Excerpt from post - the FDA is asking a please explain in relation to the use of high dosage rates of AAV vectors administered in GT clinical trials
The meeting is in progress and undoubtedly in the fullness of time the FDA will make a recommendation that will presumably include measures to reduce toxicity in the use of AAV vectors. Unfortunately it still won't be safe to go back in the water. At the same time as the meeting is taking submissions and asking tough questions, there is another storm on the horizon - the ability to re-dose patients or for that matter where antibodies against AAV vectors are already present, the ability to dose patients at all.
The article Gene therapies and COVID-19 vaccines: a necessary discussion in relation with viral vector-based approaches highlights the potential impact of viral vector vaccines e.g. AstraZeneca COVID-19 vaccine, in future gene therapy treatments.
The article points out that the cross-reactivity among different AAV serotypes can be as high as 50%. Will the efficacy of gene therapies be impacted by the immune response elicited by COVID-19 vaccines that use a viral vector approach? It should be noted that Pfizer is a mRNA vaccine which is a non-viral platform.
The AZ vaccine that according to reports is the world's most widely used COVID vaccine with more than 1B doses issued in 170 countries has muddied the waters in ways which may make gene therapy collateral damage.
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