COVID testing in India and ICMR strategies and vaccines according to data available in January 2021

1. COVID TESTING AND ICMR
STRATEGY AND VACCINES
- RISHIKA THAKUR (1866)

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3.  The decision to test should be based on clinical and
epidemiological factors and linked to an assessment of the
likelihood of infection.
 Healthcare workers who
collect specimens should follow proper SOPs and
should be trained for appropriate specimen collection,
storage, packaging and transport.
 All specimens collected for laboratory investigations should be
regarded as potentially infectious.

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7. Specimens which can be delivered promptly to
the laboratory can be stored and shipped at 2-
8 °C.
When there is likely to be a delay in specimen
reaching the laboratory, the use of viral
transport medium is strongly recommended.
Specimens may be frozen to -20 °C or ideally -
70 °C and shipped on dry ice if further delays
are expected.
It is important to avoid repeated freezing and
thawing of specimens.

8.  1. MOLECULAR TEST – Nucleic acid amplification test
(NAAT), RT-PCR test
 2. ANTIGEN TEST – Rapid diagnostic test
 3. ANTIBODY TEST – Serological test, Blood test.

10.  Routine confirmation of COVID- 19 cases is based on detection of unique
sequences of virus RNA by NAAT such as real- time reverse- transcription
polymerase chain reaction(rRT-PCR).
 It is the gold standard for detection of COVID-19 cases.
ADVANTAGE:
 Accuracy of detection.
 Ability to run upto 90 samples in a single run.
DISADVANTAGE:
 Cannot be performed at every district level lab which do not have
molecular virology facilities.

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 Moderate sensitivity but high specificity.
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12. A. Routine surveillance in containment zones and screening at points of
entry:
 Choice of Test (in order of priority)
i. Rapid Antigen Test
ii. RT-PCR or TrueNat or CBNAAT
1. All symptomatic cases including health care workers and frontline workers.
2. All asymptomatic direct and high risk contacts of a laboratory confirmed case
to be tested once between day 5 and day 10 of coming into contact.
3. All asymptomatic high risk individuals in containment zones.

13.  Choice of Test (in order of priority):
i. RT-PCR or TrueNat or CBNAAT
ii. Rapid Antigen Test (RAT)
1. All symptomatic individuals with history of international travel in the last 14 days.
2. All symptomatic contacts of a laboratory confirmed case.
3. All symptomatic health care workers/frontline workers involved in containment and
mitigation activities.
4. All symptomatic cases among returnees and migrants within 7 days of illness.
5. All symptomatic high risk contacts in family and workplace, elderly ≥ 65 years of age,
those with co- morbidities etc. ( RAT is recommended as first choice of test in order
of priority)

14. i. RT-PCR or TrueNat or CBNAAT
ii. Rapid Antigen Test (RAT)
1. All patients of Severe Acute Respiratory Infection.
2. All symptomatic patients presenting in healthcare setting.
3. Asymptomatic high risk patients who are hospitalised or seeking immediate hospitalisation such as
immunocompromised individuals, patients diagnosed with malignant disease, transplant patients etc.
4. Asymptomatic patients undergoing surgical/non-surgical invasive procedures.
5. All pregnant women in/near labour who are hospitalised for delivery.
6. All symptomatic neonates presenting with acute respiratory/sepsis like illness.
7. Patients presenting with atypical manifestations ( stroke, encephalitis, hemoptysis, pulmonary embolism, acute
coronary symptoms, multiple organ dysfunction syndrome, Kawasaki disease ) based on the discretion of the
treating physician.

15. 1. All individuals undertaking travel to countries/ Indian states mandating a negative
COVID- 19 test at point of entry.
2. All individuals who wish to get themselves tested.
FREQUENCY OF TESTING:
 A single RT-PCR/TrueNat/CBNAAT/RAT positive test is to be considered
confirmatory, without any repeat testing.
 No re-testing is recommended prior to discharge from a COVID-19 facility after
clinical recovery, including for transfer from a COVID area/facility.
 If symptoms develop following a negative RAT test, a repeat RAT or RT-
PCR should be done.

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19.  Pre-clinical studies with small and large animals completed.
 DCGI approval for Phase 1 and 2 human clinical trials
received.
 Phase 1 human clinical trial completed.
 Phase 2 human clinical trial completed.
 DCGI approval for Phase 3 human clinical trial received.
 Phase 3 human clinical trial ongoing.

