The Maine Center for Disease Control is pausing the administration of the single-shot Johnson & Johnson vaccine as federal authorities investigate reports of six U.S. recipients who suffered a rare and severe type of blood clot.
The cases were in six women, aged 18 to 48, who developed a unique type of blood clot -- called a cerebal venous sinus thrombosis -- about a week or two after receiving the single dose of the Johnson & Johnson vaccine. Those six cases are out of nearly 7 million people total who've received the vaccine. State officials are not aware of any instances in Maine.
In response, Gov. Janet Mills and state health officials announced Tuesday that the state will follow a U.S. Food and Drug Administration recommendation and advise health care providers to temporarily suspend administration of the Johnson & Johnson vaccine.
They said the pause was “out of an abundance of caution” and that it was unclear when it could be lifted. A federal advisory committee will be meeting on Wednesday to further evaluate the safety of the vaccine.
During a news conference Tuesday afternoon, Maine health commissioner Jeanne Lambrew acknowledged that the decision will likely affect the state's vaccine rollout, but just how much is so far unclear.
"Will this slow things down? Probably. When we have less doses, we have less shots in arms," Lambrew said.
Maine CDC Director Dr. Nirav Shah said that the pause is inconvenient and may concern some who have received the Johnson & Johnson shot, but that the clots have been exceedingly rare and that the review by federal officials is a standard part of approving new drugs that should encourage confidence in the process.
“This is not an atypical event in the sense that our entire system of looking for adverse events is set up to do what we are seeing unfold across the country in real time,” he said. “The fact is the FDA and CDC are doing this for every single drug on the market all the time.”
Part of the reason for the pause was to advise health care providers on how to treat people who may have the rare clots. Shah said the symptoms of the rare clots could include severe headaches, abdominal pain, shortness of breath or leg pain.
In the immediate term, the pause is not expected to have a huge impact on Maine’s vaccine rollout, but that could change if it lasts for longer than a few weeks.
Lambrew said that the pause will likely mean that some clinics using the Johnson & Johnson vaccine need to cancel appointments. However, she said the state has learned it could see an increase in vaccine doses from Pfizer and Moderna next week and will work to redirect doses to get as many people vaccinated as possible.
The state received just 2,500 doses of Johnson & Johnson this week in its regular allocation from the federal government and was not expecting a big increase in next week’s supply. In total, about 51,000 doses of Johnson & Johnson vaccine have been administered in Maine, out of more than 906,000 vaccine doses.
The majority of this week’s Johnson & Johnson doses, 2,200, were meant to be used at a new mobile vaccination clinic that's partly run by the Federal Emergency Management Agency. It's stationed at the Oxford Casino this week and will travel to other rural and underserved communities across Maine in the next few weeks.
About 150 of the appointments at that mobile clinic had to be cancelled Tuesday morning after the pause was announced, but they resumed later in the day and will continue for the rest of the week with doses of a different vaccine: the two-shot one made by Moderna.
For at least the next day or two, those Moderna shots will be reallocated from a vaccine clinic run by MaineGeneral Health in Augusta, but they will come from other sites going forward, Shah said.
If the pause continues for a longer period of time, he said the state would have to reevaluate its approach to vaccinating more vulnerable populations such as those living with homelessness.
That's a challenge that other health care providers could face, including those serving vulnerable populations. Greater Portland Health COO Elizabeth Jackson says that a two-shot vaccine presents more logistical and scheduling hurdles, particularly when it comes to vaccinating hard-to-reach populations, such as people who are unsheltered.
But despite that, Jackson says she appreciates that the state and federal government are taking a cautious approach in evaluating the vaccine's safety.
"We hope it ends up being deemed that it's a vaccine that is still appropriate to offer. But we appreciate the precautions that are being put into place," she said.
Part of the reason the Johnson & Johnson shots were originally supplied to the mobile clinic was because they’re easier to store and require just one shot, making the logistics of administering them simpler than for the two-shot Pfizer and Moderna vaccines. Shah said the state is now working to establish a way for anyone who gets the Moderna shot at the mobile clinic to receive a second dose in about a month.
The remaining 300 doses of Johnson & Johnson vaccine that Maine received this week had been allocated to a few other providers, including the state’s public health nurses for special clinics on islands, state correctional facilities and the Houlton Band of Maliseets, according to Lambrew.
While the pause in the Johnson & Johnson vaccine could heighten the hesitancy of people to get any of the coronavirus inoculations, Mills said on Tuesday that the state is coordinating outreach campaigns through social media and with communities across Maine to build confidence in them.
The pause in Johnson & Johnson shots comes as COVID-19 rates have been rebounding in the state since mid-February. For now, Mills said the state is not abandoning its plans to relax indoor and outdoor gathering limits at the end of May.
The Maine CDC added 571 new cases of COVID-19 Tuesday — a significant increase over recent days. And two more deaths have been added.
That brings the total number of identified cases to 54,827, and the total number of deaths to 753.
More than 900,000 vaccines have been administered throughout the state. Ten CVS pharmacies will add to the growing number of locations where vaccines are available throughout Maine starting Wednesday.
