CME INDIA Presentation by Dr S K Gupta, MBBS MD(Med), CFM (France), Senior Consultant Physician and Internist MAX Super Speciality Hospital, New Delhi. Secretary, Community Health Care Foundation,
Director, Shivam Nursing Home.

India – Vaccine Pharmacy of the World.

“This Over 2.91 crore COVID-19 vaccine doses administered so far, 9.74 lakh till 13 March 2021 evening. Injection of 20 lakh doses on Friday 12 March is highest one day record. Policy changes to vaccinate all above 45 years of age will bring acceleration and joy to the Indian population.

Vaccines bring joy but hesitancy is widely prevalent. In spite of all odds, Indian success in Vaccine development, production, roll out and supremacy will be remembered till decades. India extended a helping hand to more than 75 countries in world by supplying Covid Vaccine. COVID-19 vaccine rollout is “India’s gift’ to the world in combating the virus.

Vaccine Supplies in Developed World Hue and Cry

• Australia and Italy hurling Brickbats over 2.5 lakh doses of Astra Zeneca vaccine while India distributing 27 times the numbers (67.5 lakh doses) free of cost to its neighbours.

What is the issue between two Nations?

• Italy has blocked the export of 250,000 doses of the AstraZeneca vaccine to Australia -from its plant in Anagni, near Rome in view of worse conditions in Italy and comparatively better scenario in Australia.
• Italy’s decision to block the exports has been reportedly backed by the European Commission. Logic (1) Because Italy has been hit badly by the pandemic (2) The country has registered more than 2.9m cases and nearly 99,000 deaths.
• Australia, on the other hand, has reported just over 29,000 cases and 900 deaths.
• Italy had been given the green signal to previous Australian vaccine supplies in view of limited numbers of samples for scientific research, but the latest one – being much larger – was rejected.

What about the other Nations of the EU?

• France could potentially do the same thing with the vaccines being made there. World’s premiere Vaccine Pasteur institute is situated in France. France has Raffle to fly but no vaccine for its citizens who die
• Germany said drug makers must honour their contracts to EU countries, but has not seen any reason to block shipments to other countries so far. AstraZeneca is not produced in Germany, but some of the final product is bottled there.
• Poland said the European Commission could have overruled Italy’s export ban, “but it did not dare do so”.
• Australia has a contract with AstraZeneca to receive 53.8m doses of the vaccine. About 3.8m of those will be imported from overseas. Only 300,000 doses have been sent, which the government says will last until late March, when it will begin making its own AstraZeneca vaccines domestically.
• US is already in process of banning supplies of raw material like glass bottles required for vaccine
• Supply problems in EU with all vaccines
• The EU signed a deal for 300 million doses of the Pfizer-BioNTech vaccine in December, but there have been problems with production.
• The rollout in some countries was delayed because of a temporary reduction in deliveries, to enable Pfizer to increase capacity at its processing plant in Belgium.
• Distribution of the Moderna jab also ran into problems, with Italy and France both saying they were receiving fewer vaccines than expected.
• The Oxford-AstraZeneca vaccine has been in short supply within the EU as well, with production shortfalls at plants in Belgium and the Netherlands.
• Whole world is clamouring for vaccines and unfortunately few groups within India, still critical of India’s efforts doubting and denying Indian vaccines. Such people need to come out from their deep slumber and shift their mindset from Shame to Fame

India serving as Vaccine Pharmacy to the World

Facts

• India has provided 67.5 lakh doses of coronavirus vaccines under grants assistance to a number of countries. The vaccines were sent to Sri Lanka, Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles.
• India has cleared supply of around 361.94 lakh doses of anti-Covid vials to 25 countries on a commercial basis in February, more than twice the 10.5 million vaccines that were exported in January.
• While 67.5 lakh doses of the total vaccines have been supplied as grant assistance, 294.44 lakh on commercial basis.
• Consignments of coronavirus vaccine doses were supplied as gifts to Bangladesh (20 lakh), Myanmar (17 lakh), Nepal (10 lakh), Bhutan (1.5 lakh), the Maldives (1 lakh), Mauritius (1 lakh), Seychelles (50,000), Sri Lanka (5 lakh), Bahrain (1 lakh), Oman (1 lakh), Afghanistan (5 Lakhs), Barbados (1 Lakh) and Dominica (70,000).
• India has exported vaccines to more than 70 countries and will be adding 40 countries to this list soon, Jaishankar said on 5th March 2021

