Regional vaccinations trend upward, J&J suspension could cause setback

Last week, Norton Sound Health Corporation immunized another 2.3 percent of the region’s population against COVID-19. The regional vaccination rate is now 56 percent and has been increasing by just one or two percent a week for the last month. But NSHC Medical Director Dr. Mark Peterson said a number of positive developments may help the region achieve its 80 percent goal. However, the Centers for Disease Control announced on Tuesday that it was recommending a pause in delivery of the Johnson & Johnson vaccine to investigate an extremely rare but potentially dangerous side effect.
Last week, the Nome hospital received a shipment of 300 doses of Johnson & Johnson vaccine earlier than expected. The J&J vaccine has been particularly popular in the region, Dr. Peterson said, because it only requires a single dose.
In the immediate future, though, those doses will not be going into people’s arms. On Tuesday, the CDC and FDA recommended that health organizations pause delivering the vaccine, and NSHC announced that it would comply with those recommendations.
The pause is in response to a number of incidents in which patients developed dangerous blood clots in the weeks after receiving the vaccine. In the U.S., there have been six such cases out of more than 6.3 million recipients of the J&J vaccine.
All the cases were in women aged 18 to 48 who already had low levels of blood platelets, which are involved in clotting. The cases occurred six to 13 days after they received the shots.
It’s not immediately clear whether the cases are directly linked to the vaccine or just coincidental, but the FDA recommended temporarily pausing delivery to it could investigate the cases out of “an abundance of caution,” according to an FDA statement.
The other two approved vaccines, made by Pfizer and Moderna, are still being delivered and have not been associated with any dangerous side effects.
The suspension could be a major setback for the region, where J&J vaccine has been increasingly popular because of the convenience of its single-dose delivery.
It can also last for months at regular refrigerator temperatures without losing its effectiveness, unlike other vaccines that need to be kept at extremely cold temperatures for long-term storage. The easier storage requirements mean that village clinics can each have their own stockpiles of J&J vaccine to give out as needed, instead of requesting special shipments from Nome. The early delivery of new doses means that all village clinics should have extra doses on hand this week. “We sent vials to all the village clinics, so it should be sitting in their refrigerators continuously now,” Dr. Peterson said.
He added that a number of villages already had lists of residents waiting for the J&J vaccine, so now that the region has an ample supply, it could lead to a bump in the vaccination rate.
One J&J manufacturing plant in Maryland has made the news lately after a production mistake meant a large batch of doses had to be discarded. But Dr. Peterson clarified that the incident will have no bearing on NSHC’s supply.
 “It’s important to understand that the plant where the mistakes were made was not even yet an FDA approved plant,” he said. “And that plant was never going to send out vaccine until it got FDA approved.” All the J&J doses currently in and coming to the region were produced at facilities that already surpassed the FDA’s strict quality control standards, the same standards that caught the mistake at the Maryland plant.
While the setback may cause delivery delays elsewhere in the country, Norton Sound will be receiving weekly shipments from other suppliers. “It’s not affected our supply,” Peterson said.
 But due to Tuesday’s halt of delivering the J&J vaccines, plans to set up additional vaccination clinics at the post office, AC store and City Hall have been delayed.
NSHC still hopes to make vaccines as readily available as possible. While it’s not clear how long the pause may last, NSHC will be poised to start delivering J&J vaccine again immediately if the rare clotting cases are determined to be coincidental.
He also said that Pfizer is due to submit data on its vaccine for children ages 12 sometime in the next few weeks. They recently announced that clinical trials found their vaccine to be just as effective in children 12 and up as in adults and will soon submit the data to the FDA for emergency use authorization.
“Historically during this pandemic, it’s taken the FDA about two weeks to approve the vaccines once the data’s submitted,” Dr. Peterson said. “I think the earliest we might have a vaccine for 12-, 13-, 14- and 15-year-olds would be late May. More likely it would be by June.”
The vaccine tested on younger age groups is the exact same as the one already approved for adults, so NSHC could immediately start giving out the doses of Pfizer vaccine it already has stockpiled as soon as the FDA gave the go ahead.
Dr. Peterson estimated that approval for ages 12 and up would result in a five to eight percent boost in the region’s vaccination. Sometime after that, vaccine companies will submit data for children eight and older.
“What we’re hopeful for is that they would have a vaccine for all school-aged groups by the time that school starts in the fall,” he said. “But it might be later in the fall or early winter before they get all the age groups done.”
Moderna and Johnson & Johnson are also running clinical trials for their vaccines in children, so those vaccines will also likely be available for younger age groups later on if their data shows strong safety and effectiveness.
Although the regional vaccination rate has slowed down over the past few months, Dr. Peterson said he was confident that the region would reach its 80 percent goal. “There is interest out there,” he said. “It’s just evident that we need to bring it to people. People are willing to get it, but if it’s not as convenient they’re not as likely to get it.” Having Johnson & Johnson available in all village clinics, plus public places in Nome, is part of the push to make vaccines as convenient as possible.
“And I think hesitancy is reduced over time,” he added. As more and more people get vaccinated and communities begin to lift certain restrictions for vaccinated people, Dr. Peterson was confident that many of the previously hesitant would come around and agree to get vaccinated.
At the same time, though, he was concerned about the recent uptick in case numbers, both in Alaska and in the region. Part of that increase may be due to viral variants that spread more efficiently than previous versions of the virus.
“I also think what we’re seeing is a kind of COVID fatigue,” he said. “People are traveling more, they’re not masking as much, they’re not being as cautious. And that’s why we’re seeing more cases.” He emphasized the importance of wearing masks and avoiding large gatherings and unnecessary travel, even for the vaccinated. While the vaccine greatly reduces a person’s chance of catching and spreading the virus, it’s not 100 percent effective. Also, nearly half the region is still unvaccinated, which offers the virus plenty of susceptible hosts.
Dr. Peterson said the number one thing people can do, aside from following all the same distancing protocols that have become familiar over the last year, is show up to get the shot.
“We’ve got to get vaccinated,” he said.  “That’ll protect us.”

Reporting for this story was supported by the Alaska Center for Excellence in Journalism.

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