INTRODUCTION:

Several new viral diseases have a big effect on our health and well-being. Virus outbreaks like Crimean Congo hemorrhagic fever, Ebola, Lassa fever, Marburg virus, SARS-CoV, MERS-CoV, Nipah, Zika virus, Rift Valley fever virus, and COVID-19 are proof of the crisis.

The WHO called H1N1 in 2009, Polio in 2014, Ebola in West Africa in 2014, Zika in 2016 and Ebola in Congo "public health emergencies of international concern" because they had a big effect on life around the world (2019). A new coronavirus (2019-nCoV), which is currently called COVID-19, showed up for the first time in Wuhan, China, in December 2019 and has since spread all over the world.^1,2 Since early 2020, the COVID-19 pandemic, which is caused by the newly discovered coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has been a global disaster.^3,4 The COVID-19 pandemics were announced by the WHO on January 30, 2020. COVID-19 is very contagious in nature because it has changed to fit human infections, is easy to spread, and doesn't make people immune. Modern transportation networks, which have made the world more like a village, make it easier for infectious agents like COVID-19 viruses to spread quickly. COVID-19 was able to spread the infection to more than 210 countries. As of April 9, 2020, there have been 15, 21, 966 laboratory-confirmed cases and 88,659 deaths.^5,6

Coronaviruses are a large group of viruses that can make both animals and people sick with respiratory and digestive infections. The virions are large (100–160 nm), round, and have a shell around them. The envelope protects a single-stranded, positively charged RNA genome in a capsid that is 27–32 kb in size. Coronaviruses have four kinds of spikes: many long (20 nm) glycoprotein S-spikes, small hemagglutinin-esterase (HE) spikes in some viruses, a few transmembrane glycoprotein spikes, and envelope protein spikes.^7,8

Figure 1: Clinical Symptoms (Adopted and modified by using Microsoft Windows Paints Version 21H1)

COVID-19 shares some symptoms with the flu and other respiratory viruses. COVID-19 has a wide range of symptoms and how bad they are. Heart disease, high blood pressure, diabetes, and the age of the patient are all co-morbidities that can affect how the illness turns out. An adult with no major co-conditions got better quickly, but an older person with serious co-conditions needed intensive care and a ventilator to get better.^9,10 Most people have a fever, cough, sore throat, stuffy nose, tiredness, and a headache. People with weak immune systems, like the elderly, are more likely to have and have more severe atypical symptoms.^11,12

Figure 2: Diagnostic Protocol of SARS-CoV-2 (Adopted and modified by using Microsoft Windows Paints Version 21H1)

Coronavirus infections don't need to be diagnosed because they go away on their own and only cause a mild upper respiratory infection. The symptoms of coronavirus and other respiratory viruses are very similar. Assays done in a lab can give a correct diagnosis. At first, coronavirus can be diagnosed with virus isolation, electron microscopy, and serological tests, but after that, molecular assays are better (after genome sequences). Molecular diagnostic tests are faster, more sensitive, more specific, and less expensive than they used to be.^13,14 Real-time RT-PCR was used to diagnose COVID-19 once the full genomic sequence of the virus was known. All COVID-19 diagnoses made in more than a hundred virology labs in India that are approved by the NABL. Real-time RT-PCR is used to diagnose COVID-19, as recommended by the WHO and ICMR.¹⁵

A good vaccine or drug that fights viruses could help any virus. Without these, prevention is the only thing that can be done. Outbreaks of MERS, SARS, Nipah, and Zika teach us that staying away from animals and infected people and washing our hands often will keep us safe. COVID-19 is like other respiratory viruses in that it can spread through droplets, contaminated body parts, and direct contact. After touching these infected things, people who were more likely to get sick got sick, which made the virus stronger and spread it to more people? To stop the spread of viruses, a person who is sick or who might be sick should keep a safe distance, cover coughs and sneezes with tissues or clothing, wash their hands often, and safely throw away infected items. ^[10] Patients can get oxygen therapy; help with staying hydrated, antibiotics that kill microbes, and other treatments.^16,17 Antivirals like Remdesivir, lopinavir-ritonavir, and interferon-a 2b, as well as other drugs, were tried to control the 2019-nCoV, but they did not work as planned. There is no specific antiviral treatment for COVID-19. Hydroxychloroquine (400 mg BD for 1 day, then 200 mg BD for 4 days) and Azithromycin (500 mg OD for 5 days) can be given together as long as a doctor is watching closely.^18,19

