%20(3).png){kind=small}
![TFD [LOGO] (10).png](https://static.wixstatic.com/media/bea252_c1775b2fb69c4411abe5f0d27e15b130~mv2.png/v1/crop/x_150,y_143,w_1221,h_1193/fill/w_179,h_176,al_c,q_85,usm_0.66_1.00_0.01,enc_avif,quality_auto/TFD%20%5BLOGO%5D%20(10).png)
MODERNA COVID-19 CAN NOW BE KEPT AT ROOM TEMPERATURE LONGER
- By The Financial District
- Apr 2, 2021
- 2 min read
Moderna today announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has authorized the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours.
Additionally, a punctured vial is now usable for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.
The FDA also authorized the inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial.
The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses).
The Company expects that the 15-dose vials will begin shipping in the coming weeks.
“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs,” said Stéphane Bancel, Chief Executive Officer of Moderna.
He added that the company remained focused on doing all that it can to help end the COVID-19 pandemic with a vaccine.
The company is continually learning, adapting and working closely with partners like the U.S. FDA and CDC to identify ways to facilitate accelerated vaccine administration, address bottlenecks and accelerate production.
One identified constraint on the production process has been the capacity of the fill-and-finish process. Moderna is now studying the possibility of adding more doses to each vial of vaccine to address bottlenecks; thus, accelerating production and reducing the need for consumable materials that are in high demand.
Moderna is committed to continuing closely collaborating with its manufacturing partners and the U.S. federal government to increase the efficiency of its production process without compromising quality measures or safety standards.
