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0:05 First reaction
2:00 Effects on vaccine supply
4:38 What FDA, CDC will decide
6:40 Possible links to oral contraceptives
8:54 The importance of the mRNA vaccines
10:01 Advice for clinicians
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The Johnson & Johnson COVID-19 Vaccine Pause: What You Need to Know
Jason Gallagher, PharmD, adds context behind the FDA and CDC's decision to pause and review blood clotting events in 6 women given the company's COVID-19 vaccine.
Earlier today, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) stopped administration of the Johnson & Johnson COVID-19 vaccine at federal sites and launched investigation of 6 US cases of cerebral venous thrombosis among women aged 18-49 given the one-shot vaccine.
The decision, which also called on states to withhold available doses of the vaccine previously given Emergency Use Authorization (EUA) by the FDA, proceeded the reported death of 1 affected woman, and the critical condition of another.
The news also comes at a time when COVID-19 cases are fluctuating state-by-state, while first doses have been administered to half of all US adults in pursuit of majority immunity rates.
FDA and CDC investigators from the Advisory Committee on Immunization Practices (ACIP) will convene in an emergency meeting on the matter this Wednesday, in order to discern whether the company’s EUA should continue as-is or become altered.
The news, at face value, is ultimately disappointing. But there’s more context to discuss beyond the vaccine pause.
In an interview with Contagion, editor-in-chief Jason Gallagher, PharmD, clinical professor at the Temple University College of Pharmacy, shared his perspective into the impact the pause may have on US COVID-19 vaccine rollout goals.
“As disappointing as it is, it is the system working: picking up these adverse effects, investigating them and pausing the administration of the vaccine while we figure it out,” Gallagher said. “It’s not just like it’s been approved and we ignore what happens.”
Gallagher also shared his anticipation into what will be decided in the ACIP meeting, in terms of possible alteration to the Johnson & Johnson EUA, or a planed resumption of administration after federal assessment has concluded.
On the matters of why Ad26.COV2.S is now the second adenovirus-based COVID-19 vaccine linked to thrombotic event risk after the AstraZeneca product last year, Gallagher discussed the possibility of limiting heparin prescription to such vaccinated persons, as well as a supposed link to oral contraceptives and vaccinated persons’ risk of thrombotic events.
Lastly, Gallagher provided advice for clinicians and caregivers likely fielding new concerns today from persons already vaccinated with Johnson & Johnson, who may not have perspective on the absolute risks versus benefits.
“No matter what, even if there’s 10 times as many cases, it’s still something very uncommon—so uncommon that it wouldn’t show up in vaccine trials of 40-50,000 people,” he explained. “We’ve got a long way to go before the vaccine is not worth it.”
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