EMA Begins Review of SK biosciences’ New Non-mRNA COVID-19 vaccine

On August 18, the European Medical Association (EMA) announced that their Committee for Medicinal Products for Human Use (CHMP) began a review of a conditional marketing authorization application for Skycovion. Developed by SK Biosciences, Skycovion is a potential non-mRNA COVID-19 vaccine.

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Skycovion: A Non-mRNA Vaccine for COVID-19

The COVID-19 pandemic saw the side usage and popularization of mRNA vaccines. Unlike traditional vaccines, these vaccines inject a code of mRNA into a patient’s body. The mRNA teaches the body’s cells how to make a protein that triggers the immune system, resulting in effective protection.

Counted among this type of vaccine are Moderna’s Spikevax and Pfizer’s Comirnaty, both of which gained approval in early 2021.

Traditional vaccines inject a ‘dead’ virus into a patient’s body. These viruses are either weakened or inactive to the point where they do not cause illness but cause the immune system to respond. The result is much the same as mRNA vaccines: the body develops antibodies for subsequent exposures to the expressed disease.

Currently, the non-mRNA COVID-19 vaccines approved by the United States Food and Drug Administration (FDA) and the EMA is Johnson & Johnson’s Jansen and Norovax’s vaccine. However, Skycovion seeks to join this list as well. 

Skycovion works the same way as the other two traditional vaccines for COVID-19. It contains nanoparticles of the spike protein found on the surface of the COVID-19 virus. While these minuscule particles are themselves harmless, they cause the patient’s body to produce natural defenses against them. If the patient comes into contact with someone infected by COVID-19, their antibodies and T cells spring into action, killing the virus. 

What does a ‘Conditional Marketing Authorization’ mean for the vaccine?

The EMA grants Conditional Marketing Authorization to medicines that meet the unmet medical needs of the public. Applicants receive these authorizations for medicines lacking comprehensive clinical data typically needed for approval. 

For example, Pfizer’s vaccine received a such authorization on December 21, 2020, while Moderna received theirs on January 6, 2021.

After submission by SK biosciences on August 1, the CHMP only began their review of the submitted data on August 18.

While there is no set timeline for when the CHMP will make its decision, both Pfizer and Moderna submitted their findings to the EMA on December 1, 2020. This means that Skycovion faces at least a month-long wait before they hear whether or not their vaccine will be granted the Conditional Marketing Authorization.

Author

Max Heirich