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India, like the rest of the world, is gearing up by allocating additional equipment required for storage and distribution of the much-anticipated COVID vaccines to all our states and union territories.

Companies have applied for the Emergency Use Authorization (EUA). The day isn’t far when one or more of the vaccine candidates will receive the green light.

The different branches of RxDx Healthcare are preparing to vaccinate the city of Bengaluru in its trademark friendly ways. In Clinic. In Camps.

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FAQs

on COVID-19 Vaccine

Dr Guleria, Director, AIIMS sharing FAQs on COVID 19 vaccine rollout

Update

COVID-19 vaccine is scheduled for roll-out in the country on 16th January 2021 and the states/UTs have already received vaccines for the same.

In this regard, a comparative factsheet for both the vaccines that will be used during the introduction have been prepared which contains information on vaccine platform, physical specifications, dosage, cold chain storage requirements, contraindications and minor AEFIs. A detailed note on contraindications and special precautions has also been prepared and is enclosed.

Source: Office of Additional Secretary, Ministry of Health & Family Welfare, dated January 14, 2021

Know More

Indian vaccine candidates Bharat Biotech’s Covaxin and Oxford-Astrazeneca’s Covishield got the DCGI nod for restructured emergency use authorization.

Covishield is in phase 3 trials in India but global data show that this vaccine has an overall efficacy of 70.42%. Recommended doses: age group >18 years, 2 shots, 4-6 weeks apart, intramuscular. As per media reports, possible price in India: around ₹400.

Covaxin has just started phase 3 Clinical Trials and more data is required. Recommended doses: 2 shots, Day 0 and 28. As per media reports, possible price in India: less than ₹100.

Vaccination will be initially prioritised for beneficiaries like healthcare and other front-line workers. Clinical trials will continue. DCGI and other authorities will keep monitoring the new strain reported.

India has been conducting vaccine dry runs across several states to prepare for the actual drive. Drills include registration, verification, mock vaccination, and post-shot observations.

RxDx Healthcare is prepping up to provide

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Training of Vaccinators

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Cold chain logistics support

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Vaccine administration in urban and rural set-ups

We already have substantial experience in handling COVID testing, home isolation services, and Long COVID Rehab.

The First in the line to receive COVID vaccination

As a majority of the SARS-CoV-2 vaccine candidates are still in various stages of trials, the demand-supply match will need more time. Not everybody can get the shots at once.

What will be the most justifiable order of immunisation?

Healthcare professionals (those who work in a healthcare setting)

Other frontline workers or first responders (paramedical staff, army, civil servants working in the city sanitisation, police, paramilitary, media, etc.)

People with comorbidities like diabetes, hypertension, organ transplant, chemotherapy patients

Citizens above 50 years of age

Who’s next?

Healthy adults

Teenagers

Children

Newborn (if applicable in the future)

Five principles guiding the vaccination drive


Technology-driven well-planned implementation


Existing healthcare services like national programmes and primary care will remain uncompromised 


Apply the strategies of elections and universal immunisation programme

Ensure participation of the general population

Strict adherence to scientific and regulatory norms and other SOPs

Vaccine for COVID: The Global Race

Several candidates are in various stages of development. Some of them are expecting license shortly. “Every single Indian who needs to be vaccinated will be vaccinated,” National Expert Group on Vaccine Administration of Covid-19 (NEGVAC) has promised.

This count is for publicly disclosed vaccines

  • 45 candidates in pre or clinical evaluation
  • 10 vaccines in phase 2/3 trials
  • 7 vaccines received emergency use authorization / approval

Algorithm

Vaccines: What are they?

Not a treatment.

Vaccines follow the classic principle of “Prevention is better than cure.”

A vaccine is a natural or genetically engineered, weakened or inactive form of the pathogen itself. When transferred to the host body, it trains the immune system to fight the infection if contracted in future.

What are we looking for, in the highly anticipated novel Coronavirus vaccine?

  • Dosage
  • Safety
  • Efficacy
  • Ease of Storage and Distribution
  • Mechanism of Action (MOA)
  • Cost
    Not necessarily in that order.

How does a vaccine work against viral infections?

Virus only replicates when it finds a living host. The vaccine stops that replication, hence spreading, as a result, either prevents sickness or reduces symptom severity from the infection. The pathogen dies eventually.

Steps of Vaccine Development

Vaccine development is a long, slow, sequential process, but the COVID crisis has forced our hands. Fastest developed vaccine was for mumps. It took 4 years. The phases of vaccine development:
  1. Preclinical phase

Testing out a potential vaccine in animals or laboratory environment

  1. Clinical phase

Phase I
Examine dosage, efficacy, safety, and possible side effects of candidate vaccine in a small group of people (30-50)

Phase II
Look for immunogenicity (does the vaccine elicit expected immune response?) besides safety and efficacy

Phase III
More advanced stage of testing the candidate vaccine’s safety and efficacy along with large scale monitoring of adverse events. Chances of approval are related to the risk benefit ratio.

Who approves vaccines for manufacturing?

Companies file Biological License Approval (BLA) requests with regulatory authorities like FDA (US), MHRA (UK), DCGI (India), TGA (Australia) with safety and efficacy data on vaccines and other pharmaceutical products.
The regulators keep up the scrutiny even after approval process is over, to ensure continued safety.

Safety recap

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Mask

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Hygiene

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Distance

A round-up on the novel coronavirus vaccines

Most of the COVID vaccines are intramuscular shots, to be administered in two doses, at 21-28 days interval. FDA has voted in favour of the Pfizer vaccine for COVID stating that benefit outweighs risk in population 16 years of age and above. Pfizer is adding a warning in the labelling indicating that Appropriate medical treatment and supervision should be readily available in case of anaphylaxis. This happened due to a few severe allergic reactions reported in UK and USA. The Oxford-AstraZeneca vaccine was temporarily stalled when a case of neurological issue was reported in a woman which was reported to be possibly related to her pre-existing medical condition and not the vaccine.
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Vaccines mostly have low to mild effects, mostly commonly fatigue, muscle aches, mild fever, etc which is more about body’s response to the shot than the disease

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Those who have COVID infection should wait for complete recovery before getting the vaccine but there is no contraindication so far for patients who have had a previous SARS-CoV-2 infection.

As we see a lot of contradiction regarding the concept of immunisation, doubt often creeps in our mind. Do we really need vaccines? Do they harm more than benefit us? Should I wait for my neighbour to try it out?
We need to remember that vaccines are the best way to prevent infectious diseases.

Remember small pox, remember polio, remember tetanus! Then, ask yourself, are vaccines good or bad for you.

Truly, nothing is risk-free in this world. The speed at which COVID has set the vaccine race, many find it concerning. However, technology of vaccine development is way more advanced compared to what we knew even a decade ago. Also, in today’s world, everything happens under the watchful eyes of the public, the government, regulatory authorities and the media. So, let’s set our worries aside and wait for our turn to get that preventive shot against the pandemic.