CME INDIA Presentation by Admin.
“This is not the time for vaccine hesitancy, mass vaccination campaign should continue with confidence. Healthcare professionals should stay informed of evolving evidence and encourage communities for taking up vaccine if and when available”- Dr Atul Kalhan, UK.
One video from a very learned and eminent cardiologist of Delhi has become viral stating that per day one death might be correlated with Covid vaccine. It says that reactogenic vaccine can trigger the rupture of vulnerable plaque in coronary arteries. It says that even without report of post mortem, such heart attack cases are said to be not related to vaccine induced clots. Video says to adopt a simple solution – to do a 100 Rs test-CRP and if it is more than 1, then get ready to lower it first. Video starts with an incident which occurred at Mumbai and got published in Hindustan Times Clip – PUBLISHED ON MAR 11, 2021 11:32 PM IST.
Dr H D Sharan, Cardiologist, Ranchi:
This amounts to rumour mongering.
- We have many politician scientists amongst us whose main effort these days are to find newer methods to remain in news. His allegations in this video mainly are:
- On an average, one patient is dying every day from Coronary Artery Thrombosis following vaccination in India.
- That the administration and media immediately declare these deaths as not related to vaccine without getting a post mortem done.
- That this thrombosis is caused by the enhanced inflammatory response caused by the vaccine.
- That those who are in high inflammatory state as depicted by the high CRP should avoid taking vaccine.
- Therefore, everyone must get the CRP test done before taking the vaccine.
- Is this lack of knowledge or an effort to sabotage the vaccination program by increasing vaccination hesitancy? Nothing can be more over simplification of scientific facts than saying that CRP of more than 1 will predict thrombus formation.
- The medical community and ICMR should strongly condemn this video. This amounts to rumour mongering.
CME INDIA Discussion
Dr Atul Kalhan, Internist, Visiting Professor at University of South Wales, Cardiff, Wales, United Kingdom:
I am a bit perplexed by the message
- I am a bit perplexed by the message being delivered in this video.
- there is no conclusive signal so far regarding vaccines and increased risk of sudden cardiac or Embolic event related mortality.
- CRP as a predictor of coronary event is gross over simplification (and inaccurate twist) of scientific facts.
- we should be promoting vaccines rather than seeding doubts in minds.
- I am going to challenge it over social media; vaccine hesitancy would not be good for community.
- Such misinformation would not help any one
- This video was forwarded to me by an elderly and anxious relative back home. I am not aware about the credentials of the speaker and assume he is knowledgeable and learned. But felt the way message has been delivered seemed like advancement of CRP measurement prior to vaccination and fear mongering. Words of a senior medical colleague have far reaching impact and need to be chosen judiciously specially when we are living amidst pandemic (sans limited ability of masses to tease out science from quasi fiction).
- The AZ vaccine has so far been given to 20 million people in UK and Europe Economic Area (EEA). There have been 7 cases of disseminated intravascular coagulation (DIC) and 20 cases (13 in UK and 7 in EEA) of cerebral venous sinus thrombosis (CVST) which have been reported so far. The causal link between CVST/DIC is being analysed and not proven yet. The European Medicine Agency (EMA) has reported no increased risk of thromboembolic events with AZ vaccine use and clearly the benefit of the therapy in preventing serious covid infection outweighs possible rare (and yet not proven) risks. This is not the time for vaccine hesitancy, mass vaccination campaign should continue with confidence. Healthcare professionals should stay informed of evolving evidence and encourage communities for taking up vaccine if and when available.
Dr Mahadev Desai, Senior Physician, Ahmedabad:
Every effort should be made to allay the fear and anxiety of general public.
- Vaccination is the only way to stop this pandemic, and every effort should be made to allay the fear and anxiety of general public. One casual or ill-conceived comment will be blown out of proportion by “breaking news hungry” media and will do irreversible damage. Let us all be more sensible in sending the right message and refrain from making controversial, or unproven provocative statements. Regarding the video, lesser we discuss, the better.
