Janssen: UK employee’s LinkedIn post about unlicensed Covid-19 vaccine candidate ruled pre-authorisation promotion (AUTH/3390/9/20)

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Key facts

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Case	AUTH/3390/9/20
Company	Janssen
Complaint source	UK health professional (described as “concerned UK health professional”)
Channel	LinkedIn (employee personal account; response to US senior executive’s personal post)
Subject	Janssen/Johnson & Johnson Covid-19 vaccine candidate Ad26.COV2.S entering Phase 3 (ENSEMBLE)
Key issue	Proactive dissemination of candidate-specific Phase 3 update to an audience including members of the public
Complaint received	30 September 2020
Case completed	1 March 2021
Applicable Code year	2019
Breach clauses	3.1, 9.1
No breach clauses	26.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A UK health professional complained that a Janssen UK employee promoted a not-yet-licensed Covid-19 vaccine candidate on LinkedIn (a platform visible to the public).
The UK employee, using a personal LinkedIn account, responded to a senior Johnson & Johnson (US) executive’s personal LinkedIn post announcing a Phase 3 trial and linking to an article (“The Next Phase of Our COVID-19 Vaccine Development”).
The US post included an image of two Janssen vials labelled with the vaccine candidate number Ad26.COV2.S.
The UK employee’s response said they were “incredibly proud” the “Janssen vaccine” had commenced Phase 3 trials and thanked colleagues, using hashtags (#janssen #vaccinedevelopment #j&j).
Janssen stated the employee had completed social media training; its policy warned that personal social media activity is a public forum and subject to the ABPI/IPHA Code, including when engaging with parent/affiliate posts from countries with different rules.
Janssen acknowledged the employee’s followers included pharma employees, some health professionals, and some members of the public; the post was taken down.

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Breach of Clause 3.1 (promotion of a medicine prior to the grant of its marketing authorisation).
Breach of Clause 9.1 (high standards not maintained).
No breach of Clause 26.1 on a narrow technical point: Clause 26.1 applies to prescription only medicines, and the vaccine was not yet licensed (so Janssen did not have a POM available at the time).
No appeal.

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