U.S. recommends "pause" for Johnson & Johnson COVID vaccine to review blood clot cases

As CBS News' Debora Alfarone reports, federal health officials are advising a temporary stop to administering Johnson & Johnson's coronavirus vaccine after reports of some adverse reactions. CBS News reporter Alex Tin joins CBSN's "Red and Blue" anchor Elaine Quijano to discuss the latest on the vaccine situation.  

A top CDC official said Tuesday that their probe of the rare combination of blood clots and low platelet counts had turned up a similar case during Johnson & Johnson's clinical trials. 

"There was one episode of an event that looks a lot like this, it was actually in a man," Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention, said in an interview with PBS.

Federal health officials initially said all six cases they were examining had occurred "among women between the ages of 18 and 48." However, previous reviews of those who had received the vaccine manufactured by AstraZeneca - which is based on a similar platform to Johnson & Johnson's shot - had turned up a handful of similar suspected clotting cases in some men as well. 

"As you can imagine, when you have an event that might be as rare as one in a million, that may not show up in a clinical trial, even as large as the trials were before the FDA authorization. And that's why we take very seriously monitoring safety," said Dr. Schuchat. 

In its review of Johnson & Johnson's submission for emergency use authorization in February, the Food and Drug Administration had initially urged further surveillance of a slight "numerical imbalance" in blood clotting events after receiving the shot. At the time, the regular concluded there was "insufficient" data to determine "a causal relationship" with the vaccine. 

One of those events flagged by the FDA was in a 25-year-old man with "no past medical history" who experienced several common side effects, including a headache, following his shot. While the trial participant recovered from most of his side effects, the headache persisted and he eventually experienced a "tonic clonic seizure." 

The FDA's reviewers said that event led Johnson & Johnson to pause their study. But in October, the drugmaker announced they would resume the trial saying there was "no evidence that the vaccine candidate caused the event." After an investigation found other "possible contributing factors," Johnson & Johnson ultimately concluded that the event "was not related to the study product." 

Federal health officials have asked states to pause administering the Johnson & Johnson vaccine in the U.S. after six women developed a rare blood clot. Jericka Duncan shares the latest. 

Johnson & Johnson said late Tuesday that it is suspending vaccinations in their ongoing clinical trials, after earlier saying only that they would "proactively delay" the rollout of their shots in Europe. 

"We have made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants," the company said an updated statement on Tuesday. 

The drugmaker has a handful of ongoing clinical trials to test their shots, including a recently expanded Phase 2 study trialing the doses in adolescents. 

U.S. regulators hinted at the possibility Johnson & Johnson might suspend the trials, asked about it at a press briefing earlier Tuesday. 

"I think you can look at statements that will come out of J&J today about their voluntary actions in response to this request for a pause," Dr. Peter Marks, director of the Food and Drug Administration's Center for Biologics Evaluation and Research, told reporters.

Hours after the Centers for Disease Control and Prevention and the Food and Drug Administration recommended a pause on giving out the Johnson & Johnson vaccine due to adverse reactions in six women, Dr. Anthony Fauci spoke with "CBS Evening News" about what the decision means. 

The interview below has been edited for length and clarity. 

CBS News: People who just got the Johnson & Johnson vaccine are worried. What should they look out for? 

Dr. Anthony Fauci: Well, it depends on when they got it. It appears that this adverse event occurs between six days and 13 days. So if you've had it a month or two ago, I think you really don't need to worry about anything. Having said that, you still wanna be alert to some symptoms, such as severe headache, some difficulty in movement, or some chest discomfort and difficulty breathing. 

These are women of childbearing age. Does this suggest that it could be hormonal?

Absolutely and that's one of the things that we wanna investigate. There have been similar types of phenomena that have occurred during pregnancy. Clotting abnormalities are known in women who take birth control pills, so certainly there could be a hormonal aspect to this.

