FDA Approves PrEP Injections, Moderna Develops HIV Vaccine

FDA Approves PrEP Injections, Moderna Develops HIV Vaccine

Amazing developments in the efforts to end HIV and AIDS: The FDA approved an injectable form of PrEP, to be administered every two months, and Moderna started human trials for its HIV vaccine based on the COVID-19 vaccine.

ViiV Healthcare has developed the injectable PrEP treatment called Cabotegravir. It will be marketed under the brand name Apretude and will only work for patients who are HIV negative. The news about the PrEP injections comes as Moderna announces human trials on its HIV vaccine.

The treatment begins with four weeks of Cabotegravir tablets (marketed as Vocabria) – to check the patient’s tolerance of the drug ahead of the first injection. Then two injections a month apart, and then every other month.

“ViiV Healthcare is proud that Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial,” Deborah Waterhouse, CEO, ViiV Healthcare, said.

 The FDA approval comes after a trial on 7,700 participants in 13 countries. That study concluded Apretude was even more effective than daily PrEP pills at preventing HIV infection. The distribution of the injections will begin in early 2022.

HIV Vaccine Started Human Trials

Biotech company Moderna has begun human trials for two mRNA-based HIV vaccines, according to the National Institutes of Health’s clinical trial registry.

The new vaccine development has been determined to be safe to test on humans, and phase 1 (ends in 2023) will deal with collecting information about the safety of the vaccine and its impact on HIV.

The potential vaccine is using the same technology that is in Moderna’s COVID-19 vaccine.  Scientists hope that the mRNA strands can do with HIV what they did with COVID-19. Moreover, a possible mRNA vaccine could also help beat HIV variants “because it just requires an update to the coding sequences in the mRNA that code for the variant,” Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital and chair of the HIV Medicine Association, told Verywell.