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What are vaccines?

Vaccines are essentially the agents that activate the immune system without causing the disease. They can be manufactured from weakened or inactivated viruses, viral proteins, genetic material (mRNA) that encodes a viral protein. Taking a vaccine resembles getting survived from the disease, minus the drawbacks.

What are the concerns with the current vaccines for COVID-19?

  • There is very little knowledge regarding the long-term immune response to COVID-19.
  • A vaccine, when available, will only initiate the beginning of a prolonged and sluggish ramp down and the duration of this ramp down will rest on the vaccine’s efficacy.
  • Vaccines are always tested on healthy individuals. Their effectiveness in the real-world scenario is still unknown and vaccines may provide hope, but just relying on the vaccine is not advisable, as per the expert opinion.
  • Vaccine-induced immunity, though, tends to be weaker than immunity that arises after an infection. Vaccines are typically given as a shot straight into a muscle. Once your body recognizes the outside invader, it mounts an immune response by producing long-lasting antibodies that circulate in the blood.
  • However, respiratory viruses don’t usually attack the muscles. Instead, they invade respiratory cells and usually enter through the smooth linings of the nose and throat. Vaccinations do not encourage ample antibody production in these linings despite induction of antibodies in the blood, implicating that they are not completely reliable in preventing the virus from entering the body. However, they can indeed protect deeper tissues in the body from viral invasion. This trait of the vaccine agent prevents the worsening of the infection. Experts believe that a COVID-19 vaccine is not likely to attain “sterilizing immunity,” which, in simpler terms, means complete disease protection.
  • Hence, currently, it is perceived that the first vaccine might just restrict COVID-19’s infection severity, minus a total viral spread.
  • Also, contemporary regulatory guidelines have identified that the initial COVID-19 vaccine may be far from a 100 percent effectiveness mark; as the regulatory benchmark for a vaccine is that it should prevent or reduce severe disease in at least 50 percent of people who receive the vaccine, which is not ideal.
  • Several vaccines from different corporations have shown favorable data that their investigative vaccine products can induce antibodies that kill the coronavirus in lab tests as well as in clinical trials, but their real-world scenario is unknown, as of now.

Challenges in Vaccination

  • The success in delivering hundreds of millions of doses, and the willingness of people to get it at all. It is awful to contemplate the suffering still ahead. It is easier to think about the promise of a vaccine.
  • Biologically, a vaccine against the COVID-19 virus is unlikely to offer complete protection.
  • Logistically, manufacturers will have to make hundreds of millions of doses while relying, perhaps, on technology never before used in vaccines and competing for basic supplies such as glass vials. Then the federal government will have to allocate doses, perhaps through a patchwork of state and local health departments with no existing infrastructure for vaccinating adults at scale.
  • All of this means that we may have to endure more months under the threat of the coronavirus than we have already survived. Without the measures that have beat back.

What is the best way to prevent COVID-19 infection, even after vaccines are available?

  • Experts state that the outcome of COVID-19 is not going to change overnight, and the continuation of COVID-19 pandemic behavior remains important. Perceiving the vaccine as a magic bullet is troubled by danger. Social distancing accompanied by biological vaccination will have to continue in this long fight against this viral pandemic.
  • When vaccines are approved, ample doses that can fulfill the needs of the entire population will not be available, and an effective system will be required to store and distribute these vaccines.
  • Some of the foremost COVID-19 vaccines could also pose new transportation challenges, as they require storage at temperatures lower than –80°C.
  • Again, it is quite probable that a COVID-19 vaccine will require two doses; the first dose to activate the immune system, while the second dose to induce a stronger immune response. Administrators would have to balance supplying two doses to the entire population, ensuring each individual receives both the doses.
  • It seems it will create a situation where some individuals will be eager to get the vaccine, while some will be scared to get the vaccine.
  • Currently, there is no evidence of any major virus mutation. But sadly, in addition to reports of a mutated strain of COVID-19 virus from Britain entering India, our COVID-19 preventive behavior has also fatigued and people have become careless and are not following social barriers, as religiously as they need to do. Everyone has to pitch in and become a COVID-19 warrior once again, as they did during the early days of the pandemic.

