Moderna (MRNA) Gives First COVID Jab Booster Data to the FDA
Moderna's (MRNA) booster dose of COVID-19 vaccine elicits antibody levels that were much higher than that seen after the two-dose primary schedule.
Moderna, Inc. MRNA has submitted initial data from a phase II study, which evaluated the third, or booster, dose of its mRNA-based COVID-19 vaccine, mRNA-1273, to the FDA.
The company had amended the design of its previous phase II study that evaluated the initial two-dose regimen of mRNA-1273 to offer a booster dose of mRNA-1273 at the 50 microgram-dose level to interested participants. The booster or third dose was administered six months after the second dose. Initial data from the study demonstrated that the booster dose boosted neutralizing titers significantly compared with the level achieved in the phase III COVE study. The boost in neutralizing titers was seen across all age groups, notably in the age group of 65 and above (older adults).
The company stated that the neutralizing antibody titers had significantly waned prior to boosting at approximately six months in study participants.
Data from an additional analysis showed that the booster dose significantly increased geometric mean titers for all the variants of concern. These titers increased 32-fold for Beta (B.1.351), 43.6-fold for Gamma (P.1),and 42.3-fold for the Delta (B.1.617.2) variant.
Moderna plans to submit this booster dose study data to the European Medicines Agency (EMA) and regulatory authorities in other countries soon.
Shares of Moderna have skyrocketed 273.3% so far this year compared with the industry’s rise of 1.2%.
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Currently, Pfizer’s mRNA-based vaccine, Comirnaty (previously BNT162b) is the only fully approved COVID-19 vaccine in the United States. Moderna is also seeking full approval for mRNA-1273 in the United States and submitted a biologics license application for the same to the FDA earlier this month.
Last month, Pfizer began filing a supplemental BLA to seek approval for a “booster” or third dose of Comirnaty. Clinical data have shown that the Comirnaty booster dose elicited antibody response against the initial SARS-CoV-2 virus (wild type) after one month of the dose that was 3.3 times the levels seen one month after the second dose. The company plans to file a similar regulatory application across the world in the upcoming weeks.
Last week, J&J also reported positive encouraging interim data from two phase I/IIa studies evaluating the booster dose of its adenovirus-based, single-shot COVID-19 vaccine in previously vaccinated people with its dose. The administration of a booster dose in previously vaccinated people generated nine-fold higher spike-binding antibodies compared with the antibodies level 28 days following the initial vaccine dose.
Meanwhile, the rising risk of the new COVID-19 infection cases due to the prevalence of the Delta variant is pushing health officials to take emergency steps. The U.S. health officials decided last month to start providing booster doses to the country’s citizens in September. The current scenario looks beneficial for the COVID-19 vaccine makers, especially with a booster dose of their vaccine in development. The push from different governments for a booster dose will likely drive the top line of Pfizer, BioNTech, J&J,and Moderna in the upcoming quarters.
Moderna currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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