Read more here or watch in the player below:

A top official with the FDA said Tuesday that there was "no clear association" between reports of rare blood clots following the Johnson & Johnson COVID-19 vaccine and oral contraceptives. But Dr. Peter Marks, the  head of the FDA's Center for Biologics Evaluation and Research,  cautioned the agency still was investigating the six reports of women who had developed the potential side effects. 

"In fact, the minority were on oral contraceptives. So there — that doesn't seem to be the association," Marks told an American Medical Association webinar. 

Some had worried about the potential link to birth control pills after the FDA disclosed Tuesday that all six of the cases they were examining were in adult women, ages 18 to 48. Blood clots are a known, rare potential risk posed by the drug.

However, in Europe, an investigation of similar side effects from AstraZeneca's COVID-19 vaccine — which is based on a similar technology to Johnson & Johnson's — had also uncovered several men who also had suffered the rare events after those doses as well. 

The World Health Organization says they are in "close contact" with the FDA following the U.S. pause on Johnson & Johnson's COVID-19 vaccine, and is monitoring reports of rare blood clots combined with low blood platelet counts.

"The WHO Global Advisory Committee on Vaccine Safety is monitoring these reports closely and will communicate any findings following a review," the international health agency said in an email on Tuesday. 

The WHO cleared Johnson & Johnson's COVID-19 vaccine for an emergency use listing in March, following sign-off from regulators in the U.S. and Europe. 

The WHO's authorization is a key step for using drugs in many countries that do not have the ability or resources to conduct their own thorough audit of new medicines. It is also a prerequisite for use of the shots in the international COVAX vaccination effort backed by Gavi, the Vaccine Alliance, which struck a deal in December for up to 500 million doses of Johnson & Johnson's vaccine.

The pause on Johnson & Johnson vaccines could be over as soon as Wednesday, according to a health alert issued to medical providers by the CDC on Tuesday, which only urges clinicians to pause using the doses until an advisory committee convenes to deliberate on changes to use of the doses. 

The CDC's Advisory Committee on Immunization Practices will convene Wednesday for an emergency session, with a vote scheduled on "updated recommendations for use" before the group adjourns at 4:30 PM ET. 

"Pause the use of the J&J COVID-19 vaccine until the ACIP is able to further review these [cerebral venous sinus thrombosis] cases in the context of thrombocytopenia and assess their potential significance," the CDC's notice said.

Acting FDA Commissioner Janet Woodcock said earlier she expected the pause only to last "a matter of days." 

Virginia state health authorities say they are still gathering details surrounding a potential death matching the worrying combination of rare blood clots and low blood platelets following the Johnson & Johnson vaccine in the state. 

"We have a call into the CDC to (A) confirm if that is the individual that has been counted as a death here, and if not, then should it be counted as an additional case," Dr. Danny Avula, Virginia's COVID-19 vaccine coordinator, told reporters at a press briefing on Tuesday.

A Food and Drug Administration official said Tuesday that the regulators were examining six total cases of the rare blood clotting events after receiving the Johnson & Johnson vaccine, including one death and one that remained in "critical" condition. A spokesperson for the agency later declined to confirm any more details about the cases, citing federal privacy regulations. 

Last week, officials in Nebraska had confirmed a resident in their late 40s had been treated for this kind of rare blood clotting event, after receiving the Johnson & Johnson vaccine.

Briefly addressing concerns over vaccine supply given the Johnson & Johnson pause, President Biden said he's made sure the U.S. has enough vaccine doses for all American adults from Pfizer and Moderna alone. 

"I made sure we had 600 million doses – not of either Johnson & Johnson and/or AstraZeneca," the president said, insisting there'll be enough vaccine that is "basically 100% unquestionable" for "every single solitary American."

Both Pfizer and Moderna require two shots. 

Pfizer CEO Albert Bourla says his company has accelerated the delivery of its COVID-19 vaccine to the U.S. next month. Bourla said Pfizer can deliver 10% more doses to the U.S. by the end of May. 

"In the fight against COVID-19, we're in this together," he tweeted Tuesday. 

