Officials: ‘Pause’ on shot won’t hurt vaccination timeline

Following CDC guidance, RIDOH suspends use of Johnson & Johnson vaccine

PROVIDENCE — Despite invoking a “pause” on the administration of the Johnson & Johnson COVID-19 vaccine yesterday, state health officials say only a few hundred people may be forced to reschedule appointments, and they remain confident of hewing to their existing timeline for fully immunizing 75 percent of the state’s population by early June.

Rhode Island Department of Health Director Dr. Nicole Alexander-Scott and Executive Director of COVID Response Thomas McCarthy briefed the media on the developments via Zoom Wednesday, hours after RIDOH announced it was suspending use of the one-shot Johnson & Johnson product. The move adopts new guidance from the federal Centers for Disease Control, issued a day earlier, in response to a very small number of reports about women who have developed blood clots after receiving the J&J vaccine.

The health officials spent a good portion of the briefing providing context for the CDC’s move, emphasizing just how miniscule the risks are based on the known data, and downplaying the notion that news of a potentially flawed product may fuel increased hesitancy among citizens to get vaccinated.

“The biggest thing here is getting the facts out there as quickly and transparently as we can,” said McCarthy. “What we have to take away is that our monitoring system works, and it’s really, really good.”

To date, McCarthy said, the Johnson & Johnson vaccine has accounted for a comparatively small share of the total volume of some 86,000 doses of vaccine the state has been receiving on a weekly basis. Amid widely reported issues about quality control that have circled around Johnson & Johnson’s manufacturing contractors, the share had been growing even smaller of late.

But there are about 2,000 doses in the state pipeline that will be on hold as a result of the pause. Of those, McCarthy said, many were scheduled to be administered through the state’s network of mass vaccination sites and certain retail pharmacies. Most of the people who made appointments for those will not have to reschedule – they’ll simply be given either the Pfizer or Moderna product when they show up.

However, McCarthy said, there are about 300 people who made appointments at two retail pharmacies and a neighborhood nonprofit in Providence who will need to reschedule. They are White Cross, Green Line and the Rhode Island Free Clinic, and anyone who had an appointment with one of those will be contacted to make a new one.

There are an unknown number of other people who have scheduled appointments at other retail outlets for the Johnson & Johnson vaccine from supplies that come not from the state, but directly through the federal government. McCarthy said he expects that people who booked appointments at those locations, including CVS Health, Walgreens and Stop & Shop will be contacted if they need to reschedule an appointment.

Addressing the risks associated with the Johnson & Johnson vaccine, Alexander-Scott said the CDC is acting out of an abundance of caution in calling for the suspension of its use, and “Rhode Island will follow.”

In issuing the new guidance, the CDC and the Food and Drug Administration cite just six documented cases of blood clots that have arisen in a pool of roughly 6.9 million total doses of Johnson & Johnson vaccine administered to date. All of the cases involved women between the ages of 18 and 48 who developed symptoms 6-13 days after receiving the shot.

The condition can be life-threatening – one woman died and another in Nebraska was in critical condition, according to The New York Times – but Alexander-Scott said the statistical risk of developing it appears to be tiny.

“With those numbers the adverse event seems to be extremely rare,” said Alexander-Scott.

About 31,000 doses of the Johnson & Johnson product have been administered in Rhode Island without triggering one report of an adverse event, the health director said.

Based on the data, she said the risk of developing an adverse reaction is “extremely low” for anyone who received the J&J vaccine after March 13. But the incidence of adverse reactions is so infrequent that the risk is still “very low” for anyone who got it after that.

Then why is the federal government taking such extraordinary measures to freeze the administration of the vaccine?

Echoing remarks that Dr. Anthony Fauci, the nation’s leading voice of the COVID response, made on national TV earlier in the day, Alexander-Scott said one goal is to make sure health care providers are informed that the usual course of treatment – a blood thinner sold under the brand name Heparin – should not be prescribed for the type of clotting the afflicted have experienced. Another is to give researchers time to figure out if the incidence of adverse reaction is really as statistically low as it appears.

Early symptoms of the condition, Alexander-Scott said, include severe headaches, abdominal and leg pain, and shortness of breath. They’re “very different from the mild, flu-like symptoms” that many recipients of the vaccines, including the Pfizer and Moderna products, have reported, particularly after receiving the second shot, she said.

Alexander-Scott expects the pause to be brief, but the national Advisory Committee on Immunization Practices meets today to review the data and will provide a recommendation to the CDC on how to proceed.

At one point, McCarthy acknowledged that the J&J vaccine has some advantages that make it useful for bringing shots to hard-to-reach populations, like the homeless and homebound. Among other things, it can be stored at temperatures that don’t require sophisticated freezing equipment, so it’s more portable and there are fewer logistical problems with appointments because only one dose is required.

But officials said that if they’re compelled to abandon the J&J product longer than they expect, they’ll pivot and find a way to work with the supplies of Pfizer and Moderna vaccines to reach the goal of fully vaccinating 75 percent of the population, or about 750,000 people, by June 5.

“Right now there is no immediate impact to our timeline,” said McCarthy. “I think we have contingencies in place so we’ll be able to adjust without skipping a beat.”