Millions of Johnson & Johnson vaccines are set to expire in June, and thousands could be wasted because fewer and fewer Americans are getting vaccinated, according to reports by The Wall Street Journal and The New York Times.
Some states have considered shipping excess doses to other states or even overseas, but said they faced legal and logistical hurdles.
As the Food and Drug Administration (FDA) investigated the blood clot concerns in April, it told states to pause use of Johnson & Johnson’s shot. This, combined with the overall decline in vaccinations in the US and the public’s hesitancy towards Johnson & Johnson’s vaccine, has left states with millions of doses due to expire this month – and few people willing to take them.
Most Americans don’t get to choose which vaccine they receive, but some pharmacies only offer certain brands, so people may choose their pharmacy accordingly.
CDC data shows that just 53% of Johnson & Johnson vaccines delivered to states have been administered, compared to 83% for Moderna and 84% for Pfizer. Just over 10 million Johnson & Johnson are still waiting to be given out, largely due to the decline in vaccination rates and the FDA-mandated pause.
Ohio Gov. Mike DeWine said Monday that the state had around 200,000 doses of the Johnson & Johnson vaccine set to expire on June 23, while Dr. Jennifer Dillaha, Arkansas’ state epidemiologist, said on June 2 that it was pausing new vaccine orders because it already had up to 60,000 doses of Johnson & Johnson’s vaccine set to expire this month.
Dillaha told 5 News that overall demand for vaccines was dropping in Arkansas – but that the Johnson & Johnson shot was the least sought after.
Other states, including Michigan and Philadelphia, have reported similar problems – but they’ve struggled to shift excess doses elsewhere.
Pennsylvania’s Department of Health told The Journal that it had worked with the CDC to try to transfer Chester County’s 50,000 expiring Johnson and Johnson doses to Oregon. The deal fell through when Oregon said there wasn’t enough demand for the jab, officials told The Journal.
Ohio said it was not legally able to send the vaccine abroad or to other states, and said it had been “aggressively” working with vaccine providers to use as many doses as possible before they expire.
“There is a very, very small fraction of doses that have been sent out to states that will ultimately not be used,” Andy Slavitt, a White House pandemic adviser, said Tuesday, per The Times. He added that the FDA was looking into ways to extend the vaccine’s shelf life.
Public health experts are recommending that the US resume using Johnson & Johnson’s coronavirus vaccine, after immunizations were halted to investigate reports of rare blood clots.
A Centers for Disease Control and Prevention advisory committee voted 10 to 4, with 1 abstention, on Friday that use of the shot should resume. US health regulators will now craft new language to be included along with the vaccine, warning of the risk of unusual clots in women under 50.
Use of the vaccine had been paused since April 13, amid rare reports that several people who’d gotten the shot had developed a rare type of blood clot, along with a drop in their platelet levels. Platelets are the part of your blood that binds together to form clots.
Officials have identified 15 cases of these clots, called cerebral venous sinus thrombosis (CVST), in women who’d received the shot. Three of the women have died. (A 16th case, in a young man, was observed during J&J’s clinical trials).
The risk is highest for women between the ages of 30 and 39, according to data presented to the committee Friday.
“The last 11 days, to me, have been reassuring because we haven’t identified hundreds of cases across the US,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Hospital , who serves on the committee.
The FDA will change the label on J&J’s shot
J&J’s vaccine was authorized for emergency use by the Food and Drug Administration in February. The FDA will need to update the emergency use authorization for J&J’s vaccine with information warning about the risk of rare blood clots.
Public confidence in the vaccine has dropped significantly in the week and a half since this pause began. Just 19% of Americans would now be willing to get the shot, according to data presented to the advisory group Friday.
J&J representatives said the company’s shot should be reintroduced because it holds up well against virus variants that are spreading in the US. The vaccine is also a single-shot that can be stored in standard refrigerators. That makes it easier to give to people who are homebound, homeless, scared of needles, or incarcerated.