Pfizer has already supplied more than 123 million doses to the U.S., according to the CDC. To reach 220 million doses, the company would have to supply around 14.1 million doses a week by my rough math

The nation's capital city joined several states in suspending the Johnson & Johnson COVID-19 vaccine that's become the focus of a federal examination of rare blood clots.

District of Columbia health director Dr. LaQuandra Nesbitt says she's not aware of any cases of dangerous blood clots among the 16,000 Washingtonians who had received the J&J one-dose vaccine before the temporary halt recommended by federal health authorities.

"This pause means that the system is working properly," Nesbitt says.

J&J said in a statement Tuesday it was aware of the reports of blood clots, but that no link to its vaccine had been established.

A CDC committee will meet Wednesday to discuss the cases. The FDA has launched an investigation into the cause of the clots and low platelet counts. There have been six reported clots among the 6.8 million shots administered.

U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin. "In this setting, administration of heparin may be dangerous and alternative treatments need to be given," the FDA and CDC say.

South Africa has suspended giving the Johnson & Johnson vaccine as a "precautionary measure" following the FDA decision in the United States to pause using it while very rare blood clot cases are examined.

South Africa has given more than 289,000 jabs of the J&J vaccine to the country's health workers without any reports of blood clots, Health Minister Dr. Zweli Mkhize said Tuesday.

He said South Africa is halting the use of the J&J doses "out of an abundance of caution" and he expects that the questions over the J&J vaccine should "be cleared within a matter of days."

Earlier, Johnson & Johnson said it was delaying the rollout of its coronavirus vaccine across Europe amid the U.S. probe, a move that experts worried could further shake vaccine confidence and complicate COVID-19 immunization efforts. 

Jeffrey Zients, White House COVID-19 response coordinator, stressed during Tuesday's White House briefing the FDA's announcement "will not have a significant impact" on the Biden administration's vaccination program. Johnson & Johnson's vaccine makes up less than 5% of the more than 190 million shots administered to date, and the federal government has secured enough doses from Pfizer and Moderna to remain on the current pace of 3 million shots in arms per day, he said.

Fauci said there have been "no negative red-flag signals" with regard to Pfizer and Moderna's vaccines, which indicates "you're dealing with a really safe vaccine."

The recommendation from the FDA and CDC has raised concerns as to whether vaccine hesitancy will grow among the public, particularly in communities that may be less confident in the shots.

But Fauci said the "pause is a testimony to how seriously we take safety."

Zients, too, said the move underscores how safety and efficacy of the vaccines are being monitored.

"The FDA acting the way they did today shows that they are indeed the gold standard and I think that should reassure the American public that they will be very diligent and conservative in how they approach the vaccines," he told reporters. 

Dr. Anthony Fauci, chief medical adviser to President Biden, said the suggested pause on administering Johnson & Johnson's coronavirus vaccine allows federal health agencies to examine the reported blood clot cases and raise awareness among physicians who may be treating patients with this specific type of blood clot.

"This is an unusual occurrence of a serious adverse event that you want to make sure before you go forward you investigate it thoroughly," Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during Tuesday's White House press briefing.

Fauci said the goal of the announcement from the FDA and the CDC was to "make physicians aware of this," given the clinical implications. While a drug called heparin is typically used to treat blood clots, Fauci said that treatment "would be a mistake in this situation," as it could be dangerous.

"The pause not only allows us to take a look at the cases and learn more, but it is also a signal out there to help the physicians," he said.

For those who have recently received Johnson & Johnson's vaccine, Fauci encouraged people not to "get an anxiety reaction," but to pay attention to whether they present symptoms such as headache, shortness of breath or chest discomfort.

"This is a really rare event," he said. 

New Jersey, Wisconsin and New Mexico were among a growing list of states on Tuesday following federal guidance and putting Johnson & Johnson vaccines on hold.

Health Commissioner Judy Persichilli in New Jersey said all of the state's vaccination sites - about 700 total, officials have said - will cancel or put appointments for the J&J vaccine on hold.

