POST 151. April 13, 2021. CORONAVIRUS. PARADOXICAL EFFECT: the J&J vaccination pause. “ Federal officials are concerned that doctors may not be trained to spot or treat the rare disorder if recipients of the vaccine develop symptoms of it…” “…a standard treatment for blood clots — use of an anticoagulant drug — could be dangerous or even fatal in such cases…”

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The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot. One of the cases was fatal and one is currently in critical condition.

The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“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,” the statement said. “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.”

Johnson & Johnson issued a statement on Tuesday noting that the company has decided to “proactively delay the rollout” of its 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 statement said in part.

For people who have received the Johnson & Johnson shot, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, according to the statement.

“It’s a very rare event. You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled,” Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, told CNN’s John Berman and Poppy Harlow on Tuesday morning.

“But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more, and really trying to understand what’s going on,” del Rio said. “I think vaccine safety has always been a priority — and I think this is exactly the right move until we understand what’s going on and what’s the way forward.””  (A)

“Speaking at the White House, Dr. Anthony Fauci, the nation’s top expert on infectious disease, said the pause would allow the FDA and the CDC to investigate the clotting cases and “to make physicians more aware of this.”

A CDC committee will meet Wednesday to discuss the cases, and the FDA has launched an investigation into the cause of the clots and low platelet counts.

FDA officials emphasized that Tuesday’s action was not a mandate. Doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks.

The agencies recommend that people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal or leg pain or shortness of breath within three weeks.

J&J said in a statement that it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it would delay the rollout of its vaccine in Europe as a precaution.

U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin.

European authorities investigating the AstraZeneca cases have concluded clots appear to be similar to a very rare abnormal immune response that sometimes strikes people treated with heparin, leading to a temporary clotting disorder.

While it’s not clear yet if the reports among J&J recipients are related, doctors would treat these kinds of unusual clots like they treat people who have the heparin reaction — with different kinds of blood thinners and sometimes an antibody infusion, said Dr. Geoffrey Barnes, a clot expert at the University of Michigan.

Even without J&J’s vaccine, White House officials said they remain on track to have enough supplies to vaccinate most American adults by the summer…

Asked if the government was overreacting to six cases out of more than 6 million vaccinations, the CDC’s Dr. Anne Schuchat said recommendations will come quickly.

Because these unusual clots require special treatment, “it was of the utmost importance to us to get the word out,” she said.” (B)

“No such issues have been reported with the Covid-19 vaccines made by Pfizer-BioNTech or Moderna, health officials said…

The pause “will not have a significant impact” on the country’s vaccination plan, Jeff Zients, the White House Covid-19 Response Coordinator, said in a statement, adding that there is “more than enough supply” to meet President Joe Biden’s “goal of 200 million shots by his 100th day in office.”..

“I know that the information we’re providing today is going to be very concerning to Americans who have already received the Johnson & Johnson vaccine,” Dr. Anne Schuchat, principal deputy director for CDC, said during the briefing. “For people who got the vaccine more than a month ago, the risk is very low.”

For those who recently got the Johnson & Johnson vaccine, Schuchat advised to be aware of sudden, severe headaches, abdominal pain or shortness of breath…

It was not clear if the woman, who spoke to NBC News on the condition of anonymity, was one of the six people in question. In a statement, the FDA said it was unable to “confirm or share personally identifiable information,” citing HIPAA rules.

The woman said she got the vaccine on March 19 at a Nashville hospital and initially experienced normal reactions, such as a fever. Then, about a week later, she went to the emergency room with uncontrollable shaking, troubling breathing and a fever.

“Since then, [I] have just had a few strange symptoms that could have been chalked up to a viral infection, mostly just a headache that persisted for two weeks, and some leg pain and swelling,” she said in a phone interview from her hospital bed, “and then also just some random bruises that would appear throughout my body.”

When she went to the ER the week after her shot, she said that doctors did not find anything strange in her blood work, and nothing at that point to suggest clotting or low platelets — so she went home. But the symptoms continued to worsen over the following week.

“Then, when I went back to the ER, it was because my leg was so swollen that I couldn’t really walk, so at that time they found the DVTs or the clots in my legs,” she said, saying they were in both legs and she had a low platelet count.

She added that she has been in the hospital for about a week, and she was in the intensive care unit until Sunday. When asked if she had any regrets, she said, “No, absolutely not. I just want to be clear, vaccines are good and they save lives.”” (C)

“Dr. Janet Woodcock, the acting commissioner of the F.D.A., said at a news conference Tuesday that the pause was only expected to last “a matter of days,” although she said the time frame depends on “what we learn in the next few days.” Dr. Schuchat said at the same briefing that the pause was enacted in part to “prepare the health care system to recognize and treat patients appropriately.”