20.  The Serum Institute of India and Indian Council of Medical
Research are jointly conducting a Phase 2/3 , observer-blind,
randomised, controlled study to determine the safety and
immunogenicity of Covishield (COVID- 19 Vaccine)
 UPDATE:
 Promising result of Pre-clinical animal studies shown.
 DCGI approval for Phase 2 and 3 human clinical trials received.
 Participants enrollment and vaccination of Phase 2/3 human
clinical trial completed.

21.  Zydus Cadila, focused on discovering and developing NCEs, Novel
Biologists, Biosimilars and Vaccines, announced its plasmid DNA
vaccine to prevent COVID-19, ZyCoV-D.
 It has commenced Phase 2 trial.
 UPDATE:
 DCGI approval for Phase 1 and 2 human clinical trials received
 Phase 1 human clinical trial completed.
 Phase 2 human clinical trial ongoing.

22.  Dr Reddys Laboratories Limited and Sputnik LLC are jointly
conducting multi-centre, phase 2/3 adaptive clinical trial to
assess safety and immunogenicity of Gam-COVID-Vac
combined vector vaccine
 UPDATE:
 DCGI approval for Phase 2 and 3 human clinical trials
received.
 Phase 2 human clinical trial ongoing.

23.  Biological E. Limited is conducting a prospective open label randomised
Phase 1 seamlessly followed by Phase 2 study to assess the safety,
reactogenicity and immunogenicity of Biological E's novel Covid-19
vaccine containing receptor binding domain of SARS-CoV-2 for
protection against Covid-19 disease when administered intramuscularly
in a two dose schedule(0, 28D) to healthy volunteers.
 UPDATE:
 DCGI approval for Phase 1 and 2 human clinical trials received.
 Phase1/ 2 human clinical trial ongoing.

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26.  Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction
(e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
 Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished
response to the Moderna COVID-19 Vaccine.
 Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain
at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness,
fever, swelling at the injection site, and erythema at the injection site.
 Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-
associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the
breastfed infant or on milk production/excretion.

27.  BNT162b2, mRNA based COVID-19 vaccine.
 Ingredients of the vaccine-
Active: each vial contains five doses, of 0.3mL with 30 micrograms mRNA each.
 The lipid nano particle
 Lipid ALC-0315 = (4-hydroxybutyl azanediyl)bis(hexane-6,1 diyl)bis(2-hexyldecanoate)
 Lipid ALC-0159= 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
 1,2-Distearoyl-sn-glycero-3-phosphocholine
An adjuvant: potassium chloride
To balance pH:
 Potassium dihydrogen phosphate sodium chloride/monobasic potassium phosphate
 Disodium hydrogen phosphate dihydrate/sodium diphosphate
Stabilizer: sucrose
So the active substance is mRNA and above are the lipid components and inactive ingredients.

28.  Injection site pain 84%
 Fatigue 62%
 Headache 55%
 Chills 31%
 Joint pain 23%
 Fever 14%
Why are we experiencing these side effects?
Our body is creating our defense system to fight against the virus, In that
process, our immune system is getting activated which causes the symptoms.
These are the side effects of our body doing its job.

30. OXFORD
VACCINE-
ChAdOx1
nCoV-19
ChAdOx1 nCoV-19 was chosen as the most suitable
vaccine technology for a SARS-CoV-2 vaccine as it has
been shown to generate a strong immune response from
one dose in other vaccines.
The Oxford vaccine contains the genetic sequence
of surface spike protein of COVID-19.
The vaccine is called Covishield in India and is in trial in
India.

31. NAME VACCINE TYPE TRIAL PHASE PRIMARY DEVELOPER
1. BNT162b2 mRNA based 3 Pfizer, BioNTech; Fosun
Pharma
2. mRNA-1273 mRNA based 3 Moderna
3. Covaxin Inactivated vaccine 3 Bharat Biotech; National
Institiute of Virology
4.Sputnik V Non replicating viral
vector
3 Gamaleya research
institute, Russia
5. AZD1222 Replication-deficient viral
vector vaccine
3 Oxford University;
AstraZeneca; Serum
institute of India
6.BCG vaccine Live attenuated vaccine 2/3 University of Melbourne
and Murdoch Children's
Research Institute
7.Ad5-nCoV Recombinant vaccine 3 CanSino Biologics,
Wuhan