How WHO reacted with Jubilance

• “Thanks India & Prime Minister @narendramodi for supporting #VaccinEquity. Your commitment to #COVAX and sharing #COVID19 vaccine doses is helping 60+ countries start vaccinating their #healthworkers and other priority groups. I hope other countries will follow your example,”– WHO Chief on 26th February

How Scientists are expressing Gratitude

• Dr Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM) in Houston during a recent webinar said that the two mRNA vaccines may not impact the world’s low- and middle-income countries, but India’s vaccines, made in collaboration with universities across the world such as BCM and the Oxford University, have “rescued the world” and its contributions must not be underestimated.
• Whole world is clamouring for vaccines and unfortunately few groups within India, still critical of India’s efforts doubting and denying Indian vaccines. Such people need to come out from their deep slumber and shift their mindset from Shame to Fame
• Vaccines usually do not prevent infection, they prevent disease. Vaccines produce antibodies and memory T cells. When a Virus enters the body, the memory cells recognise it and stimulate immune response against it and destroy it.
• Media should, therefore use extreme caution while publishing news of people being found positive after both doses of vaccine. Vaccine will prevent serious disease or death. One can get infected and transmit the Virus to others even after vaccination.
• It is therefore advised that we should continue to observe Pandemic Appropriate Behaviour even after getting full dose of the vaccine.
• There are some vaccines however, like the Intra Nasal vaccine against Covid, that can kill the virus at the entry point. Even here, depending upon the time when the nasal swab is taken, the rt PCR test may be positive.
• According to details given by Govt of vaccines shipped from India till March 4, out of 481.06 lakh vaccine doses sent to various countries,
  • 73.5 lakh doses supplied as grant assistance,
  • 288.4 lakh on commercial basis
  • and 119.16 lakh doses for WHO COVAX facility.
• India has emerged as the ‘pharmacy of the world’ with the production of two affordable vaccines.

Covid Vaccine and Anaemia

1. G6PD deficiency

• If someone is G6PD deficient then prevention of infection is important.  There is no scientific evidence that vaccines are a medication that will trigger an episode. Therefore, immunisations are not contraindicated in people with G6PD deficiency.
• One case of haemolytic anaemia was seen in a control arm of Covishield trial but it was not clarified if patient was having underlying G6P deficiency. It is noteworthy that Covishield trial Used meningococcal vaccine as placebo.

2. Aplastic Anaemia

• Where possible its advisable proceeding with vaccination unless someone have a contra-indication.
• Important to understand that for people with aplastic anaemia, there is a small risk of relapse associated with all vaccinations, and research is still ongoing into this. The general advice is that the benefit of being vaccinated against COVID-19 outweighs the risk associated with vaccination, however, one should discuss one’s own circumstances with medical team.
• The vaccine is administered intra-muscular which can, in some cases increase the risk of bleeding.
• If platelet count is below 30K, one should seek advice from your medical team
• If someone is within 6 months of receiving ATG it is possible one may not respond to the vaccine, so   advised to discuss with local haematology team before undergoing vaccination.

Second Wave comes with a silver lining?

