COVID-19: Moderna, Pfizer to include HIV+ volunteers in final stage of vaccine trials

Moderna and Pfizer, which has partnered with German biotech firm BioNTech to come up with a COVID-19 vaccine, have announced that a handful of HIV-positive volunteers will be included in the final stage of human trials. This comes after the US biotech firm had previously excluded them. With global coronavirus infections nearing to 20 million and over 732,200 deaths as per Johns Hopkins University tally, Moderna-NIAID and Oxford-AstraZeneca had entered the human trials in August of their COVID-19 vaccine candidate named mRNA-1273. 

This is a major development in the testing of the potential vaccine of the disease caused by the novel coronavirus or  SARS-CoV-2 because prior to this, vaccine trials have excluded the patients with pre-existing medical complications and co-morbidities. The protocol for the NIAID-Moderna vaccine candidate, excludes those volunteers who have an “immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection”. Meanwhile, the guidelines for the Oxford-AstraZeneca trial does not include the people with “any confirmed or suspected immunosuppressive or immunodeficient state" without mentioning HIV. 

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Moderna ‘modified’ Phase 3 study protocol

‘Modifying’ the existing protocol for Phase 3 of human trials of COVID-19 vaccine, Moderna has said in a statement that after several discussions with its partners including BARDA, NIAID, and Operation Warp Speed (OWS), limited volunteers with HIV “who are not otherwise immunosuppressed” would be included in the study. This comes after advocates submitted a petition to the United States National Insitute of Health AIDS Director Francis Collins about the US biotech firm excluding people with HIV without any underlying scientific proof. 

Moreover, several medical institutions including the United States Centre for Disease Prevention and Control have recommended routine immunizations for the people with HIV with a warning for live vaccines that “if the CD4 T Cell count is below 200”. While Moderna released a statement on August 5, Pfizer also said in a letter to the petition signatories on August 7 that it has edited the protocol and have made the vaccine trials available to the HIV positive people in Phase 2 and Phase 3 along with people who have been treated for hepatitis B and hepatitis C previously. 

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Image: AP