Jennifer Long, 50, of Franklin Lakes, New Jersey, had a 7:40 a.m. appointment Tuesday for a Johnson & Johnson vaccine at a Walmart in Riverdale. She considered skipping it, given reports that a few women had developed blood clots after getting the J&J vaccine, but she wanted the protection because she lives with her 91-year-old father.

Moments after getting the shot, she opened her phone to news the U.S. was now recommending a pause to study the issue.

"I showed the pharmacist the breaking news on my phone. I think I got the last one," said Long, a lawyer and adjunct law professor at Georgetown University. "I mean, I wasn't happy. I was a little panicked."

Her sister, a nurse, talked her "off the ledge," reminding her that the number of reported problems was very low and the link uncertain.

"I feel like there are a lot of unknowns, but the only known is how severe COVID can be if you get it," Long said.

Johnson & Johnson said it will "proactively delay" the rollout of their vaccine doses in Europe, following the recommended pause for the shots by federal health officials in the U.S. 

"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," the company said in a statement Tuesday. 

The Department of Defense is "immediately" pausing use of the Johnson & Johnson vaccine, Pentagon press secretary John Kirby said Tuesday in a statement. 

"The safety of our force and their families is a top priority for the Department," he said. "We are communicating this pause to our military health facilities and are reviewing our global vaccine distribution to address this issue and ensure we can continue to provide vaccines to our DoD population at home and abroad."

Walgreens says it is "immediately suspending" administration of the Johnson & Johnson vaccine at both its stores and clinics off site following the FDA and CDC recommendation. 

"We are reaching out to patients with scheduled appointments and rescheduling vaccinations from other manufacturers, as supply allows," it said in a Tuesday statement.

The company said it is awaiting further guidance and will keep working closely with the CDC and FDA. 

Federal health officials said Tuesday there were no similar reports of rare blood clotting issues from the Moderna and Pfizer COVID-19 vaccines that have been administered in the United States. 

In a statement, Moderna also said a review of "available safety data" for the doses of their vaccine administered around the world "does not suggest an association" with the concerning blood clots and low blood platelet counts. 

Johnson & Johnson's COVID-19 vaccine relies on a modified version of an adenovirus designed to mimic a characteristic component of the virus that causes COVID-19, different from the mRNA technology that underlies the Moderna and Pfizer shots. 

However, federal officials acknowledged that the symptoms bore a striking resemblance to cases of rare side effects after the AstraZeneca vaccine -- another "adenoviral vector" vaccine -- was administered abroad. 

"It is plainly obvious to us already that what we're seeing with the [Johnson & Johnson] vaccines looks very similar to what was being seen with the AstraZeneca vaccine," said Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research. 

"I can't make some broad statement yet. But obviously, they are from the same general class of viral vectors," said Marks. 

A U.S. database tracking reports of potential side effects after vaccination includes a handful of cases of blood clots after receiving
the Johnson & Johnson COVID-19 vaccine. 

One report details the case of a Virginia woman in her 40s who passed away after a clot formed in her brain several days after receiving the single-shot vaccine and was diagnosed with low blood platelet counts.

A week after receiving the vaccine, the woman reported a "gradually worsening headache" and was eventually hospitalized, according to the report. She passed away on March 18, around 12 days after receiving the shot. 

Of the six cases where federal regulators say they are examining the rare overlap of blood clots and low blood platelets, officials confirmed Tuesday that one had passed away and another was in critical condition. 

After Johnson & Johnson's clinical trials, Food and Drug Administration reviewers had noted a "numerical imbalance" in cases of these types of "thromboembolic events" but said there was "insufficient" data at the time to determine if they were caused by the vaccine. 

"FDA will recommend surveillance for further evaluation of thromboembolic events with deployment of the vaccine into larger populations," the agency had noted. 

Acting FDA Commissioner Janet Woodcock told reporters on Tuesday that she expects the recommended pause to last "a matter of days," while federal health officials review the data and mull updated guidelines for use of Johnson & Johnson's vaccine.

The CDC is convening tomorrow an emergency meeting of their Advisory Committee on Immunization Practices to deliberate whether to change recommendations around the shot. After reports of similar side effects in Europe after the AstraZeneca vaccine, some countries moved to limit the use of that shot to older patients at higher risk of death or severe symptoms from COVID-19.

