COVID-19 Vaccination Clinical Trials MUST Include PLWHAs

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

As the COVID-19 pandemic enters its ninth month, the world is still struggling to create a vaccination and find medication to treat the virus properly. President Trump has been saying for months that the vaccine trials and research are going well, and America should expect a vaccination by the end of the year. While this sentiment is hopeful (and considered by many to be driven by politics and not science), it does exclude the major process involved in vaccination trials: testing trials, which can take months to years. 

Photo Source: health management.com

Vaccination trials have begun around the world but are a slow process. One vital aspect of these trials is testing and planning for the immunocompromised population, who are often most affected by the diseases typically vaccinated for. In a vaccination trial for COVID-19 by Moderna Inc., the biotechnology company initially excluded people living with HIV from COVID-19 vaccine trials (Smart Brief).

After pressure and lobbying from HIV advocates, the biotech company expanded their vaccine trials to include HIV positive persons. 

“Moderna Inc. is committed to working with all communities who could benefit from our COVID-19 vaccine. While we had always planned to evaluate mRNA-1273 in people living with HIV (PLWH) in a separate study, as we are doing for other participant groups, we have heard the preference of the community to be included in the ongoing Phase 3 study in the U.S.,” Moderna Inc. shared on their Twitter account on Aug. 5. (Twitter).

Photo Source: Moderna

Those with underlying health conditions such as HIV and those above the age of 50 are at highest risk for COVID-19. According to the U.S. Centers for Disease Control & Prevention (CDC), nearly half of people in the United States who are diagnosed with HIV are 50 and older. (CDC)

As COVID-19 is a relatively new virus, the long-term effects of it are unknown on those with HIV. As of now, there is no evidence to suggest those with HIV have an increased risk of infection and severity of illness if they were to contract COVID-19, according to the Journal of the International AIDS Society. 

“It is thought that people living with HIV who have achieved viral suppression through antiretroviral treatment and do not have a low CD4 count will be affected by COVID-19 in a similar way to what a person not living with HIV would be, based on other coronavirus-caused disease outbreaks such as SARS (caused by SARS-CoV-1) and MERS (caused by MERS-CoV), where only a few cases of mild disease among people living with HIV were reported,” said JIAS. (JIAS) 

In an opinion article written for the website Devex in late May of this year, Mitchell Warren makes an excellent observation about the connection between the COVID-19 vaccination trials and what we can learn from previous experience with the HIV responses around the world. 

“As we know so well from over 40 years of experience in the HIV response, developing and delivering prevention and treatment options at scale is essential to containing an epidemic. But no durable and sustainable end to any epidemic is possible without a vaccine,” Warren said. (Devex)

Vaccine trials are expected to continue through the end of the year and into 2021, until a proper vaccination is discovered for COVID-19. Until then, the CDC recommends all those with underlying health conditions such as HIV take extra precautions while going out in public and conversing with others. It is equally important the PLWHA not be excluded from the clinical trials for any COVID-19 vaccination

References:

• Moderna. (2020, August 05). Today, we are sharing an important update about our protocol for the Phase 3 COVE Study of mRNA-1273, our vaccine candidate against COVID-19. pic.twitter.com/jigTXUi9v2. Retrieved August 26, 2020, from https://twitter.com/moderna_tx/status/1291056643464192001?ref_src=twsrc^tfw|twcamp^tweetembed|twterm^1291056643464192001|twgr^
• People with HIV to join Moderna COVID-19 vaccine trial. (2020, August 10). Retrieved August 26, 2020, from https://www.smartbrief.com/branded/D4C8EBAD-9C67-4D55-869C-CC2C8F893F9E/83E1E967-BCC2-4A2E-AF19-D2FCF2C8EBF2
• Warren, M. (2020, May 27). Opinion: To accelerate search for COVID-19 vaccine, look to HIV and act globally. Retrieved August 26, 2020, from https://www.devex.com/news/opinion-to-accelerate-search-for-covid-19-vaccine-look-to-hiv-and-act-globally-97267
• What to Know About HIV and COVID-19. (n.d.). Retrieved August 26, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/hiv.html
• What you need to know. (n.d.). Retrieved August 26, 2020, from https://www.iasociety.org/covid-19-hiv

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.