POST 155. April 24, 2021. CORONAVIRUS. As the J&J vaccine pause is ended Senator Johnson said “The science tells us that vaccines are 95% effective. So if you have a vaccine, quite honestly, what do you care if your neighbor has one or not? I mean, what is it to you?”

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“People in the United States will once again be able to receive the one-shot Johnson & Johnson coronavirus vaccine after a review by the Centers for Disease Control and Prevention and the Food and Drug Administration. Federal health officials decided to end the pause on the vaccine, ultimately determining that its benefits far outweigh the rare risks of a severe blood clot. Officials said 15 vaccine recipients had developed the blood clot out of 8 million shots that were given. Overall, there were three deaths. State and local officials can now immediately resume giving out any of the vaccine they still have available.

In lifting the pause, the FDA decided against putting any limits on the use of the vaccine by age or gender. But Information about the rare possibility of blood clots will be made available at vaccination sites and the FDA and Johnson & Johnson will update the vaccine’s label so that it mentions the rare risk of blood clots. The label specifies that “most cases” have occurred in women between 18 and 49 years old. European regulators earlier in the week had come to the same decision that the risk was rare enough to allow the vaccine to be administered.” (G)

“Johnson & Johnson’s COVID vaccine will be made available to the public again, ending an 11-day pause initiated after a rare blood clotting disorder was associated with the shot.

The Food and Drug Administration and Centers for Disease Control and Prevention determined the benefits of the J&J vaccine outweighed the risks of keeping it off the market. Out of nearly 8 million who received the vaccine, 15 people have developed the condition and three have died.

The two agencies held a joint news conference Friday evening to announce their decision to allow distribution of the J&J vaccine to resume.

“Both agencies have full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years and older,” said Dr. Janet Woodcock, the FDA’s acting commissioner.

The J&J vaccine should be available almost immediately, “by tomorrow morning even,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Everyone who receives the shot should receive an information sheet mentioning the rare clotting problem and the symptoms to look out for, officials said. Providers also will be given information about the condition and the appropriate treatment for managing it.

The rare condition involves a combination of blood clots, many in unusual locations such as the brain or abdomen, and low levels of platelets, which help wounds heal. It has been dubbed thrombosis with thrombocytopenia syndrome or TTS.

The unusual side effect, seen six to 14 days after receiving the J&J vaccine, seems to most often strike women under age 50.

The effect has not been seen with the two other vaccines authorized for use in the U.S., by Pfizer-BioNTech and Moderna, which have so far been given to about 130 million Americans.

Earlier Friday, a CDC advisory committee voted to resume distribution of the vaccine…

Resuming the use of the J&J vaccine in the United States would prevent 1,435 deaths from COVID-19 and 2,236 admissions to hospital intensive care units, according to a CDC analysis. It could cause approximately 24 cases of TTS, a CDC staffer said…

Women should be aware of this rare side effect, but if they’re unlikely to come back for a second dose, then they’re far better off getting the J&J than getting a single shot of Moderna or Pfizer-BioNTech, said Dr. Paul Offit, a pediatrician and head of the Vaccine Education Center at Children’s Hospital of Philadelphia.”  (A)

“ACIP members heard from Tom Shimabukuro, MD, MPH, MBA, the deputy director of the Immunization Safety Office at the CDC, who shared that the agency had detected a total of 15 TTS cases, including 3 fatalities, up from 6 when the pause was first instated. The cases had been detected using the Vaccine Adverse Event Reporting System (VAERS).

“TTS is rare but clinically serious and potentially life threatening and a potentially life threatening adverse event that has been observed in association with the Janssen COVID-19 vaccine,” Shimabukuro said.

All 15 of the cases were women, and all but 2 were under the age of 50. Seven of the 16 cases were in women ages 30 to 39. As of Apr 21, Shimabukuro said the CDC was investigating less than 10 additional possible cases.

Seven of the 15 cases were in obese women, and two women were taking oral contraceptives. None had blood clotting disorders.

Of the 15 cases, 3 women died, 5 were recovered or recovering at home, and 7 remained hospitalized, including 4 in the intensive care unit. All women experienced symptom onset no sooner than 6 days post-vaccination, but no later than day 15, and all reported headache, fatigue, and abdominal pain.