COVID‑19 Vaccines:

Developing a vaccine usually starts with a phase called "exploration," which focuses on basic research and computer modelling to find natural or synthetic antigens that could be used as vaccine candidates. After that, 18–30 months of pre-clinical research start with cell culture, then animal tests to see how safe and effective the vaccine candidate is.^20,21

After getting the right results in vivo for safety, immunogenicity, and effectiveness, human clinical studies on safety and immunogenicity in small groups and then in large groups began (Phase 1 or I, 2 or II and 3 or III). The goal of making the COVID-19 vaccine was to cut this 10–15-year time frame down to 12–24 months. As soon as the SARS-CoV-2 genomic sequence became available, the first step could be taken.^22,23 By using information from the preclinical development of SARS-CoV and MERS-CoV vaccines and skipping the exploratory phase, a lot of time was saved. Some vaccines used preclinical and toxicological data from similar vaccines, while others changed the way vaccines that were already available were made. So, in March 2020, the first CVC clinical trial got under way.^24,25

By having the phases of a clinical trial happen at the same time, the time horizon was cut down. As soon as the phase I/II data had been looked at in the past, the phase I/II trials were quickly moved to phase III trials. Under Operation Warp Speed, the US sped up the development of five CVCs so that they could be used in an emergency by the end of 2020 and billions of doses could be ready by 2021. Manufacturers got ready to make billions of doses quickly, and some have already started making vaccines for sale without knowing the results of phase III trials. Emergency Use Authorization (EUA) makes it easier for countries like the UK and the US to review things, and many others will do the same. The hard work of making CVCs is done in a record 12–16 months, compared to the 10–15 years it takes to make a standard vaccine.²⁶

COVID 19 Vaccines Approved for Emergency Use:

In the past, people have used live attenuated viruses, dead viruses, protein or polysaccharide conjugated subunit vaccines, and virus-like particles. Vaccines now include nucleic acids, such as DNA and RNA, as well as viral vectors and recombinant proteins. Both T cells and B cells have a good immune response to SARS-CoV-2 that comes from their ability to adapt. IgG and IgM antibodies also start to show up about 10 days after infection. Most people can become seropositive in three weeks. The antibodies are made against the virion's intrinsic nucleoprotein (N) and spike protein, which have a neutralising effect (S). When antibodies bind to the receptor-binding domain (RBD) of the spike protein, the virus can't attach to the host cell. Here is a list of some vaccine candidates that have reached or finished Phase 3 trials and have been approved under EUA.²⁷

Sputnik V by Dr. Reddy’s Laboratories:

Gam-COVID-Vac is a COVID-19 vaccine that was made by the Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. It is also known as Sputnik V. Sputnik V is a two-vector viral vaccine for humans that are made from adenovirus. Sputnik V uses the adenoviruses Ad5 and Ad2618. The SARS-CoV-2 S protein cDNA is found in recombinant adenovirus types 26 and 5, which were made using biotechnology. Both are injected into the muscle between the shoulder blades. The Ad26-based vaccine is given on day one, and the Ad5 vaccine is given on day twenty-one. This is done to boost immune responses. The Russian Sputnik V vaccine needs to be kept at a temperature of -18°C. The DCGI has given Dr. Reddy's Laboratories in Hyderabad permission to test the Russian Sputnik V vaccine on humans in India in the middle to late stages. Several Indian companies have signed contracts with the Russian RDIF Gamaleya Institute to mass-produce the Sputnik V vaccine.^28,29

Covaxin by Bharat Biotech Ltd:

CovaxinTM is India's first COVID-19 vaccine. It was made by Bharat Biotech International Limited in collaboration with the ICMR's National Institute of Virology. It is one of two vaccines that the company is currently testing in clinical trials and stockpiling under a "at-risk manufacturing and stockpiling licence." CovaxinTM is a vaccine against viruses that has been killed and was made in Vero cells. As an adjuvant, the inactivated virus is mixed with Alhydroxiquim-II (Algel-IMDG), which is an imidazoquinoline chemosorbent on aluminium hydroxide gel that boosts immune response and gives longer-lasting immunity. This technology can be used because of a licencing deal with ViroVax, which is based in Kansas. On November 16, 2020, Bharat Biotech Ltd. and the ICMR started Phase-III studies of CovaxinTM with 26,000 volunteers in 25 centres across India. ^30,31 The business says that it is India's largest COVID-19 vaccination clinical trial. The company has done safety and immunogenicity tests on mice, rats, rabbits, Syrian hamsters, and non-human primates (Rhesus macaques) and hamsters. They have also done challenge tests on non-human primates and hamsters. All of these facts have been sent to India's drug regulatory authorities. In Phase I and Phase II clinical trials, almost 800 people were given the vaccine. The results showed that it is safe and gives a strong immune response and protection. The Phase-III effectiveness test began in India with 25,800 volunteers. So far, 22,500 people have been vaccinated all over the country. Based on the information we have now, the vaccination is safe. Bharat Biotech already has 10 million doses of Covaxin, and by February 2021, they will have another 10 million doses. By July and August 2021, the company will have made 150 million doses, and by the end of the year, 700 million doses will have been made. The company is also working on a plan to test the vaccine on more kids between the ages of 2 and 15.^32,33

Covishield by the Serum Institute of India:

The Serum Institute of India (SII) in Pune has agreements with Oxford-AstraZeneca, Codagenix, and Novavax. It is now making a lot of the Oxford-AstraZeneca Adenovirus vector-based AZD1222 vaccine, which in India is also called "Covishield" and has about 50 million doses. The company made 100 million doses every month after January 2021. SII wants to be able to make 2 billion doses of medicine per year. Covishield has been given a "at-risk manufacturing and stockpiling licence" by the Drugs Controller General of India (DCGI) and the Indian Council for Medical Research (ICMR). The ICMR paid for clinical trials of the Covishield vaccine, which was made with master stock from Oxford-AstraZeneca. The SII and the ICMR worked together on a Phase II/III randomised, controlled study in 14 centres across India with healthy people to compare the safety of Covishield (made in India) and the original Oxford-ChAdOx1 in preventing COVID-19 illness. 1600 people who were at least 18 years old took part in the study. The 400 people in the immunogenicity cohort were chosen at random to get either Covishield or Oxford-ChAdOx1 in a 3:1 ratio. The other 1200 people in the safety cohort were randomly given either Covishield or a fake drug called Placebo. The effectiveness of the ChAdOx1 vaccine was 70.42 percent when it was given in two doses with 5 1010 virus particles to 23,745 people aged 18 and up in clinical trials outside of India. In terms of safety and immune response, the results of the clinical trial in India were the same as those of other trials done outside of India.^34,35

Figure 3: Marketed available vaccines (Adopted and modified by using Microsoft Windows Paints Version 21H1)

Covid-19 Vaccination in India:

Vaccination could make people's immune systems stronger, get rid of serious diseases, and lessen the current health crisis. It looks like the only way to stop the pandemic from getting worse. The Indian government knows how important it is to get vaccinated against COVID-19, so it has approved the clinical use of two vaccines, the ChAdOx1 nCoV-19 vaccine (also called "Covishield" or the Oxford-AstraZeneca Vaccine) and the BBV152 vaccine (also called "Covaxin"), starting on January 16, 2021. First, the vaccination was given to health care workers (HCWs), who are the first line of defence against COVID-19. From May 2021 on, anyone in India who was 18 or older could join. COVID-19 vaccines are thought to be safe, but their effectiveness and side effects have been called into question. As HCWs are more likely to get infected with a virus and may be a source of further transmission, it's important to know that a COVID-19 infection could happen even after vaccination. The Centers for Disease Control and Prevention (CDC) says that new infections happen more than 14 days after the primary vaccine series is done.^36,37

METHODOLOGY:

With the help of questionnaires from many different districts, a cross-sectional study was done. We made the questionnaire and used it to find out things like which side effects happen most often after the first, second, and booster doses of a vaccine. We also find out how many people get the Corona virus after getting the vaccine.³⁸

Study design:

We conducted an online descriptive cross-sectional survey in March 2021.