As we enter 2021, experts all around the world are bending their backs to find a way to control COVID-19 and take humans away from year-long health hazards. Let’s talk about what is Herd Immunity and why is it important?

What is Herd Immunity?

Herd Immunity is nothing but ‘Herd Protection’ or ‘Population Immunity’. To protect the growing cases of Coronavirus, scientists and medical experts all around the world are trying to attain ‘Herd Immunity’- a concept that is used for vaccination.

Herd immunity occurs when most of the population becomes immune to a disease, making the spread of disease from person to person unlikely. As a result, the whole community becomes protected — not just those who are immune. Here, a population can be protected from a certain virus if the vaccination has reached a certain threshold. In the past Herd Immunity has been attained for many such diseases. Similarly, a Herd Immunity for COVID-19 is also in the phase of being developed. The percentage of people who need to have antibodies to achieve herd immunity against a particular disease varies.

How does Herd Immunity work?

To fight the disease, vaccines train our body to create proteins known as ‘antibodies’. These antibodies build our immune systems to protect us from the diseases and prevents them from passing on. Thus, breaking a chain of transmission of the disease. Individuals can become immune by recovering from an earlier infection or through vaccination. When we talk about Herd Immunity, it acts as indirect protection against the diseases that reduce the likelihood of infection for individuals who lack immunity.

Why is Herd Immunity important?

Once this threshold of herd immunity has been reached, the disease gradually disappears from the population – which is called eradication. Attaining Herd Immunity for COVID-19 is important to control and minimize the spread of diseases. It can be attained naturally or through inducting vaccines among people. Herd Immunity only applies to contagious diseases i. e. a disease that is passed on from one person to another. Herd Immunity has helped to eradicate many epidemics or pandemics in the past like Smallpox, measles, polio, etc. Each of these diseases has a Herd Immunity of 95% (for Measles), 80% (for Smallpox and Polio) respectively. 

Is Herd Immunity a way to fight COVID-19?

The scientists are still learning about Herd Immunity for COVID-19. Most of the people who have been infected with COVID-19 develop immunity in the initial weeks. But it is yet to be studied how long or strong the immune response is. As per WHO, it is also scientifically problematic and dangerous to reach Herd Immunity by exposing people to viruses. Because letting COVID-19 spread through any age or population will lead to serious infections or death.

There are also exceptions to Herd Immunity like infants who are too young to receive any vaccines or people who are immunodeficient due to HIV/AIDS, Lymphoma, Leukaemia, Bone Marrow Cancer, etc. Vaccines on these people will be ineffective. In addition to not being immune, they may also be at risk of developing complications and other infections due to their immunodeficiency.

Herd Immunity is just one of the ways to fight COVID-19. It is thought that 60-70% of the global population must be immune to achieve Herd Immunity and stop the coronavirus from spreading. Till then, the world continues to take other precautions to combat the battle of COVID-19 – right from lockdowns, social distancing, sanitization.

How far are we from achieving Herd Immunity?

A community is said to have reached Herd Immunity when a large percentage of its population gains antibodies or natural immunity for the said infection. It is yet to determine the threshold of Herd Immunity for COVID-19 given the trajectory of the pandemic and we are still far from reaching the same. However, European Union has launched a mass vaccination campaign after giving a go-ahead to Pfizer vaccine and India is gearing up for the dry runs to inoculate 30 crore ‘priority population’ which includes the frontline and healthcare experts. Vaccines such as Pfizer/BioNtech, AstraZeneca, Moderna, Sputnik, etc. are being introduced and are being approved by countries to induce Herd Immunity Vaccines. Although vaccination is in process, researchers still need to work on how long will the protection last. Thus, when it comes to Herd Immunity, we are in the process of identifying its full potential and effectiveness.

Herd Immunity in India

When it comes to Herd Immunity in India, given its vast population, we have a long way to go. Precautions are being taken to test the vaccines and attain an assured result of India can bank on for COVID-19 vaccines. As per India today’s latest article from 90k cases per day to 45k cases per day, the experts say that COVID-19 is done affecting the metropolitan cities and would be engulfing the rural areas in the coming months. Although people in slum areas have shown a higher prevalence of antibodies, the process of vaccination is being sped up tenfold to control the spread of the disease in all parts of India.

