CME INDIA Presentation by Admin.

“We’re tired with good reason, but our flag is still there. This virus attacks the weakest and most vulnerable and has thus disproportionately affected certain portions of the population. All the rules and restrictions have made us weary, yet it’s more important than ever to be vigilant” – Stephanie Zacharek in Time Magazine

Dr Vinay Dhandhania, Diabetologist, Ranchi asks: Patients recovered from COVID-19 should receive vaccine or not? Any idea😇😇…

CME INDIA Discussion

Dr K L Manohar, Diabetologist, Bengaluru: Practically, No!! Unless someone wants to do an antibody titer and take if negative! But in clinical trial post-COVID would be excluded!!

Dr S K Goenka, Internist, Begusarai: If antibodies have not formed at all, then?

Dr Manish Ranjan, Asansol: In my opinion – not needed.

Dr T Rekha MD, Internist, Salem, TN: We can check Antibody titres & decide. Because in mild COVID-19, Antibody response is not much when compared to severe patients as per studies we have read.

Dr Surendra Kr Goyal, Sr Physician, Kota: There is conflicting opinion among virologist and epidemiologist on the issue.

Dr Vikash DNB, Med: Dengue vaccine results should be considered. Difference in those infected and those not infected.

Dr Harishkesh, Ranchi: The most worrying aspect is the speed tracking in the vaccine program. Is it going to be the Vaccine equivalent of Thalidomide? Wonder if the introduced mRNA will have auto degeneration or could potentially become a prion!

Dr Kapil Sud, Internist, MD Delhi: The question should not be whether he requires vaccine but when?

Dr Rajneesh Tyagi, Physician, Noida, UP: If the vaccine is useful, certainly one should get it. We have been infected by influenza many times but still most of us get flu shot.

Dr Mahadev Desai, Sr Physician, Ahmedabad: Vaccine in post-COVID19 infection is a very tricky issue. At least they are not the candidate for viral vector-based vaccines because if their antibodies are high, the vaccine will not be effective in mounting antibody response.

Dr H K Jha, MD, CMO, CGHS, Ranchi: How long antibody remains in post COVID patient should be addressed. Even if antibody doesn’t last longer. T cells memory will be sufficient to produce enough antibodies to prevent COVID 19 infection.  I think they don’t need vaccination. But in case of mutation, like influenza virus, person may need vaccination?? But there are conflicting opinions.

Dr Nishikant Sharma, Physician, Mumbai: Idea of vaccinations is to generate antibodies. Those who had past infection and robust antibodies need not. However, strains may be different. Then it becomes trickier. This is my personal opinion.

Dr Jagdeeshan, Chennai: Vaccine will act as booster any way.

Dr Awadhesh K Singh, DM Endo. Kolkata: Of course – without any question. Read the paper by Eric Topol in Nature – as to why everyone should receive vaccine irrespective of previous Corona infection.

(Please see CME INDIA Learning points below)

Prof Dr Jacob John, Vellore (at IMA Trivandrum branch on NOV 26, 2020):

• COVID-19 vaccines are not vaccines in the true sense. They are m RNA carried in liposomes or Adenovirus vectored DNA vaccines which contain viral genome that code for viral spike protein which when introduced to human cells guide the cells to synthesise protein which acts as antigen and body produces antibody and cell mediated immunity against it.
• COVID 19 VIRUS has not undergone much antigenic drift minor shift from 614 to D 614G has happened which has made the virus more easily transmissible than the parent virus. Hence vaccine produced will be effective.
• Antibody produced against spike protein by natural infection is short lived not more than 6 months hence cell mediated immunity important.
• Vaccines may produce more longer lasting and potent immunity than natural infection but we will have to wait till further studies available to confirm or refute it. Vaccines sometimes elicit a different response from natural infection e.g., HPV virus infection does not protect against ca cervix but vaccine does.
• m RNA of virus is introduced into our body when we get a natural infection also so there should not be much concern with an mRNA vaccine.
• These vaccines are non-replicable and non-infectious hence can be given to immunosuppressed but immune response may be lower.
• DNA vaccines are usually not much effective unless packaged in vector virus which can enter cell DNA.
• Bharat biotech covaccine is a killed vaccine with aluminium. Adjuvant and tagged with a protein hence able to elicit both Th1 and Th2 response hence is able to overcome the limitation of routine adjuvanted vaccines which only mainly produce antibody mediated response. Covaccine stimulates both antibody and cell mediated immunity.
• mRNA vaccines need – 70 storage which is not possible in India as these freezers are available only in certain research institutes. Pfizer moderna vaccine needs only – 20storage facility.
• Oxford vaccine covishield efficacy only 62% if 2 full doses given. But if 1st dose is half dose and second full then efficacy 90%in less than 55yrs age group. Lower efficacy when full dose used for primary vaccination may be because of inhibition of cell entry of virus the second time when full dose given.
• Reported efficacy: sputnik 92.5%efficacy. Pfizer moderna 95%efficacy.

