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Apr. 13—Maine paused the use of the Johnson & Johnson COVID-19 vaccine on Tuesday, following the recommendation of federal agencies, and is redirecting doses of other vaccines to help some clinics keep appointments with patients.
Gov. Janet Mills said in a media briefing on Tuesday that while the pause is unwelcome news, in the long run it will be a "blip" in the vaccination effort.
"Stick with us, logistical challenges like this one are expected," Mills said. "There should be no reason for (vaccine) hesitancy because of this blip."
Maine reported 571 new cases of COVID-19 on Tuesday and two additional deaths.
The U.S. Centers for Disease Control and Prevention is meeting Wednesday to investigate extremely rare incidents — six cases out of more than 6 million J&J shots given nationwide — of blood clot complications from the vaccine. The Food and Drug Administration will also investigate.
The pause will interrupt the flow of vaccinations, especially in rural areas of Maine, where clinics run by hospitals and other providers in nearly 80 locations received shipments of 20,600 Johnson & Johnson vaccines last week. It's not clear how many of those doses have already been given and how many appointments are being canceled.
Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said at the briefing that the federal government will not be shipping J&J doses to states next week. But Jeanne Lambrew, Maine's health and human services commissioner, said that blow may be softened with increasing supplies of the other two vaccines, Moderna and Pfizer, although final numbers for next week's shipments will not be released until Wednesday or Thursday.
Shah described the pause as a "speed bump" and said health care providers should hold onto the J&J doses for when the pause is lifted, which federal officials said on Tuesday could be a matter of days.
"This is just a pause. This is not chucking the doses out the window," Shah said.
The Johnson & Johnson doses represent about 5 to 8 percent of all doses given so far in Maine, which as of Tuesday was more than 916,000 doses.
A mobile vaccination program that launched this week at the Oxford Casino parking lot and used the J&J vaccine had appointments from 8:30 a.m. through 12:45 p.m. on Tuesday canceled. However, the state said it is redirecting Moderna vaccine doses to the mobile site from MaineGeneral Medical Center in Augusta.
Shah announced the state's move to pause the vaccine in an early-morning tweet. "Consistent with a recommendation from the U.S. FDA and U.S. CDC, the State of Maine is pausing the administration of the J&J vaccine out of an abundance of caution," Shah tweeted.
2/This recommendation follows reports of 6 U.S. cases of a rare and severe type of blood clot. To our knowledge, none of these cases occurred in Maine.
This pause is in effect until the U.S. CDC's scientific advisory committee has reviewed the safety data around this vaccine.
— Nirav D. Shah (@nirav_mainecdc) April 13, 2021
Shah said in a tweet and later, at the briefing, that none of the six cases of rare blood clots occurred in Maine.
He also tweeted that "we understand that this pause will impact Maine people who were scheduled to receive the J&J/Janssen vaccine."
St. Mary's Regional Medical Center put two vaccination clinics scheduled for today and next week on hold because of concerns with the Johnson & Johnson vaccine.
At St. Mary's, 417 people had appointments Tuesday afternoon and evening. "We're in the process of contacting those people who had appointments," hospital spokesman Steve Costello said Tuesday morning. "We will be in touch with them to let them know when it will be rescheduled."
Those who had appointments for today, April 13, can call the hospital's main number at 777-8100, Costello said. "We will be back in touch with them when it gets rescheduled," he said. "We don't know what a rescheduled date will be at this time."
St. Mary's has 1,000 Johnson & Johnson doses on hand, 500 of which were to be used for Tuesday's clinic, with the remaining doses going to community agencies to vaccinate populations who are homebound or lack transportation. Those agencies include Androscoggin Home Health, the B Street Clinic, the Auburn Fire Department and United Ambulance.
All appointments at the Oxford Casino site from 8:30 a.m. to 12:45 p.m. were canceled and will be rescheduled, according to the Maine CDC. All appointments at the mobile site from Tuesday afternoon through Friday will be kept, but the Moderna vaccine will be used. The J&J is a one-shot vaccine, while the Moderna requires two doses, so follow-up appointments will be scheduled.
The Moderna doses were re-directed from MaineGeneral, and Shah said that largely consists of second doses that can be replenished with further shipments of Moderna. The mobile site was expected to give about 250 doses per day.
Those who had appointments canceled at the Oxford site can call 888-445-4111 to reschedule.
Maine has received a total of 34,400 doses of the Johnson & Johnson vaccine for the state vaccination program since it became available for use five weeks ago. An additional estimated 30,000 Johnson & Johnson doses have gone to the retail pharmacy program in Maine, which includes Walmart, Walgreens, Hannaford, Shaw's and others.
It was not immediately clear how the U.S. CDC's recommendation would affect the federal pharmacy vaccination program, although Walgreens has announced that appointments with the J&J vaccine are canceled and will be rescheduled. Walgreens was given 900 doses of the J&J vaccine this week, although far more of its supply was the Pfizer vaccine, at 7,020 doses.
The state vaccination program received 2,500 doses of the Johnson & Johnson vaccine this week, and the federal government sent 2,600 doses to Maine pharmacies for the retail pharmacy program. That means Johnson & Johnson vaccine accounts for 5,100 of the 54,000 doses of all vaccines coming to Maine this week.
Of the 2,500 doses for the state program, 2,200 were for the mobile unit now at the Oxford Casino, while the remaining 300 doses were allocated in batches of 100 doses each to the state's public health nursing program, the Houlton Band of Maliseet Health and Wellness Center and the Department of Corrections.
Last week, the state vaccination program received 20,600 Johnson & Johnson doses. Of those, 10,100 went to hospitals in more rural areas, 3,700 were shipped to independent pharmacies, 3,500 went to local public safety departments and 3,000 were sent to smaller primary care practices.
The state strategy for the Johnson & Johnson vaccine is to more likely use it in more rural parts of the state, partly because it doesn't require the ultra-cold storage needed for the Moderna and Pfizer vaccines, making the J&J vaccine easier to transport and store.
This morning, the U.S. FDA and the U.S. CDC recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution following reports of six cases of a rare and severe type of blood clot in recipients in the United States.1/
— Governor Janet Mills (@GovJanetMills) April 13, 2021
Another vaccine that is not in use in the United States — AstraZeneca — also has had extremely rare incidences of blood clots in younger people. The Canadian government is currently pausing use of AstraZeneca for everyone under age 55.
The extremely rare blood clots in the Johnson & Johnson vaccine have all occurred in women ages 18 to 48.
A U.S. CDC statement on Tuesday indicated that part of the reason for the pause is to make sure health care providers knew how to treat blood clots that arise as a complication from the vaccine.
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given," according to the U.S. CDC. "CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.
"FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."
Symptoms of blood clots for patients and doctors to look for within one to two weeks after the vaccine is given include severe headache, pain in the legs or abdomen and shortness of breath, said Dr. Peter Marks, an FDA official, in a media conference call on Tuesday.
Mills said in a phone call she had with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, that the pause was largely to make sure physicians didn't "inadvertently make a mistake in therapy" by using incorrect medications.
The vaccination program continues its brisk pace, with a total of 520,089 people receiving at least the first dose, representing 38.7 percent of Maine's 1.3 million population. Also, 386,624, or 28.8 percent of the state's population, have received the final dose of the vaccine.
"We will persevere, continue to pivot and adapt to get shots into arms as quickly as we can," Mills said.
Material from the Sun Journal was used in this report.