Before the federal pause, 6% of Americans overall said they’d prefer to get a one dose coronavirus vaccine, a statistic that held true regardless of a person’s age, sex, or income.
These unusual cases of CVST clots in patients with low platelets have not been meaningfully connected in any way to the messenger RNA vaccines from Pfizer and Moderna. J&J’s shot is also significantly cheaper than both Pfizer and Moderna’s mRNA vaccines, making it a critical tool in fighting back the virus worldwide.
Without J&J’s vaccine, the CDC’s Dr. Sara Oliver estimated it would take 14 days longer to immunize all adults in the US.
The Centers for Disease Control and Prevention is investigating the death of an Oregon woman who developed a rare, but serious blood clot within two weeks of receiving Johnson & Johnson’s vaccine, the Oregon Health Authority (OHA) announced Thursday.
The pause followed six reports of central venous sinus thrombosis (CVST), a rare blood clot that forms in the brain, among women ages 18 and 48 who had received J&J’s shot. The women developed the clots within two weeks of being vaccinated. They also reported low levels of platelets – colorless blood cells that help clots form.
In the statement, the OHA said the Oregon woman had the same combination of CVST and low platelets.
Dr. Shimi Sharief, senior health advisor with the OHA, told reporters that the woman’s symptoms were consistent with that of the other rare blood clot cases. Symptoms for this type of clot include severe and unusual headache, shortness of breath, stroke-like symptoms, abdominal pain, and small microbleeds.
Sharief emphasized that the possible adverse effect is very rare.
The CDC is still investigating whether CVST cases are related to the J&J vaccine. On Friday, an independent advisory panel for the CDC will vote on whether to end the pause on the shot – 10 days after the recommendation was issued.
The death of the Oregon woman will be discussed at that meeting.
She is the second death associated with rare blood clots following the J&J vaccine: A 45-year-old woman in Virginia also died after receiving the shot in March.
More than 8 million doses of the J&J vaccine have been administered in the US. Sharief said that, to her knowledge, Oregon health authorities are not investigating any other cases in the state.
This is a developing story. Check back for updates.
These highly unusual brain clots, though exceedingly rare, have shown up in about one in a million vaccine recipients so far, resulting in one death. More cases may still be unreported (the clots we know about haven’t shown up until 6-13 days after vaccination), making it hard for experts to gauge the true scale of the issue.
Last week, an independent advisory committee that makes vaccine recommendations to the Centers for Disease Control and Prevention made a plea to shot-givers across the US: let’s continue to pause use of this vaccine for now, to gather more data on how many of these dangerous clots are really out there.
But all signs are suggesting that the pause could be coming to an end this weekend.
Insider spoke with five of the 15 CDC vaccine advisory committee members who are meeting on Friday to vote on whether to continue the J&J pause across the US. Barring any more major surprises in the data, they all seemed eager to get the vaccine back into syringes and arms across the nation ASAP.
Millions of Americans got the shot before it was paused
As of last Wednesday, monitoring from the federal government and J&J collectively had flagged a total of seven worrisome clot cases in women under the age of 60, plus one case (during clinical trials) in a young man.
CDC Director Rochelle Walensky hinted at a White House briefing earlier this week that at least another “handful” of cases have been spotted during this week and a half long pause.
Are these one-in-a-million clots caused by the vaccine, or just a fluke?
The clots, cases of cerebral venous sinus thrombosis (CVST) are especially worrisome because they come with low blood platelet levels (thrombocytopenia). That means one of the most common blood clot treatments (heparin) only makes them worse.
Symptoms almost always start with a headache and some chills. Then they progress into severe abdominal pain and loss of consciousness. Eventually they can lead to brain damage and language impairment.
Some on the advisory committee, like Dr. Kevin Ault, an OBGYN at the University of Kansas, still haven’t ruled out the possibility that these cases could just be a fluke, and not related to vaccine administration at all. Others are more convinced this rare but worrisome issue is a highly unusual vaccine reaction.