According to the reports, the majority of cases are still concentrated in less than 50 percent of India’s 28 states. Amongst these top 50% states, most cases are concentrated in and around large metros like Mumbai, New Delhi, Chennai, Bengaluru, Lucknow, Ernakulam, Hyderabad, etc.

Since people are looking up on Herd Immunity as a hope to end COVID-19, the journey is still far-fetched. From past experiences, experts have seen that Herd Immunity has its pros and cons. However, with the advancement in medical technology in the coming year, it can be overcome and zero spread of infections can be seen among people.

Till then, let’s not forget to keep a safe distance and sanitize!

Introduction: COVID Vaccine in India  

There are several institutions including academic/research and vaccine manufacturing companies in India that are in the process of developing of Covid-19 vaccine. There are four companies listed on the WHO website that are in the process of various stages of development. Serum Institute of India, in collaboration with Oxford University and Astra Zeneca, is undertaking a Phase 3 trial of the ChAdOx1 nCoV-19 vaccine in approximately 1600 healthy subjects 18–55 y of age. On successful completion of the Phase 3 trial with one dose of vaccine, the company shall start mass production.

Current Major Players in India for COVID-19 Vaccine

1) COVAXIN™

COVAXIN™ is India’s original COVID-19 vaccine developed by Bharat Biotech in cooperation with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) – Government of India. This native form of the vaccine is developed and manufactured at Bharat Biotech’s high containment facility having the maximum bio-safety level (BSL-3).

The vaccine received approval from the concerned regulatory authorities for conducting human clinical trials to check its safety and effectiveness in healthy subjects. After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN™, Bharat Biotech also received approval for Phase 3 clinical trials in 26,000 participants in over 25 centers across India.

Present Status of COVAXIN™ Vaccine Trial in India

  • Pre-clinical studies with small and large animals: COMPLETED.
  • DCGI approval for Phase I & Phase II Human Clinical Trials: RECEIVED.
  • Phase I Human Clinical Trial: COMPLETED.
  • Phase II Human Clinical Trial: COMPLETED.
  • DCGI approval for Phase III Human Clinical Trials: RECEIVED.
  • Phase III Human Clinical Trial: ONGOING.

2) Covishield

The Serum Institute of India (SII) and Indian Council of Medical Research are jointly conducting advanced phases of clinical trials to determine the safety and the ability of Covishield (COVID-19 Vaccine) to induce an immune response.

ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD. At present, SII and ICMR are conducting Phase 2/3 clinical trial of the vaccine at 15 different centers, across the country. It has completed the enrolment of all 1600 participants, as of 31 Oct 2020. The vaccine is being developed at the SII Pune laboratory with a master seed obtained from Oxford University/Astra Zeneca. The original vaccine prepared in the UK is currently being tested in large effectiveness trials involving participants from the UK, Brazil, South Africa and the USA. The encouraging outcomes from these trials so far have boosted assurance that COVISHIELD could be a genuine way out from this fatal pandemic. COVISHIELD is by far, in the most advanced phase of vaccine testing in Indians. SII along with ICMR will track the first disposal of this vaccine for the Indian population based on the Phase 2/3 trial results. SII has already mass-produced > 40 million doses of the vaccine, under a license from DCGI.

3) ZyCoV-D

Indian pharmaceutical giant, Zydus Cadila, involved in manufacturing innovative medicinal products, has declared its vaccine, ZyCoV-D for prevention of COVID-19 infection. The safety of this vaccine in healthy individuals is established in its Phase I clinical trial and has been recognized by an Independent Data Safety Monitoring Board (DSMB). On this basis, Zydus commenced the Phase II trial of its vaccine.

Present Status of ZyCoV-D Vaccine Trial in India

  • DCGI approval for Human Clinical Trials: RECEIVED
  • Phase I Human Clinical Trial: COMPLETED
  • Phase II Human Clinical Trial: ONGOING

4) Sputnik

Dr. Reddy’s Laboratories Limited and Sputnik LLC are together carrying out a multicentre, phase II/III adaptive clinical trial to evaluate the safety and ability of its vaccine to invoke an immune response.

