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Photo: Alastair Scholarship / AP / TT
The European Medicines Agency (EMA) has started the first evaluation of a covid vaccine. The vaccine is manufactured by the Swedish-British pharmaceutical company Astra Zeneca. Stock Photography.
The European Medicines Agency (EMA) has now started the first evaluation of a covid vaccine for possible authorization.
The current vaccine has been developed by the Swedish-British pharmaceutical company Astra Zeneca in collaboration with researchers from the University of Oxford. This is also one of the vaccines that the Swedish government has agreed to.
The review, writes the Swedish Medicines Agency in a press release, will be carried out on an ongoing basis through so-called ‘continuous review’, which is a process that can be used to speed up the evaluation of a medicine should the situation become consider critical.
At present, the authority states, it is not possible to draw any conclusions about the safety or efficacy of the vaccine.
“It is not possible to predict when a possible vaccine approval decision could be made, even if the ongoing review may significantly shorten the research time,” says Charlotta Bergquist, vaccine coordinator for the Agency for Medical Products.
Normally, all documentation on the efficacy, safety and quality of a drug must be submitted at the same time that an authorization is requested. However, in an ongoing review, the authority reviews information as it becomes available from ongoing studies.
PODD So a vaccine can be ready
Aftonbladet Daily speaks with coordinator Richard Bergström.
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