Dr Varun Kumar, DM, Card., Ranchi:
Only raised hs- CRP can’t predict future development of Acute coronary syndrome
- Looks like he just made statements or acts to keep himself in limelight.
- Perhaps what he was trying to say is about vascular inflammation which is quite well known in pathology of ACS.
- For that purpose, hs-CRP is tested & a value of more than 2 is taken as significant, but only raised has- CRP can’t predict future development of ACS…
- If you test hs-CRP in general population then you well get the high level quite frequently, in my own study of hs-CRP in AMI patients, I found 44% of patients had normal HS-CRP. So, just saying that those with raised CRP should not receive vaccine sounds absurd, particularly when you don’t have any proof.
- Everyday lots of people die of sudden cardiac arrest and here we are giving vaccine to everybody so, it could be just incidental observation.
- Lastly sudden cardiac arrest just doesn’t mean AMI, there are lots of other causes of sudden cardiac arrest, but definitely those who are dying post vaccination their autopsy must be done to ascertain the cause of death.
Dr Deepak Gupta Ranchi DM, Card Pulse Hospital, Ranchi:
- I don’t think cardiovascular events should be linked with vaccine.
- Incidence and prevalence of Cardiovascular disease is so high it will be difficult to directly link to vaccination, but it is good practice to investigate it .
- I also observed two young patients developed Acute MI after 1 week of vaccination in Ranchi.
- CAG done in both patient – 1st patient had LAD, Chronic total occlusion and developed acute Inferior wall MI . Finding suggestive of chronic CAD. 2nd patient also had very strong family history of Prematured CAD. Putting in other way If you immunise all society , does it decrease the incidence of MI and stroke? Not at all.
- I don’t think CRP level will predict anything in this scenario.
Dr Keyur Acharya, intensivist, UK:
Cautious vaccination on fear of this means imminent danger to both Human health and economic recovery
- Many countries in EU suspended use of vaccines over fear of blood clot.
- 13 countries of the EU bloc opted to pause as a ” precautionary measure”. This precautionary principle goes back to 1970s German principle of VORSORGE or foresight based on the belief that society ought to avoid environmental damage by forward planning.
- This ‘vorsorgeprinzip’ (precautionary principle) was developed into law to justify policies to tackle acid rain, global warming. This was adopted by several countries (national environmental policy act, clean water act etc.) and by EU. Essentially “better safe than sorry.”
- Key here has been that one does not need scientific certainty before taking preventive measures.
- Critics of this will say that:
- This is not based on sound science and decision makers are sometimes selective
- No minimum threshold for threshold of scientific uncertainty or plausibility has not been established
- negative consequences of application – technology which could bring advantages could be banned.
- On positive sides this is why GMOs are heavily restricted, chlorine washed chicken is no no in EU.
- Can we apply this in vaccine? Most likely no. It is a distortion of Vorsorge. Benefits are clearly to be seen. Cautious vaccination on fear of this means imminent danger to both Human health and economic recovery. It might instil ” permanent damage” to people’s willingness to take not only COVID vaccines but also other vaccines. Question here is Do you trust science or regulatory agencies?
- This may be the reason (precautions) why they were slow to approve vaccines. They haggled over drug makers liabilities if something goes wrong. US and UK waived this. This slow down approval and procuring.
- Anyway, now they have decided to resume vaccines roll out.
- ” Just in case”/ risk aversion is not always wise strategy!!
Dr Akash Kumar Singh, Internist, Spandan Multispeciality Hospital, Baroda:
The video does its best to confuse the general masses and the suggestions given serve no purpose neither can be implemented in the general public at large.
- I have seen the video voiced by said doctor on https://youtu.be/lwqaDRSmmbI, an honourable and senior member of the maternal fraternity who has been in recent controversies regarding his vaccination earlier (the video was viral all over India).
