December 2019. Since the breakout of coronavirus (2019-nCoV), researchers around the world have attempted to grow the virus with the intention of developing a vaccine against it. On 10 January 2020, it was successfully sequenced in a laboratory, which is an important step in vaccine development”, said Nikolai Brun, Head of Medical Evaluation & Biostatistics at the Danish Medicines Agency.

As soon as a company believes it is ready for vaccine approval, they must submit documentation on the vaccine’s efficacy and safety to the authorities. Medicines for the treatment of infectious diseases must in Europe be reviewed according to the so-called centralised procedure. This means that it must be authorised by the European Medicines Agency, which authorises the product on behalf of all countries in the EU.

“It is clear that in a situation like this where we urgently need to put a vaccine on the market, it is a top priority for the drug regulatory authorities. Right now, the primary concern is for the EMA to allocate resources to offer support and guidance to the companies on how to test the vaccine so that it can be marketed as soon as possible. The process must not be delayed by slowness of the authorities, but it is paramount that the documentation of efficacy and safety is in order”, said Nikolai Brun.

Fast emergency procedure

Normally, it takes several years to develop and have a new medicinal product authorised. However, when vaccines for emergency situations are needed, it is possible to do it much faster. In such situations, the European Medicines Agency (EMA) will try to enact the possibility of approval under what is known as the Emergency authorisation procedure, which results in a conditional approval. The procedure can be completed in about 70 days against normally 210 days because the so-called rolling review is used.

”Rolling Review means that the pharmaceutical companies submit their data to the EMA as soon as they become available. This is different from the normal procedure according to which the companies submit all data at once after all tests have been completed. It does not in any way imply that the safety is compromised. The assessment is carried out by a highly qualified group of experts and in close dialogue with the healthcare sector in the countries affected by the virus outbreak. Furthermore, a close follow-up in relation to side effects is also ensured once the vaccine is put on the market”, said Nikolai Brun.

The European Medicines Agency also used the emergency authorisation procedure and rolling review in 2009 when the EMA authorised the H1N1 swine flu vaccine. Likewise, a similar setup for approval of a vaccine for Ebola was organised when the epidemic hit West Africa in 2014.

Read the announcement from the European Medicines Agency on how they support the development of medicines for coronavirus.