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In our latest COVID Action Alert, we put today’s news of a Phase III trial launched by the biotech company Moderna in context. Larger trials mean an even greater need for robust community engagement to support the research and plan for uptake of an eventual vaccine. HIV vaccine and prevention advocates can lead the conversations that pave the way for ethical trials and swift implementation. How so? Read on.
On Monday, Moderna announced that enrollment has begun in a 30,000-person Phase III study of its mRNA SARS-CoV-2 vaccine candidate (mRNA-1273). The Moderna study is one of five large-scale, randomized, controlled efficacy trials currently slated to be conducted in partnership with the new NIH-funded COVID Prevention Trials Network (CoVPN) and with US government funding. At the same time, four other vaccine candidates have already entered into efficacy trials in Brazil, China, South Africa and the UK, and at least five more are expected to progress to Phase III by the end of this year. This work is being conducted through a number of global research collaborations, including the CoVPN.
The Moderna study will be conducted exclusively in the US in individuals “whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.” The other Phase III trials planned with the CoVPN are expected to be conducted in the US and various international locations.
Anyone can get COVID-19. However, faultlines of racial and socioeconomic disparity run through this pandemic, as with HIV. In order to conduct research in communities and individuals that have been failed by the state and its health system, trials need robust community engagement—meetings with leaders and community members to share information, develop messages, address concerns and answer questions about eventual access plans. As HIV prevention activist Rob Newells said in a Washington Post story over the weekend, “... we have to engage people early in the research end of it, so by the time something gets approved, it’s not something brand new. I think it’s going to take time to talk to people about vaccine research.”
Moderna Phase III participants will be enrolled at 89 sites across the US, 24 of which are affiliated with the CoVPN, which includes groups and researchers with a long history of community-based research engagement. The remaining sites will be enrolled via a clinical research organization called PPD whose commitment to engagement is unknown.
Advocates and activists can take action by:
- Responding to recruitment announcements with a request for information on the local advisory mechanisms.
- Working with communities to develop priorities to inform engagement with research. This can include information on future access and health care for individuals in the trials.
- Push for community-driven inclusion and exclusion criteria. Both the Moderna and Pfizer Phase III protocols indicate that individuals with HIV are not eligible for participation. Many groups, including AVAC, have joined together to raise urgent concerns about how this data gap will impact access for PLHIV, demanding that the trial sponsors review and change the criteria. The trials also exclude pregnant women, raising yet more concerns about how this research will replicate gender gaps that have hindered public health equity for years. Sign-on letters on both issues are in process.
- Sharing experiences. The world needs a COVID-19 vaccine; activists and advocates can help make sure that speedy research is safe, ethical and inclusive by rapidly disseminating what’s working and what isn’t—because if the research process does not build community trust and confidence now, then future vaccine access will be severely jeopardized.
To help ensure these and other steps happen effectively and efficiently, AVAC, ITPC, TAG and other partners have established a global COVID Advocates Advisory Board (the CAAB), that seeks to connect advocates, build power and elevate core issues. If you’re interested in learning more, please email us at avac@avac.org.
More about the Moderna candidate
The Moderna candidate uses an mRNA platform. mRNA is “messenger” ribonucleic acid, a single strand of genetic material that contains instructions for a specific protein. The Moderna vaccine contains a synthetic mRNA sequence that teaches the body to produce a protein found on the outside of SARS-CoV-2. The instructions don’t teach the body how to make the whole virus; there is no chance that the vaccine itself will cause SARS-CoV-2. In smaller trials, people who received this candidate made antibodies against SARS-CoV-2 that blocked viral activity in test tubes. This trial will help evaluate whether the vaccine-induced immune responses do the same in humans. Scientists are enthusiastic about the promise of mRNA vaccines, as they would be relatively easy to manufacture quickly and in large numbers. However, there are no licensed mRNA vaccines as of yet.
In July, Moderna published Phase I data from 45 volunteers, split evenly between men and women, at sites in Seattle and Atlanta. The data showed that the vaccine was safe, though it caused side-effects (chills, fatigue, headaches, etc) in many volunteers, particularly at higher doses. The vaccine was shown to elicit neutralizing antibodies; after two doses volunteers had more neutralizing antibodies than most individuals who have recovered from COVID-19. It is important to note that the level and duration of antibodies required for protection is not yet known. Phase II trials are ongoing, but the data were sufficiently promising to warrant launching the Phase III trial, which will randomize volunteers to receive either a placebo or the vaccine. The trial will primarily be looking to see if the vaccine prevents symptomatic COVID-19 disease, but researchers are also interested to see if it prevents severe disease.
For a snapshot of the larger COVID-19 vaccine pipeline, check out this update done in collaboration with TAG, and stay tuned for details on upcoming webinars on this and other COVID-19 vaccine candidates in development.