Using the data that’s been collected, Shimabukuro said the risk of TTS from the J&J vaccine would be 7 TTS cases per 1 million doses administered to women ages 18 to 49. The risk for women older than 50 would be .9 per 1 million doses.

Shimabukuro said no TTS has been documented in recipients of the Moderna or Pfizer vaccines, the two mRNA vaccines authorized for COVID-19 in the United States…

Those who were in favor of lifting the pause said the 10-day window had allowed clinicians to understand the threat of TTS and improve clinical outcomes in patients. They also cautioned that most vaccination sites do not offer a choice of vaccines, but rather have one option for adult recipients.

In the end, the group decided to fully recommend the vaccine for use in all adults over the age of 18. Those who voted against lifting the pause argued the vaccine should contain patient warning language for women under the age of 50.

J&J said the company had agreed on warning language with the FDA, which will say the vaccine has, in rare instances, caused TSS in women under the age of 50.” (B)

“Specialists say the warning isn’t just a regulatory maneuver to please lawyers or to make clear the benefits outweigh the one-in-a-million risk. Instead, despite the disruption caused by the pause, there has been one clear public health benefit: Doctors are now aware of this rare complication, and how best to treat it.

“[The pause] has brought the condition to public and broader scientific attention,” said Dr. Laura Finn, director of hematology and bone marrow transplants at Ochsner Health.

The handful of initial cases were discovered when entered into the Department of Health and Human Services’ national Vaccine Adverse Event Reporting System database. They were investigated rapidly and revealed that if you get the J&J shot, you should be aware of the symptoms. Doctors will also be on alert for how to treat this uncommon disorder and, perhaps, just as importantly how not to treat it.

“This is a treatable condition if you recognize it right away,” Dr. Francis Collins, director of the National Institutes of Health, told “Good Morning America” Friday prior to the recommendation. “One of the reasons I think it’s been good to have this pause is to get everybody apprised of that so that all physicians know this is something to watch out for and can be prepared to treat it appropriately if it should happen again in the future.”

The pause will allow the CDC to offer recommendations and guidelines for doctors and patients, according to Dr. Simone Wildes, an infectious disease specialist at South Shore Health in Massachusetts.

Crucially, doctors have already been warned not to use a common blood thinner called heparin, which might accelerate the problem.

“Until we have a full grasp on this interplay of the vaccine, the blood system and anticoagulation, it’s best to avoid heparin when treating blood clots possibly related to a COVID-19 vaccine and treat with alternative anticoagulation medications and possibly IVIG (intravenous immunoglobulin) instead,” Finn told ABC News.

Meanwhile, anyone suspected of having a rare blood clot can be given a blood test screen for PF4 enzyme-linked immunosorbent, and consult with a hematologist that specializes in these types of clotting events.

Patients who get the J&J vaccine now know that the symptoms to watch out for are different than typical post-vaccine discomfort like a sore arm or flu-like symptoms that come on within 48 hours after the injection and usually go away within days.

The more rare, but concerning clots seem to come on within six to 15 days after injection and may include a persistent headache, a full-body rash, swelling, abdominal pain, leg pain and or shortness of breath. These are the symptoms for which you should contact your doctor immediately.

This warning is meant to empower patients and health care workers alike, because although the risks from the vaccine are extremely rare, the risk of complications from COVID-19 are significant.

“The risk of thrombosis with COVID-19 infection far outweighs the risk with any of the vaccines,” said Dr. Carol Gonsalves, a thrombosis expert and associate professor of medicine at the University of Ottawa. “It is in our best interest for personal safety but also our civic duty to be vaccinated.”” (C)

“Blood clots are formed by platelets, which bind together to form a clot, and typically a lot of them are needed to do that. The clots seen with the Johnson & Johnson vaccine formed even in patients who had low platelet counts in their bloodstream. That combination is unusual. Typically, when you have really low platelet counts—a condition called thrombocytopenia—you actually have problems with being able to form clots, and you can develop ongoing bleeding that is hard to stop. Furthermore, we’re seeing this phenomenon of clots forming in serious places such as the brain, the lungs, the legs or the abdomen, despite the fact that platelet counts are really low. That’s a very unique phenomenon. The closest thing we’ve seen is a rare condition called heparin-induced thrombocytopenia (HIT)…

What are the symptoms of these blood clots in people who have had the Johnson & Johnson vaccine?

