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Regulatory Focus™ > News Articles > 2020 > 5 > FDA warns Seattle-based company for marketing COVID-19 vaccine

FDA warns Seattle-based company for marketing COVID-19 vaccine

Posted 22 May 2020 | By Michael Mezher 

FDA warns Seattle-based company for marketing COVID-19 vaccine

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Thursday warned Seattle-based firm North Coast Biologics for marketing an unapproved vaccine for SARS-CoV-2, the virus that causes COVID-19, on Facebook and LinkedIn in March and April.
The warning letter comes nearly a month after Washington Attorney General Bob Ferguson sent a cease and desist letter to North Coast Biologics President Johnny Stine ordering him to “immediately stop making misrepresentations” about the vaccine.
The warning letter cites statements made on the company’s website, Facebook page and Stine’s Facebook and LinkedIn pages. While most of the statements referenced in the warning letter have been removed from the websites, comments made by Stine on the Facebook page of Farhad Ghatan, mayor of Friday Harbor, Washington, are still available online as of writing and were previously covered by The Seattle Times.

Screenshot taken on 22 May 2020
In another statement made on Facebook on 2 March, FDA says Stine offered the vaccine for sale. “If interested parties pay $400/person, I can order up enough protein to be made to give each person a primary vaccination with two boosts,” Stine allegedly wrote.
Other now-removed statements from Stine include a Facebook post dated 21 March that claimed he had “just vaccinated 12 people in west Seattle tonight … 12 more to vaccinate in Burien … off to Anchorage and PHX next.”
FDA notes that on 28 April North Coast Biologics’ Facebook page was updated to say its vaccine “is no longer available due to a ‘cease and desist’ letter from the [Attorney General],” but says that other claims still online at the time necessitated the warning letter.
“Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that you do not resume selling your product for prevention of COVID-19,” FDA writes.
FDA says North Coast Biologics must reply to the warning letter within 48 hours describing the steps taken to address the violations cited in the letter. “Failure to immediately correct the violations cite in this letter may result in legal action, including, without limitation, seizure and injunction,” FDA writes.

Tags: coronavirus, US

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