Discussion – Haryana Health minister becoming positive after taking Vaccine

Dr Hem Shankar Sharma, Asso. Prof Med, Bhagalpur: It’s a live attenuated vaccine. You may have a positive test, but without virulence. Remember, you can develop measles, following vaccination, but it’s never wild variety, as it’s a live attenuated vaccine.

Dr Meena Chhabra, Delhi: He got the vaccine 10 days back.

Dr Awadhesh K Singh, DM Endo, Kolkata:

1. It is live attenuated vaccine.
2. He is vaccinated on the part of vaccine trial thus no one knows whether he was in placebo arm or active arm?
3. Was he tested for COVID-19 before the trial? In all likelihood yes and was found to be negative before the recruitment.
4. Don’t expect protection within 15 days
5. Many other possibilities.

Two doses of the vaccine on the interval of 30 days need to be administered. He had only primary dose. Even if it is vaccine it may take minimum 3 weeks for antibody production. Told you exact date on Nov 20!

Dr Ambrish Mithal, DM Endo, Delhi: Vaccines take time.

Dr Hem Shankar, Bhagalpur: There are many factors related to vaccinations…many fallacies, case selection, time of vaccinations, post vaccinations exposure to the wild viruses, etc…

Dr Ravi Kirti, HoD Med AIIMS, Patna: We do not know whether he received the vaccine or placebo. And unless there are some positive cases from the trial population, no meaningful conclusion can be drawn.

Dr Vinod Mittal, Diabetologist: I am sure, he must have received vaccine and not placebo… state health minister

Dr Raj Kamal Chaudhary, Asso.Prof Med., Medical college, Bhagalpur: The mRNA – essentially the body’s instructions for how to make a protein – has been modified and packaged in fat particles that allow the mRNA to enter the the cell without disintegrating. The vaccine never enters the nucleus of the cell, which is where DNA is kept.

“Nobody has identified a safety concern yet with the mRNA vaccines given, and no serious adverse effects have been seen. I see the mRNA vaccines as safe and surprisingly effective in these initial studies. The question is, what don’t we know yet?”

Dr Gaurabh Gupta, New Delhi: How about triggering autoimmune response, since many a times these proteins so produced out of mRNA from cell machinery will be placed on d cell membrane to be detected as non-self along with MHC class 1 molecule…. if and this we don’t know yet that how fool proof process is for not mixing up d self and non-self-protein while it is packaged from within d cell on its way to the membrane or even while being scanned with even a tiny bit of self-protein by APCs. This is d real concern. Getting into DNA is not direct but indirectly as autoantibodies possibly per se.

Dr Pankaj Singhal, Kota: https://microbenotes.com/differences-between-primary-and-secondary-immune-response/ Reason why patients who already had COVID need vaccination

Dr Kapil Sud, Internist, Delhi: Wasn’t it supposed to be double blind trail.

Dr Jagdeeshan, Chennai: I believe vaccination cannot stop COVID, it develops antibodies to fight it. More over all these vaccines underwent trials for prevention of disease, and trial prevention of severe disease. Like flu vaccines, COVID also may prevent severity of the disease mostly. Even if it is vaccine it may take minimum 3 weeks for antibody production.

Dr A C Bhardwajan, Shillong: Two doses of the vaccine on the interval of 30 days need to be administered. He had only primary dose.

Only two vaccines have been approved: Sputnik V developed by the Gamaleya Research Institute in Moscow; EpiVacCorona, another Russian vaccine, has been granted regulatory approval also without entering Phase 3 trials. This vaccine contains fragments extracted from the virus (synthetic peptide antigens). Vaccines in India: Covaxin (Bharat Biotech), Sputnik V, Oxford-AstraZeneca

Dr N K Singh: Great confusion in mind of all even doctors. Vaccine does not prevent from infection, it protects only from severity, is it clear?

Dr Jagdeeshan: Yes, it is prevention from severity, not prevention from disease anyway.

Pfizer and moderna very clear about that. Modern clearly said their vaccine are 100 percent (😨😳), effective from preventing severe disease. Even the flu vaccines, prevents the severity of the illness effectively than prevention of disease.

Dr Kapil Sud, Internist, Delhi: These are mRNA vaccines. Are flu vaccines the same?

Dr Jagdeeshan: No. Pfizer vaccine is the first mRna vaccine approved for human use.

Dr Kapil Sud, Internist, Delhi: So, we are treading in unknown waters and are over enthusiastic about them?

Dr Jagdeeshan: Minimum 3 weeks for all vaccines to produce antibodies. Now moderna says, it’s vaccine will give at least 3-months protection.