Data collection tools and procedures:

Based on a literature review, an extensive survey questionnaire was created. These COVID-19 vaccination hesitancy questions were validated and published; they were adopted and modified for the purposes of this study. Participants were given a link to the Google Forms-designed online questionnaire. After a participant had submitted their finished survey, the resubmission option was disabled to prevent them from responding to the survey more than once. English was used to write the survey questions. Open-ended questions were also used to gather qualitative data, which will be published separately.³⁹

RESULT AND DISCUSSION:

Adverse effects seen after taking first dose of vaccine:

Adverse Effect	Covishield	Covaxin	Sputnik V
Fever	760	180	60
Nausea	150	20	-
Diarrhea	200	10	-
Weakness	520	90	20
Headache	690	70	60
Chills with shivering	560	90	60
Pain at site of Injection	580	150	80
Loss of appetite and Weight loss	100	50	20
No side effect	300	150	10

Adverse effects seen after taking second dose of vaccine

Adverse Effect	Covishield	Covaxin	Sputnik V
Fever	720	220	60
Nausea	40	40	20
Diarrhea	60	20	-
Weakness	560	80	20
Headache	540	120	80
Chills with shivering	420	60	-
Pain at site of Injection	820	60	120
Loss of appetite and Weight loss	140	40	20
No side effect	68	420	40

Adverse effects seen after taking booster dose of vaccine

Adverse Effect	Covishield	Covaxin	Sputnik V
Fever	40	-	-
Nausea	20	-	-
Diarrhea	-	-	-
Weakness	-	-	-
Headache	20	-	-
Chills with shivering	20	-	-
Pain at site of Injection	40	-	-
Loss of appetite and Weight loss	20	-	-
No side effect	20	40	-

51.7% of respondents who responded to the poll were female, and 48.3% were male. Responses to this poll came from a number of Maharashtra districts, including Mumbai, Pune, Nashik, Dhule, Palghar, Jalgaon, Sangali, and Raigad, among others. Nine responses came from Dhule, making up the majority of the responses (187), while one response came from each of the other districts.

According to a survey of 1000 people, 16.4% of respondents had a corona infection prior to receiving the vaccine. The remaining 83.6% of people were healthy. In this survey of 1000 people, we gather data on the vaccinations that respondents have received. And as a result, we discovered that the majority of people—72.6%—had received the Covishield vaccine. While just 4.5% of people took Sputnik V, 22.9% of people took Covaxin. Then we learn that out of 201 individuals, 6% had only received the first dosage of the vaccine, and 91.5% had received both the first and second doses. While 2.5% of the population had received the initial vaccination and the booster shot, then we collected information on the side effects of the vaccine's initial dose. The most typical adverse effect, occurring in 63.7% of cases, is fever. There were other negative consequences, ranging from 3 percent to 40 percent. While 46% of people report no negative effects, additionally, we discovered that participants had higher side effects following their first dosage of the Covishield vaccine. After receiving the second dose of the vaccine, participants reported fewer side effects. 46.3 percent of participants reported no side effects. Additionally, we discovered that people report higher side effects following the second dose of the Covishield vaccination. We can observe from this survey that relatively few respondents had taken a booster dose. That enables us to determine that 60% of people had no negative effects. The remaining 40% of patients experienced adverse symptoms such as fever, nauseousness, headaches, chills, shivering, pain at the injection site, and appetite loss. We also conducted a survey to determine how many vaccine recipients became infected with corona. Also, only 4% of those who received the immunization became ill with the Corona virus.

CONCLUSION:

Based on this survey of Covid 19 vaccines and vaccine breakthrough infections, we are able to draw the conclusion that more people experience adverse effects, such as fever, nausea, weakness, headache, chills with shivering, pain at the site of injection, and so on, after receiving their first, second, and booster doses of the Covishield vaccine. These adverse effects include: The majority of the time, we discovered that individuals became infected with the Corona virus after taking Covishield and Covaxin. As a result, we came to the conclusion that the Covishield vaccine may be less successful than the Covaxin and Sputnik V vaccines. This was due to the fact that more people became ill after receiving the Covishield vaccine.

This survey may prove helpful in the continued research on a vaccination against COVID-19. By making additional adjustments to the formulation of the vaccine, we can reduce the severity of the adverse effects. The effectiveness of COVID-19 vaccinations may also be improved in the not-too-distant future. These findings may be potentially valuable in future surveys about the vaccination against COVID-19.

DECLARATIONS:

Consent for publication:

All the authors approved the manuscript for publication.

Availability of data and material:

All required data is available.

Competing interests:

All authors declare no competing interests.

ACKNOWLEDGMENT:

The authors would like to thank the Principal and Secretary of Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, India.

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Received on 12.02.2023 Modified on 02.04.2023

Asian J. Res. Pharm. Sci. 2023; 13(3):195-200.

DOI: 10.52711/2231-5659.2023.00034