• While the second wave of the coronavirus epidemic has set off alarm bells, a reassuring sign is that the severity of the disease appears to be significantly less than before, as is evident from the declining death rate.
• India’s overall case fatality ratio (CFR), or the number of deaths as a proportion of confirmed infections, is around 1.4 per cent.  But among those who were infected from January onward, this ratio is only about 0.87 per cent.
• Another indicator, the number of critically ill patients in hospitals, adds to the evidence that newer cases are mostly mild in nature.
• Pre-Caution: Directorate General of Civil Aviation (DGCA) Saturday issued a statement saying that passengers violating the Covid-19 protocol or not wearing mask properly inside an aircraft will be de-boarded.
• However not all experts Agree-According to Dr RR Gangakhedkar, former chief epidemiologist ICMR “Unless there is a consistent trend you should not say that this is an emergence of a second wave. But this is the moment where we have to issue caution to people that they to need to continue to follow COVID-appropriate behaviour because if you don’t, we will end up in a second wave”.
• At the moment, the trend of data in India is constantly going up, which is a matter of concern. One can appreciate in Graph that number of daily New cases from 8 Feb to 12 March are exact replica of cases observed from First Week of June 20 to early July 2020.
• Though it may not be uniform spread but Cases have increased in 17 of the 20 most populous states of the country.
• Reasons for second wave could be changing human behavioural laxity towards Covid precautions, festive season, crowd gatherings and mutant strain changing behaviour Virus which is yet to be proven
• Questions about beginning of second wave of COVID-19 may remain, but no going back on Covid appropriate behaviour in addition to motivation of masses for vaccination

Covid Vaccine and Zoster

• Herpes zoster following COVID‐19 vaccine: Coincidence or reactivation of dormant infection?
• Since the start of Corona Vaccination number of cases of Zoster (Shingles) are being reported. Is it mare coincidence or real awakening of latent Herpes virus by Vaccine related immunomodulation?
• According to Google Trends, searches for the term “Covid shingles” hit peak popularity on the search engine in Mid Feb. Exact figures may not be available but search Trends on Google is enough indictor for the size of problem.
• Almost 1 out of 3 people will develop shingles in their lifetime. It is not surprising that shingles cases are appearing, since many of the millions of people across the world who have gotten their COVID-19 vaccine are older and risk of getting shingles increases with age. Almost certainly, those who got shingles did not have themselves Shingrix vaccinated. Infact, Vaccine has been out of supply for quite sometime.
• Also, in general, the CDC advises that no other vaccines be given within 14 days of getting the COVID-19 vaccine.
• Review of literature doesn’t point to a constant pattern in appearance of Zoster and Covid/Vaccination. Someone received the first dose of the COVID-19 vaccine, 20 days later, the user developed shingles. Patients however, are bound to think, it is probably not a coincidence. But for scientists, basal rate of disease, chronology of events and age factors are important too.
• Infectious disease specialists, hence disagree that this is cause and effect, but interest in the possible connection remains high.
• We have to differentiate medical events that might be causal from coincidence. So far, we don’t have any other events other than allergic reactions [linked to the vaccine] …is the opinion of a leading virologist from New York.
• Herpes zoster caused by reactivation of VZV may occur spontaneously or be triggered by trauma, stress, fever, or immunosuppression. It is well known that fever, stress are common side effects of current Covid vaccines.
• Also Outbreaks of shingles are also often linked to stress, stressful life events, and depressive symptoms — all of which have been common during the pandemic.
• Anyone who has had chickenpox is at risk for shingles. More than 99% of people born before 1980 have had chickenpox. Shingles happens when the varicella zoster virus, which causes chickenpox, is reactivated after lying dormant in Dorsal Root Ganglion in the body.
• On the other hand, case reports of three different cases of herpes virus reactivation following inactivated influenza, hepatitis A, and rabies with Japanese encephalitis vaccines. And Recently, VZV reactivation in immunocompetent cases during COVID‐19 infection has also been reported

Acyclovir Therapy and COVID-19 Vaccines

• Some people on regular Herpes (ophthalmicus) prophylaxis with acyclovir 400mg are in dilemma to go ahead for Covid Vaccination or defer the same.
• Fears are twofold.
• Firstly, if anti-viral drugs acyclovir / Famciclovir /valacyclovir would render the vaccine less effective.  Do these drugs have the potential to inactivate the adenovirus in Astra Zeneca /other vector-based vaccines making the vaccination ineffective.
• Fear appears unfounded as Adeno virus even in immunocompromised settings are managed by cidofovir, ribavirin, ganciclovir, and vidarabine.
• More importantly Adenovirus in vector-based Vaccines is Replication defective. Acyclovir which acts by inhibiting Viral DNA polymerase requires viral replication for its action.
• Expert from American Academy of Allergy, Asthma & Immunology clearly say that such therapy would not be a reason to delay the COVID-19 vaccine dose.
• Bharat Biotech Covaxin which has an inactivated virus or mRNA vaccines could be preferred choices in such settings.
• However, those having active Zoster may defer their vaccination until completion of treatment and recovery as CDC too advises to avoid Covid vaccine during active disease.

