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Moderna (MRNA) Early-Stage HIV Vaccine Study Begins, Stock Up

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Moderna, Inc. (MRNA - Free Report) announced that the first participant has been dosed in a phase I study (HVTN 302) evaluating its mRNA-based human immunodeficiency virus (“HIV”) trimer vaccine candidate, mRNA-1574.

The phase I study, which is being sponsored by a division of the National Institute of Allergy and Infectious Diseases (NIAID), will evaluate the safety and immunogenicity of mRNA-1574 in nearly 100 participants not infected with HIV aged between 18 and 55 years. The premise of starting this study is that this trimer vaccine is not only well-tolerated and safe in HIV-negative participants but also generates neutralizing antibodies against the virus.

Moderna has only one approved product in its portfolio -– its COVID-19 vaccine. Although the vaccine has shown robust demand in multiple countries and generated billions of dollars in revenues for the company once it ran its course, the demand for the same is likely to fade. Moderna is utilizing the profits from COVID vaccine sales to fund other clinical studies evaluating mRNA-based vaccines targeting different diseases caused by viruses like HIV.

Currently, there are no HIV vaccines that have achieved sustainable antibody levels against HIV. If left untreated, HIV causes AIDS, a progressive illness for which there is no effective cure yet. Per management estimates, nearly 38 million are suffering from HIV, out of which nearly 1.2 million are living in the United States.

Given the potential of mRNA technology, especially the effectiveness as demonstrated in mRNA-based COVID-19 vaccines, the NIAID has initiated this phase I study to check whether an mRNA-based vaccine generates sustainable antibody levels against HIV.

Other than mRNA-1574, Moderna is also evaluating HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core in a phase I study. This study is being conducted by IAVI with support from the Bill & Melinda Gates Foundation.

Shares of Moderna were up 8.6% on Monday, following the news announcement. Yet, the stock has plunged 40.9% in the year so far in comparison with the industry’s 20% decline.

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Another reason for the stock price rise on Monday is the surge in COVID-19 cases in China, which prompted lockdowns throughout the country. The need for COVID vaccines was further highlighted by the recent interview of Pfizer’s (PFE - Free Report) CEO Albert Bourla with CBS, wherein he mentioned that a second-booster shot would be necessary and that PFE is preparing to submit data to support the authorization for this second booster of its COVID vaccine with the FDA.

Similar to Moderna, Pfizer’s COVID jab is also based on mRNA technology. Its COVID vaccine called Comirnaty holds an edge over Moderna’s COVID vaccine. In 2021, Pfizer reported $36.8 billion from Comirnaty sales, while Moderna recorded $17.7 billion from COVID vaccine sales. Pfizer’s Comirnaty is also authorized for use in children and adolescents in the United States, while Moderna is yet to gain authorization for its COVID vaccine for this age group.

Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include BioDelivery Sciences and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 79.7% year to date.

Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark once, the average surprise being 33.7%.

Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 10.1% year to date.

Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, with the average being 10%.


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