Pfizer Slashes Enrollment For Lyme Disease Trial Following CRO Trouble

Due to issues that arose with the CRO responsible for developing Pfizer’s Lyme disease vaccine, the head of vaccine R&D, Annaliesa Anderson, Ph.D., has said that a significantly smaller number of participants than the 18,000 who were originally anticipated will be recruited. 

“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,” Anderson stated in an interview.

After an intense exchange between Pfizer and a contract research company called Care Access, which is owned by Reify Health, the revised enrollment estimates for phase 3 of the VLA15 experiment have been established. Pfizer said in February that because of violations of Good Clinical Practice, about half of the individuals who had been recruited up to that point would be disqualified. 

The research was initially scheduled to begin in August 2022 with the intention of recruiting a total of 18,000 healthy individuals who live in regions where Lyme disease is endemic and follow lifestyles that place them at a greater risk of getting bitten by ticks. In order to guarantee a read-out by the second quarter of this year, an initial enrollment of 6,000 people was planned to take place. 

Anderson mentioned that the process of recruiting had gotten back on track a few months ago. Although she was unable to provide a precise estimate of the revised anticipated enrollment number, she did state that it would be “much less than 18,000.” As per the ClinicalTrials.gov page of the study, the anticipated number of participants was reduced to 6,400 in the midst of July, returning to 18,000 by the conclusion of the month. 

Pfizer and its partner, Valneva, have made further disclosures that imply the problem has put the clinical study at least one year behind schedule. Both firms had anticipated submitting an approval request for VLA15 to authorities in 2025; however, the decision to do so has been moved back to 2026. According to the clinical trial data, the conclusion of the research is anticipated to take place towards the end of 2025. 

Pfizer purchased the vaccine from Valneva in 2020 for an upfront payment of $130 million while the vaccine was progressing through a handful of midstage clinical studies. A different phase 3 trial that began late in the previous year aims to determine whether or not the injection is safe for children aged 5 to 17 years old; about 3,500 kids are anticipated to take part in the study. The trial record was updated in July, and it appeared to reflect that recruiting had been completed at that point. 

With today’s clearance of the RSV vaccine Abrysvo in pregnant women, Pfizer’s struggle with Lyme disease is an exception in an otherwise successful vaccine portfolio. The approval from the FDA follows an earlier nod for the elderly. 

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