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www.fdanews.com/articles/200906-oxford-immunotec-pitches-in-on-valnevas-early-stage-covid-vaccine-trial

Oxford Immunotec Pitches in on Valneva’s Early-Stage COVID Vaccine Trial

January 15, 2021

Oxford Immunotec is teaming up with Valneva to help the French biotech with a phase 1/2 UK trial of its inactivated COVID-19 vaccine candidate, VLA2001.

Specifically, Oxford Immunotec will conduct testing on vaccinated trial participants using its T- cell response diagnostic to determine if the vaccination generates a T-cell response in patients.

“Understanding the T-cell response as well as the antibody response will lead to a greater understanding of the breadth of the immune response to this candidate,” said Oxford Immunotec CEO Peter Wrighton-Smith. “That could be vitally important, particularly as new variants of SARS-CoV-2 continue to appear.”

Valneva’s phase 1/2 study, which began in December, is assessing the safety and immunogenicity of three dosage levels (low, medium and high) of a two-dose regimen in approximately 150 healthy adults. The company said it expects to report initial safety and immunogenicity data in April and plans to ultimately test its vaccine in more than 4,000 patients in additional trials.

Valneva has already struck a large supply deal for its vaccine, pledging to provide up to 190 million doses of the inactivated vaccine to the UK government. Under the agreement, the firm will supply the UK with 60 million doses in the second half of 2021 if the vaccine turns out to be a success.

The company is also in advanced talks with the European Commission on a supply deal that would provide up to 60 million doses to the EU.

In other vaccine news this week, interim phase 1/2a trial data for Johnson & Johnson’s (J&J) COVID-19 vaccine published in the New England Journal of Medicine showed that the single-dose vaccine elicited an immune response in patients aged 18 to 55 years that lasted for at least 71 days and was generally well-tolerated.

J&J said it anticipates announcing topline phase 3 data late this month and will file for Emergency Use Authorization shortly after if the vaccine proves safe and effective.

Read the J&J study findings here: bit.ly/3qmLliS. — James Miessler