Can people with Positive ANA take Vaccine?

• ANA can be positive in number of conditions like SLE, Sjogren’s Sx, Scleroderma Rheumatoid Arthritis and can even be false positive without any illness.
• Vaccination should be encouraged in all patients with positive ANA.
• Vaccination is advised even in Frank cases of SLE Sjogren Sx as current vaccines are unlikely to lead to flare up or progression of these conditions.
• However, as patients of SLE have higher incidence of Drug induced adverse reactions and hypersensitivity. Hence, Extra caution is advised among them during process of Vaccination.

Will the COVID-19 vaccine be safe for pregnant women or children with lupus?

• There are not yet any data on the safety and effectiveness of any of the current COVID-19 vaccines being studied for women who are pregnant or breastfeeding. However, due to the overall safety of the vaccines and the known risks of COVID-19, the CDC recommends that pregnant women should receive the vaccine if they are in another high priority group
• Evidence: The American College of Rheumatology COVID-19 Vaccine Clinical Guidance recommends that people with autoimmune and inflammatory rheumatic disease (which includes lupus) get the vaccine unless they have an allergy to an ingredient in the vaccine.
•  We will have more information as more research studies are conducted and analysed over time

National Blood Transfusion Council debars blood donation for 28 days after Covid vaccine

• The order, signed by NBTC Director Sunil Gupta and dated March 5, states that the criterion has been finalised with “28 days post vaccination deferral after the last dose of COVID vaccination, irrespective of the type of vaccine received. The deferral period may be reviewed as and when necessary”.
• With this, the donor has to wait for 28 days after the second dose of the vaccine, which effectively means that he/she cannot donate for 56 days after first and second dose of Vaccine.
• This would lead to a marked shortage of donors, especially when vaccination opens up for those below 45 years as well.
• American Red Cross is of opinion that “There is no deferral time for eligible blood donors who are vaccinated with a non-replicating inactivated or RNA-based COVID-19 vaccine manufactured by AstraZeneca, Janssen/J&J, Moderna, Novavax, or Pfizer”.”Eligible blood donors who received a live attenuated COVID-19 vaccine or do not know what type of COVID-19 vaccine they received must wait two weeks before giving blood”
• Currently there are no Live attenuated vaccines approved against SarsCov 2. Neither Covishield nor Covaxin are live-attenuated vaccines.
• Possible reasons for the purported order by NBTC are Antibodies or antigens from the recently-vaccinated donor may prompt the recipient’s immune system to attack its own body, if they suffer from autoimmune disorders. All vaccines have a waiting period of two to four weeks when blood cannot be donated
• (Fact: There is no deferral time for eligible blood donors who are vaccinated with a non-replicating inactivated or RNA-based COVID-19 vaccine manufactured by AstraZeneca, Janssen/J&J, Moderna, Novavax, or Pfizer.) Eligible blood donors who received a live attenuated COVID-19 vaccine or do not know what type of COVID-19 vaccine they received must wait two weeks before giving blood.