They are different than some of the symptoms people experience right after getting their vaccination, such as fatigue, soreness at the injection site or joint aches. These sorts of things are common, they appear shortly after the vaccination, and they usually go away after about three to five days. The symptoms related to the blood clots tend to appear about a week or two after the vaccination and then continue to worsen. A headache that won’t go away is one symptom. Now, if you’ve just exerted yourself by going for a run or gardening in the sun on a hot day, you might have a headache, fatigue, leg or abdomen pain, or shortness of breath, but if you sit in a cool spot and drink some water, these will probably go away. But if you are experiencing these symptoms, and they continue to get worse despite the fact that you’re doing things that would normally make you feel better, that would be more concerning.

We’re not precisely sure yet, but it sounds like it should not be heparin because of the risk of HIT. There are similar, more expensive blood-thinner medications that may be able to treat these blood clots. An April 12 study in the BMJ recommended the use of non-heparin anticoagulants along with immunoglobulins—antibodies produced by white blood cells—to treat vaccine-induced clotting.

We don’t know for sure. But our leading hypothesis is that they might be associated with this antibody against the protein platelet factor four, PF4 for short. That antibody seems to be implicated in the AstraZeneca clots and also is the mechanism for heparin-induced thrombotic thrombocytopenia, so the evidence all seems to be pointing in the same direction. HITT Is definitively linked to that antibody. And we have some evidence that it may be implicated in the AstraZeneca and Johnson & Johnson clotting cases. Hopefully, as we get more evidence, it will make us more confident in that mechanism.” (D)

“Lifting the pause will allow states to restart vaccination efforts among hard-to-reach populations like rural Americans, migrants and elderly people who have difficulty leaving their homes. Their access to the vaccine had been hampered by the suspension, which left roughly 10 million doses sitting on shelves.

In Wisconsin, officials said they intended to begin using their Johnson & Johnson doses as soon as possible.

“We have also heard from a number of vaccinators who say that there are lots of people who don’t like needles,” said Julie Willems Van Dijk, the deputy secretary of the state health department. “They just want to get the vaccine that requires them to have one shot versus two shots.”

Dr. Rochelle P. Walensky, the C.D.C. director, said governors in a number of states had expressed intense interest in resuming use of the shots.

“They wondered why we had paused, and they were anxious to have this back, have an opportunity for a single-dose vaccine, for a one-and-done possibility,” she said.

About 135.8 million people in the United States have received at least one shot of a coronavirus vaccine. But daily doses have fallen by almost 13 percent since last week, from a peak of 3.38 million daily doses on average to about 2.95 million.

It is difficult to say what is driving the decrease. Even before use of the Johnson & Johnson vaccine was paused, shipments had dipped because of a factory error that had ruined millions of doses…

Dr. Walensky said the federal government planned to emphasize the vaccine’s safety to Americans who might be hesitant to take it after the pause.

“We have to do extraordinary outreach to clinicians, as we have been doing this past week,” she said. “We already have plans to start that on Monday, to public health officials. And then we have to do extraordinary outreach to patients, to meet people where they’re at, to educate them.”…

“As we did this intensive scientific evaluation over recent days, I think we became more and more confident about the decision that was made today,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said on Friday…

Top U.S. health officials have stressed that finding the small number of cases of a rare disorder and pausing use of the vaccine demonstrated that safeguards were in place to assess risks and to raise awareness among doctors and hospitals about the unusual symptoms.

“This pause was essential to our ability to inform the public,” Dr. José R. Romero, chairman of the expert panel, the Advisory Committee on Immunization Practices, said on Friday.

A poll released this week from Ipsos/Axios found that the pause itself boosted confidence in federal vaccine monitors, with 81 percent saying that the C.D.C. and the F.D.A. acted appropriately. The sentiment was unusually bipartisan, with 87 percent of Republicans and 91 percent of Democrats sharing that view.

