Effectiveness and Possible Side effects of the Covishield Vaccine in Preventing Covid-19
Pratibha Tiwari1*, Prerna Tiwari2, Pratixa Patel3
1,2ROFEL Shri G.M. Bilakhia College of Pharmacy, Vapi, Gujarat.
3Department of Pharmacology, ROFEL Shri G.M. Bilakhia College of Pharmacy, Vapi, Gujarat.
*Corresponding Author E-mail: tiwaripratibha.lc@gmail.com
ABSTRACT:
This review evaluates the Covishield vaccine, which was developed by AstraZeneca and is produced in India by the Serum Institute, focusing on its effectiveness and potential side effects. The analysis employed various study designs, including test-negative case-control studies and cohort studies, to assess the vaccine's performance in preventing COVID-19 across diverse populations. The findings indicate that Covishield provides substantial protection, with a single dose offering approximately 49% effectiveness and two doses increasing the effectiveness to around 54% in preventing COVID-19 infection. Importantly, the vaccine demonstrates high effectiveness—about 95%—in preventing severe cases of COVID-19 that require oxygen therapy, highlighting its role in mitigating serious disease outcomes. Common side effects reported following vaccination include malaise, headache, fatigue, and fever. These symptoms generally onset 6-8 hours after vaccination and resolve within 24-100 hours. Additionally, some cardiovascular adverse events, such as tachycardia and hypertension, were noted, though their causal link to the vaccine remains unconfirmed. Overall, Covishield proves effective in reducing both the incidence of COVID-19 infections and the severity of the disease, with side effects that are typically manageable and transient.
KEYWORDS: Covid-19, Covishield Vaccine, Vaccine Side effects SARS-CoV-2, Vaccination, Early Response COVISHIELD, Vaccine effectiveness.
INTRODUCTION:
The December 2019 marked the identification of a new coronavirus (CoV) in Wuhan, China's Hubei province. The World Health Organization (WHO) declared a public health emergency of international concern on January 30, 2020 because of the new coronavirus's rapid spread.1-4
The novel coronavirus, which causes the pandemic coronavirus illness (COVID-19), was called SARS-COV-2 due to its strong sequence resemblance to the severe acute respiratory syndrome (SARS) coronavirus (SARS-CoV).5-12
One key strategy for avoiding COVID-19 is vaccination.13 India began immunizing against COVID-19 on January 16, 2021 in a phased manner. Health care workers (HCWs) and other frontline workers were given priority, followed by people over 60 and those with comorbidities between 45 and 60 years old. Finally, all adults were vaccinated against the virus.14
The Indian pharma regulator has approved two vaccines for use in an emergency: Covaxin(Table 1), which is an inactivated entire viriome produced in Vero cells, and Covishield (Table 1), which is a recombinant, replication-deficient chimpanzee adenovirus vector that encodes SARS-CoV-2 spike glycoprotein.15 About 88% of all doses administered in the nation to far have been Covishield, which is immunological and compositionally similar to the Oxford-AstraZeneca (ChAdOx1 nCoV-19) vaccine. In several places, including our city, Covishield has been the only vaccination administered as it’s overview given in Fig 1.15-18
In phase I/II trials, Covishield demonstrated a satisfactory safety profile; in the interim analysis of phase III trials, its efficacy in preventing infections was 74%. It is necessary to determine whether this vaccination is effective among Indians. In real-world settings, effectiveness is defined as the decreased risk of illness or sickness among persons that is attributed to vaccination.19-23
Fig 1 Overview of Covishield Vaccine 1-36
Table 1. Comparison between COVISHIELD and COVAXIN24,25
|
Characteristics |
COVISHIELD |
COVAXIN |
|
General name |
COVISHIELD |
COVAXIN |
|
Generic name |
ChAdOx1nCoV-19 |
BBV152 |
|
Developer |
The Oxford-AstraZeneca and manufactured by the Serum Institute of India (SII] |
