The US Centers for Disease Control on Friday (4-23-21) recommended the resumption of Johnson & Johnson vaccine. After an extensive review of the data following reports of a rare blood clotting condition, the agency advised “that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks.” Sitka’s Harry Race Pharmacy will have the J&J vaccine (which requires only a single dose) available at its next clinic 11 AM – 12 noon Wednesday, April 28, at the Sitka Firehall.
The restart of the Johnson & Johnson vaccine won’t have much of an effect on overall vaccinations in Alaska right away since the Johnson & Johnson vaccine — although convenient and requiring only one dose — has not been available in the state in large supply.
KCAW’s Robert Woolsey recently attended a teleconference with the state’s top health officials to learn more about Alaska’s vaccine progress as we head into summer.
Dr. Coleman Cutchins is a clinical pharmacist with the state Department of Health and Social Services (DHSS).
He says the CDC’s recommendation to temporarily halt the Johnson & Johnson vaccine to investigate an extremely rare blood clotting disorder was par for the course for any drug, and means the system is working. It doesn’t mean that the vaccine is experimental, or wasn’t fully tested before receiving emergency authorization for use by the Food & Drug Administration (FDA).
“There’s no difference in the safety checkpoints that an emergency-use drug went through than versus a full-approved drug,” said Cutchins. “The FDA is really clear: They don’t use the term ‘experimental’ but they use the term ‘investigational.’ So once a drug receives EUA, Emergency Use Authorization, it is no longer considered an ‘investigational’ drug.’ And a good example to show this is what we’re seeing right now with Johnson and Johnson. This is the process. This is the way it works. And this is why we have the safest drug-approval process in the world.”
The Johnson & Johnson vaccine was studied for a possible connection to six cases of a rare blood clotting disorder, out of the seven million people who received the shot. Cutchins says these extremely rare one-in-a-million side effects aren’t usually encountered in clinical trials of any drug, which only involve tens of thousands of people. If it weren’t for the high-profile nature of the pandemic, the Johnson & Johnson pause to study blood clots might never have made the news.
“This event came up, and they’re studying it, which is what we do with a lot of other drugs,” said Cutchins. “It happens, honestly, a few times some years. It just isn’t under the spotlight because there isn’t as much front-and-center attention as these covid vaccines.”
Cutchins says the three coronavirus vaccines available in the US ( Johnson & Johnson, Pfizer, and Moderna) won’t receive full approval from the FDA until all the clinical trials are completed — including the trials which are currently underway for children ages 12-15.
Only 85 doses of the single-shot Johnson & Johnson vaccine were administered in Sitka by the vaccination team at Harry Race Pharmacy, out of the over 4,700 people who’ve been vaccinated so far. Statewide, the first Johnson and Johnson vaccine didn’t arrive until mid-March, and it represents only a small fraction of the 513,000 doses of vaccine that have been administered to Alaskans so far. The single-dose Johnson and Johnson was thought to be a game-changer in Alaska, where thousands of seasonal workers arrive in summertime. But Kelsey Pistotnik, with the state Section of Epidemiology, says that was never the case.
“Because Janssen (aka Johnson & Johnson) had been in such limited supply, we knew that we needed to pivot,” said Pistotnik. “In general, not make too many plans for that vaccine specifically, until we had a comfortable level of stock. We’re not there.”
Pistotnik said the pause had raised additional questions about when stock of the Johnson and Johnson vaccine would be adequate to use in something like the state’s airport vaccination plan, which is currently out to bid and doesn’t specify which vaccine the contractor should use.
Dr. Anne Zink, chief medical officer for the state, says large seafood processors and other companies are directing vaccine programs for their employees prior to their arrival in the state, so the limited availability of Johnson and Johnson shouldn’t be a problem. A bigger question mark for her is cruise ships. Alaska is joining the state of Florida in suing the CDC to lift its Conditional Sailing Order for cruising in 2021. Zink says vaccination is critical to safe cruising.
“From a health perspective, vaccines make a huge difference,” said Zink. “If you have everyone vaccinated, that is the best thing. I personally would not get on a cruise without being fully vaccinated — I wouldn’t do a lot of things without being fully vaccinated, to be perfectly honest, including a cruise with a lot of other people! But it’s also a numbers game, so the more people you have mixing, the more risk that there is, and so a cruise of 200 is really different than a cruise of 2,000 people.”
Regardless of how Alaska’s suit against the CDC pans out, it will make no difference for the cruise industry in 2021, as Canada’s ports remain closed to large passenger vessels until early next year, meaning that only smaller, US-flagged cruise ships will sail this summer.
Additionally, a bill introduced in the US Senate by Alaska Sen. Dan Sullivan and Florida senators Marco Rubio and Rick Scott called Careful Resumption Under Improved Safety Enhancements (CRUISE) Act also seeks to revoke the CDC’s Conditional Sailing Order by July 4 of this year. However, the measure was blocked (on 4-21-21) in the Senate by Washington Sen. Patty Murray, who said “While I am as eager as anyone else to see a return to travel, we cannot cut corners. Doing so risks lives and will only further delay returning to normal, hurting our economy more in the long run.”