Category: Health

Categories
Health

Open center seats might cut back Covid publicity of maskless passengers

Open middle seats could reduce Covid exposure of maskless passengers

View of the cabin of a Delta flight between Minneapolis and Baltimore on April 25, 2020.

Sebastien Duval | AFP | Getty Images

Passenger exposure to the virus that causes Covid-19 could be reduced by more than half if the center seats on airplanes were left open, according to a new study published Wednesday.

Researchers from the Centers for Disease Control and Prevention and Kansas State University used laboratory models to find that passenger exposure to SARS-CoV-2, which causes Covid-19, could be reduced by between 23% in large and narrow-body aircraft and 57% when airlines leave middle seats open – Even if they don’t wear masks.

The study comes after airlines have spent much of the last year promoting increased on-board cleaning procedures and filtration to reassure travelers worried about flying during the pandemic. The demand for travel has recovered somewhat since then, as more people are vaccinated against Covid-19.

U.S. airlines, including JetBlue Airways and Southwest Airlines, limited the capacity on board their aircraft at the start of the pandemic, but have since abolished the policy, citing hospital-grade filtration and other safety measures to limit the risk of exposure on board. Delta Air Lines plans to end the lockdown of the center seats next month, the last U.S. carrier to make the change. However, capacity caps were halted over the Easter weekend as staff shortages resulted in dozens of flight cancellations.

The researchers’ study did not look at wearing masks on flights, which became an airline and federal government policy during the pandemic.

However, they cited a New Zealand case study which stated that “some of the virus aerosol is given off by an infectious masked passenger, so distancing might still be useful.”

They used a surrogate virus to stand up for SARS-CoV-2 in the air.

Categories
Health

Drug Overdose Deaths Have Surged Through the Pandemic, C.D.C. Says

Drug Overdose Deaths Have Surged During the Pandemic, C.D.C. Says

On Tuesday, several dozen organizations dealing with addiction and other health issues asked Mr. Biden’s Health and Welfare Minister, Xavier Becerra, “to act urgently” to remove the rule that doctors go through a day of training before they get federal permission to prescribe Buprenorphine. Many addiction experts are also calling for the abolition of rules that were already relaxed during the pandemic so that patients do not have to come to clinics or doctor’s offices to receive addiction drugs.

Although many programs offering treatments, naloxone, and other services to drug users resumed, at least in part, as the pandemic dragged on, many others remain closed or severely constrained, especially if they were initially on a tight budget.

Sara Glick, an assistant professor of medicine at the University of Washington, said a survey of about 30 syringe exchange programs she conducted last spring found many were temporarily closed at the start of the pandemic. After reopening, many programs would have limited the services or the number of people they could help.

“With health departments spending so much on Covid, some programs really had to cut their budgets,” she said. “That can mean seeing fewer participants or stopping their HIV and hepatitis C tests.”

At the same time, increases in HIV cases were reported in several regions of the country with high drug use, including two cities in West Virginia, Charleston and Huntington, and Boston. West Virginia lawmakers passed law last week introducing new restrictions on syringe exchange programs that proponents of the programs say would force many to complete.

Mr. Biden’s American Rescue Plan Act provides $ 1.5 billion to prevent and treat substance use disorders and $ 30 million to fund local services that benefit addicts, including syringe exchange programs. The latter is important insofar as federal funds can still largely not be spent on syringes for drug users, but the restriction does not apply to money from the stimulus package, according to the Office for Drug Control Policy. Last week, the government announced that federal funds could now be used to purchase fentanyl rapid test strips, which can be used to check whether drugs have been mixed or cut with fentanyl.

Fentanyl or its analogs have been increasingly detected in counterfeit pills illegally sold as prescription opioids or benzodiazepines – sedatives like Xanax used as anti-anxiety drugs – and meth in particular.

The northeastern states, which have been hardest hit by opioid deaths in recent years, had some of the lowest deaths in the first half of the pandemic year, with the exception of Maine. The states hardest hit included West Virginia and Kentucky, which have long led the way in overdose deaths, as well as western states like California and Arizona, and southern states like Louisiana, South Carolina and Tennessee.