Hyderabad-based Bharat Biotech International Ltd. in collaboration with the National Institute of Virology (NIVI) and the Indian Council of Medical Research (ICMRI) |
|
Type of vaccine |
Non-Replicating Viral vector The platform for
viral vectors |
Inactivated Whole-virus The inactivated vaccine was created using whole virion inactivated vero cell derived technology. |
|
FDA Approval |
Jan 1,2021 |
Jan 3,2021 |
|
Mode of action |
Adenoviruses are rendered Non-replicating and are used to introduce the gene for the spike protein Antigen into Human cells |
After being cultivated in Vero cell lines, SARS-CoV2 virus variants are adsorbed on and rendered inactive by beta-propiolactone. |
|
Ingredients |
L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, ethanol, sugar, sodium chloride, disodium edetate dihydrate (EDTA), magnesium chloride hexahydrate, and water for injection |
Contains 15 µg of imidazoquinolinone, a TLR 7/8 agonist, and 250 µgl of aluminium hydroxide gel, among other inactive substances. Six units of entire virion inactivated SARS-CoV-2 antigen [Strain: NIV-2020-7701] are included. 2. Phenoxyethanol 2.5 milligrams and up to 0.5 ml of phosphate buffered saline. Thus, inactivated or dead virus combined with the previously described compounds were used in the development of the vaccine. |
|
Doses |
Vaccination course consists of two separate doses of 0.5 ml, each given 4-6 weeks apart |
Vaccination series is two doses given 4 weeks apart with a dose of 0.5 ml each |
|
Site of administration |
The vaccination will only be administered intramuscularly (IM), ideally in the deltoid muscle. |
The vaccination will be administered by injection into the upper arm's deltoid muscle. |
|
Age limit |
people who are at least 18 years old Authorized for limited usage in an emergency |
|
|
Storage guidelines |
Stored at 2°C-8°C, which is a household refrigerator temperature |
|
|
Approx. cost per dose |
Rs. 225 retail prices for each dose |
|
|
Effectiveness |
Up to 90% of people can benefit from Covishield |
It has been determined that Covaxin is 78-81% effective |
|
Efficacy |
70.4% The vaccine demonstrated an overall effectiveness of 62.1%, with 90% of participants completing both doses. Over a 21-day period, the efficacy for both groups was 70.4%. The efficacy increased to 90% after receiving both dosages. Participants who received two standard doses had lower efficacy (70.4%) compared to those who received a lower first dose followed by a standard booster (90%). When the second dose was administered within six weeks of the first, the effectiveness was 53.4%, but it increased to 65.4% when given after six weeks. |
81% According to research, COVAXIN is 77.8% effective against COVID-19 disease with symptoms and 93.4% effective against severe COVID-19 disease. 33 The covaxin immunization is 78% effective against COVID-19 infection against mild, moderate, and severe illnesses. The first dosage of the vaccine had a 76.7% efficacy rate after 14 days of treatment. However, a phase 3 research showed an efficacy of 66.9% after 14 days and 66.1% after 28 days. The efficacy of preventing a major infection was 76.7% after 14 days and 85.4% after 28 days. |
|
Adverse effects |
With the second dose of AZD1222 compared to the first, adverse effects were usually mild or moderate and occurred less often. As per Folegatti's study, the most common side effects of AZD1222 were headaches, weariness, injection site pain, muscle soreness, and fever. fever, headache, chills, lightheadedness, sleepiness, and edema. and weakening of the arm, in addition to disorders of the digestive tract, neurological system, skin, and subcutaneous tissues, and lack of appetite.The most typical vaccination adverse effects were discomfort, fever, chills, muscle pain, headaches, and exhaustion. nausea, diarrhoea, edema, redness at the injection site, low blood platelet counts, stomach pain, itching, rash, swollen lymph nodes, decreased appetite, drowsiness, disorientation, and tiredness.