The move could 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 has not been authorized for emergency use in the United States. At the news conference, Dr. Marks drew a connection between the two vaccines, saying the cases involving rare blood clots were very similar…

Federal officials are concerned that doctors may not be trained to spot or treat the rare disorder if recipients of the vaccine develop symptoms of it. They said on Tuesday morning that a standard treatment for blood clots — use of an anticoagulant drug — could be dangerous or even fatal in such cases…

In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare. Dr. Schuchat described the condition as “a severe strokelike illness linked to low platelet counts.”…

Government experts are concerned that the blood clots are linked to an immune system response triggered by the vaccine. Federal officials said there was broad agreement in the senior ranks of the administration about the need to pause use of the vaccine while the cases are investigated.

Dr. Marks said that the federal government was not issuing an order to suspend the vaccine, adding that health providers may decide that for a particular patient, the benefits of a shot outweigh the risks. “We’re not going to stop that provider from administering the vaccine because it could be right,” he said…

It is common for regulators to investigate “safety signals” in new vaccines and other medical products. Very often, the signals prove not to be of concern. But the concerns about Johnson & Johnson’s vaccine mirror concerns about AstraZeneca’s, which European regulators began investigating last month after some recipients developed blood clots.

Out of 34 million people who received the vaccine in Britain, the European Union and three other countries, 222 experienced blood clots that were linked with a low level of platelets. The majority of these cases occurred within the first 14 days following vaccination, mostly in women under 60 years of age.” (D)

“In most clinical settings, an anticoagulant drug called heparin is administered to treat blood clots; however, health officials said using this drug in these instances could be dangerous, and they recommended alternative treatments.

Health officials don’t know the definitive cause of the blood clots but suspect similarities in cases of blood clots in a small number of people who received the AstraZeneca vaccine, which is made using the same technique as the Johnson & Johnson vaccine.

The immune system of the person who got the vaccine may react to the vaccine by attacking the body’s own blood platelets or other parts of the coagulation system.

“That’s the leading theory or hypothesis about what’s going on,” acting FDA Commissioner Janet Woodcock said.” (E)

“More than two dozen states took steps Tuesday to halt inoculations with Johnson & Johnson’s coronavirus vaccine, shortly after the Food and Drug Administration recommended to pause its use after reports some women developed a rare blood clotting disorder.

The states, like the FDA and the Centers for Disease Control and Prevention, stressed that they were acting out of an abundance of caution, as more than 6.8 million doses of J&J’s vaccine have been injected and only six of the blood clotting cases have so far been reported.

J&J said in a statement that “no clear causal relationship” has been identified between the rare type of blood clots and the vaccine, adding it is working closely with regulators to assess the data.

New York Health Commissioner Dr. Howard Zucker said the state will “immediately” stop administering the single-dose J&J inoculation, and will use Pfizer’s two-shot vaccine in its place for already scheduled appointments.

At least 25 other states, along with Washington, D.C., and Puerto Rico, also announced they are taking J&J’s vaccine doses out of their distribution plans.

Those precautions may not be in effect for long, however: Acting FDA Commissioner Janet Woodcock said Tuesday that she expected the pause to last only for a matter of days.

Dr. Anne Schuchat, principal deputy director of the CDC, noted Tuesday that people who got the J&J vaccine more than a month ago are at very low risk for developing the blood clots. All six reported cases occurred in women ages 18 to 48, whose symptoms developed within two weeks after they received the shot.

New Jersey’s Department of Health said that all vaccination sites in the state “have been told to cancel or put on hold appointments for the J&J vaccine until further notice.” The agency said it will work with those sites to replace J&J appointments with an alternative two-dose vaccine.

Virginia “will cease all Johnson & Johnson vaccines” while the FDA investigates the “extremely rare possible side effect,” according to a statement from the state’s vaccination coordinator, Dr. Danny Avula.

Connecticut’s Department of Public Health recommended all Covid vaccine providers stop using J&J’s vaccine “for the time being” while the FDA and the CDC complete their review.

Ohio Gov. Mike DeWine and top health officials in his state issued a similar advisory.

Massachusetts’ Department of Public Health notified all vaccine providers in the state to stop administering the J&J vaccine, “effective immediately.”

The other states are Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, North Carolina, Rhode Island, South Dakota, Texas, Utah and West Virginia.” (F)

“Gov. Gretchen Whitmer and state health officials learned of the federal request for a pause at the same time as the general public. The state will follow the advice of medical professionals and stop the use of the Johnson & Johnson vaccine while the investigation is underway.

“More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and these adverse events appear to be extremely rare. However, out of an abundance of caution, we are following recommendations from FDA and CDC and pausing the use of the Johnson & Johnson vaccine in Michigan,” said Dr. Joneigh Khaldun, the state’s chief medical executive, in a statement.

