So: about these COVID variants - we’re going to have to tweak existing vaccines in order to provide protection against them, right? But how do we test the revised vaccines for efficacy before they are made available?
The European Medicines Agency released a reflection paper [Link is to PDF] today - a reflection paper being pretty much what it says - the agency is sharing its thoughts with us; in due course, and taking account of comments from medical, industry and other experts, this will become a guideline which tells you what you have to do.
The (current) EMA position is that no large scale efficacy studies will be required; approval of the updated vaccine - presuming that it is formulated, manufactured, tested etc etc like the “parent” vaccine was - will be based on human immunogenicity studies. Basically, trial subjects get a shot of the vaccine, their immune response gets tested to show that the new vaccine does the same thing against the new strain, compared to old vaccine/old strain. The paper covers combi vaccines (old + new in a single shot) - the approach is similar but (obviously) a bit more complicated. Safety data for authorisation would come from the subjects included in these studies.
The FDA moved faster (I was a couple of days late getting to this) and have already revised existing guidance. As you would hope, they are thinking pretty much along the same lines as the EMA. Link to announcement (from which you can hunt down the guidance document, if you wish).
The updated guidance outlines the FDA’s scientific recommendations for modifications to authorized vaccines. For example, the FDA expects that manufacturing information will remain generally the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer. For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support an EUA for a modified vaccine. Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies.
Obviously this is just a very brief summary of the documents. If you have questions, I can try to field them, but I’m not an immunologist. @BippityBoppityBoo - you may be better than me in that area (it wouldn’t be difficult!).
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