- Much to my horror, he has come up again with another controversial video on the covid19 vaccination which is timed horribly wrong.
- The entire country is reeling under the COVID19 second wave and a catastrophic epidemic is raging in the country. The country is getting crippled again with the dire consequences of the Covid epidemic and everyone clearly knows that vaccination on a mass level can only salvage the situation.
- It is like fighting a war and not accepting single mortality amongst the soldiers. If you look at deaths in the general population even without vaccination, there are episodes occurring and such incidences will keep happening in the post-vaccination state.
- Some patients who have underlying critical heart disease which has not been properly diagnosed or is occult may get destabilized with the high-grade fever which some of the recipients develop leading to tachycardia and cardiac decompensation or Myocardial Infarction. So, a thorough clinical judgment rather than some non-specific tests as suggested by doctor A would be of more benefit.
- Moreover, the CRP he is referring to seems to be hsCRP which he has not specified. And we all know that decreasing hsCRP with medical interventions may take a long time, may not happen and this would deprive the high-risk population of the vaccine they so desperately need. I strongly condemn dr A statement and note that although it may have popularised him amongst the anti-vaccine lobby and the non-medical people, it will surely harm the general masses who are already confused about whether to take the vaccine or not, which in turn will cause grave harm to the country.
- The economic and the work-related (due to prolonged absence from work in covid patients) repercussions of this disease are much serious than the trivial danger to the patients he has projected in his video. I strongly support vaccination and appear the medical fraternity to use good sense and their clinical acumen to identify and advise the necessary precautions to the high-risk class of patients and to promote vaccination in the eligible masses which comprise more than 99% of the population.
Dr Hem Shankar Sharma, Asso. Prof of Medicine, JLNMCH-Bhagalpur:
- I have gone through. Half-truths. Oversimplified statements. Not to be quoted like this. No of Beneficiaries of covid vaccination… How many got a complication like this?
- Any RCT?
- How many patients admitted during this period, non-covid, with myocardial infraction??
Dr Rajneesh Tyagi, Physicain, Noida, UP:
- His concern is worth noticing but the solution is very absurd.
Dr Preet Mohinder Singh Puri, MD Medicine,UK:
- Can one manipulate CRP to <1 if there is no obvious cause known at that time? Also, if one has co- morbidity which raises CRP then should they all refrain.
Dr Raju Sharma, Internist, Jamshedpur:
- True. Sometimes people forget the implications of a post. Especially on a public forum.
Dr Pradeep Sahay, Physician, Giridih:
- MI can occur at any time anywhere. We can only link the vaccine to an MI due to thromboembolism only if s Post Mortem reveals an embolism without signs of significant pre-existing artery disease. A CRP can be raised, through there are several causes.
- Recent studies have allowed the use of blood thinners and oral anti-coagulants prior to Covid vaccination.
- The benefits of the vaccine far outweigh the risks. I believe this video should not have been circulated in the public domain. The Astra vaccine had been cleared by experts.
Dr Nand Kishor Manti, Family physician, Pune:
- How to keep CRP less than 1?
Dr Vivek Gumber, Resident SMBT Medical College, Nashik:
- Colchicine is one the best to bring CRP less than before vaccination and we need to control diabetes.
Dr N K Singh:
- Video says – Do CRP, if more than 1 then reactogenic vaccine can trigger the plaque rupture and MI.
- He says, before vaccine do CRP. Keep it less than 1. To me it looks funny.
- Only CRP cannot predict MI
- Lowering CRP is not an easy task, neither only inflammation is the causative of MI. To understand MI….remember 6 blind men and elephant story
- some studies do corelate it with inflammation. CRP is an inflammatory marker only. Diet, exercise, Statin, Azithromycin–many are said to lower.
- Mediterranean Diet has been consistently shown to decrease CRP when it’s adhered to.
