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** COVID Action Alert: Today’s Phase III trial and a call for community engagement
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July 27, 2020

Dear Advocates,

In our latest COVID Action Alert ([link removed]) , we put today’s ([link removed]) 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 ([link removed]) 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 ([link removed]) (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 ([link removed]) .” 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 ([link removed]) 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 ([link removed]) 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.
* Tracking inclusion and exclusion criteria. The original Moderna vaccine protocol indicated that individuals with HIV were not eligible for participation. Advocates recognized that in the absence of data on PLHIV, regulators would be reluctant to approve for use in people coinfected with HIV, further aggravating existing disparities. Concerted outreach and advocacy secured a change in the protocol—setting an important example of how community input can be swifty incorporated into clinical trials, and why it is critical.
* 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 ([link removed]) , TAG ([link removed]) and other partners have established a global COVID Advocates Advisory Board ([link removed]) (the CAAB), that seeks to connect advocates, build power and elevate core issues. If you’re interested in learning more, please email us at [email protected] (mailto:[email protected]) .

More about the Moderna candidate

The Moderna candidate uses an mRNA platform ([link removed]) . 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 ([link removed]) 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 ([link removed]) , and stay tuned for details on upcoming webinars on this and other COVID-19 vaccine candidates in development.

Best,
AVAC

Upcoming Webinars
* Wednesday, July 29 at 10am EDT - Understanding the EMA Opinion: Next Steps for Dapivirine Vaginal Ring to hear about next steps on the regulatory process and implications for rollout from advocates, IPM and the WHO. Register here. ([link removed])
* Thursday, July 30 at 9am EDT - One Year After ECHO: Integration in the Time of COVID, co-convened by AVAC and FP2020, to discuss what gains have been made in the year following the ECHO trial results; how COVID-19 is impacting HIV/SRH services and efforts to integrate them; and what the future of HIV/SRH integration can and should look like. Join leading researchers and advocates for this conversation on advancing SRH integration. Register here. ([link removed]) (And to hear more from the experts on SRH integration, check out our One Expert/One Question/One Minute Campaign mash-up video ([link removed]) , and additional videos and resources at SRHintegration.org ([link removed]) .)

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