Dr. Scott Ratzan and Kenneth Rabin co-authored an opinion piece on NJ.com on April 22, 2021 in which they advocate strongly for the safe use of the Johnson & Johnson vaccine, but they now believe that additional safeguards should be used to monitor its safe use.
For the past two years, we have both been involved in extensive U.S. and international social research programs on vaccine confidence generally and COVID-19 vaccine hesitancy in particular. Our goal is to convince people worldwide to accept COVID-19 vaccination as our best hope to control the pandemic, restore economic growth and rebuild social connectedness.
From the first announcement that Johnson & Johnson was developing a COVID-19 vaccine with the specific features — one-time dosing, stable formulation, ease of shipment and storage — that the world desperately needs, we were optimistic that it would prove to be a key factor in resolving the major global public health crisis of our lifetimes.
When we learned in early March that a similar vaccine developed by Astra-Zeneca had encountered rare but serious blood-clotting effects that have subsequently undermined public confidence in this technology in Europe and many developing countries, we assumed that Johnson & Johnson would have anticipated that it could encounter similar problems. We assumed that the company had designed a prudent mechanism to discover and report such events and to communicate the product’s benefits and risks so that it would be positioned to be used safely and effectively to protect the millions of people who need it worldwide.
We first became concerned about the confidence in the vaccine for other reasons on April 1, when the U.S. Food and Drug Administration announced that serious quality problems in Johnson & Johnson’s contract manufacturing facility in Baltimore, Emergent BioSolutions, had effectively destroyed 15 million vaccine doses and forced the company to essentially assume control of that plant going forward. What was particularly worrisome is the contractor’s prior history of violations, which should have been a red flag in the first place. The plant remains offline.
Then on April 13, the FDA and Centers for Disease Control and Prevention announced that they had ordered a “pause” on distribution and administration of the Johnson & Johnson vaccine based on a half-dozen reports of the clotting disorder that seemed similar to the Astra Zeneca vaccine in Europe, a decision that was supported by the U.S. Advisory Committee on Vaccine Practices (ACIP) pending a more complete review of the data that is expected to be discussed at the end of this week.
To build confidence in the vaccine and our regulatory system that approves lifesaving medicines, devices and vaccines, we strongly recommend that ACIP consider stipulating that the Johnson & Johnson vaccine be returned to the market only in the context of a proactive independently managed registry of all persons who receive it.