|
The most frequent side effects were headache, fever,
weariness, and injection site discomfort, with a high safety profile
documented. A severe allergic reaction may ensue, presenting with symptoms such as dyspnea, weakness, fast heartbeat, facial and throat swelling, rash all over the body, and disorientation. |
|
Advantages |
Effective induction of humoral and cellular immunity |
Mature technology and simple preparation. Good safety profile and stability |
|
Disadvantages |
High standards for the virus's activity and purity; potential pre-existing immunity |
Requires multiple vaccinations due to weak immunogenicity. Inadequate and brief immunity; adjuvants are necessary Inactivated vaccines have the advantages of being less expensive, easier to produce, and safer for people with compromised immune systems. |
MECHANISM OF ACTION OF THE COVISHIELD VACCINE:
A Segment of the Coronavirus: A portion of the SARS-CoV-2 virus11-more especially, its spike proteins, which the virus utilizes to enter human cells—is used in the Covishield vaccine. The Oxford-AstraZeneca vaccine, also known as Covishield, employs double-stranded DNA to store the genetic instructions for manufacturing the spike protein, in contrast to the Pfizer-BioNTech and Moderna vaccines, which use RNA.26,27
Fig 2 Covishield Vaccine: Mechanism of Action31
Genetic Material within an Adenovirus: This DNA is introduced into an adenovirus, a common virus that mimics the symptoms of the common cold. A modified chimpanzee adenovirus known as ChAdOx1, which may enter cells but not reproduce, was employed by the Oxford-AstraZeneca team.28 This strategy, which is based on Adenovirus technology, has been researched for many years and was also included in an Ebola vaccine.
Because the genetic material of the Adenovirus is protected by its protein coat, which keeps it chilled at 2-8°C for at least six months (Fig 1), the Covishield vaccine is more stable than mRNA vaccines.
Penetrating a Cell and Producing Spike Proteins: After injection, the adenovirus binds to the target cell, is absorbed, and releases its DNA into the nucleus.29,30 After reading the spike protein gene, the cell makes mRNA, which tells the cell to start producing spike proteins as shown in Fig 2.31
Detecting the Foreign Entity: The immune system recognizes these proteins when they either break into fragments or protrude from the cell's surface. Helper T cells employ spike protein fragments that antigen presenting cells show to identify and activate other immune cells as part of the immunological response. Producing Antibodies and Eradicating the Virus: Subsequently, B cells generate antibodies that attach themselves to the spike proteins, designating the virus for elimination and impeding infection.
Destroying Infected Cells: In order to eliminate any infected cells exhibiting spike protein fragments, killer T cells are also activated. All things considered, Covishield provides immunity against COVID-19 by teaching the immune system to identify and react forcefully to the coronavirus spike protein.1,30,31
SAFETY PROFILE:
Common Side Effects:
The Covishield vaccination has short-term, minor side effects that occur moderately frequently. The most prevalent adverse effect seen was insomnia, while the most common side effects were malaise, headache, weariness, sneezing, nausea, and chills in participants. Pyrexia (fever) with a sore throat was the next most common side effect.33 The adverse effects began 6–8 hours after the immunization and take an average of 24–72 hours to subside.34-37
Rare Adverse Events:
Two common side effects of the vaccines under investigation were flushing (12.17%) and Tachycardia (16.41%). Among them include peripheral coldness (2.41%), hypertension (5.82%), and hypotension (3.60%). There were four ECG endpoints (pressure, one severe flush, and one hypertension) and nine clinical cardiovascular endpoints. Four tachycardias were reported from the electrocardiographic endpoints, one of which was considered to be quite significant (Fig 1).36,37
Monitoring and Reporting:
Acute myocardial infarction, cardiac arrest, and circulatory collapse were linked to vaccinations reported from vaccines whose descriptions were not included in the database, per the disproportionality analysis based on IC025 values. Four tachycardia episodes (one serious), one blood pressure drop (serious), one blood pressure increase, one flushing incident (serious), and one hypertension event were among the clinical endpoints linked to unidentified vaccinations.
Four Tachycardias were reported from the electrocardiographic endpoints, one of which was deemed to be quite significant. The vaccination used in the age group over 75 years was linked to acute myocardial infarction, cardiac arrest, and circulatory collapse, per the disproportionality analysis based on IC025 values. In nearly all age groups and genders, vaccination against hypertension and severe hypertension, such as hypertensive emergency and urgency, was linked to the condition. Moreover, palpitations, sinus tachycardia, paroxysmal tachycardia, supraventricular tachycardia, and other rhythm abnormalities have been linked to vaccinations are given in Fig1 and Fig 3.36 Additionally, it was discovered that vaccination use was connected to peripheral circular failure.