Present Status of Sputnik Vaccine Trial in India

  • DCGI approval for conducting Human Clinical Trials: RECEIVED
  • Phase II Human Clinical Trial: ONGOING.

5) Biological E’s novel Covid-19 vaccine

Biological E Limited is piloting an initial phase of a clinical trial to assess the safety and capacity of its novel Covid-19 vaccine to induce an immune reaction against SARS-CoV-2 for preventing Covid-19 disease, upon intramuscular administration in two doses (0, 28D) to healthy volunteers. (Information based on ICMR website)

Present Status of Biological E Vaccine Trial in India

  • DCGI approval for Phase I & Phase II Human Clinical Trials: RECEIVED
  • Phase I/II Human Clinical Trial: ONGOING

Government Plan to roll out COVID-19 vaccine in India

The Indian government is getting prepared to roll out its Covid-19 vaccination drive through state-of-the-art technologies and alphanumeric trackers while depending on the established methods of distribution of vaccines. The strategic planning of vaccine roll out and its distribution throughout the country is being done by the National Expert Group on Vaccine Administration, a member at the NITI Aayog.

1) Criteria For Identifying Who Gets Vaccinated First:

As per government authorities, a full study on the urgency segments of the population that would have the first right of entry to the vaccination has been prepared based on recommendations of CDC (USA) and the WHO. Regardless of their financial background, the vaccine will be initially offered to individuals who are in urgent need.

2) Priority Groups Identified For The First Phase Of Covid-19 Vaccination:

The first allotment of 3 crore people to be vaccinated has been recognized. These include approximately 1 crore doctors and 2 crore health care personnel, including policemen, home guards, defense officers, civic workers including Asha workers and community workers.

People aged > 50 years and those aged < 50 years but having co-morbidities will be vaccinated in the second round.

The government strategizes to use the novel eVIN (Electronic Vaccine Intelligence Network) platform for storage and tracking of the vaccine and the citizen digital health ID to guarantee immunization while counting on the identical route of the Universal Immunisation Program (UIP).

3) Vaccine Stocking:

The authorities have confirmed that the eVIN network, is being re-equipped for delivering the COVID vaccine. The eVIN platform is currently functional across twelve states in India. It aims to help the Indian Government’s Universal Immunization Programme by providing actual information on available vaccine stocks and their transportation, as well as storage temperatures across all cold chain logistical hubs in these locations.

Approximately, 17,000 government officials have been skilled on the eVIN application while more than 6,700 temperature loggers have been functionalized. The program is to be ascended to cover the entire nook and corner of the country.

4) Vaccine Distribution:

The vaccine distribution will be as per the voter registration application to ensure each citizen is covered.

5) Role of State Governments

The Central government has notified the State governments to form committees for the Covid-19 vaccine roll-out. The state’s role will be to vaccinator identification through government and private sectors to restrict disturbances in repetitive immunization services at the time of Covid-19 vaccine introduction, and planning and charting sessions of vaccination for health care personnel. Mostly, the Covid-19 vaccination drive will last over a year with many groups being vaccinated serially beginning from health care workers. Hence, a strong guidance and coordination mechanism is vital to be created at the state and district level to monitor the process of Covid-19 vaccination with the assurance of minimum disturbance to other regular healthcare services.

As of today, the vaccine will take some time for the actual rollout but transport provisions will have to be kept ready well in advance to prevent any last-minute problems.

COVID-19 is a worldwide illness currently affecting millions of patients. Patients suffering from cardiovascular diseases (CVD) are especially vulnerable to respiratory tract infections, including COVID 19 and also these patients are at an elevated risk of ill health and even death from COVID 19.  However, the extent of damage in heart patients is currently uncertain.

