November 10, 2020
HIV prevention advocates following COVID-19 vaccines got not one but two pieces of scientific news in the past two days—both as welcome as the US election results announced over the weekend. The HIV Prevention Trials Network announced that injectable long-acting cabotegravir (CAB-LA) provided high levels of protection among cisgender women at risk of HIV; and Pfizer announced high levels of protection in its COVID-19 vaccine candidate.
Two trials, two injections, one bottom line: A product doesn’t protect if it’s not available. While neither CAB-LA for cisgender women nor the COVID-19 vaccine have published peer-reviewed results—as they must—planning for licensure and access must start now. More details about CAB-LA are here, and join HPTN’s webinar on Friday, November 13 at 7am EST to learn more about the results.
Read TAG and AVAC’s statement on the Pfizer announcement and find our key messages below:
- Pfizer’s early results are welcome news but they must be read cautiously as the information on the data is still limited and only available through a company press release.
- Current data do not yet support Emergency Use Authorization (EUA), and certainly not licensure. The trial’s continuation is essential.
- The US FDA has requested at least two months of safety follow up after the second vaccination before considering an EUA; this is a bare minimum for any regulatory review.
- When available, these data need to be evaluated by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
- Any EUA should place specific requirements for continued data collection and clearly articulate the pathway and timeline for a full application for licensure.
- The Pfizer/BioNTech vaccine is designed to induce immune responses against the SARS-CoV-2 spike protein, a strategy that is employed by most other candidates in efficacy trials; these early data provide some cause for optimism that multiple other vaccines may prove efficacious.
Resources for additional context on COVID-19 vaccines:
- A useful Twitter thread from Dr. Natalie Dean, a biostatistician at the University of Florida.
- A transcribed Q & A on the Pfizer results with Dr. Wayne Koff, CEO of the Human Vaccines Project.
- A short video from STAT offering a two-minute primer on the mRNA technology used in the Pfizer and Moderna vaccine candidates.
- To understand the process and strategic considerations around the regulatory process read AVAC’s Regulatory Approval Primer for Vaccine Advocates.
- And no matter how good the Pfizer candidate turns out to be when the data are complete and reviewed, the world will need multiple COVID-19 vaccines; check out AVAC’s cheat sheet on the pipeline.
Use these resources and others to stay informed and connected. Together, let’s make our way to a safe and effective people’s vaccine against COVID-19 that the world can trust and use.