“I think almost surely this is going to turn out to be related to the vaccine because of the clustering and because of the extraordinary, unusual presentation and findings of the patients who have it,” Dr. Sarah Long, a professor of pediatrics at Drexel University who’s serving on the committee, said.
Without more data, advisors say they are sort of flying blind
Every expert on the committee that Insider spoke to said they want to know if there have been any more cases of the rare blood clots reported in the interim.
That will help them better decide whether to warn certain populations (like young women) about getting this shot.
“We’re a data-driven group. So I want to see data,” Ault said. “We’re glad the system worked, that we were able to find a one in a million potential problem, with this rather unusual diagnosis.”
Advisors may ask for the shot may to come with a warning for women
Long said if cases continue to be clustered in younger women, there could be a warning given out with the shot, “or we could say we recommend it only for men and older women.”
Dr Wilbur Chen, a professor at the University of Maryland School of Medicine on the committee, is hopeful that with more public awareness about the rare condition, it can be recognized early and treated appropriately, avoiding prolonged hospitalizations and more deaths.
“For women 18 to 48 years, or 18 to 50 maybe, we may say ‘you may get vaccinated, but we’d like to just make sure that you are aware of this very rare event,'” he said.
Like putting on a helmet before riding a bike or fastening a seatbelt before driving a car, safety measures can be implemented, he added.
“You can’t completely remove risk with any vaccination, but you can darn well try to make sure that you reduce risk as much as possible,” Chen said. “And that’s what we’re trying to do at this point.”
Ultimately, all of the advisors want us to find a way to reap the benefits of this one-shot vaccine
Experts desperately want to put the J&J shot to use. It is the only one-shot COVID-19 vaccine on the market in the US, making it a critical tool in places like college campuses, homeless shelters, and for homebound adults who may all have logistical challenges to getting a second shot.
“I think it’s extremely unlikely that we’re going to say it’s too risky to use this vaccine,” Dr. Jose Romero, chair of the advisory committee, and director of the Arkansas Department of Public Health, said, suggesting that the issue is likely an “abnormal immune response” that a very small number of patients may have to the shot.
Romero, like others on the committee, is hopeful that the pause will reinforce public confidence in the vaccine safety system. But, with new variants spreading quickly, they all know time is of the essence.
“I’m not willing and eager to continue the pause for much further,” Chen said. “The truth is that the value of the vaccine is proven. 100% efficacy against hospitalization and death is virtually what the data is showing, so that’s terrific. And on the other side for the safety, we think that this [clotting] is super rare.”
‘Are we blowing this up out of proportion?’
Other committee members have warned that the longer this pause goes on, the more hesitant people may be to take the shot once it’s back in action.
“I have mixed feelings,” Lynn Bahta, an infectious disease nurse at the Minnesota Department of Public Health who is also on the panel, said. “Are we blowing this up out of proportion?”
She agreed it’s important that the public knows experts are being cautious and careful, taking vaccine safety seriously, but “to keep delaying is not helpful,” she said.
Some states, like Maine, were planning to rely heavily on J&J to vaccinate homebound residents, and they are now having trouble getting as many people vaccinated as quickly as they had originally intended.
Dr. Walensky has signaled that as soon as the advisory committee makes a final decision on Friday, the CDC and FDA will work together to quickly incorporate their advice into the national vaccination plan.
“I don’t want to get ahead of the advisory committee,” she told NBC’s Today show Thursday, while adding “I’m really hopeful that we’ll be able to use the [J&J] vaccine soon.”
The agency said that the overall benefit-risk remains positive, but said the link should be listed as “very rare side effects of the vaccine.” The EMA suggested a warning be attached to product information about the shot.
An expert panel that advises the Centers for Disease Control and Prevention recommended continuing the pause on administering Johnson & Johnson’s COVID-19 vaccine.
