The agency is developing a guidance guide for manufacturers planning to modify existing antigens.
The European Medicines Agency (EMA) has asked all vaccine developers to investigate whether their vaccine can offer protection against any new variant of Covid-19, such as those identified in the United Kingdom, South Africa and Brazil, and that present the relevant data.
Likewise, the agency is also preparing a guide guidance for manufacturers planning Modify existing vaccines against Covid-19 to deal with these new variants.
Despite the existing concern that these variants affect the efficacy of the vaccines authorized so far, the EMA recalls that a slight reduction in immunity against Covid-19 would not necessarily translate into less protection against severe forms of the disease and its complications, although this requires gathering more evidence.
Normally, viruses mutate when the genetic material of the virus changes. This occurs at different rates for different viruses, and mutations do not necessarily affect the effectiveness of a vaccine.
Precisely, the variants of Covid-19 have been present since March 2020, spreading constantly even before the start of vaccination campaigns. This is why the EMA is clarifying its regulatory approach on vaccine variants that may be necessary to ensure that effective vaccines remain.
In addition, the EMA is working with other regulatory authorities within the framework of the International Coalition of Medicines Regulatory Authorities (ICMRA) to determine possible changes in the composition of Covid-19 vaccines and align a global strategy.