Migraine and Covid vaccine

• Headache is a very common side effect of currently approved Covid Vaccines The leaflet insert of Covishield (AstraZeneca Oxford) lists headache among common adverse events encountered in more than 1 in 10 people after vaccination. Practically speaking incidence is far more than listed, Unpublished reports say headache is being seen in more than 50%people. Pfizer clearly   admits that ~64.5% people reported headache after the jab.
• Those who have migraine, are concerned about the headache as side effect they experience after getting the shot.
• That worry is totally understandable; most people with migraine know that anything that could cause a headache in someone else — a virus, an infection, not getting adequate sleep, too much caffeine, not enough caffeine stress — is quite often a trigger for them that can cause a migraine attack.
• Hence, it is possible that the current Covid vaccines may precipitate migraine. Usually, it is mild and likely to subside in a day or two with usual medications.
• Rare instance of debilitating and prolonged headaches requiring neurological intervention and imaging studies have been reported in Social Media.
• The physicians as well as patients should be aware and take an informed decision especially in tropical climate of India where incidence of headache is bound to increase in approaching Summers.
• Though no agency has advised differing the Covid vaccine solely due to migraine. But it may prudent to postpone the same at least till acute attack subsides completely.

CME INDIA Case Scenarios

1. Posted by Dr Sandeep Chopra Senior Anaesthesiologist New Delhi:

• Yesterday itself, I was busy with a family friend, a doctor who had received her second dose of covishield on 4th of March. A known patient of migraine, she had a few episodes of headache in the following days. But this Sunday, she developed vertigo, which increased in severity over the day. Not related to any posture, even on opening eyes while lying down. Couldn’t eat or drink as she would vomit. Yesterday got her MRI brain and cervical spine, and colour Doppler neck done, which were reported Normal. Neurologist has labelled it as Vestibular neuritis.
• Wonder if we can label this as a complication of the vaccine.

2. Dr Arvind Gupta, Diabetologist, Jaipur: COVID Vaccine and Diplopia

My associate’s husband (a doctor) experienced severe headache, throbbing 7 days back followed by diplopia next day. Had been examined by Neurologist and ophthalmologist, Had MRI/ MR angio and biochemistry normal. No H/O DM and Hypertension. Recovering well after steroids. No headache now but diplopia continues. Provional diag- Tolosa Hunt Syndrome. This episode occurred 10th day after second dose of Covaxin. (May be a coincidence) We need comments and advise. Or If any similar case is reported elsewhere.

Dr N K Singh: Similar neurological problems reported after covishield. Could be with Covaxin. May be related to vaccine, may not be. Worth to see this abstract: https://www.karger.com/Article/FullText/511025

“Influenza vaccines are known to have a few neurological complications, such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and acute disseminated encephalomyelitis. However, oculomotor palsy caused by influenza vaccination is extremely rare. We present a case report of a 25-year-old woman without any medical history who developed complete oculomotor palsy 2 weeks after influenza vaccination. Other possible causes of oculomotor nerve palsy, such as stroke, compressive lesions, infections, and autoimmune disorders, were eliminated by blood tests, cerebrospinal fluid examination, and imaging studies. Hence, influenza vaccine was considered as the likely cause.”

3.  Can Covid vaccine can be given to Splenectomised patients?

Yes

4. Alcohol and Vaccine

Dr H D Sharan Ranchi:

• Binge of alcohol is known to cause immune response so it could adversely affect the immune response to vaccine. But in moderation, it will not affect the immune response.
• Surprisingly no one ever asks whether they can enjoy a drink when they have taken a PCV13 or flu vaccine.
• Russian scientists have asked people not to take alcohol from a week before the 1st dose to a week after the 2nd dose. Studies in US have not found any effect of alcohol on antibody production in response to vaccine.

5. Can a Patient of hepatitis B take vaccine?

Dr H D Sharan Ranchi: Yes, but only after consulting your doctor.

6. Liver Transplantation and Vaccine

Dr H D Sharan Ranchi: One doctor who is a recipient of a liver transplant has received vaccination.

Dr S K Gupta, Delhi: Yes, safely but the immunogenicity may be compromised. It may deferred in cases of Active liver damage. Cirrhotic have high case fatality rate with Covid Data with multiple non Covid vaccines suggest: cirrhotic have lower response rates with vaccines. Otherwise, vaccines are well tolerated.

CME INDIA Tail Piece

(By Dr Suresh Kumar, Infectious disease specialist, Apollo Chennai)

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