Categories
Health

EMA says advantages of J&J Covid vaccine outweigh dangers

EMA says benefits of J&J Covid vaccine outweigh risks

Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.

SOPA pictures | LightRocket | Getty Images

LONDON – The European Medicines Agency said Wednesday that the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risk of side effects following reports of extremely rare blood clotting.

It comes shortly after the US Food and Drug Administration asked states to temporarily suspend J & J’s use of the vaccine “out of caution” after six cases of bleeding disorder were detected with more than 6.8 million doses of the shot were.

All six cases in the United States occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot. The FDA said one woman died from complications from blood clotting and another was in critical condition.

The European Medicines Agency has currently investigated all reported cases and will decide whether regulatory action is required.

“The EMA is currently accelerating this assessment and is currently expecting to issue a recommendation next week,” the European Medicines Agency said in a statement.

“During the ongoing review, the EMA continues to believe that the vaccine’s benefits in preventing COVID-19 outweigh the risks of side effects.”

South Africa has stopped the launch of the shot while J&J has announced it is “proactively delaying” delivery of its vaccine to Europe, which began last week.

The vaccine was approved in the EU on March 11, but widespread use of the shot has not yet started.

“Right now, these adverse events seem extremely rare,” the FDA said on Tuesday in a joint statement with the Centers for Disease Control and Prevention. “The safety of COVID-19 vaccines is a top priority for the federal government and we take all reports of health problems following COVID-19 vaccination very seriously.”

Last week, the European Medicines Agency said it had identified a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems. AstraZeneca has not received approval for use in the United States

Oxford-AstraZeneca and J&J vaccines work in a similar way, and both use an adenovirus, a common type of virus that typically causes mild cold symptoms.

Categories
Health

A Key Software in Covid Monitoring: The Freedom of Info Act

A Key Tool in Covid Tracking: The Freedom of Information Act

Times Insider explains who we are and what we do, and provides a behind-the-scenes look at how our journalism comes together.

In the first few months of the pandemic, blocks of data in some U.S. communities suggested that the coronavirus infected and killed blacks and Latinos at much higher rates than whites. A team of New York Times reporters who followed outbreaks across the country believed that the collection of detailed national data from the Centers for Disease Control and Prevention could confirm this trend. There was only one problem: the federal government failed to honor reporters’ email request for the data.

To overcome this hurdle, the Times journalists relied on a decade-old law known as the Freedom of Information Act, which gives the public access to records from almost every federal agency, as well as state open record laws. After reporters received the data, their July article provided a detailed picture of 640,000 infections discovered in nearly 1,000 US states. This was the most comprehensive look at coronavirus cases across the country to date. The report also confirmed that blacks and Latinos actually had the worst pandemic.

Over the past year, dozens of Times journalists denied case-related data have filed more than 400 FOIA or other open records requests with government agencies. Many of these inquiries have enabled reporters to track cases, deaths and uncover locations of Covid-19 outbreaks.

“Having good information, solid data, and a respectful view of the agencies to make sure they are transparent leads to better accountability and, hopefully, better policies,” said Mitch Smith, a correspondent for the National Desk covering the Midwest and one of them was the journalists covering the history of racial inequality.

For the most part, submitting a FOIA request is as easy as writing an email. A reporter can submit a form on the federal or equivalent state FOIA website listing the information they are looking for. FOIA officials will then approve or deny the application despite sometimes not making a decision for an extended period of time – weeks, months, sometimes years.

Updated

April 14, 2021, 5:50 a.m. ET

Journalists can appeal after a rejection or after a deadline for deciding or responding to a request. However, if the appeal fails or an agency fails to respond, journalists can get the information, as the Times did to get the CDC data on which its report on racial inequality is based. Sometimes governments try to put up roadblocks in the form of exorbitant fees for conducting a file search, or requiring a reporter to be in the state where the application is being made, or simply requiring a form to be hand-made is delivered to a post office. Again, in some of these cases, the courts may have recourse.

Danielle Ivory, an investigative reporter for The Times, started filing FOIA and Open Records inquiries shortly after joining the Covid tracking team a year ago. Early on, she and her colleagues filed in almost every state for lists of nursing homes with coronavirus cases and deaths. Ms. Ivory estimated that later, when they reported on coronavirus clusters in universities, they sent over 200 requests to at least 150 colleges for case data alone, which helped them track more than 400,000 Covid cases back to universities by 2020.

“A lot of these places didn’t want to divulge the information,” Ms. Ivory said. “Some places told us they thought it was private. We asked for aggregated information so we disagreed with that assessment and in many cases we were right because some of them ultimately gave it to us. “

When prisons and jails started reporting spikes in coronavirus outbreaks last year, open file requests proved helpful in tracking the spread of cases. Danya Issawi, a member of the team that worked on this project, said filing FOIAs in the sheriff’s offices and local health departments has become almost a daily routine, not just about the number of infections and deaths in these Establish facilities, but also for the population of prisons and information for testing.

“All of this data represents real human life and real human consequences in places where numbers are not easily shared,” said Ms. Issawi. “Every time we file a FOIA and get information back, it seems like you’re filling a small gap with someone who might have a loved one or friend.”

As vaccination efforts continue, FOIA inquiries and other open records requests can continue to play an important role in ensuring that governments are transparent. This year alone, journalists have submitted dozens of FOIA inquiries to The Times looking for distribution patterns or problem areas.

However, Ms. Ivory is always optimistic that it will become easier and easier to discover the value of this data as more and more people realize the value of this data. “To be honest, I’m really hopeful,” she said.

Categories
Health

NFL to require vaccinations for workers, with some exceptions

NFL to require vaccinations for employees, with some exceptions

Signs display information for a vaccination center operated by the Santa Clara County Health Department at Levi’s Stadium, home of the San Francisco 49ers NFL soccer team, in Santa Clara, California on February 9, 2021.

Brittany Hosea-Small | Reuters

The NFL is taking its strongest stance yet on getting back to normal from the pandemic.

The message? To be vaccinated.

In a memo received from CNBC, Commissioner Roger Goodell said: “Given the expanded eligibility of vaccines, it is now appropriate to take further steps to educate and promote the availability and uptake of vaccines within the NFL.”

As part of this policy, the league states that all employees except the players (Tier 1 and Tier 2 employees) are expected to be vaccinated unless they have a medical or religious reason not to to do.

Tier 1 employees include trainers and coaches, and Tier 2 employees include managing directors, assistant coaches, and football team members. The memo states that anyone who declines to do so without an approved reason will not have access to the “Football Only” restricted area and will not be able to work with players directly or in close proximity.

While there is currently no vaccination required for players, the memo instructs teams to report the number of employees vaccinated on a weekly basis. It is said that they are actively working with the NFLPA on a number of protocol changes that would apply to clubs if vaccination levels reached a certain threshold that would allow them to relax the protocols put in place due to the pandemic. That would mean they could relax everything from quarantine restrictions to using the cafeteria and locker room.

The league also encourages teams to hold vaccine briefing sessions for players, families and staff to address any concerns.

“Educate your employees and tell them about the work-related benefits of vaccination,” the memo says.

The NFL was also instrumental in ensuring that the general public was vaccinated. At its recent annual meeting, the NFL reported that more than 1.5 million doses had been administered in club facilities. Tuesday’s memo encourages teams to continue using their stadium or training facilities to vaccinate employees, players and their families through “vaccination days” or the like.

“The overwhelming consensus among medical professionals and public health professionals is that the most effective way for someone to avoid the risk of contracting Covid-19 – and the risk of contracting others – is to get vaccinated,” the memo concludes .

Categories
Health

Pause in Vaccinations Results in Canceled Appointments Throughout States

Pause in Vaccinations Leads to Canceled Appointments Across States

The Albany County Health Department in New York said it would be providing doses of Pfizer for a Johnson & Johnson clinic at a local university on Tuesday. The Detroit Chief Public Health Officer said people who had appointments for a Johnson & Johnson vaccine at a city-operated location will be able to keep their time and receive a Pfizer or Moderna shot. And New Hampshire officials who had planned to use the Johnson & Johnson vaccine in clinics and for patients in the home country on Tuesday said they would work to find Pfizer or Moderna doses instead.

Updated

April 13, 2021, 10:49 p.m. ET

“This news is not going to slow New Hampshire down,” Governor Chris Sununu said in a statement. “While the federal government has taken a brief hiatus on the J&J vaccine, the state is already working with our partners to ensure they have alternative care of Pfizer or Moderna to continue their efforts today.”

But in some places there was no immediate alternative. In Aurora, Illinois, a mass vaccination clinic scheduled for Tuesday was canceled, leaving 1,000 patients without an appointment. In Riverside County, California, mobile clinics that planned to vaccinate about 400 people in less populous areas on Tuesday have been canceled. And in rural Jefferson County, southeast Iowa, a last-minute Johnson & Johnson clinic aimed at manufacturing workers was scrapped.

“It was so heartbreaking for me,” said Christine Estle, the county nurse, who said she and her colleagues had encouraged the approximately 140 planned people to make appointments at local pharmacies or hospitals.

The Johnson & Johnson vaccine has long been considered key to the country’s vaccination effort because, unlike the two-dose Moderna and Pfizer therapies, it requires only one shot and is easier to store. In cities across the country, public health experts had begun using the vaccine in places where reluctance to get one shot – let alone two – is great.

Class disturbed

Updated March 29, 2021

The latest on how the pandemic is changing education.

“I just want to do whatever I can to ensure that the people who have signed up for appointments still come to them with Pfizer or Moderna,” said Dr. Allison Arwady, the Chicago public health commissioner, feared the hiatus would undermine vaccine confidence and that she had already heard from skeptical patients asking if the other shots were safe.

Dr. Arwady said her department used the Johnson & Johnson vaccine to reach people who would otherwise be unlikely to find one, by offering it in workplaces, churches and even along bus routes.

Categories
Health

Moderna says its shot is 90% efficient 6 months after second dose

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination facility operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021.

Facebook Facebook Logo Log in to Facebook to connect with Mike Segar Reuters

Moderna’s Covid-19 vaccine was more than 90% effective against Covid and more than 95% effective against serious diseases up to six months after the second dose, the company said Tuesday, referring to updated data from its clinical Phase 3 study.

The update brings Moderna one step closer to filing its application for full US approval for its vaccine. Full approval requires a more rigorous review process to show that the shot is safe and effective for its intended use. With full approval, Moderna can begin marketing the recordings directly to consumers and selling them to individuals and private companies in the United States

The new data included Covid-19 cases through April 9 and assessed over 900 cases, including more than 100 serious cases. The vaccine is currently approved for emergency use by the Food and Drug Administration for those aged 18 and over. The authority can revoke the emergency permit (EUA) at any time. Moderna only submitted safety data to the EEA for two months. The FDA typically takes six months for full approval.

The company said its results are preliminary. Moderna announced that updated data on effectiveness against asymptomatic infections and antibody persistence will be released later this year.

The new data comes from a study published in the New England Journal of Medicine that showed that antibodies induced by the Moderna vaccine were still present six months after the second dose. It also comes after Pfizer said earlier this month that its vaccine, which uses technology similar to Moderna’s, was also shown to be highly effective six months after the second dose.

Dr. Isaac Bogoch, an infectious disease specialist who served on various drug data and safety monitoring boards, described Moderna’s update as “amazing news” and is pleased to hear that both mRNA vaccines are highly effective after six months.

“I think it’s fair to estimate that both will have decent effectiveness over many months,” he said.

Moderna is still evaluating its vaccine in people aged 17 and younger.

The company announced Tuesday that its study testing the vaccine in adolescents ages 12 to 17 is now fully enrolled and has approximately 3,000 participants in the United States

Participants are currently enrolling in his study, which is testing the vaccine in children aged 6 months to 11 years. It is expected that 6,750 healthy pediatric participants will be enrolled in the US and Canada. As in Pfizer’s study, children first receive a low dose of the vaccine before gradually moving on to higher doses.

Categories
Health

J&J Vaccine and Blood Clots: A Danger, if It Exists, Is Tiny

J&J Vaccine and Blood Clots: A Risk, if It Exists, Is Tiny

On Tuesday morning, U.S. health officials recommended a break in using Johnson & Johnson’s Covid-19 vaccine while examining six reports of blood clots in women ages 18 to 48. One has died, another is in critical condition in the hospital.

As of Monday, 6.8 million people in the United States had received the vaccine with no other serious side effects reported.

Experts are yet to determine to what extent the vaccine may be responsible for the clots. However, the investigation follows action by European regulators who concluded that a vaccine made by AstraZeneca may also be the cause of a similar, extremely rare, coagulation disorder.

US and European public health experts have emphasized that for most people, the benefits of Covid vaccines far outweigh the risks.

Several countries in Europe last week restricted the use of the AstraZeneca-Oxford vaccine to older adults due to the rare occurrence of a blood disorder in younger people. The AstraZeneca vaccine was not approved in the United States.

Fewer than one in a million J&J vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.

The FDA recommends people who have received the Johnson & Johnson vaccine within the past three weeks to see their doctor if they have severe headache, abdominal pain, leg pain, or difficulty breathing. Doctors who see people with these symptoms, especially if the patients are young women, should ask if they have recently had a Covid shot, said Dr. Anthony Fauci, senior scientific advisor to the Biden administration, at a press conference Tuesday.

People shouldn’t worry about mild headaches and flu-like symptoms for the first few days after vaccination. These are common, harmless side effects caused by the immune system’s defense against the coronavirus.

For people who got the vaccine a month or two ago, the blood clot problem means “nothing,” said Dr. Fauci. The six cases occurred within a “fairly narrow window” of six to 13 days after people got the shot, he said.

During clinical trials and after the widespread use of vaccines, experts track all of the medical problems that arise in people who receive them. If an unusually large number of cases arise, regulators may decide to stop a study or stop using a vaccine for further investigation.

Breaks are frequent, and tests usually show that the medical problems were incidental. If the investigation reveals that a vaccine poses a risk, regulators can write new guidance on who should or should not receive it. The break also gives them time to advise doctors on how to recognize and treat the disease.

If so, the Food and Drug Administration and Centers for Disease Control and Prevention recommend a break States have already followed the advice of the agencies. Companies that are temporarily discontinuing use of the vaccine include CVS Health and Walgreens.

In a press conference Tuesday, federal officials said the government review would likely only take a few days. A CDC panel is expected to discuss the issue at a meeting on Wednesday.

Six women in the United States who received the Johnson & Johnson vaccine developed a rare blood clot disorder within about two weeks of being vaccinated. In people with this condition called cerebral venous sinus thrombosis, clots form in veins that drain blood from the brain. The results are “stroke-like,” said Dr. Anne Schuchat from the CDC.

Researchers studying a very similar disorder in AstraZeneca recipients in Europe say it appears to be caused by an intense immune system response to the vaccine, which makes antibodies that activate platelets, a blood component that helps to form normal blood clots in the Contributes to wound repair. In addition to clots, abnormal bleeding occurs. European researchers have named the disorder identified there as “vaccine-induced immune thrombotic thrombocytopenia”.

Dr. FDA’s Peter Marks said it was the unusual combination of clotting and bleeding that set a red flag for regulators as a possible safety signal.

So far, researchers have failed to find a way to predict who will develop the disorder and have not identified an underlying condition that could indicate a susceptibility.

Updated

April 13, 2021, 5:17 p.m. ET

Dr. Fauci said if scientists could identify a common core trait among the women who developed the blood clots, it could help identify who is at risk and allow regulators to pinpoint categories of people who are not receiving the J&J vaccine should.

A blood clot is a thickened, gelatinous clot of blood that can block blood flow. Clots form in response to injury and can also be caused by many diseases, including cancer and genetic disorders, certain medications, and prolonged sitting or bed rest. Covid itself can cause serious coagulation problems. Clots that form in the legs sometimes break off and travel to the lungs or, rarely, to the brain, where they can be fatal.

In the United States, 300,000 to 600,000 people each year develop blood clots in their lungs, leg veins, or other parts of the body, according to the CDC

Based on this data, approximately 1,000 to 2,000 blood clots occur daily in the US population. With millions of people being vaccinated every day now, some of these clots appear in those who just happened to receive the shots, regardless of the vaccine.

In the UK, about 1 in 1,000 people are affected by a blood clot in a vein each year, according to regulators.

However, the worrying coagulation disorder among vaccine recipients is much rarer and different from typical blood clots. In addition to clotting in the brain – cerebral venous sinus thrombosis for short, or CVST for short – all patients had remarkably low levels of platelets, which made them prone to abnormal bleeding.

On Tuesday, Johnson & Johnson announced that the company was aware of an extremely rare condition involving people with blood clots combined with low platelets in a small number of people who received the vaccine. “In addition, we have examined these cases with the European health authorities,” said the company in its statement. “We made the decision to proactively delay the launch of our vaccine in Europe.”

At the press conference on Tuesday, Dr. Marks from the FDA said the cases are “very, very similar.”

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

Both Johnson & Johnson and AstraZeneca use adenoviruses to transport DNA into human cells and begin the process of creating immunity to the coronavirus. It is not yet known if this technology is causing the problem.

German researchers have speculated that DNA from the vaccine could trigger the immune response in some people. However, the condition is so rare that researchers say patients likely also have an individual biological trait – which is still unknown – that predisposes them to the immune overreaction.

Last month, European regulators began investigating similar cases of cerebral vein thrombosis related to low platelets. They concluded that the disorder was a very rare side effect of the AstraZeneca vaccine. It’s too early to know if Johnson & Johnson’s vaccine is responsible for the same type of rare blood clot.

European regulators had recommended that recipients of the vaccine seek medical help for a number of possible symptoms, including leg swelling, persistent abdominal pain, severe and persistent headache or blurred vision, and tiny spots of blood under the skin outside of the area where the Injection was given was given.

However, these symptoms were so vague that the UK emergency departments almost immediately saw an increase in patients worried they were as they were described.

Still, German researchers say such symptoms need to be followed up in vaccine recipients. Blood tests can detect the antibodies.

Doctors in Germany and Norway have treated patients with blood-thinning drugs to stop the clot from growing and with intravenous immunoglobulin, which can help clear up the misdirected antibodies that are causing the problem.

The researchers there and the US federal health authorities advised against the use of a conventional blood thinner, heparin, on Tuesday and recommended that alternative drugs be chosen instead. The reason is that the disorder is very similar to a rare syndrome caused by heparin and it is possible that heparin could make the situation worse in these patients.

Heparin could “do a lot of damage,” said Dr. Marks.

German researchers have stressed that treatment should start as soon as possible as the condition can worsen quickly.

We do not know yet. The six cases studied in people who received the J&J vaccine all involved women. However, this number is so small that no clear conclusions can be drawn from it.

When asked on Tuesday whether the use of contraception could be a risk factor, US health officials said they knew no connection.

In Europe, it initially appeared that women were at a higher risk of blood clots associated with the AstraZeneca vaccine, although in some cases men who had received the vaccine were affected.

Upon closer inspection, it was found that in some countries more women overall received the vaccine because they were overrepresented among health workers. UK regulators now say they have no evidence as to whether men or women are more likely to be affected by blood clots.

The FDA did not find any similar cases in people who received the Moderna or Pfizer-BioNTech vaccines.

However, decreased platelet counts have been reported in a few patients who received the Moderna, Pfizer-BioNTech and AstraZeneca vaccines. One recipient, a doctor in Florida, died of a cerebral haemorrhage when his platelet counts failed to restore, and others were hospitalized. US health officials have stated that the cases are being investigated, but they have not reported the results of those reviews and have yet to advise that they are linked to the vaccines.

Benjamin Mueller contributed to the reporting.

Categories
Health

Panicked sufferers name medical doctors as Covid vaccine hesitancy rises with J&J blood clot challenge

Panicked patients call doctors as Covid vaccine hesitancy rises with J&J blood clot issue

More Americans are likely to refuse to receive the Covid-19 vaccine from Johnson & Johnson after U.S. health officials said six women developed a rare bleeding disorder with one dead and another in critical condition, experts said for public health and vaccines using CNBC on Tuesday.

The Food and Drug Administration asked states early Tuesday to temporarily stop using J & J’s single-shot vaccine “out of caution” after six women aged 18 to 48 out of the roughly 6.9 million people who received the shot developed blood. A coagulation disorder known as cerebral venous sinus thrombosis, or CVST.

All women developed the condition that occurs when a blood clot forms in the venous sinuses of the brain that prevents blood from flowing back to the heart within about two weeks of receiving the shot from the brain, health officials told reporters on a phone call .

“People who have recently received the vaccine in the past few weeks should be aware if they are looking for symptoms,” said Dr. Anne Schuchat, the deputy chief director of the Centers for Disease Control and Prevention, during a press conference on Tuesday. “If you have received the vaccine and have severe headache, stomach pain, leg pain, or shortness of breath, you should contact your doctor and see a doctor.”

Shortly after the FDA issued the warning, more than a dozen states, as well as some pharmacies, took steps to stop vaccination with J & J’s vaccine. Some replaced scheduled appointments with either the Pfizer or Moderna vaccine. Some doctors say they are already taking calls from worried patients.

People were already skeptical of vaccines before the coronavirus emerged as a new pathogen in China in December 2019, infecting more than 31.2 million Americans and killing at least 562,718 people in just over a year. Warning from U.S. health officials to states is likely to be even more reluctant to take J & J’s shot and the other vaccines, and threatens to hold back the nation’s recovery from the pandemic, health experts told CNBC.

“Unfortunately, this is likely to exacerbate those who are a little hesitant about getting a vaccine,” said Isaac Bogoch, an infectious disease specialist who served on several drug data and safety oversight panels. “Senior public health officials need to continue to be open, honest, transparent, and most importantly, contextualize that this is a low risk.”

According to Dr. Anthony Fauci, President Joe Biden’s chief medical officer, the goal is to vaccinate between 70% and 85% of the US population – or about 232 to 281 million people – to achieve herd immunity and suppress the pandemic.

To date, more than 120 million Americans, or 36% of the total US population, have received at least one dose of a Covid-19 vaccine, according to the CDC. Around 74 million Americans, or 22% of the total US population, are fully vaccinated, according to the CDC. Children under the age of 16 are not yet eligible to shoot in the United States, and some adults are likely to refuse to get a vaccine.

“This puts a wrench in the plans. It will slow down the rollout,” said Dr. Jeffrey Kahn, director of the Berman Institute of Bioethics at Johns Hopkins University. “People will say, ‘I don’t want this, I want one of the others who don’t have this problem,’ even if it’s an extremely rare occurrence.”

Some Americans, especially in black, Hispanic, and rural communities, have already been reluctant to get the J&J vaccine, especially because they found it to be worse than Pfizer and Moderna’s. The highly effective J&J shot, especially against serious illnesses, showed 72% effectiveness in protecting against Covid in the US about a month after inoculation. This is comparable to the effectiveness of Pfizer and Moderna vaccines with two doses of around 95%.

Single-dose vaccines like J & Js were critical to “getting into communities where a two-dose regimen was impractical or even possible,” Kahn said. US health officials used J & J’s vaccine primarily to reach poorer urban and rural areas where residents could not easily get to a vaccination clinic or did not have reliable internet access.

“These communities are also the hardest hit by Covid,” said Kahn. “Interrupting Use of J & J. [is] one stroke to do that effectively and quickly. “

Dr. Stephen Schrantz, who was part of the team leading a J&J vaccine study at the University of Chicago Medicine, said he already had patients who didn’t want the J&J vaccine and said the news would give them more evidence give to say, “See, I told you.”