The agency is weighing whether to adjust its recommendations for the shot after at least six cases of rare but potentially fatal blood clots surfaced in people who’d recently been vaccinated.
But a last-minute advisory-committee meeting on Wednesday failed to yield a definitive answer to that question, with the panel concluding that the pause should continue and more data should be gathered.
Doctors and public-health experts overwhelmingly felt uneasy making a firm recommendation based on the minuscule amount of data available.
“I just don’t feel we have enough information to make an evidence-based decision” Dr. Beth Bell, a professor of global health at the University of Washington, said during the CDC Advisory Committee on Immunization Practices (ACIP) meeting Wednesday afternoon.
“It’s important from the perspective of the public: When we say rare, what does that mean? I want to be able to feel comfortable with my family members and myself getting this vaccine,” she added.
More data emerging on the people with rare CVST blood clots
The CDC and Food and Drug Administration had already recommended a pause on administration of J&J’s COVID-19 vaccine “out of an abundance of caution,” the two agencies said in a joint statement Tuesday morning.
That recommendation came after at least six cases of a rare type of blood clot called cerebral venous sinus thrombosis (CVST) were reported in women across the US. The clots occurred between six and 13 days after administration of J&J’s one-dose vaccine. One of the women, who was 45 years old, died, while two others are still in intensive care.
During the meeting, Aran Maree, the chief medical officer for Janssen, the medical-research arm of Johnson & Johnson, said a seventh woman, a 59-year-old, developed CVST after she received the vaccine in the US.
“Really, headache is the initial presenting feature,” Dr. Tom Shimabukuro from the CDC said during the ACIP meeting.
Many of the patients also had a low platelet count, which makes it difficult for the body to clot blood. A low platelet count also makes it dangerous to administer one of the most common blood-clot treatments, the blood thinner heparin.
An ‘abundance of caution’ prompted the pause
More than 7.2 million people across the US have received the J&J one-dose jab. It is both cheaper and easier to distribute than messenger-RNA vaccines.
With a goal to give out 200 million shots by President Joe Biden’s 100th day in office (April 30) – and a global push to build immunity quickly – a pause is a setback, some of the panelists said.
“Any extension of the pause will invariably result in the fact that the most vulnerable individuals in the country who would benefit from the Johnson & Johnson vaccine will remain vulnerable,” Nirav Shah, the director of Maine’s CDC, said during the meeting.
The news in the US also prompted worldwide movement away from J&J’s shot.
The company announced on Tuesday that it would “proactively delay” its vaccine rollout in Europe and pause all clinical trials of its vaccine around the world until guidance is updated. Australia also said it was not planning to buy any J&J shots.
South Africa is putting J&J’s vaccine on pause, effectively halting that country’s vaccine drive entirely, since no other COVID-19 vaccines are available there. Among the more than 289,000 healthcare workers who have been vaccinated in South Africa, none of these clots have been reported.
Tell Americans how to spot the signs of a blood clot, advisors said
One of the key reasons that the federal government recommended the pause, CDC Director Rochelle Walensky said during a White House press briefing on Wednesday morning, was to inform clinicians of the best ways to treat this type of rare clot.
“Usually, an anticoagulant drug called heparin is used to treat blood clots,” the joint statement from the CDC and FDA said. “In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”
There is a lot that isn’t known about these blood clots and what, if any, role J&J’s vaccine plays. Those open questions include how common it is for people to develop CVST blood clots when they have low platelet counts and how these clots compare with what’s been reported around the AstraZeneca vaccine.
Though CVST blood clots are exceedingly rare, symptoms to watch out for include severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccine administration, the CDC and FDA said.
Maree said: “We strongly support ensuring vaccine awareness of the signs and symptoms of this very rare event, as well as the recommendations to ensure the correct diagnosis, treatment, and reporting by healthcare professionals.”