- Is inflammation the single-most important risk factor for heart disease? Although the connection between inflammation and cardiovascular disease risk has been known for two decades, the conventional approach for mitigating that risk remains focused on lowering cholesterol. Women’s Health Study that analysed 28,000 healthy women found that hsCRP was a stronger predictor of heart disease than LDL cholesterol Women in this study with the highest CRP level were four times more likely to have died from heart disease or to have suffered a heart attack or a stroke.
- JUPITER study of 17,800 healthy men and women. The JUPITER study found that giving statin drugs (normally prescribed to lower cholesterol) to study participants who had a normal LDL cholesterol level but a high CRP level, decreased the risk of heart attack and stroke.
Dr Anand Malani, MD, Sangli:
- Again, CRP is very nonspecific.
- Gets elevated in many infections.
- Elevations above 100 is common in bacterial sore throat or a febrile UTI.
- And takes really long time to settle.
- Negative predictive value should be good but positive does not necessarily mean vascular inflammation.
Dr Raj Kamal Chaudhary, Asso. Prof of Medicine, Bhagalpur:
- Vaccines can cause immediate reactions as Anaphylactic, Delayed Hypersensitivity and Cell Mediated. Just like body’s reaction to any allergen or to a foreign substance it’s with Covid Vaccination. Some people may have this with first dose or with second when the human body has adequate response with the first dose.
- Recently a Female Aged 50 years developed severe dehydration after vomiting and Diarrhoea after taking second dose of Covishield. She was immediately admitted to JLNMCH with iv fluids continued and Anti Diarrhoeal treatment. Her condition deteriorated and she was taken to a private hospital in the night and she died of Shock with Multi Organ Failure. Her RT-PCR was done which was positive and the Blood sample sent for vaccine virus. The report is awaiting.
- Any vaccine, once you receive, the body’s system recognizes as – The first shot teaches your immune cells to recognize the virus; it’s revving up. With the second shot, there are more immune cells ready and waiting to launch a major defence. The muscle ache and fever come from inflammation; your immune cells are sending out an alarm in the form of chemicals called cytokines.
- “Your immune system is ‘primed’ with dose one. You’re getting ‘boosted’ with dose two. That reflects your body’s quick response. … Your body is seeing it for the second time and remembering it, and is developing the powerful immune response that it needs to respond to infection.
- The vaccine can precipitate any Vasculitis, thrombogenic incidence so a patient knowing these conditions can get these investigations before getting vaccinated the CRP, DIMER and Antibody Identification to avoid major incidences such as Cerebral Stroke or Cardiac Arrest the Acute conditions which takes no time to respond.
CME INDIA Learning Points
- The Oxford/AstraZeneca (AZ) COVID-19 vaccine is “safe and effective” and the benefits outweigh the risks observed with blood clotting, announced the European Medicines Agency (EMA).
- Emer Cooke, EMA executive director, called the vaccine “safe and effective, and its benefits in protecting people from COVID-19…outweigh the possible risks,” adding that, “the vaccine is not associated with an increase in the overall risk of thromboembolic events of blood clots.”
- By March 16, 2021, there were seven reports of disseminated intravascular coagulation (DIC) and 18 cases of cerebral venous sinus thrombosis (CVST). Most of these occurred in the under-55 age group, and the majority were women. Nine cases were fatal, it is too premature to conclude a specific group.
- Cooke added that based on the evidence available, including laboratory results and clinical and autopsy reports, “we still cannot rule out, definitively, a link between these cases and the vaccine.”
- EMA concludes that there is no increase in overall risk of blood clots with this vaccine.
- Vaccination is the safest and most effective way to protect yourself from falling ill with COVID-19.
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After seeing thus video one of my patient got crp test as 5and now he is forcing me to give medicine to decrease it below 1 so that he can take vaccine.So now we are in afix how to reduce and difficult to convince patients that clinically he is better and got to ignore crp.
