The Pfizer/BioNTech partnership, sponsoring the Phase 3 clinical trial investigating the safety and efficacy of COVID-19 vaccine candidate BNT162b2, nears the finish line. With an eye on concluding the study, the sponsors must now center their focus on greater minority (African American and Hispanic) data collection as well as comply with appropriate FDA requirements to monitor patients for at least between two and six months. In a recent interview via local CBS affiliate, A LSU Health Shreveport trial site Principal Investigator shared that most trial sites associated with the Pfizer and BioNTech Phase 3 clinical trials were recently shut down with only a dozen or so sites remaining active. With 38,000 already treated, the sponsors only need to recruit 2,000 more subjects; the emphasis will be on minority recruitment. According to this latest account, a majority of the sites are now shut down due to two factors: 1) slower COVID-19 activity in most trial site areas and 2) shift in focus to emphasize underrepresented population recruitment, including African Americans and Hispanic volunteer recruitments.
This update was recently shared by a CBS KTBS 3 news segment focusing on an interview with LSU Health Shreveport Principal Investigator Dr. John Vanchiere. The Louisiana trial site has enrolled 164 volunteers out of the total 40,000 targeted study (NCT04368728) subjects worldwide. Dr. Vanchiere, an influential investigator, sits on the state advisory committee responsible for the COVID-19 vaccine deployment plan.
Need for More Minority Participation
TrialSite reported on Sept. 13 that Pfizer’s CEO Albert Bourla shared that the company didn’t take federal money so that they could avoid onerous federal reporting requirements, for example. In an interview in Sept., the Pfizer CEO emphasized he wanted to “liberate our scientists from bureaucracy.” The top executive emphasized in that Sept. interview that minority recruitment appeared on track, emphasizing that they weren’t experiencing any challenges.
According to this recent interview with Dr. Vanchiere: “The recruitment has shifted its focus to African American and Hispanic participants, because those are very important to include in the study. They’re the hard hit populations by this virus, and we want to include them, at this point, more preferentially in the study so that we can understand how the vaccine works in different populations, and know whether we need to deploy different vaccines in different populations.”
No Definitive End Date
The Principal Investigator additionally shared with KTBS 3 that the study team wasn’t marching rapidly to an end date in what could be deemed a complete change of tone as compared to a couple months ago. Now the FDA, appropriately, asserts that the volunteers participating in such studies be monitored from two to six months. As the messenger RNA (mRNA) trial is relatively new, it undoubtedly represents some additional amount of risk as compared to more known methods.
If Approved Who to Vaccinate First?
Vanchiere also offered a glimpse into how sponsors, trial sites and the state and federal health authorities are thinking about vaccine deployment, should a vaccine actually be approved or granted emergency use authorization (EUA). Remember, Dr. Vanchiere is part of the group contemplating deployment in that state.
Dr. Vanchiere commented, “If you want to save lives, you’re going to vaccinate the people who are most vulnerable. And that’s probably using it in nursing homes.” He continued, “However, if you want to stop transmission, then you would deploy the vaccine perhaps in young adults who are very rapid, most likely transmitting the virus. And so we’re in that sort of understanding and negotiating and collecting data phase, so that we can optimize the deployment.” He ended by explaining that in Louisiana, healthcare workers, first responders, and nursing home employees would be first on the list for vaccination.
Pfizer & BioNTech Report on Track
Just a day earlier in Bloomberg, Ugur Sahin, CEO of BioNTech (developer of the vaccine), reported that all was on track. The fact that most of the trial sites were being deactivated due to the two prong factors of 1) volunteer enrollment challenges and 2) emphasizes on minority participation didn’t make it to this story.
Both Pfizer and BioNTech reported that the large Phase 3 study was producing similar side effect patterns as the smaller studies, which is a positive observation for the COVID-19 vaccine race front-runner. The CEO commented on Mr. Bourla’s commitment in Sept. that the sponsors could produce preliminary data as to whether the vaccine works by the end of October.
This is in contrast to both Eli Lilly and Johnson & Johnson who had to pause potential therapies or shots due to safety concerns.
Additionally, this week, Pfizer and BioNTech took the unusual step to publish key data used for the rationale to narrow the field of vaccine candidates—they have opted for what’s known as BNT162b2. Published in the New England Journal of Medicine, Naomi Kresge writing for Bloomberg shared that the chosen candidate generated less “systemic side effects (e.g. chills, fever and fatigue) than the others.
A messenger RNA technology-based vaccine, for a succinct overview of the BNT162 platform follow the link to Precision Vaccinations.