Measuring the impact of the Johnson & Johnson pause is tricky, said  Liz Hamel, vice president of public opinion and research survey at the Kaiser Family Foundation. “You don’t know what the trajectory of the vaccine uptake would have been in the absence of this pause,” she said.

The biggest challenge ahead, she noted, will be the creation of vaccine-confidence messages that resonate with the public. “We don’t know whether it has increased hesitancy among women in particular,” she said.” (E)

“Sen. Ron Johnson on Thursday downplayed the urgency of vaccinating all Americans against Covid-19, putting the controversial Wisconsin Republican at odds with public health guidance aimed at easing the ongoing pandemic.

“The science tells us that vaccines are 95% effective. So if you have a vaccine, quite honestly, what do you care if your neighbor has one or not? I mean, what is it to you?” Johnson said in an interview with conservative radio host Vicki McKenna.

“You got a vaccine, and science is telling you it’s very, very effective. So why is this big push to make sure everybody gets a vaccine?” Johnson asked.

Johnson’s comments come as all states expanded their updated Covid-19 vaccine eligibility guidelines this week, opening up vaccinations to all Americans 16 years of age and older, and as the country’s leading medical experts urge all Americans to get a vaccine as soon as possible. Both President Joe Biden and Senate Minority Leader Mitch McConnell have stressed the importance of getting vaccinated and have encouraged Americans to do so.

In the McKenna interview, however, Johnson said he is skeptical of the “big push” to vaccinate all Americans.

“From my standpoint, because it’s not a fully approved vaccine, I think we probably should have limited the distribution to the vulnerable. To people that really aren’t, you know, for the very young, I see no reason to be pushing vaccines on people,” Johnson said.

Asked by CNN on Friday if he believed every American over the age of 16 should receive the vaccine, Johnson would not directly answer the question and instead insisted that he favored Americans making their own decisions about whether to get vaccinated.

“I believe government’s role (and therefore my role) is to help ensure transparency so that people have as much information as possible to make an informed decision for themselves,” Johnson said in a statement. “It is a legitimate question as to whether people at very low risk of suffering serious illness from Covid, particularly the young and healthy, should be encouraged to take a vaccine that is being administered under an Emergency Use Authorization — in other words, before it has been fully tested and fully approved.”

However, Johnson’s caution about the emergency use authorization is misleading. Both the Pfizer/BioNTech and Moderna vaccines — the two current US vaccination options — received emergency use authorization from the US Food and Drug Administration in December. For Pfizer/BioNTech, that includes everyone over the age of 16, and for Moderna, everyone who is 18 and older.”  (F)

“After the Center for Disease Control signed off on the use of the Johnson & Johnson vaccine late Friday afternoon, Governor Andrew Cuomo said administration of the single-shot COVID vaccine will resume at all state-run sites ‘effective immediately.’

In a statement sent by the Governor Saturday morning, he said the following…

“World-renowned public health experts from the federal government and our own independent state task force have reviewed the data and reaffirmed that the use of the Johnson & Johnson vaccine can resume. The state of New York will resume administration of this vaccine at all of our state-run sites effective immediately. The vaccine is the weapon that will win the war against COVID and allow everyone to resume normalcy, and we have three proven vaccines at our disposal. I urge every New Yorker to take whichever one is available to them first. The sooner we all get vaccinated, the sooner we can put the long COVID nightmare behind us once and for all.” (H)

“R.I. Department of Health spokesperson Joseph Wendelken said Saturday the state will wait until next week to make a decision, adding Rhode Island has enough vaccine doses currently available that operations will not be disrupted without it.

“We only have a limited amount of Johnston & Johnson vaccine on-hand right now, and we would not expect another shipment for two or three weeks anyway,” Wendelken said. “On top of that, we have been getting more Moderna and Pfizer vaccine. For those reasons, this pause is not significantly impacting our current operations.”

The U.S. Centers for Disease Control and Prevention and the FDA ended a pause that began April 13 when federal health officials decided to investigate six out of nearly 7 million J&J vaccine recipients who reported severe and unusual blood clots. In an announcement Friday, federal regulators said use could resume with an updated label that warned of blood-clot risks.

