December 19, 2020

expert reaction to FDA Emergency Use Authorisation for the Moderna COVID-19 vaccine

The FDA in the USA issued an Emergency Use Authorisation for the Moderna COVID-19 vaccine.

Dr Craig Hartford, member of the Policy and Communications Group of the Faculty of Pharmaceutical Medicine, said:

“The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) of the Moderna COVID-19 vaccine.  This means that the FDA regard this vaccine as meeting their standards for safety and efficacy for people in the USA over 18.

“This is another welcome step in the fight against COVID-19.  The Moderna vaccine, like the Pfizer-BioNTech COVID-19 vaccine also authorised by the FDA, is a messenger RNA vaccine and contains a small piece of the virus genetic material that instructs the body to produce the “spike” protein.  The body’s immune system produces an immune response to that protein and is then ready to combat a future COVID-19 virus infection.  This virus spike protein is the target for nearly all the vaccines in development because the virus needs it to enter human cells and start the infection.

“The Moderna vaccine needs to be stored between -25º to -15ºC (the Pfizer-BioNTech vaccine needs much colder storage), which is more or less the temperature of a domestic freezer, and can then be stored between 2° to 8°C (normal fridge temperature) for up to 30 days before first use.  The vaccine is administered as two doses one month apart.

“The FDA have clearly indicated that they have thoroughly analysed the available safety, effectiveness, and manufacturing quality, and that scientific standards and the integrity of their review process have been maintained.  Safety monitoring plans for this vaccine, as for all vaccines, include the long-term follow-up of participants in ongoing clinical trials, and many other activities aimed at monitoring the safety profile of all recipients of the administered vaccines.  Similar to the UK MHRA’s Yellow Card safety reporting scheme, in the USA side effects to vaccines are reported to the USA Vaccine Adverse Event Reporting System (VAERS) and the safety is closely monitored (see also the Faculty of Pharmaceutical Medicine’s previous comment on vaccines safety monitoring in the UK at https://www.sciencemediacentre.org/expert-comments-on-vaccine-safety-and-monitoring/).

“We look forward to the outcome of other global Health Authorities’ review of this and other COVID-19 vaccines that are potentially nearing regulatory authorisation.”

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Dr Craig Hartford: “I do not perceive a Conflict of Interest. I am a Pfizer past employee. Potential for Conflicts of Interest: I own shares in pharmaceutical companies including Pfizer.”