Officials said the pause is intended to provide doctors the opportunity to learn more about how to treat the rare combination of symptoms, which can sometimes be worsened by heparin, a standard treatment given to address blood clots.

However, officials said the recommendation was not a mandate and that patients and their providers could still elect to get the shots.

"We're not going to stop that provider from administering the vaccine because it could be right, in many cases, that benefit risk will be beneficial overall to that individual in the large majority of cases," said Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research.  

Anyone who received the Johnson & Johnson vaccine within the last couple of weeks should "be aware to look for any symptoms," said Anne Schuchat, principal deputy director of the CDC.

Those who develop severe headache, abdominal pain, leg pain or shortness of breath after getting the vaccine should contact their health care provider and seek medical treatment, she said.

Schuchat said the risk is "very low" for people who received the Johnson & Johnson vaccine more than a month ago. 

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a briefing Tuesday that the issue with the kind of blood clots being investigated is with treatment — "that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm, or the outcome can be fatal."

"So one needs to make sure that providers are aware that if they see people who have low blood platelets or, if they see people who have blood clots, they need to inquire about a history of recent vaccination, and then act accordingly in the diagnosis and management of those individuals," he said.

"This was taken rapidly in order to honor our commitment to the American public to ensure that any safety signal that came up during this vaccine rollout was addressed in a transparent manner."

The White House says the recommended pause will not significantly impact its COVID-19 vaccine plan given that the Johnson & Johnson vaccine accounts for less than 5% of the total number of shots administered in the U.S. as of Tuesday. 

"Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans," Jeff Zients, the White House COVID-19 response coordinator, said in a statement. 

"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 said. "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." 

Zients said officials are working with state and federal partners to get anyone who was scheduled for the single-shot vaccine to get Pfizer's or Moderna's vaccine instead. 

States swiftly moved Tuesday morning to implement the pause. 

New York state health commissioner Dr. Howard Zucker said the state will follow the recommendation and pause the use of the Johnson & Johnson vaccine at state-run sites. People with Tuesday appointments for Johnson & Johnson vaccines at state-run mass vaccination sites will instead get the Pfizer vaccine, he said.

In Mississippi, state health officer Dr. Thomas Dobbs, said Tuesday on Twitter that the state health department is "instructing all physicians, clinics and hospitals to refrain from using Johnson and Johnson until additional guidance (is) available from CDC/FDA." 

The city of Dallas had planned to begin an in-home vaccination program Tuesday using the Johnson & Johnson vaccine for homebound or elderly people. The city, citing the FDA announcement, said it will pause the program until more guidance is released.  

Michigan Governor Gretchen Whitmer's office said in a statement to CBS News the state will follow the FDA's and CDC's guidance. This comes just after Whitmer asked the Biden administration for more vaccine doses to combat the surge in her state, but the federal government denied her request, maintaining its plan to distribute doses based on adult population.

"We will follow the FDA's guidance to temporarily pause the Johnson & Johnson vaccine out of an abundance of caution, and adapt our vaccine strategy going forward until a further review of the data can be conducted," Bobby Leddy, press secretary for Whitmer, said in a statement.  "With this latest development, it's more important than ever for the federal government to implement a targeted strategy that allocates additional Pfizer and Moderna vaccines to hotspots like Michigan to slow the spread of COVID-19 and save lives."

Tuesday's announcement caught state officials already struggling to meet demand with scant supply off-guard and raised immediate concerns about how the move might make Americans hesitant to get the vaccine even unwilling to do so.

"Honestly, your note is the first I've heard of this," the chief of staff for a southern governor told CBS News when contacted early Tuesday.

A top aide involved in pandemic response for a northeastern governor called the pause "a very serious problem" and comes amid an already scheduled declining supply of the Johnson & Johnson that was causing changes in the system's vaccine plans.

"This really impacts how many people you can full vaccinate by the summer. Additionally it may cause more hesitancy," the official said.