“Scientists Say They Found Cause of Rare Blood Clotting Linked to AstraZeneca Vaccine” – Wall Street Journal, March 19
Can’t agree with this, here is why.
Before the era of vaccines, rare diseases never got reported to a common domain.
These incredibly rare events were likely happening all along all over the world. When they happen, the knowledge is limited among the treating doctors, and often limited in that specialty. They commonly discuss among their peers and it gets forgotten. Very few get published.
But now, because of vaccines, when *these scattered rare events are all collected into one box & shown to the world, * suddenly it seems to be a problem. The clue is how RARE these events are.
“Finding antibodies to platelets” – as was reported by Dr Holme of Norway – reported widely by European media- is nothing new to doctors who have seen blood disorders. It just means platelets were destroyed by antibodies. Almost like saying we found smoke at the site of fire.
The question is, what triggered these antibodies, or what set off the fire.
A reaction to an event- commonly a viral infection, often asymptomatic- can trigger it.
The clue is not in the numerator, but in the DENOMINATOR. That is, several millions have received it.
If the vaccine really had a tendency to cause a platelet disorder, many many more people would have got sick by now.
The rates are not more than the general population.
Low platelets were also reported “following Pfizer and Moderna” vaccines in a series of 20 cases published on 19 February in Am J Hematology.
The human mind – even an expert doctor’s – can be easily tricked into blaming the immediate preceding factor, which in these cases was the vaccine. That is why looking at big data is important.
As discussed in the thread, the paper that describes low platelets “after Pfizer & Moderna vaccine”. Some virus infection (there are hundreds of types whom we encounter everyday) would likely have triggered these events. These events happened among younger people who are more likely to socialise and pick up these viral infections.
Unless substantial clustering is found, this cannot be called as evidence of a vaccine-related event.
Dr Rajeev Jayadevan
Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine
As of 17 March 2021, more than 120 million cases of COVID-19 infections, with more than 2 million deaths, had been reported globally. Vaccination remains a critical tool to help prevent further illness and death and to control the pandemic.
So far, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield vaccine (AstraZeneca vaccine by Serum Institute of India) have been administered in India.
The GACVS COVID-19 subcommittee met virtually on 16 and 19 March 2021 to review available information and data on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination with the AstraZeneca COVID-19 vaccine.
The subcommittee reviewed clinical trial data and reports based on safety data from Europe, the United Kingdom, India, and Vigibase, the WHO global database of individual case safety reports.
Based on a careful scientific review of the available information, the subcommittee came to the following conclusions and recommendations:
The AstraZeneca COVID-19 vaccine (including Covishield) continues to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world.
The available data do not suggest any overall increase in clotting conditions such as deep venous thrombosis or pulmonary embolism following administration of COVID-19 vaccines. Reported rates of thromboembolic events after COVID-19 vaccines are in line with the expected number of diagnoses of these conditions. Both conditions occur naturally and are not uncommon. They also occur as a result of COVID-19. The observed rates have been fewer than expected for such events.
While very rare and unique thromboembolic events in combination with thrombocytopenia, such as cerebral venous sinus thrombosis (CVST), have also been reported following vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is not certain that they have been caused by vaccination. The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee has reviewed 18 cases of CVST out of a total of more than 20 million vaccinations with the AstraZeneca COVID-19 vaccine in Europe. A causal relationship between these rare events has not been established at this time (1).
Adequate education should be provided to health-care professionals and persons being vaccinated to recognize the signs and symptoms of all serious adverse events after vaccinations with all COVID-19 vaccines, so that people may seek and receive prompt and relevant medical care and treatment.
The GACVS subcommittee recommends that countries continue to monitor the safety of all COVID-19 vaccines and promote reporting of suspected adverse events.
The GACVS subcommittee also agrees with the European Medicines Agency’s plans to further investigate and monitor for these events.
The GACVS COVID-19 subcommittee will continue to review the safety data from all COVID-19 vaccines and update any advice as necessary. The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessed here.