EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new virus variants. In order to consider options for additional testing and development of vaccines that are effective against new virus mutations, the Agency has requested all vaccine developers to investigate if their vaccine can offer protection against any new variants, e.g. those identified in the United Kingdom, South Africa and Brazil, and submit relevant data.

EMA will shortly publish a reflection paper that will set out the data and studies needed to support adaptations of the existing vaccines to current or future mutations of SARS-CoV-2 in the European Union (EU). The questions that will be addressed as part of this reflection paper include:

  • Which are the options for introducing a new strain into an existing approved vaccine?
  • What will be the minimal regulatory requirements to demonstrate the quality, safety and efficacy?
  • Which bridging studies will be required to provide adequate reassurance of a vaccine’s efficacy against a new strain, either as first vaccination or as booster

EMA has authorised three vaccines for use in the EU: ComirnatyCOVID-19 Vaccine Moderna, and COVID-19 Vaccine AstraZeneca. There are concerns that some of these mutations could impact to different degrees the ability of the vaccines to protect against infection and disease. A reduction in protection from mild disease would however not necessarily translate into a reduction in protection from serious forms of the disease and its complications, for which we need to collect more evidence.

Typically, viruses mutate when the genetic material in the virus changes. This happens at different rates for different viruses and mutations do not necessarily affect how well a vaccine works against the virus. Some vaccines against viral diseases remain effective many years after their development and provide long-lasting protection, such as vaccines for measles or rubella. On the other hand, for diseases such as flu, the vaccine composition needs to be updated on a yearly basis for it to be effective, because the virus mutates and renders previous immunity ineffective.

COVID-19 variants have been present since March 2020, steadily spreading even before the start of the vaccination campaigns. EMA is clarifying its regulatory approach to vaccine variations that might become necessary to ensure that effective vaccines continue to be available, not only for Europeans, but for people around the world who are suffering as a result of the COVID-19 pandemic.

In addition, EMA is working with other regulatory authorities in the framework of the International Coalition of Medicines Regulatory Authorities (ICMRA) to determine possible changes to the composition of COVID-19 vaccines and to align a global strategy. A meeting on this topic is being co-chaired by EMA on 10 February 2021.

Posted on the EMA website on 10 February 2021