As per evidence, patients with known CVD have a case fatality rate of 10.5% in case of a COVID 19 infection. Also, evidence suggests that 16.7% of COVID 19 patients, having CVD, develop abnormal heartbeat while 7.2% patients get acute cardiac damage. Cases of acute-onset heart failure, heart attack and other fatal cardiac symptoms have also been reported in COVID 19 patients with CVD. Heart complications in COVID 19 patients are comparable with SARS and MERS patients.

Suggested precautions for CVD patients to prevent COVID 19 infection

Following precautions are advised for CVD patients to prevent COVID 19:

  • Maintain your recommended blood sugar and blood pressure levels through regular intake of medicines. Currently, it is recommended to continue the prescribed ACE inhibitors or ARBs for hypertension, despite some reports of raised risk to COVID-19 susceptibility.
  • Frequently monitor your blood sugar and BP levels to rapidly identify any irregularities and get appropriate treatment adjustments
  • Get enough supplies related to your co-morbid testing and medications, in case of local worsening of outbreak, for at least 15 days.
  • Practice frequent handwashing with soap and water
  • Practice good respiratory hygiene by covering your mouth and nose with a tissue or bent elbow, in case of coughing or sneezing
  • Avoid touching your face, nose and eyes
  • Avoid unwanted travel and socializing
  • Stay vaccinated for each available infectious disease
  • Eat plenty of fruits and vegetables
  • Consume yogurt and probiotics for a healthy digestive system
  • Sleep for at least 8-9 hours to reduce stress and maintenance of immunity levels
  • Avoid crowd exposure
  • Avoid handshaking
  • Immediately contact your doctor if you develop any respiratory symptoms such as cold, cough, feeling difficulty in breathing or fever.
  • Last but not the least, stay hydrated.

And, of course, continue to stay active and follow an overall healthy regime. Stay connected with the people you love via phone calls, chats or emails because this kind of isolation can take a toll on your physical health and well-being. It’s important to understand that we all need to be extra vigilant in case we leave home especially people with underlying cardiovascular issues. Be mindful that every surface is a probable source of infection and everything that you bring inside your house could be affected by the virus. While this pandemic is a concern for the entire world, people with a known history of hypertension and cardiac disease have to be even more careful and nowhere is the saying “Prevention is better than Cure” more applicable than in such people.

Wearing face masks is just a part of an inclusive strategy for preventing and controlling the spread of viral infectious diseases, including COVID-19. Masks can be worn by healthy persons (for self-protection while accidentally coming in contact with an infected patient) or by an already infected patient for preventing further spread of the infection (source control). But, solely using a mask cannot provide optimum protection or source control. The WHO advises people to wear masks when unable to maintain social distancing. Compliance to other infection prevention and control (IPC) measures, such as maintaining social distancing and practicing hand hygiene are imperative to prevent human transmission of the viral disease.

Guideline for using masks in the health care settings

A) Use of medical masks (surgical or procedure masks) and respirators (N95 masks) for caring suspected or confirmed COVID-19 patients

It is recommended that health workers who directly provide care or come in direct contact with COVID-19 patients, should wear a medical mask (along with other PPE components that are a part of aerosol and contact precautions), in the absence of aerosol-generating procedures (AGPs).

In areas where AGPs are being performed, it is recommended to health care personnel that they should wear a N95 or FFP2 or FFP3 or equivalent standard respirator.

B) Targeted continuous use of medical mask by health workers in locations of known or suspected COVID-19 community transmission.

In the context of areas, where community spread of COVID-19 is suspected or an intense COVID-19 outbreak exists, following recommendations are provided:

Health workers practicing in clinical area should always wear a medical mask during their routine activities throughout the entire shift; apart from the duration when they are having their meals and changing their medical mask after caring for a patient who requires droplet/contact precautions for other reasons

It is particularly vital to adopt the strategy of continuous use of masks in areas with a potentially higher risk of transmission such as triage, waiting lounges of family physicians or OPDs, designated COVID-19 hospitals, cancer units, transplant units etc.

