Update (1010ET): The health officials who spoke on today’s call started by reiterating details about the decision to halt the J&J shared with the press earlier. Officials said they would update doctors with new vaccine “fact sheets” designated certain medications that could be associated with higher risks of blood clots.
After they said they were only seeing symptoms in patients who received the JNJ vaccine, the first question from the press (asked by an FT reporter) was: what about AstraZeneca? In Europe, governments have been imposing age limits on who can receive the AstraZeneca jab for similar reasons.
Officials responded by brushing the AZ question aside, before saying they hoped the halt would last for only a few days. Pressed about what’s causing the clots, doctors said that an extremely rare immune response triggers the blood clots by sending signals in patients’ blood to clot. While they said they hadn’t seen complications with other vaccines, Dr. Marks said the US believes the problem in the JNJ and AZ vaccines is “related” to the adenovirus platform, though he didn’t offer much in the way of details.
At one point, Dr. Marks said “the real thing that is so notable here is not just the cerebral blood clods…it’s their occurrence together that makes a pattern, and that pattern is very very similar to what was seen with another vaccine.”
A reporter for CNN mentioned that they were being told that this was something being “looked into” earlier, and Schuchat explained that the CDC had first looked into how best to advise the health-care community to treat and respond.
The FDA left open the possibility that new cases of blood clots could be brought to its attention. The FDA will actively search for vaccines. New guidance to be issued will help educate doctors and other health-care professionals about risk factors that could put patients at risk of the autoimmune reaction.
After offering examples of symptoms that would be on the list of potential warning signs, Dr. Marks was pressed to open up a bit more about symptoms after a doctor who was on the call asked him about specific symptoms seen by these patients. The doctor noted that listing “headaches” on a list of suspect symptoms or “abdominal pain” could lead to a lot more tests and doctor visits. At this, Marks seemed to have trouble putting a figure on the background rate of blood clots, and other questions about the prevalence of symptoms that could be seen on the FDA’s list.
“This is going to translate to a lot more doctors visits for people like me,” the doctor said.
The press briefing was ended soon after. Of course, it’s not difficult to understand why the FDA was starting to feel uncomfortable. A wave of patients being told to seek emergency care as a precaution could push ER occupancy rates higher again. Suddenly, the numbers will be telling us that we are back in the worst of the COVID pandemic.
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Update (0955ET): The FDA is holding its joint media call led by Director Peter Marks of the FDA Center for Biologics Evaluation and Research, Acting FDA Commissioner Janet Woodcock and Principle Deputy Director Anne Schuchat.
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Update (0945ET): The White House is playing down the JNJ news, reiterating the earlier government claims that the overall timeline of the rollout won’t be impacted.
“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date,” Zients said.
US has enough Pfizer, Moderna vaccines to continue current pace of vaccinations and meet President Biden’s goal of 200 million shots by his 100th day in office.
White House is working with state and federal partners to get patients who had been scheduled for J&J vaccine rescheduled for Pfizer or Moderna.
Meanwhile, a press conference with the FDA to discuss the findings is scheduled to start in 8 minutes.
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Update (0935ET):In a sign that vaccine-makers are now releasing statements simply to reassure the public that there’s nothing wrong with their product, Moderna issued a statement reminder the world that “a comprehensive assessment of safety data” found no connection found no negative health drawbacks.
Stocks, so far at least, have mostly shrugged off the news, possibly finding solace in the CDC and FDA’s guarantees that this won’t impact the US vaccination timeline, with “the vast majority” of American adults expected to be vaccinated by the summer.
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Update (0920ET): As we wait to hear more about the blood clots, JNJ just released a statement saying that after reviewing the findings with European regulators, the company would “proactively delay the rollout of our vaccine in Europe.”
The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.
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 CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
Meanwhile,any patients who were set to be vaccinated at New York State’s mass vaccination sites will receive Pfizer jabs instead of the J&J shots, said Health Commissioner Howard Zucker, as Gov. Andrew Cuomo has promised to honor all vaccination appointments.