Prior to the announcement, Rhode Island medical director Dr. James McDonald told 12 News the state would make an independent decision about whether to proceed with the vaccine regardless.

“Rhode Island is going to look at the data, look at the recommendations and make a customized recommendation for you, because we’re your doctor, Rhode Island, and we need to make sure what we have is good for you,” he said.

The decision to wait differs from Massachusetts and Connecticut, where state health officials almost immediately directed their vaccinating partners to resume use of the single-dose regimen.” (I)

“Friday’s vote by an advisory committee to the Centers for Disease and Control Prevention to resume administering the Johnson & Johnson coronavirus vaccine was the right decision, but with a serious mistake: There should be an explicit warning against the vaccine’s use in women under the age of 50.

I’m in this group. I’m also a participant in the Johnson & Johnson clinical trial who was told that I’d received the placebo. I then opted to get the Johnson & Johnson vaccine. If I knew then what I know now, I would have chosen the Pfizer or Moderna vaccines instead…

All of this more than justifies the decision to allow the Johnson & Johnson vaccine to be administered once again. In recognition of the risk of TTS, the FDA says that it will add information to the vaccine’s label that alerts people to its signs and symptoms. This is particularly important because the standard treatment for blood clots, administering the blood thinner heparin, is dangerous and can be fatal when there are low platelets.

But this is not enough for the highest-risk group of women under age 50. We are not talking about run-of-the-mill blood clots here. TTS is a severe, life-threatening illness afflicting otherwise healthy, young women. Of the 15 women with TTS after vaccination, seven remain hospitalized, four in critical condition. Three have died.

If there were no alternatives, the benefits of the Johnson & Johnson vaccine would surely outweigh the risks. But that’s not the case. There are two other very safe and effective vaccines that do not pose any risk of TTS. Why not issue a warning that advises women under 50 to receive one of these two other vaccines instead?…

In many parts of the United States, vaccine supply already exceeds demand. People should be empowered to decide which vaccine to get based on the risks, benefits and alternatives. For younger women, the CDC needs to be much more explicit to warn them against the Johnson & Johnson vaccine based on the very rare but very severe risk associated with it — and, critically, to direct them to alternatives that don’t carry this risk at all. After all the emphasis federal health officials put on prioritizing safety, it’s what we should expect from them.” (J)

“Millions of Americans are not getting the second doses of their Covid-19 vaccines, and their ranks are growing.

More than five million people, or nearly 8 percent of those who got a first shot of the Pfizer or Moderna vaccines, have missed their second doses, according to the most recent data from the Centers for Disease Control and Prevention. That is more than double the rate among people who got inoculated in the first several weeks of the nationwide vaccine campaign.

Even as the country wrestles with the problem of millions of people who are wary about getting vaccinated at all, local health authorities are confronting an emerging challenge of ensuring that those who do get inoculated are doing so fully….

Mounting evidence collected in trials and from real-world immunization campaigns points to the peril of people skipping their second doses. Compared with the two-dose regimen, a single shot triggers a weaker immune response and may leave recipients more susceptible to dangerous virus variants. And even though a single dose provides partial protection against Covid, it’s not clear how long that protection will last…

While millions of people have missed their second shots, the overall rates of follow-through, with some 92 percent getting fully vaccinated, are strong by historical standards. Roughly three-quarters of adults come back for their second dose of the vaccine that protects against shingles…

The C.D.C. says there is limited data on the vaccine’s effectiveness when shots are separated by more than six weeks, although some countries, including Britain and Canada, are giving shots with a gap of up to three or four months.” (K)

“Vaccination rates are falling in the United States, despite the spread of highly contagious virus variants that are fueling the country’s alarmingly high caseload.

More than 50,000 new U.S. cases were reported on Saturday, and case rates are similar to those of the second wave last summer. But the average number of vaccine doses being administered each day, which rose for months and peaked at 3.38 million, has now fallen to 2.86 million, its lowest level since March 31, according to data from the Centers for Disease Control and Prevention.

