This is an excerpt from the April 15, 2021 edition of Medically Necessary, a health care supply chain newsletter. Subscribe here.
What happened? The Centers for Disease Control and Prevention and Food and Drug Administration recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after a few recipients developed blood clots.
— Six women had blood clots after receiving the vaccine. One died and another is in critical condition, according to NPR.
— Right now, the CDC says these adverse events appear to be extremely rare. So far, there have been six cases out of the 6.8 million Johnson & Johnson vaccines already delivered.
On Wednesday, the CDC’s Advisory Committee on Immunization Practices weighed the vaccine’s public health benefits against the risk of blood clots. The committee punted, saying it needed more information before making a recommendation, effectively extending the pause.
— “I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine, I don’t think that’s something I necessarily believe,” Beth Bell, an ACIP member and professor at the University of Washington’s School of Public Health, said during the meeting. “I just don’t feel we have information to make an evidence-based decision.”
The effect: The pause will slow the vaccine rollout in the U.S. But the Johnson & Johnson vaccine is currently a small part of the vaccine campaign, so the effect will likely be small.
A statement from the White House says the pause won’t significantly impact the vaccination program.
— “We have more than enough supply of the Pfizer and Moderna vaccines to keep our pace, hit our goal of 200 million shots in our first 100 days, and reach all adults who want to be vaccinated by May 31,” the White House COVID-19 Response Team tweeted.
— Johnson & Johnson’s vaccine makes up fewer than 5% of the total shots delivered in the U.S. so far, according to the White House statement.
— Bloomberg predicts the company’s vaccine will become a much bigger part of the U.S. vaccination program later this year as production speeds up.
However, several members of the ACIP pointed out that the Johnson & Johnson vaccine, which is easier to store and transport, has been used to vaccinate people whom the normal supply chain has a hard time reaching, such as homeless populations or people who are homebound.
During the meeting on Wednesday, Camille Nelson Kotton, an ACIP member and doctor with Massachusetts General Hospital, said pausing the Johnson & Johnson vaccine could have a bigger impact on those people.
— “Putting this vaccine on pause, for those of us that are front-line health care workers, has really been devastating,” she said. “I definitely want us to be cautious and very careful with our decision making, but I also want to emphasize that this one-and-done vaccine, that didn’t require the cold chain that the mRNA vaccines do, it’s a significant loss.”
Bloomberg reports that the Federal Emergency Management Agency has stopped using mobile units to administer vaccines because of the pause.
Some vaccine appointments for homebound patients in New York City have also been delayed while public health officials try to switch to a different vaccine, according to the same report.
In the real world, many vaccine clinics had to cancel appointments while they adjusted to the new guidance about the Johnson & Johnson vaccine, according to The New York Times.
— A mass vaccination site in Colorado and vaccination clinics for college students in Ohio, New York and Tennessee had to be canceled because of the pause, according to The New York Times.
— However, officials from several states told Roll Call the effect would be relatively small.
Meanwhile, Pfizer hopes to increase the number of doses it’s delivering to the U.S. That could help offset any effects if the pause on the Johnson & Johnson vaccination lasts for a long time.
— On Tuesday, Pfizer CEO Albert Bourla tweeted that the company hopes to deliver 10% more doses to the U.S. by the end of May than previously expected.
— In a presentation for investors released Tuesday, Moderna said it’s still on track to deliver at least 200 million doses by the end of May and 300 million by the end of July.
— On Wednesday, Moderna CEO Stephane Bancel told investors that vaccine production probably wouldn’t speed up immediately, according to Reuters.
What’s next? At first, FDA officials said they expected the pause to last only a few days, according to Kaiser Health News.
— On Tuesday, Politico reported that the White House is bracing for a longer pause, especially for young women, who made up most of the cases of blood clots.
ACIP’s decision not to make a recommendation means the pause will likely last until its next meeting, expected to happen sometimes in the next 10 days. The committee hopes to have more data by then and offer a clearer picture for the future of Johnson & Johnson’s vaccine.
FDA publishes guidance for remote inspection of drug facilities
New guidance: This week FDA issued guidance clarifying its procedures for inspecting drug manufacturing facilities using remote tools like videoconferencing.
— The new guidance says FDA could use teleconferencing, livestreaming video and screen-sharing to inspect facilities, according to Regulatory Focus.
— An FDA press release notes that the agency has already been using video to inspect some drug facilities during the coronavirus pandemic.
The backstory: FDA halted many in-person inspections during the pandemic, leading to a large backlog.
— During the pandemic, FDA continued some inspections by requesting documentation or relying on inspections by European regulators.
— The agency also caught many drug quality problems by beefing up inspection and testing of products as they entered the U.S.
— Regulatory Focus notes that FDA has issued four warning letters to drug manufacturers based on records reviews alone.
In a recent report, the Government Accountability Office suggested that, in addition to document requests and inspections by foriegn regulators, remote inspections could be one way to deal with the backlog.
What’s next? FDA now plans to expand its use of remote inspections.
— “Within the exceptional context of a global pandemic, we see remote interactive evaluations as part of a necessary strategy to evaluate medical product facilities,” FDA Commissioner Janet Woodcock said, according to a press release.
The agency says it could use remote tools for several stages of the inspection process, including pre-approval and ongoing surveillance.
— Facilities can decline FDA’s request for a remote evaluation, but the agency warns that could delay regulatory decisions.
— On the other hand, facilities will not be able to specifically request a remote inspection. FDA will determine when it’s appropriate.