NEWS

J&J pause shows ‘robust’ safety system, officials say

No cases of rare clotting seen in RI; state on course for vaccine eligibility expansion on April 19

By DANIEL A. KITTREDGE
Posted 4/14/21

By DANIEL KITTREDGE Rhode Island remains on track to expand COVID-19 vaccination eligibility to all residents 16 and older on April 19 despite a federally ordered pause on the administration of Johnson & Johnson's vaccine, state health officials told

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NEWS

J&J pause shows ‘robust’ safety system, officials say

No cases of rare clotting seen in RI; state on course for vaccine eligibility expansion on April 19

Posted

Rhode Island remains on track to expand COVID-19 vaccination eligibility to all residents 16 and older on April 19 despite a federally ordered pause on the administration of Johnson & Johnson’s vaccine, state health officials told members of the media on Tuesday.

The state will join in the halt on the J&J vaccine “until we have completed our assessment of the review that is being done,” Health Director Dr. Nicole Alexander-Scott said. The federal review is expected to take multiple days at least.

Meanwhile, arrangements are being made to substitute first doses of either Pfizer of Moderna vaccine for the roughly 2,000 Rhode Islanders who had scheduled J&J vaccinations through the state’s appointment system this week, according to Thomas McCarthy, executive director of the state’s COVID-19 response.

Roughly 300 people – including those with J&J appointments at Green Line Apothecary, White Cross Pharmacy and the Rhode Island Free Clinic – will be contacted directly to reschedule, McCarthy said. But “for most people” – those with appointments at state-run mass vaccination sites and regional clinics – “their appointment date, time and location will not change.”

Those with J&J vaccination appointments at other retail pharmacies, such as CVS, Walgreens, Walmart and Stop & Shop, may be contacted to reschedule as the logistics are worked out, McCarthy said. He noted that the vaccinations provided at those locations come through a federal allotment separate from what the state receives and distributes each week.

The news Tuesday morning that the Centers for Disease Control and Prevention and Food and Drug Administration had ordered a pause on administration of J&J’s single-shot vaccine raised new concerns over the rollout of vaccination in the U.S. and the potential for a spike in vaccine hesitancy.

The decision is based on cases of a rare but severe blot identified in six women between the ages of 18 and 48 who received the J&J shot. The symptoms in those women appeared between six and 13 days after their vaccination. All of the women also experienced a drop in their platelet count.

Alexander-Scott on Tuesday sought to allay safety concerns, saying at this point none of the adverse reactions to the J&J shot have occurred in Rhode Island – and that the six cases that have triggered the pause and review come from among approximately 6.85 million people who have received the J&J shot nationally, a rate of more than one in a million.

“These adverse events seem to be extremely rare,” she said.

Alexander-Scott said Tuesday’s developments are indicative of “what a robust monitoring system … looks like.” She said the pause in administering the J&J shots will allow health officials to explore whether any cases of the rare blood clotting have gone unreported and allow time for health care providers to prepare to identify and treat the issue.

Alexander-Scott advised that any Rhode Islander who received the J&J shot more than a month ago should consider themselves at “extremely low” risk for any complications. Those who have received the shot within the last month, she said, are also at “very low risk.”

Asked if there appears to be an association between the clotting, the J&J vaccination and the use of birth control, Alexander-Scott said that is “not very clear at this point,” although it appears unlikely based on the type of clotting involved. She said the “value of the pause” will be to allow health officials and scientists to more fully evaluate what might be causing the issue.

Symptoms that accompanied the clotting in the six cases, she said, include severe headaches, leg pain and shortness of breath – “very different from the mild, flu-like symptoms that people experience within a few days after receiving the vaccine.”

She also said Rhode Island has not seen significant serious side effects reported from any of the three approved shots during the course of its vaccination campaign to date.

The J&J vaccine has represented a small portion of the overall rollout thus far. Approximately 31,500 J&J doses have been administered in Rhode Island, Alexander-Scott said Tuesday – a small fraction of the nearly 700,000 shots given in the Ocean State as of April 11.

McCarthy also said the number of J&J doses coming into Rhode Island has “decreased significantly” of late, from 16,000 two weeks ago to 6,000 last week and 2,000 this week. The state had approximately 1,400 doses of the J&J shot left from last week’s allotment, he said, for a total of roughly 3,400 doses on hand as of Tuesday. In all, he said, the J&J vaccine has comprised less than 5 percent of the state’s overall vaccine allocation thus far.

The J&J developments come a day after Rhode Island expanded vaccination eligibility to include all Rhode Islanders between the ages of 40 and 49. Already, all of the older age groups, as well as anyone 16 or older with a qualifying health condition, had been eligible.

Also on Monday, vaccine eligibility expanded for the next group of hard-hit ZIP codes as identified in the state – including two in Cranston, 02910 and 02920. In those ZIP codes, all people 16 or older can now sign up for a shot. The 02905 ZIP code, which includes parts of Cranston and Providence, had already been included in the first round of expanded eligibility for hard-hit ZIP codes.

vaccine, clotting

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