On Oct. 18, 2021, Pfizer and BioNTech announced that the European Medicines Agency’s Committee for Human Medicinal Products issued a positive opinion for a new formulation of COMIRNATY (COVID-19 vaccine, mRNA).

The new formulation did not require the dilution of the concentrate and was available in a 10-vial (60 dose) pack size, therefore, helps ensure simplified handling of the vaccine. In addition, the new formulation allows for longer storage.

In addition, the new formulation allows for longer storage. Vials can be stored for 10 weeks at fridge temperatures from 2°C to 8°C, while the current formulation can be stored at fridge temperature (2-8°C) for 31 days. After first puncture, the vials with the new formulation can be stored and transported at 2 °C to 30 °C and used within 12 hours, which is longer than the current formulation, where the product stability is 6 hours at 2 ºC to 30 ºC after first puncture. The new formulation for the currently approved population (individuals 12 and older) will be available in a phased rollout starting in early 2022.

If authorized, the vaccine for the younger population from 5 to <12 years of age will be based on the new formulation, which will be adapted to allow a lower dose level of 10 µg after dilution.