While continuously using medical masks, it is also vital to:

  • Change the mask if it gets wet, soiled or damaged.
  • Not touch the mask to adjust it.
  • If you have touched it, safely remove it, perform the hand hygiene procedure and use a fresh mask.
  • Discard the mask and the PPE and use a new set after coming in contact with a patient for contact or droplet precautions.
  • Personnel not working in clinical areas need not wear a medical mask during routine activities.
  • PPEs including masks should not be shared between workers and be suitably disposed after use and not to be re-used.
  • In addition to above recommendations, precautions of social distancing and hand hygiene practices should not be avoided as they are equally important.
Table 1: Recommended type of mask for use by health workers

Considerations for using non-medical masks

The utility of medical masks by the non-affected population may lead to a shortage of this extremely important supply to the health workers, who need them the most. In settings where medical masks are in short supply, medical masks should be reserved for use by only health workers and at-risk population when need arises.

Non-medical or fabric masks are prepared from varied woven and non-woven fabrics like polypropylene. Non-medical masks may be composed from differing fabric compositions, sequences or layers and shapes. However, a non-medical mask is neither a medical or surgical device nor a PPE.

Usage Considerations

The use of non-medical masks, prepared from woven fabrics such as cloth, and/or non-woven fabrics, should only be considered for used by infected persons in unrestricted settings and not for prevention. They can be used temporarily for activities such as travelling on public transport when social distancing cannot be maintained, and their use should without fail go with frequent hand hygiene and physical distancing.

Table 2: Recommended material, source and structure of non-medical masks

Elastic materials are not preferred to prepare masks as they get stretched after each use, causing increased pore size and lower effectiveness of the mask to filter droplets.

Layers

A minimum of three layers is needed for a non-medical mask, as per the used fabric. However, cotton handkerchief masks should consist of a minimum of 4 layers. Cotton gauze is found to be very porous with a filtration efficiency of only 3%.

The ideal material combination for non-medical masks should include three layers as follows: 1) an innermost layer of a material which absorbs water (e.g. cotton or cotton blends); 2) an outermost layer made of non-water absorbing material (e.g., polypropylene, polyester, or their blends) which may restrict external impurity from penetration through to the wearer’s nose and mouth; 3) a middle non-water absorbing layer of synthetic non-woven material such as polyproplylene or a cotton layer which may enhance filtration or retain droplets.

Shape

Shape of the non-medical mask should be flat-fold, fitting closely over the nose, cheeks and chin of the wearer. If the mask’s edges are not close to the face and shift, during activities like  speaking, air penetrates through the mask’s edges rather than getting filtered through the fabric. The mask should be equipped to be held in place by the use of elastic bands or ties.

Coating

Coating the mask with materials like wax may raise the barrier and make the mask liquid-resistant, but too much coating may cause difficulty in breathing through the mask due to complete blocking of pores.

Maintenance

  • Mask should be used only by a single person and not shared by multiple individuals
  • All masks should be changed immediately, if they get wet or are visibly soiled
  • When required, masks should be removed without touching the front portion of the mask and after mask removal, do not touch the eyes and mouth
  • Discard the mask, if you wish or keep it in a sealable bag until you wash it. After washing, immediately perform hand hygiene
  • Cloth masks should be frequently washed as per the cloth’s recommended washing temperatures
  • Wash in warm hot water, 60°C, with soap or laundry detergent.
  • Non-woven polypropylene (PP) may be washed at high temperatures, up to 125°C.
  • Natural fibres may resist high temperature washes and ironing.
  • Wash the mask delicately (without too much friction, stretching or wringing) if non-woven materials are used.
  • The combination of non-woven PP and cotton can tolerate high temperatures; masks made of these combinations may be steamed or boiled.
  • Where hot water is not available, wash mask with soap/detergent at room temperature water, followed by either i) boiling mask for one minute OR ii) soak mask in 0.1% chlorine for one minute then thoroughly rinse mask with room temperature water, to avoid any toxic residual of chlorine.
Table 3: Recommendations of areas where the general public should be advised to use masks in established or suspected community transmission areas

Wearing a face mask is not a substitute for physical distancing and basic hand hygiene but in some situations where you can’t follow social distancing and other preventive measures, wearing a mask can give you some layer of protection. It is important to follow the Government’s latest guidance on safeguarding yourself during the coronavirus pandemic, including travel advice within and outside the country.