While cities will likely be able to make things work by rescheduling some second-dose appointments, rural areas, where the JNJ jab was supposed to be a major difference-maker due to the requirement for only one shot.
As we wait to hear more from other national regulators, a drugs regulator in the Netherlands, which halted use of the AstraZeneca jab earlier this month, said Tuesday that the benefits of the JNJ jab outweigh the risks.
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Update (0740ET): A press briefing will be held at 1000ET to share more details of the JNJ situation. A joint statement has been released by the CDC and FDA.
The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC.
A meeting of the Advisory Committee on Immunization Practices will also be called on Wednesday to further examine the situation.
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System.
CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.
Meanwhile, across Wall Street, everybody is trying to figure out exactly what this means for markets and the Fed. Like every other bit of vaccine-related news to date, we suspect the answer is “unambiguously bullish”.
JNJ vaccine halt is bullish as it means the Fed's "75% vaccination" taper redline will be much later
— zerohedge (@zerohedge) April 13, 2021
In a shocking report that could have dramatic implications for the US vaccine rollout, federal public health authorities in the US have decided to stop administering COVID jabs developed by Johnson & Johnson, and are asking states to do the same. The reason? Authorities have identified six cases of rare and life-threatening blood clots, at least one of which resulted in death.
According to the NYT, which broke the news, all six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the officials said.
The FDA published its own advisory shortly after the NYT broke the news.
— U.S. FDA (@US_FDA) April 13, 2021
All federal facilities will halt use of the jab immediately, and the states are expected to follow suit by ordering jabs to be suspended at their vaccination site. Regardless, we imagine most Americans would refuse a JNJ jab now that reports of the blood clots, which also were found to be associated with AstraZeneca vaccines by authorities in Europe.
Federal health agencies on Tuesday will call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination, officials briefed on the decision said.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the officials said.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
While the move is framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
The FDA and CDC will jointly examine any potential link between the vaccines and the blood clots. The decision to halt the rollout could “”substantially complicate” the country’s vaccination trajectory, and already, markets are looking shakey.
Scientists with the Food and Drug Administration and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the C.D.C.’s outside advisory committee has been scheduled for Wednesday, officials said.
An F.D.A. spokeswoman declined to comment.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That concern has driven up some resistance to all vaccines, even though the AstraZeneca version has not been approved for use in the United States.
Supply disruptions at a US factory in Baltimore coincidentally led to a dramatic reduction in supply of Johnson & Johnson vaccines on the market, leading to shortages that prompted a brief slowdown in the US vaccine rollout. Nearly 7 million people have received the JNJ jab so far in the US, and roughly 9 million more doses have been shipped. Fortunately, most of the vaccines distributed so far in the US were manufactured by Moderna and Pfizer-BioNTech. Still, the Biden Administration had been counting on using hundreds of thousands of JNJ doses per week. And what’s more, the jab – which had the advantage of being doled out in a single dose, as opposed to multiple doses for Pfizer and Moderna – was supposed to play an important role in helping Europe catch up to the US and UK.
As for how this might set back the Biden Administration’s push to vaccinate the US, “it’s unclear.” In the US alone, 300K to 600K people a year develop blood clots, according to CDC data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous thrombosis, is extremely rare. What’s more, it’s the same disorder linked to jabs produced by AstraZeneca in Europe.
Out of 34M people who received the vaccine in Britain, the European Union and three other countries, only 222 experienced blood clots, and in those cases, the clotting was linked with low levels of platelets. The majority of these cases occurred within the first 14 days following vaccination, mostly in women under 60 years of age.
Like AstraZeneca, JNJ uses the adenovirus platform for its jabs, which, as it happens, was the reason Australia cited when it announced Tuesday overnight that it wouldn’t purchase the JNJ jabs for domestic use.
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