Dr P R Parthasarathy, Chest Physician, Chennai:

1. We don’t know if minister had the vaccine or the placebo.
2. Now the company will say that he is on the placebo arm to escape undue publicity.
3. The vaccine, if given in full doses, is likely to give protection against severe illness.

Dr Rajneesh Tyagi, Phy, UP: The point is not whether he received vaccine or not. Point is he is positive after that shot only and not before that.

Dr P R Parthasarathy, Chest Physician, Chennai: It’s possible that he might have come under the 40% (the vaccine is supposed to be 60% effective) & that he hadn’t produced any antibodies.

Dr Rajneesh Tyagi Phy, UP: Now he is positive, he will produce antibodies.

Dr S N Sethi, MD Medicine, Kurukshetra: In the double-blind trial, secrecy is with third party. So, neither the patient nor the company knows what has been given.

Dr Shashank Joshi, DM Endo, Mumbai: BharatBiotech Vaccine which presumably the Harayana health Minister got is a inactivated vaccine joint project of icmr bharat team, as a part of a clinical trial program. Usually most vaccines need 2 doses. Single dose is usually needed for a live attenuated vaccine which currently in COVID space in India is not there. Currently we have 2 Indian vaccine one inactivated by bharat and one DNA by zydus both in phase 3. Then we have 2 more in phase 2 /3 clinical trails by Oxford serum and Sputnik dr reddy. Others who get approvals else where like UK USA Japan Russia or Europe can apply for EUA without trial to dcgi as well which is what Pfizer is attempting. All these EUA are super fast track.

CME INDIA Learning Points

(Amanna, I. J. & Slifa, M. K. Curr. Top. Microbiol. Immunol. 428, 1–30 (2020)) – Shared by Dr A K Singh.

• Natural infection gives better immunity than vaccination. If one survives the infection, there are certainly many pathogens for which natural infection induces stronger immune responses and more long-lived immunity than does vaccination. Measles is prototypic of this
• Vaccination against measles, on the other hand, requires two shots and may not offer lifelong complete protection but has proven to be good enough to keep the disease in check
• The man-made vaccine is ‘superhuman’; that is, it gives humans immune responses superior to those generated in response to infection.
• Haemophilus influenza type b (Hib) – Typical responses to vaccination are therefore greatly enhanced relative to the responses to natural infection.
• Among viruses, two classic cases in which vaccines generate immunity superior to that generated by natural infection are varicella zoster virus, which can lead to shingles, and human papillomavirus (HPV.
• Recently developed vaccines Zostavax and Shingrix do offer protection against shingles. Shingrix protects around 90% vaccinees across all age groups, and it is suggested for an extended time period. Protection seems to be antibody based but with important contributions from CD4+ T cells
• Where does the coronavirus SARS-CoV-2 lie along the spectrum of natural infection versus vaccine-induced protective efficacy? The answer to this question will be known only as more data are collected from ongoing natural infection and vaccine studies.
• The initial results from interim analyses by Pfizer/ BioNTech and Moderna of mRNA vaccines against SAR-CoV-2 showing a reduction in infections of around 95% are very encouraging
• Even if the levels reached do not provide complete sterilizing immunity and are insufficient to prevent the upper-respiratory-tract symptoms typical of the common cold, they may prevent serious lower-respiratory-tract disease. But the disadvantage of such an outcome is that the vaccine probably would not prevent ongoing transmission from an infected vaccine.
• One important unknown factor in the context of both natural infection and vaccination is the durability of immune responses.
• FACT Check: No vaccine has been shown to be efficacious in preventing infection. Hence, physical distancing, masking and handwashing are key preventive measures. We do not know if people can become infected and also transmit the virus even with vaccination. The PfizerBioNTech and Moderna vaccines are about protection from symptomatic disease.

CME INDIA Tail Piece

• Lots of fear, as many news keep coming on behalf of Pfizer top persons. It goes viral but authenticity is not checked. Now there is a news that head of Pfizer Research says: COVID-19 Vaccine is Female Sterilization – (Infertility of indefinite duration could result in vaccinated women.)
• He also fears that the formation of so-called “non-neutralizing antibodies” can lead to an exaggerated immune reaction, especially when the test person is confronted with the real, “wild” virus after vaccination. This so-called antibody-dependent amplification.
• The mRNA vaccines from BioNTech/Pfizer contain polyethylene glycol (PEG). 70% of people develop antibodies against this substance – this means that many people can develop allergic, potentially fatal reactions to the vaccination.
• The much too short duration of the study does not allow a realistic estimation of the late effects.
• It is too early to validate authenticity of this news.

Further Reading:

Burton, D.R., Topol, E.J. Toward superhuman SARS-CoV-2 immunity?. Nat Med (2020). https://doi.org/10.1038/s41591-020-01180-x

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