“As we learn more about this from our federal partners, we will update vaccine providers and Michiganders across the state. We encourage everyone to continue making appointments to be vaccinated with the safe and effective Pfizer and Moderna COVID-19 vaccines at this time.”

It couldn’t come at a worse time for Michigan, which is in the throes of the most severe COVID-19 outbreak in the nation. Whitmer has repeatedly asked the federal government to surge more vaccines to the state, where the per-capita COVID-19 case rate hit a seven-day average of 510.5 cases per 100,000 people Tuesday, according to the U.S. Centers for Disease Control & Prevention.” (G)

“The vaccine’s shelving has the governor doubling down on calls to President Joe Biden’s administration to deploy more vaccines to hot spots like Michigan. The government has sent more vaccination resources to the state, but not vaccines.

“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,” Bobby Leddy, press secretary for the governor, told Detroit Free Press. “Gov. Whitmer will continue fighting for the vaccines we need to protect Michiganders, so we can get back to normal as soon as possible.”” (H)

“Michigan cannot rely on COVID-19 vaccinations alone to rein in rising COVID-19 cases and hospitalizations in the state, CDC Director Rochelle Walensky, MD, said during an April 12 news briefing.

Dr. Walensky said Michigan should enact shutdown measures to help flatten the curve and emphasized the importance of social distancing, testing and contact-tracing.

“When you have an acute situation, an extraordinary number of cases like we have in Michigan, the answer is not necessarily to give vaccine[s],” she said during the briefing. “The answer to that is to really close things down, to go back to our basics.”

She said the positive effects from vaccinations are often not seen in areas experiencing serious COVID-19 outbreaks for two to six weeks.

“I think if we tried to vaccinate our way out of what is happening in Michigan, we would be disappointed that it took so long for the vaccine to work, to actually have the impact,” she said.” (I)

“The suspension “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 U.S. to date,” Jeff Zients, White House COVID-19 response coordinator, said in a statement.

“Based on actions taken by the president earlier this year, the U.S. has secured enough Pfizer  (PFE) – Get Report and Moderna  (MRNA) – Get Report doses for 300 million Americans.”

Further, “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,” Zients 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.”

The White House is “working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.”” (J)

“The emergence of possible safety issues with the Johnson & Johnson Covid-19 vaccine is certainly unwelcome news, but it is far too early for either the general public or Wall Street to panic.

U.S. health authorities recommended a pause in the usage of the shot on Tuesday, following reports of severe blood clots in six women who received the shot. About 6.7 million people have received the vaccine so far in the U.S. J&J shares traded lower on Tuesday morning, while other vaccine makers such as Moderna rallied.

While the headline is scary, especially in a pandemic setting, there is no direct evidence that the vaccine is responsible for these rare cases. Moreover, such a pause is standard practice when possible safety issues arise in a new medication or vaccine. Regulators are historically quite sensitive to safety issues in vaccines, because they are meant for the entire public. In a nonpandemic setting, several years of safety data is typically collected before bringing a vaccine to market. No surprise then that regulators chose to err on the side of caution. For members of the public who are hesitant to take a vaccine, Tuesday’s action should boost confidence, not erode it.

It is possible that the regulators will allow J&J shots to resume in short order. But if not, the U.S. government has diversified its vaccine options, a decision that is looking increasingly prescient. As such, there is plenty of supply even if the J&J vaccine is mothballed over the long term. There were roughly 39 million doses of Pfizer ’s and Moderna’s vaccines delivered to care providers but yet to be administered as of Tuesday, according to Centers for Disease Control and Prevention data, and more supply is coming online.

There will be new challenges if the J&J vaccine doesn’t rejoin the mix. It requires only one dose, while Pfizer and Moderna each require two. If the J&J shot is no longer an option, the government will need to rethink how to supply rural and other hard-to-reach communities with vaccines.” (K)

“Dr. Scott Gottlieb said Tuesday that people should be “cautious not to overinterpret” the Food and Drug Administration’s decision to temporarily halt use of Johnson & Johnson’s coronavirus vaccine.

“Let’s start with what the FDA didn’t do,” the agency’s former commissioner said on CNBC’s “Squawk Box.” “They didn’t revoke the emergency use authorization. They didn’t order this off the market.”

“This was a requested pause, which is an awkward regulatory step, but I think it reflects the level of caution on their part to not to appear to act too forcefully here,” said Gottlieb, a member of Pfizer’s board of directors.

The agency’s decision, announced Tuesday, came after six women out of millions vaccinated developed blood clots.

Gottlieb predicted that the move will nonetheless “fuel the hesitancy” from some people to get a Covid vaccine.

“Even if there isn’t a causal relationship, even if this is exceedingly rare, I think we’re going to see that whole conversation now get ignited on social media,” he said…

Gottlieb said he believes the J&J vaccine could come back into use “with some additional, perhaps, restrictions on its target populations in the interim while they continue to investigate this.”” (L)

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