A NUMBER OF posts circulating on social media sites in recent days have claimed that the US Food and Drug Administration did not fully approve Pfizer’s Covid vaccine and that the agency instead granted approval to a different vaccine called Comirnaty that is not yet even in production.
The claims state that the FDA has authorised a vaccine that “does not currently exist” and that Comirnaty, while “similar to the already available Pfizer vaccine”, is not the same vaccine.
These posts began to appear shortly after the FDA announced on Monday 23 August that it had fully approved the Pfizer/BioNTech Covid-19 vaccine – based on preclinical and clinical data, lab inspections and follow-up data months after vaccination. The brand name this vaccine is marketed under is Comirnaty.
The Pfizer/BioNtech vaccine – Comirnaty – is the first Covid vaccine to receive full approval from the US.
The vaccine had first received emergency-use authorisation in the US in December last year and the FDA reissued that EUA five times since then.
Initial misinformation posts claimed the FDA had not given full approval to the Pfizer jab and that it had only reissued emergency use authorisation. This claim was debunked by The Journal earlier this week.
More recent posts are now acknowledging that the FDA gave full approval to a vaccine, but are claiming the Pfizer vaccine and the Comirnaty vaccine are different jabs.
Since the recent full approval of the vaccine by the FDA, some media reports in the US have described or presented the Comirnaty as the vaccine’s ‘new’ name. Health and regulatory agencies across the world have in fact been publicly calling the Pfizer/BioNTech jab by this name since December 2020.
Back in December 2020 when the vaccine was the first to receive conditional marketing authorisation for use in the European Union, the European Medicines Agency (EMA) used the name Comirnaty in its announcement.
The name had been first announced by the Swiss regulatory authority Swissmedic three days beforehand when it approved the vaccine.
“Two months after receipt of the application, the Swiss Agency for Therapeutic Products, based on a careful review of the continuously submitted documents, granted approval for the corona vaccine Comirnaty® (BNT162b2),” it said in a statement on 19 December 2020.
Photographs from vaccination centres months before the recent FDA approval show Comirnaty labels on vaccine vials – here’s one from March this year in the Helix in Dublin:
In their own statement on 21 December 2020, following EMA authorisation, Pfizer and BioNTech explained the brand name:
The vaccine will be marketed in the EU under the brand name COMIRNATY, which represents a combination of the terms Covid-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigour and efficiency – and with safety at the forefront – during this global pandemic.
The name was developed in partnership with branding agency Brand Institute.
This vaccine is not the only one with its own brand name. AstraZeneca Covid vaccine’s trade name is Vaxzevria and the Moderna vaccine’s official name is Spikevax.
In its statement announcing full approval this week, the FDA said that while millions of people have already safely received Covid-19 vaccines, it recognised that for some, full FDA approval may instil additional confidence to get vaccinated.
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