select search filters
briefings
roundups & rapid reactions
before the headlines
Fiona fox's blog
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine, allowing it to be distributed in the U.S.
Dr Craig Hartford, Committee Member of the Faculty of Pharmaceutical Medicine’s Policy and Communications Group, said:
“The U.S. Food and Drug Administration has granted emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S, for the prevention of COVID-19 disease in people 16 years and older. This means that the FDA regard this vaccine as meeting standards for safety and efficacy for administration in the U.S.A.
This FDA EUA is a welcome step in the fight against the 2019 coronavirus and follows on similar conclusions about the safety, effectiveness and quality of this COVID-19 vaccine by several other Regulators, such as the UK’s MHRA. This Pfizer-BioNTech COVID-19 vaccine authorised by the FDA is the same vaccine as that authorised for emergency use in the UK by the MHRA. It contains a small piece of the virus’s genetic material that codes for the body to produce the virus’s “spike” protein, which does not cause disease. The body’s immune system produces an immune response to that protein and is then ready to combat a future COVID-19 virus infection.
“The FDA have clearly indicated that efforts to speed vaccine development have not sacrificed scientific standards or the integrity of their vaccine evaluation process. Safety monitoring plans for this vaccine, as for all vaccines in general, include the long-term follow-up of participants enrolled in ongoing clinical trials and many other activities aimed at monitoring the safety profile 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’s Vaccine Adverse Event Reporting System (VAERS) and the safety is closely monitored, as it is in the UK and elsewhere (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 the EMA/CHMP ongoing review of this vaccine for potential use in Europe, as well as the review by Global Regulators of this and other COVID-19 vaccines that are potentially nearing regulatory authorisation for use.”
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.”