Replies to post #246074 on Biotech Values

[DewDiligence]

MRNA announces Lyme-vaccine program, among other updates:

https://www.accesswire.com/viewarticle.aspx?id=748485&lang=en

The only Lyme vaccine in development (AFAIK) is the one from PFE and VALN , which is in phase-3 but has encountered delays (#msg-171531275).

[DewDiligence]

PFE/VALN acknowledge that Lyme-vaccine program will have delayed (2026) BLA submission due to the CRO screw-up reported previously; an additional tick season is needed to enroll the requisite number of patients:

https://endpts.com/valneva-pfizer-delay-their-lyme-disease-vaccine-submission-to-2026/

In #msg-171531275 (bottom), I questioned the initial guidance that there would be no delay in the BLA submission.

p.s. This delay is bullish for MRNA (#msg-171658602).

[DewDiligence]

PFE/VLAN—(belatedly)—complete enrollment in phase-3 Lyme-vaccine trial:

https://www.globenewswire.com/news-release/2023/12/04/2790478/0/en/Pfizer-and-Valneva-Complete-Recruitment-for-Phase-3-VALOR-Trial-for-Lyme-Disease-Vaccine-Candidate-VLA15.html

Enrollment was delayed by mismanagement of some trial sites by the CRO (#msg-171531275). PFE/VALN expect to submit a BLA/MAA for VLA15 in 2026.

There are no approved Lyme vaccines. MRNA has two candidate vaccines that entered phase-1/2 a few months ago (https://clinicaltrials.gov/study/NCT05975099 ).