Partners at Taysha Gene Therapies who plan to submit an investigational new drug (IND) application to the FDA later this year for their Rett Syndrome indication, TSHA-102, have provided us with this statement to share with the Rett community, regarding the use of adenovirus vector Covid-19 vaccines and how this might impact eligibility to take part in clinical trials of gene therapy.
The short answer is, that from what we know now, it should not. Please read the whole statement below for more information.
Also please note that in the UK, whilst the Johnson and Johnson vaccine has not yet been approved for use, we are expecting a decision on this very soon. Also authorised for use in the UK are the Pfizer and Moderna vaccines mentioned in the statement, as well as the Oxford/AstraZeneca vaccine.
Taysha Gene Therapies Statement on COVID-19 Vaccines
We are aware of concerns about the adenovirus vector COVID-19 vaccine from Johnson & Johnson (J&J) and its potential impact on eligibility to receive an investigational gene therapy in the future; however, available evidence suggests that receiving the J&J COVID-19 vaccine will not disqualify an individual from participation in any potential clinical trial with TSHA-102, Taysha’s investigational AAV9 gene therapy product candidate for Rett syndrome.
While both the COVID-19 vaccine from J&J and the TSHA-102 investigational gene therapy use viral vectors as a vehicle to deliver genetic material or medicine to cells in the body, they are distinct viral vectors that are not related in genetic composition. The J&J COVID-19 vaccine utilizes an adenovirus type 26 (Ad26) vector while TSHA-102 utilizes an adeno-associated virus serotype 9 (AAV9) vector. Because they use different types of viral vectors, currently, there is no evidence to suggest that the adenovirus vector COVID-19 vaccine would impact enrolment in future clinical trials of TSHA-102. The same holds true for the AstraZeneca-Oxford COVID-19 vaccine, which utilizes an adenovirus ChAdOx1 vector.
In addition to the adenovirus vector COVID-19 vaccines, there are two other COVID-19 vaccines available from Pfizer and Moderna that use mRNA, and the American Society of Gene & Cell Therapy (ASGCT) has educational information about them here. Please talk with your doctor if you have questions about the COVID-19 vaccines.
Below are additional educational resources on gene therapy and the COVID-19 vaccines: