This adenovirus vaccine from J&J has proven itself extremely effective at preventing serious Covid that results in death. It has also shown increased efficacy in South Africa against their troublesome local strain of coronavirus, the B1.35.1 variant. On top of this, the J&J vaccine is a single shot (no follow-up shot is required) and it doesn’t have to be transported by frozen polar bears. Simple refrigeration suffices.

For poorer third world countries, this far cheaper, easily stored, and transported, single application vaccine is a godsend. Its also considerably cheaper, always an issue in developing countries where healthcare budgets are tight. With all this in mind, the reaction by governments worldwide to the handful of adverse reports and deaths, for both this and the AstraZeneca virus (also an adenovirus vaccine) have been in keeping with the general PR fiasco surrounding Covid. 

An absolute and complete PR fiasco

When determining risk, all vaccines have to pass rigorous safety trials. Over a period of time, often years, deaths will be an inevitable part of the administration of almost every vaccine we manufacture. Patients dying from unusual and isolated reactions to medication are hugely unfortunate but expected and accepted risks. If however, those deaths exceed a previously determined level, set by regulatory authorities on a country by country basis, drugs and vaccines are withdrawn from the market.

America may accept one death in a million as an acceptable risk, where Germany may consider a figure of 1.3 per million acceptable and the UK may draw the line at 0.8 per million. The one constant in all of this is someone, somewhere, will die, particularly with an increase in the number of patients the drug is administered to. An unpleasant, unavoidable, level of risk, made acceptable by the benefit the vaccine or drug confers on the general public. There are no perfect solutions in medicine.

The current risk ratio for the J&J vaccine, based on the 6 reported instances of patients affected by these rare blood clots is around 0.16 people per million. As of the 12th of April, according to the CDC, nearly 7 million J&J vaccines had been administered in the US. Let’s compare this with the risk profile for an individual who is immune-compromised, diabetic, obese, or suffers from any of the risk factors highlighted for developing serious Covid.

As there are no really reliable figures for this, let’s use the following flawed logic. We’ll use the known Covid deaths versus the US total population. That gives you a figure of approximately 1697 people in every million (560 000 deaths, approx population 330 million)that are likely to die from Covid. Now we know that most under 45’s don’t die from covid, deaths are concentrated in the older age groups and in at-risk populations, so realistically, that figure becomes higher. Much higher. You could probably comfortably double or even quadruple it for a more fair risk evaluation.

Compare these odds of dying from Covid to the possibility of dying from a rare blood clotting disease, which, coincidentally may also have proved fatal to these patients were they to contract the natural virus, we don’t know, For an at-risk patient, making an informed decision and exercising their right to choose, that 0.16 in a million queue looks more attractive by the minute.

The same logic can easily be applied to AstraZeneca and I would assume the associated risks would balance out in much the same way they have for Johnson and Johnson. The problem we now face is that none of this matters any longer. Both Johnson & Johnson and AstraZeneca have effectively been sidelined by bungling bureaucracy. Neither vaccine is available and a ‘temporary hold’ is in effect for distribution. In terms of the long-term damage to the public’s perception of the two brands, that is unknown at this stage.

Never before has the light of public scrutiny and accountability shone so brightly on the healthcare industry and its regulators. Like a pack of circling hyenas, the press and public wait, ever hopeful that the FDA, the CDC, or their European cousins will overstep their mark. Anti-vaccination pressure has added to the hysteria and the end result has been kneejerk PR. Reaction instead of action, quickly issued statements and poorly thought-through policies designed to appease fractious minorities, rather than serving the larger public interest.

The AstraZeneca and Johnson & Johnson vaccines are textbook examples of how poor decision-making and public-facing policy can impact and override the healthcare needs of the broader public.

Our regulatory organizations work for all of us, and it is their duty, first and foremost, to ensure all our interests are considered, equitably. 

Identifying possible strategic blunders

A contributing factor to the PR and policy chaos is undoubtedly the much-proclaimed theory of achieving herd immunity at any cost. To this end, everyone needs to be vaccinated. This policy extends to all sectors of the community, children, healthy adults, and the populations identified as being at risk. There were a few glaring flaws in this policy, right from the outset, most notably the fact that between 30–60% of individuals, depending on which country and which news channels you prefer, are vocally opposed to being vaccinated. Whether through mistrust, misinformation or simple vaccine hesitancy, is irrelevant.

Vaccine hesitancy percentages were and are high enough to ensure that achieving herd immunity through vaccination alone was never a viable reality. I raise this issue as it relates directly to risk and accountability. Encouraging/forcing your healthy and younger populations to vaccinate engages a whole new dynamic and it’s one that’s backfired spectacularly on governments. Sadly, the biggest victims have been the vaccines themselves.

The risk ratios I described above are hugely acceptable for individuals that face a real threat from developing serious Covid. In fact, most at-risk populations would probably happily accept even higher ratios without question, only too glad for the opportunity to avoid the life-threatening conditions associated with serious Covid. Not so if you are healthy. Not so if you are really young and healthy. These patients do face a small risk, but that risk profile is in actual fact, unknown and unquantified.

Vaccinate this healthy population and you better ensure your vaccine is foolproof, as you’re potentially exposing a healthy person to the risk of death, however slim that risk may be. Apparently, according to the CDC and FDA, 6 out of 6.8 million is way more risk than they’re willing to go with, particularly as that risk is narrowed to the exact age demographic that can argue they don’t require vaccination. The real victims of this ‘risk assessment policy’ are the at-risk patients and the vaccines.

Were the vaccines designated for the at-risk segments of our population only, we probably wouldn’t be having this conversation right now. People, in general, are averse to the idea of dying and willing to accept an accompanying risk to avoid it.

Rethinking the path forward

Restoring confidence in these vaccines will fall to the media whose track record is at best questionable, each network differing in the narratives they transmit to the public, and the government’s own narrative has become so disjointed as to appear, unreliable to the general public. I watched with interest today as Eric Topol, one of the countries eminent virologists, spoke on CNN, in defense of the Johnson and Johnson vaccine and echoed our sentiments. 

Immediately resume vaccination of the at-risk sectors of our population with the adenovirus vaccines. They are safe. Not foolproof, but safe within expected limits.

It may be time to fundamentally rethink our global vaccination strategy, for a number of reasons. There is an alternate path moving forward that would allow the vaccines to rebuild and repair their tarnished reputations and would address global vaccination disparity, an issue of increasing concern as many countries are yet to begin vaccination. To achieve this we should consider the first crucial flaw in our current system.

Immediately stop vaccinating the naturally immune

We have limited time and limited vaccines to address a global population, that is, almost to a man ad woman, at risk of contracting the SARS-CoV2 virus. Many have already contracted the virus. Our fallible statistics tell us that as of today, we’ve confirmed 138 million via testing. Realistically, actual infection rates are probably far closer to 500 million, with many untested and asymptomatic infections. 

That equates to 500 million spare vaccines, half a billion people we don’t need to vaccinate, they are naturally immune and while we can stand here arguing till the sun goes down about the benefits of vaccinated versus natural immunity, the clock carries on ticking away. Immune is immune, by whatever method. Neither is perfect and either is acceptable. It is also, crucially, 500 million fewer people to add into the herd immunity calculations.

The next logical question this approach raises is how do we tell who is immune and who isn’t? This would require testing at the point of vaccination or possibly offsite. A simple test able to return an immediate result for SARS-CoV2 antibodies. No antibodies, roll up your sleeve. If you’ve natural immunity, smile, thank the nurse, and get on with your day. 

This is a realistic and viable path towards reducing the impact of Covid globally. It will increase vaccine availability and ensure that the at-risk populations we innoculate are really in need of the vaccine, further justifying whatever minimal risk is involved. This is patient-focused medicine on a global scale, allowing us to free up much-needed vaccine stock for third-world countries. We cannot vaccinate the entire American population and expect that countries with no access to vaccines aren’t going to simply re-infect us with new variants.

Adopting this strategy would also have the immediate effect of restoring faith in the vaccination process. No political agendas linked to immunity passports and enforcing vaccination, just policies driven by efficient administration to protect our global populations. With clear, distinct, and transparent policies the public can understand and relate to, everything else will follow. 

Our first steps now are to restore credibility to the two amazing and effective vaccines we have so seriously undermined in the public mind. We can ill afford to be choosy at this point in the pandemic and failure to address this now may very well return to haunt us in the coming months.

April 17. 2021: The risk figures quoted in the original article were in fact incorrect. These have been adjusted now to accurately reflect a risk rate of death from Covid in the general population in the US: 1697 in a million people. Our thanks to Philip Deane for highlighting this glaring error.

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Date of Release: April 13, 2021

The message following is from Christopher M. Zahn, MD, Vice President of Practice Activities for the American College of Obstetricians and Gynecologists (ACOG), and was developed in partnership with Laura E. Riley, MD; Richard Beigi, MD; Denise J. Jamieson, MD, MPH; Brenna L. Hughes, MD, MSc; Geeta Swamy, MD; Linda O’Neal Eckert, MD; and Mark Turrentine, MD, the authors of ACOG’s Practice Advisory on Vaccinating Pregnant and Lactating Patients Against COVID-19. 

“ACOG is aware that the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have put the Johnson & Johnson COVID-19 vaccination program on hold out of an abundance of caution based on a possible safety signal that requires further investigation. To date, six cases of cerebral sinus venous thrombosis (CVST) have been reported among recipients of the Jonson & Johnson vaccine, out of a reported total of 6.8 million doses administered in the United States. The available data on these cases shows that all occurred in women ages 18–48 years. The clinical syndrome includes cerebral venous thrombosis associated with thrombocytopenia occurring 6–13 days post vaccination. 

“This syndrome is similar to the cases reported in Europe associated with AstraZeneca COVID-19 vaccine, which is another adenovirus vector vaccine. “

Because the CDC and the FDA have placed the Johnson & Johnson vaccine program on hold out of an abundance of caution, it is not currently available for anyone, including women of reproductive age. Those who wish to be vaccinated in the interim should be aware that the Pfizer and Moderna COVID-19 vaccines remain available.” 

What Obstetrician–Gynecologists Should Know

“At this time, there is no clear phenotype of women who are more or less likely to experience this rare complication. However, until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna. “Individuals who have been vaccinated with the Johnson & Johnson vaccine within the last 21 days who experience severe headache, abdominal pain, leg pain, or shortness of breath should seek immediate evaluation. They should be certain to communicate that they have received the Johnson & Johnson vaccine to prompt appropriate evaluation. Given the elevated risk for thrombosis experienced by women during pregnancy or the postpartum period and while using birth control pills, evaluation of acute thrombosis is commonly performed in our specialty. Rapid treatment with anticoagulation is the standard; however, this is not the same event and anticoagulation for treatment of CVST is dangerous.” 

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care. Importantly, treatment with heparin is contraindicated in these cases.”

For more information:

1. CDC Health Alert Network on Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
2. Joint CDC and FDA Statement on the Johnson & Johnson COVID-19 Vaccine

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The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients*

Date of Release: Oct. 6, 2020

IRVINE, Calif. /PRNewswire/ — Johnson & Johnson Medical Devices Companies^** today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH^® SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF).^† The approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and demonstrated 80 percent of persistent AF patients experienced clinical success at 15 months after ablation therapy using the THERMOCOOL SMARTTOUCH SF Catheter with the CARTO VISITAG™ Module.^‡1,2 In addition, patients experienced clinically meaningful improvement in quality of life and the study showed significant reduction in healthcare resource utilization post-ablation.^1,2

Atrial fibrillation (AF) is a significant public health issue affecting the health of millions of people and placing a critical burden on healthcare systems. Persistent AF is defined as continuous AF that lasts for more than seven days and up to one year. The management of persistent AF aims to prevent AF recurrence and associated disabilities while reducing side effects from treatment.

“Every patient and every arrhythmia are unique,” said Dr. Francis Marchlinski***, Director of Electrophysiology, University of Pennsylvania Health System. “This approval and the PRECEPT data provide evidence to support a tailored approach using the CARTO^® 3 System and THERMOCOOL SMARTTOUCH SF Catheter to treat persistent AF patients, who are more at risk for stroke and other complications from their AF.”

The PRECEPT study is the first prospective, multi-center investigational device exemption study designed to evaluate the safety and effectiveness of radiofrequency (RF) catheter ablation in patients with persistent AF, and was conducted using the THERMOCOOL SMARTTOUCH SF Catheter. Results of the PRECEPT study demonstrated 80 percent of persistent AF patients experienced clinical success at 15 months after ablation therapy and 86 percent experienced freedom from repeat procedures at 15 months.³ The CARTO 3 System and THERMOCOOL SMARTTOUCH SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in a more advanced persistent AF patient group (continuous AF > 7 days < 1 year).^*2

Radiofrequency ablation with the THERMOCOOL SMARTTOUCH SF Catheter led to a clinically meaningful improvement in Quality of Life (QOL), as well as a reduction in antiarrhythmic drug (AAD) use, cardioversion and hospitalization in persistent AF patients.^§3

“Persistent AF patients face a higher risk of complications such as stroke, heart failure, and death,” said Uri Yaron, Worldwide President of Biosense Webster, Inc. “This approval and data from the PRECEPT study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients.”

The PRECEPT study enrolled a total of 381 patients with documented symptomatic persistent AF who did not respond or were intolerant of one or more AADs (Class I or III). The study was conducted at 27 sites across the United States and Canada.¹ The primary effectiveness endpoint was freedom from documented recurrence of atrial flutter/atrial tachycardia episodes of 30 seconds or longer and freedom from additional five failure modes: acute procedural failure, use of a non-study catheter, repeat procedures, use of new/higher dose antiarrhythmic drugs, surgical AF ablation.¹ A tailored ablation strategy was used, allowing for pulmonary vein isolation (PVI) and additional left atrial ablations (PVI+) at the operator’s discretion based on the patient’s disease state.¹ The study resulted in a 4.7 percent primary adverse event (PAE) rate which is comparable to PAE rates reported in paroxysmal AF studies using CF-sensing RF catheters.^4,5,6

About Atrial Fibrillation

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia (abnormal heart rhythm) and affects nearly one percent of the population.⁷ During AF, the upper chambers of the heart, the atria, beat rapidly or in an uncontrolled manner, which can feel like a flutter. When the heart beats erratically, it does not pump blood as efficiently as it should. When oxygen is not being properly delivered to all parts of the body, the patient may feel ill or experience other AF symptoms. AF may not be life-threatening; however, it is important to seek treatment to control the symptoms, as AF can lead to stroke.

As with any medical treatment, individual results may vary. Only a cardiologist or electrophysiologist can determine whether ablation is an appropriate course of treatment. There are potential risks including bleeding, swelling or bruising at the catheter insertion site, and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); heart attack; or death. These risks need to be discussed with your doctor and recovery takes time. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.

About Biosense Webster, Inc.

Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of the Johnson & Johnson Family of Companies, the specialized medical-technology company is headquartered in Irvine, Calif., and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at www.biosensewebster.com and connect on LinkedIn and Twitter.

About Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding THERMOCOOL SMARTTOUCH^® SF Ablation Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc., the Johnson & Johnson Medical Devices Companies, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*In a prospective, multicenter study (PRECEPT, n=333) protocol defined primary effectiveness was the freedom from documented AF/AT/AFL recurrence ≥30 s.
^† The THERMOCOOL SMARTOUCH® SF Catheter is indicated for drug refractory recurrent symptomatic persistent atrial fibrillation (AF) (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.
^‡ In a prospective, multicenter study (PRECEPT, n=333) where clinical success is defined as freedom from documented symptomatic AF/AT/AFL recurrence.
^§ In a prospective, multicenter study (PRECEPT, n=333), improvements based on mean AFEQT composite and subscores seen from 6– 15 months, exceeding Clinically Important Difference (±5 points). Class I/III AAD use was reduced from 97% to 25%, incidence of cardioversion decreased from 62% to 10%, and the 15–month Kaplan–Meier estimate of freedom from hospitalization was 84%.
**Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
***Dr. Marchliniski is a paid consultant to Biosense Webster, Inc.

¹ Mansour M, Calkins H, Osorio J, et al. Persistent atrial fibrillation ablation with a contact force sensing catheter: the prospective multicenter PRECEPT trial. Presented at: Heart Rhythm Society Scientific Session Virtual Meeting; May 2020.
² Mansour M, Calkins H, Osorio J, et al. Persistent Atrial Fibrillation Ablation with Contact Force–Sensing Catheter. J Am Coll Cardiol EP. 2020 Aug, 6 (8) 958-969.
³ Natale A, Calkins H, Osorio J, et al. (2020). Positive Clinical Benefit on Patient Care, Quality of Life and Symptoms After Radiofrequency Ablation with Contact Force in Persistent Atrial Fibrillation: Analyses from PRECEPT. Poster presentation at the European Society of Cardiology Scientific Session, August 29 – September 2, 2020.
⁴ PRECEPT IDE G140102.
⁵ Natale A, Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-656.
⁶ Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace. 2018;20(FI_3):f392-f400.
⁷ Johan E.P. Waktare, MB, ChB, MRCP, Atrial Fibrillation, AHA Journals.org.

© Biosense Webster, Inc. 2020   151997-200904

SOURCE Biosense Webster, Inc.

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