The vaccination rate stopped climbing on April 13, when federal health officials recommended pausing the use of Johnson & Johnson’s vaccine to allow researchers to examine a rare blood-clotting disorder that emerged in six recipients. The Food and Drug Administration lifted the pause on Friday, opting to add a warning about the risk to vaccine labeling…

“We’re entering a new phase” in the country’s vaccination effort, said Dr. Mark McClellan, former commissioner of the Food and Drug Administration and director of the Duke-Margolis Center for Health Policy at Duke University. “In most parts of the country now, there are unfilled vaccination appointments available.”

People who were clamoring for a vaccine have been inoculated, including those who were willing to schedule appointments and wait in long lines at mass vaccination sites, he said.

“Now, it’s more about bringing vaccines to the people who want them but haven’t been able to easily reach the existing sites,” Dr. McClellan said. Walk-in availability, which New York City allowed at city-run sites starting on Friday, could also help vaccinate more people, he said.

Dr. Ashish Jha, the dean of the Brown University School of Public Health, cautioned that it would be “hugely problematic” to broadly denounce those who had yet to get a vaccine — because of indifference or inconvenience — as “resisters.” He said on National Public Radio last week that “there are lots of people who are perfectly happy to get a vaccine but aren’t desperate for it — aren’t convinced that they need it badly.”

Rupali J. Limaye, a professor who studies vaccine behavior at Johns Hopkins Bloomberg School of Public Health, said as vaccinations continued, some might think: “If these other people are vaccinated, why do I need to get it?” but added, “We still need those people to get it to reach herd immunity.”” (L)

“Nearly as soon as vaccines entered clinical trials, wealthy countries began hoarding doses, ensuring that instead of the most vulnerable people everywhere being vaccinated, their residents would be first in line…

There is no shortage of solutions to these problems, but the countries with leverage, clout and excess supply — like the United States — need to act now, in the following ways:

Stop hoarding doses. The richest nations account for 16 percent of the global population but hold 53 percent of all purchased coronavirus doses, according to the Duke-Margolis Center for Health Policy. The United States is projected to have 300 million extra shots by late July, even after accounting for the supply needed to vaccinate the millions of children who are expected to be eligible by the end of the year…

Suspend patents. Nearly 60 nations have petitioned the World Trade Organization to allow countries to temporarily override intellectual property rights for coronavirus-related drugs and vaccines, but so far the measure is languishing. The Biden administration should support this waiver, nudge vaccine makers into voluntary licensing agreements and help build the public-private partnerships needed to bring those agreements to fruition. It should also press companies to offer better deals to the countries trying to secure doses — no more absurd indemnity clauses that protect company profits over human lives.

Share technology and resources. More than eight months ago, the World Health Organization established a technology access pool where companies and countries could share their technology and expertise with governments trying to scale up vaccine manufacturing. The Biden administration signaled its willingness to participate in this effort back in January, but so far, the National Institutes of Health has not joined in, nor have the major vaccine makers. That needs to change quickly…

Build more capacity. Experts say that virtually no vaccines are being manufactured in Africa and that very few are being made in Latin America. The reasons for this shortcoming are complex — a longstanding underinvestment in regional capacity combined with an overreliance on multinational corporations. But the solutions to it are clear. Britain has managed to scale up its manufacturing capacity from just two plants at the start of the pandemic to four now, with two more under construction. There’s no reason the same can’t be done in other countries where the need is even greater. Throwing his weight behind such an effort could be one of Mr. Biden’s most enduring legacies…

No country has cleared every hurdle to vaccinating its entire population. In the United States as much as anywhere, vaccine hesitancy persists and some especially vulnerable populations, like the homebound and unhoused, remain hard to reach even as supply increases. But the world cannot afford to wait for all of those problems to be solved in one country before it works to make coronavirus vaccines more available to all countries. The global vaccine gap is a matter of life and death, and all nations should be working to close it as quickly as possible.”..

Fortunately, there are other promising alternatives in the offing. One of them is based on the same technology used to make the hepatitis B vaccine that’s been in use for nearly 40 years. This coronavirus vaccine is cheap and easy to make, its early clinical data looks good and its creators — Dr. Peter Hotez and Maria Bottazzi at the Baylor College of Medicine — have no plans to patent it. If the United States put half as much weight behind this simple technology as it put behind the mRNA vaccines, manufacturers could churn out billions of doses of it in fairly short order.”  (M)

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