NJ.com: Opinion Piece by Dr. Scott Ratzan – More safeguards needed to monitor use of J&J’s vaccine

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.

Additionally, it was disclosed in the Wall Street Journal that Johnson & Johnson — which had received over $1.5 billion from Operation Warp Speed to develop and manufacture its vaccine — may have discussed management of this adverse event issue with its competitors before bringing it to the FDA and CDC.

While we continue to advocate strongly for the safe use of this vaccine, we believe that there is now more than enough evidence that monitoring its safety requires additional safeguards. The promise of the vaccine to help stem the pandemic globally is too important to be left to current voluntary actions by the company and passive VAERS (Vaccine Adverse Events Reporting System) that the CDC has implemented to identify vaccine injuries. People who become ill following a vaccination trigger this system by themselves or their physician can report an adverse event or side effect to their local, state or tribal health authority.

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.

ACIP can suggest lifting the pause with some conditions of use based on the current data available. They can also immediately recommend real-time collection of data — a registry — of everyone who gets the Johnson & Johnson COVID-19 vaccine, or any similar vaccine, as well as when and by whom it was administered. The registry should be set up to detect safety issues, such as signals of events involving blood flow in the brain, as well as others that may suggest insufficient vaccine efficacy, such as with variants and the frequency of breakthrough infections.

This step would create a viable platform for a speedy response from the CDC and state public health authorities. It would also improve public confidence in vaccination, addressing personal concerns about safety and encouraging uptake of the vaccine. This idea of increased transparency after delivery of the vaccine, what public health practitioners call “post-marketing surveillance,” can be a vital tool to improve public trust.

This is not pie in the sky. An autonomous proactive vaccine adverse event surveillance system of this type is now being developed by the Canadian government.

Our ongoing social research tells us that the great majority of Americans believe that vaccines are the only way to control COVID-19 effectively. For this to happen, however, we need to track the use of COVID-19 vaccines and regulate manufacturers like Johnson & Johnson more effectively than has been the case.