Investigations and laboratory tests revealed that the vaccination administered to a particular age group, gender, or set of individuals was linked to aberrant ECG readings, elevated C-reactive protein, rise in D-dimer, and increase in troponin .36,39
Fig 3 Covishield Vaccine Efficacy and Side effects16,25
Efficacy: The recombinant Covishield chAdOx1-S vaccination exhibits a 70.4% effectiveness rate against the SARS-CoV-2 Covid-19 illness.The Covishield vaccine has been proved its efficiency and effectiveness in real worldwide and also has a significant health impact on the public in terms of lowering infection, hospitalization, and also death as given in Fig 3.40
Storage conditions: It should be kept between +2˚C and +8˚C in the refrigerator. When storing multi-portion vials between 2˚C and 25˚C, they should be utilized as soon as possible after opening, ideally within 6 hours.36-44
COVISHIELD BOOSTER DOSE:
The adverse effects of the Covishield booster dose were similar to those observed with the initial two doses but were more pronounced. Common side effects included pain at the injection site, body ache, fever, headache, muscle pain, and fatigue. Specifically, 79.2% of Covishield booster recipients reported pain at the injection site, which was the most frequent local adverse effect. Other common side effects observed were body ache (43.1%), headache (34.7%), fever (30.6%), and muscle pain (26.4%). No severe side effects requiring hospitalization were reported, indicating that the adverse effects were generally mild to moderate in severity.45
Thus, Covishield booster dose is associated with several mild to moderate adverse effects, they are manageable and similar to those experienced after the initial doses. The most common side effect is pain at the injection site, followed by general symptoms like body ache and fever.25
FUTURE DIRECTIONS:
Ongoing Research: Ongoing studies continue to investigate the long-term efficacy and durability of the Covishield vaccine, particularly among elderly populations. Future research plans include monitoring antibody levels beyond the 9-month mark, examining cellular immune responses, and assessing the vaccine's effectiveness against emerging variants of SARS-CoV-2.8 Additional studies are focusing on the comparative effectiveness of Covishield with other vaccines and the potential benefits of heterologous booster regimens.46,47
Booster Doses: The significant decline in antibody response observed over nine months underscores the need for booster doses to maintain immunity, especially in older age groups.41 Related studies are being conducted to determine the optimal timing and composition of booster doses. Research is also examining the safety and immunogenicity of administering different types of vaccines as boosters, including mRNA and protein subunit vaccines. These efforts aim to enhance long-term protection and address waning immunity in vulnerable populations.45-49
CONCLUSION:
The Covishield vaccine has proven effective in preventing COVID-19, reducing the severity of the disease, hospitalizations, and deaths. It elicits a strong immune response, providing significant protection against SARS-CoV-2 and its variants. Common side effects are mild and short-lived, such as pain at the injection site, fever, and fatigue. Rare but serious side effects like thrombosis with thrombocytopenia syndrome (TTS) are continuously monitored.
Overall, the benefits of Covishield in preventing COVID-19 far outweigh the risks of potential side effects. Ongoing research ensures its long-term safety and efficacy, particularly with emerging variants and the need for booster doses.
COMPETING INTERESTS:
The authors have no relevant financial or non-financial interests to disclose.
AUTHOR CONTRIBUTIONS:
All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed and the first draft of the manuscript was written by Pratibha Tiwari, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
DATA AVAILABILITY:
The authors confirm that the data supporting the findings of this study are available within the article.
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Received on 14.08.2024 Revised on 11.11.2024 Accepted on 15.01.2025 Published on 03.05.2025 Available online from May 05, 2025 Asian J. Pharm. Res. 2025; 15(2):176-182. DOI: 10.52711/2231-5691.2025.00029 ©Asian Pharma Press All Right Reserved
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