We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Moderna (MRNA) Gets EUA for Third Dose of COVID-19 Vaccine
Read MoreHide Full Article
Moderna, Inc. (MRNA - Free Report) announced that the FDA has expanded the emergency use authorization (“EUA”) for its mRNA-based COVID-19 vaccine, mRNA-1273, to include a third dose for certain immunocompromised individuals. The additional dose needs to administered after at least 28 days from the completion of the two-dose regimen.
Per the Centers for Disease Control and Prevention (CDC), the immunocompromised individuals include patients who have undergone solid-organ transplant and taking immunosuppressive therapy, patients undergoing treatment for solid tumor and hematologic malignancies, patients who have received CAR-T-cell or hematopoietic stem cell transplant, patients suffering from moderate or severe primary immunodeficiency or HIV infection, and individuals receiving steroids or other immunosuppressive or immunomodulatory agents.
Data from a recent clinical study conducted by the company in 120 participants who had undergone solid organ transplant demonstrated that a third dose of mRNA-1273 improved immune response compared to placebo.
Along with Moderna, the FDA also expanded the EUA for another mRNA-based vaccine, Pfizer (PFE - Free Report) / BioNTech’s (BNTX - Free Report) BNT162b to include certain immunocompromised individuals. We note that while mRNA-1273 is authorized for use in individuals 18 years or above, BNT162b can be administered to population as young as 12 years. We note that the CDC stated that an EUA amendment to include immunocompromised individuals in authorized label of J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data.
Moderna’s shares have surged 273.1% so far this year compared with the industry’s 0.4% increase.
Image Source: Zacks Investment Research
We note that although immunocompromised individuals represent less than 3% of the U.S. adult population (per a Reuters article) and are unlikely to impact anticipated vaccine sales significantly, the authorization for this population reflects the rising risk of COVID-19 infections due to the prevalence of the Delta variant. New cases rose to above 250,000 a day in the United States in January and declined significantly thereafter amid the availability of vaccines. Infections cases are fast approaching 200,000-new cases per day as the pace of infection has gained traction since the beginning of July, suggesting a lurking danger. However, deaths seem to be lower than the previous infection wave seen during the end of 2021 and early 2021.
Per the CDC, immunization with mRNA-based COVID-19 vaccines have effectively reduced in risk of severe infection cases that can lead to hospitalization or death. According to data from a few clinical studies demonstrated that antibodies in immunized individuals persisted for up to six months. However, health authorities remain on high alert due to the highly contagious nature of the Delta variant as well as presence of other COVID-19 variants. Moreover, a comparison study data showed that amid the prevalence of the Delta variant, the effectiveness of both vaccines declined with a more pronounced decrease for BNT162b.
Amid the rising cases of infection, the CDC is also considering recommendation for booster doses of available COVID-19 vaccines in specific populations. However, the need and timing of such a dose is yet to be established.
Image: Shutterstock
Moderna (MRNA) Gets EUA for Third Dose of COVID-19 Vaccine
Moderna, Inc. (MRNA - Free Report) announced that the FDA has expanded the emergency use authorization (“EUA”) for its mRNA-based COVID-19 vaccine, mRNA-1273, to include a third dose for certain immunocompromised individuals. The additional dose needs to administered after at least 28 days from the completion of the two-dose regimen.
Per the Centers for Disease Control and Prevention (CDC), the immunocompromised individuals include patients who have undergone solid-organ transplant and taking immunosuppressive therapy, patients undergoing treatment for solid tumor and hematologic malignancies, patients who have received CAR-T-cell or hematopoietic stem cell transplant, patients suffering from moderate or severe primary immunodeficiency or HIV infection, and individuals receiving steroids or other immunosuppressive or immunomodulatory agents.
Data from a recent clinical study conducted by the company in 120 participants who had undergone solid organ transplant demonstrated that a third dose of mRNA-1273 improved immune response compared to placebo.
Along with Moderna, the FDA also expanded the EUA for another mRNA-based vaccine, Pfizer (PFE - Free Report) / BioNTech’s (BNTX - Free Report) BNT162b to include certain immunocompromised individuals. We note that while mRNA-1273 is authorized for use in individuals 18 years or above, BNT162b can be administered to population as young as 12 years. We note that the CDC stated that an EUA amendment to include immunocompromised individuals in authorized label of J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data.
Moderna’s shares have surged 273.1% so far this year compared with the industry’s 0.4% increase.
Image Source: Zacks Investment Research
We note that although immunocompromised individuals represent less than 3% of the U.S. adult population (per a Reuters article) and are unlikely to impact anticipated vaccine sales significantly, the authorization for this population reflects the rising risk of COVID-19 infections due to the prevalence of the Delta variant. New cases rose to above 250,000 a day in the United States in January and declined significantly thereafter amid the availability of vaccines. Infections cases are fast approaching 200,000-new cases per day as the pace of infection has gained traction since the beginning of July, suggesting a lurking danger. However, deaths seem to be lower than the previous infection wave seen during the end of 2021 and early 2021.
Per the CDC, immunization with mRNA-based COVID-19 vaccines have effectively reduced in risk of severe infection cases that can lead to hospitalization or death. According to data from a few clinical studies demonstrated that antibodies in immunized individuals persisted for up to six months. However, health authorities remain on high alert due to the highly contagious nature of the Delta variant as well as presence of other COVID-19 variants. Moreover, a comparison study data showed that amid the prevalence of the Delta variant, the effectiveness of both vaccines declined with a more pronounced decrease for BNT162b.
Amid the rising cases of infection, the CDC is also considering recommendation for booster doses of available COVID-19 vaccines in specific populations. However, the need and timing of such a dose is yet to be established.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank
Currently, Moderna carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.