J&J uses the same kind of vaccine technology as AstraZeneca
Regulators in the UK have recommended that people under 30 not take the AstraZeneca vaccine because of the very minor risk of clots, and other European countries are recommending the shots should be given to older adults only.
The Biden administration has said that removing the J&J shot from the nation’s vaccination article will not have a significant effect on its April 30 goal.
“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines,” Jeff Zients, the White House’s COVID-19 response coordinator, said in a statement.
He added: “This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office.”
Massachusetts’ COVID-19 immunization program, for one, was “built primarily on the back on the Pfizer and Moderna vaccines,” Gov. Charlie Baker said Wednesday. The state received 11,600 doses of J&J’s vaccine last week, compared with a combined 380,000 doses of Pfizer’s and Moderna’s shots.
Federal officials have already said that Massachusetts will receive about an 8% increase in its Pfizer and Moderna vaccine allocation next week, Baker said.
Massachusetts had planned to allocate its Johnson & Johnson vaccine supply to homebound patients. Replacing that vaccine with the two-shot mRNA vaccines will double the work to vaccinate those people.
The 27 member states, Norway, and Iceland, had started receiving doses of the Johnson & Johnson on Monday. The bloc was expecting 55 million doses by June, and 120 million doses in the following quarter.
“We have been reviewing these cases with European health authorities,” the company said in a statement Tuesday. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
Officials with the US Centers for Disease Control and Prevention said Tuesday that health agencies should immediately pause giving the shot, citing an “abundance of caution” over extremely rare reports of blood clotting among the millions of doses administered.
Six women between 18 and 48 years old who received the vaccine developed the clots within two weeks of being vaccinated, the CDC and the Food and Drug Administration said in a joint statement Tuesday.
Federal agencies immediately suspended using the shot, and many state and local health authorities followed suit Tuesday morning.
Following the announcement, Sweden said it would be reviewing its use of the Johnson & Johnson shot in the next couple of days. Belgium and the Netherlands said that, for now, they would continue to use the shot.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” Johnson & Johnson said.
Zients said in a statement that his team is working with federal and state partners to have anyone scheduled to receive a Johnson & Johnson vaccine rescheduled for a Pfizer or Moderna vaccine.
“Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” he said in the statement. “Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans.”
US officials recommended an immediate pause on the rollout of the Johnson & Johnson vaccine on Tuesday, citing reports of blood clots forming in people who have received the shot.
The Centers for Disease Control and Prevention and the Food and Drug Administration said on Tuesday that six women between 18 and 48 years old developed blood clots between six and 13 days after receiving the vaccine.
Zients said in his statement that there are enough Pfizer and Moderna shots to make up for paused Johnson & Johnson doses.
“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines,” he added. “This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office-and continue on to reach every adult who wants to be vaccinated.”
France received its first doses of the Johnson &Johnson vaccine on Monday, and will be offering the vaccine to everyone over the age of 55, France 24 reported on Monday.
Germany is expecting 275,000 doses this week, Health Minister Jens Spahn has said.
Spain expects 300,000 Johnson & Johnson shots on Wednesday, and will first administer the vaccines to those aged 70 to 79, DW reported. On Tuesday, the Spanish prime minister said that the benefits of the vaccine outweight its risk, but that authorities would slow down the roll out of the vaccine.
Belgium said on Tuesday it would keep using the shot. The country received its first shipment, 36,000 doses, on Monday.
Ireland should receive 605,000 doses by the end of June.
The US CDC and FDA both recommended immediate suspension of the use of the vaccine while 6 reports of blood clots were being investigated. So far 6.8 million doses of J&J vaccine have been used in the US.
The Dutch plant that delivered the initial supply of Johnson & Johnson vaccine doses to the US also distributed doses on a varied schedule, causing a further slowdown across states, according to the New York Times.
As of Friday morning, at least 112 million people in the US, or 33.7% of the population, had received their first doses of the COVID-19 vaccine. More than 66 million people have been fully vaccinated, CDC data shows.