“I suspect that vaccine adoption and uptake will slow down, there will be a move away from the J&J vaccine even if the CDC and FDA conclude that there is no causal link,” he said. “And as the wearing of masks wears off, there may be more cases like we have in Michigan.”

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors, predicted the move will fuel “the reluctance” of some people to get a Covid vaccine.

“Even if there is no causal link, even if it is extremely rare, we will see that the whole conversation is now ignited on social media,” he told CNBC in an interview.

Dr. Purvi Parikh, an infectious disease allergy and immunology specialist at NYU Langone Health, described the FDA warning Tuesday as a “double-edged sword” and said it would likely raise concerns for already reluctant Americans. She also said she had already received “panic calls” from her own patients about the J&J vaccine.

“But if anything, I would like to repeat again: This only gives me more confidence in our system because these security checks work. Hopefully it will give some people peace of mind,” she added on “Squawk on the Street”. “” “Again, to look at the bigger picture, the benefits still far outweigh the risks of this vaccination.”

Dr. Archana Chatterjee, pediatric infectious disease specialist and member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, echoed Parikh’s remark. She added that there is nothing “unusual” in the way US health officials are addressing the problem.

“This is a normal procedure that occurs,” she said.

“But of course whenever a serious adverse event is reported about a vaccine that raises public concern,” she added. “If you talk about vaccine trust or vaccine reluctance, could it have an impact? It certainly is possible.”

Dr. Paul Offit, another member of the Advisory Committee on Vaccines and Allied Biological Products, hopes Americans will be “rational” about the problem, adding that cases of blood clots seem extremely rare. He noted that convincing people in hard-to-reach communities could be a challenge.

“It should be reassuring to the people that the officials are still looking [at the vaccine], even for rare side effects, “he said.

– CNBC’s Kevin Stankiewicz contributed to this article.

Categories
Health

U.S. Requires Pause on Johnson & Johnson Vaccine After Blood Clotting Instances

U.S. Calls for Pause on Johnson & Johnson Vaccine After Blood Clotting Cases

Dr. Marks said the federal government hadn’t issued an order to suspend the vaccine, adding that health care providers could decide that for a given patient, the benefits of a shot outweigh the risks. “We’re not going to stop this provider from giving the vaccine because it might be right,” he said.

The decision is a new blow for Johnson & Johnson. Late last month, the company discovered that employees at a subcontracted facility in Baltimore had accidentally contaminated a batch of vaccine, forcing the company to throw away the equivalent of 13-15 million cans. That facility would handle the delivery of the vaccine to the US from Johnson & Johnson’s Dutch plants, which were federal certified earlier this year.

FDA certification of the Baltimore facility has now been delayed while inspectors investigate quality control issues and severely reduce the supply of Johnson & Johnson vaccines. The sudden drop in available doses sparked widespread complaints from governors and state health officials who had anticipated much larger deliveries of Johnson & Johnson’s vaccine this week than they did.

States have used the vaccine in a variety of settings, including at mass vaccination sites and on college campuses. The vaccine’s one-shot approach has proven popular, and officials have directed it to temporary, rural, and isolated communities where second-dose follow-up is more complicated.

It is common for regulators to investigate “safety signals” in new vaccines and other medical products. Very often the signals do not turn out to be critical. However, concerns about Johnson & Johnson’s vaccine echoes concerns about AstraZeneca’s vaccine, which European regulators investigated last month after some recipients developed blood clots.

Of 34 million people who received the vaccine in the UK, the European Union and three other countries, 222 had blood clots associated with low platelet levels. The majority of these cases occurred within the first 14 days after vaccination, mainly in women under 60 years of age.

On April 7, the European Medicines Agency, the main regulator, concluded that the disorder is a very rare side effect of the vaccine. Researchers in Germany and Norway published studies on April 9, suggesting that the AstraZeneca vaccine, on very rare occasions, caused people to make antibodies that activated their own platelets.