Pfizer Cuts Enrollment Numbers in Lyme Vaccine Trial

In a breaking Fierce Biotech news article, 08.22.2023, Pfizer announced that the number of people enrolled in the phase 3 clinical trial for the Lyme vaccine (VLA15) will be significantly less than the planned 18,000 “healthy” enrollees. In order to ensure a read out by the second quarter of 2023, 6,000 people were already supposed to be enrolled.

Pfizer had been working with Care Access contract research organization (CRO) since the trial commenced in August of 2022. Pfizer then alleged in February 2023 that half of the already enrolled people would be removed from the phase 3 vaccine trial due breaches of “Good Clinical Practice.” According to the news article, the Care Access CEO contested this decision; and it was later reported that Pfizer terminated work with Care Access CRO. 

The new enrollment numbers intended for the phase 3 vaccine trials have changed substantially as Pfizer now projects that much fewer than the planned 18,000 trial participants will be recruited. Annaliesa Anderson, Ph.D., vaccine Research & Development chief, is quoted in the article interview, “By moving just to the high endemic areas and taking out sites where we didn’t think that people would really be at risk of getting Lyme disease, it meant that we could actually considerably reduce the number of participants that we enroll.” 

For More Information

Read the Fierce Biotech News Article

Read Why Lyme Vaccine Candidates Were Pulled Out of Study

Read More LDA Articles on Lyme Vaccine