Research in the Efficacy and Safety of COVID-19 Vaccines
Author - Sri Manoj Kumar from ATHEENAPANDIAN PRIVATE LIMITED
Co-authors - Rashika Murugan, Mohammed Sahil & Sudherson
About the development and deployment of COVID-19
The development and deployment of COVID-19 vaccines have been pivotal in the global fight against the coronavirus pandemic. These vaccines represent a beacon of hope, offering a pathway towards controlling the spread of the virus, reducing severe illness, and ultimately saving lives. With multiple vaccines authorized for emergency use, the world has witnessed an unprecedented effort to immunize populations at an accelerated pace.
Reason for developing vaccines need years why?
Developing vaccines typically requires years due to the extensive research and testing involved. This process includes identifying a vaccine candidate, conducting pre-clinical trials in animals, progressing to clinical trials in humans, and obtaining regulatory approvals. The time-consuming nature stems from ensuring safety, efficacy, and long-term effects of the vaccine on a large population.
Vaccines used in Covid 19
Ø Covishield,
Ø Covaxin,
Ø Sputnik V,
Ø CorBEvax,
Ø Covovax,
Ø ZyCoV-D
Technolgy Used In Vaccines
Ø Covishield is a Viral Vector-based Technology.
Ø Covaxin is a whole-Virion Inactivated Corona Virus Vaccine.
Ø Sputnik V is a Combined vector vaccine.
Ø CorBEvax is a protein subunit vaccine.
Ø Covovax is a rS Protein COVID-19 recombinant spike protein Nanoparticle Vaccine.
Ø ZyCoV-D is a recombinant DNA vaccine.
Each vaccine has specific compositions and technologies used in their development.
Phase of clinical trail of vaccines
· Phase I Clinical Trial: Involves a small number of participants to assess vaccine safety, immune response, and determine the right dosage (short duration).
· Phase II Clinical Trial: Includes a few hundred participants to assess safety and the ability of the vaccine to generate an immune response (short duration)
· Phase III Clinical Trial: Conducted with thousands of participants to determine vaccine effectiveness against the disease and safety in a larger group of people (duration 1-2 years).
Composition of the above vaccines
Ø Covishield: Inactivated adenovirus with segments of Corona Virus, Aluminium Hydroxide Gel, L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, and Disodium edetate dihydrate (EDTA).
Ø Covaxin: Inactivated Corona Virus, Aluminium Hydroxide Gel, TLR 7/8 agonist, 2-Phenoxyethanol, and Phosphate Buffered Saline.
Ø Sputnik V: Component I - Replication incompetent recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene. Component II - Replication incompetent recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene. Excipients include Tris, sodium chloride, sucrose, magnesium chloride hexahydrate, EDTA disodium salt dihydrate, polysorbate-80, ethanol 95%, and water for injection.
Ø CorBEvax: Aluminium hydroxide gel, CpG 1018, Buffer (Tris and NaCl in WFI).
Ø Covovax: SARS-CoV-2 rS Protein, DS Adjuvant Matrix-M1 Disodium hydrogen phosphate heptahydrate, Sodium dihydrogen phosphate monohydrate, Sodium chloride, Polysorbate 80.
Ø ZyCoV-D: Recombinant DNA Novel Corona Virus-2019-nCoV vaccine.
Dose schedule for the vaccines
Ø Covishield: Two doses, an interval of 12-16 weeks (84-112 days).
Ø Covaxin: Two doses at an interval of 4-6 weeks (28-42 days).
Ø CorBEvax: Two doses at an interval of 4 weeks (28 days).
Ø Covovax: Two doses at an interval of 3 weeks (21 days).
Ø Sputnik V: Two doses at an interval of 3 weeks (21 days).
Ø ZyCoV-D: Two doses at an interval of 4 weeks (28 days).
Side Effects of COVID-19 Vaccines.
Ø Covishield
Injection site tenderness, pain, headache, fatigue, myalgia, malaise, pyrexia, chills, arthralgia, nausea. Rare events of demyelinating disorders, thrombosis with thrombocytopenia syndrome reported.
Ø CorBEvax Vaccine
The CorBEvax vaccine may cause common side effects such as fever, headache, fatigue, body pain, myalgia, and nausea. Uncommon side effects include arthralgia, urticaria, chills, and lethargy. Local reactions at the injection site can include pain, erythema, swelling, and rash. It is important to monitor for these side effects and seek medical advice if needed.
Ø Covovax Vaccine
The Covovax vaccine commonly causes injection site pain, tenderness, fatigue, malaise, headache, fever, muscle soreness, joint pain, and nausea. Additionally, chills, redness, swelling, and body ache are common side effects. Uncommon reactions may include weakness, itching, rash, and redness. It is essential to be aware of these potential side effects and seek medical attention if necessary.
Ø Sputnik V vaccine
The side effects of the Sputnik V vaccine may include immediate symptoms like chills, fever, arthralgia, myalgia, asthenia, general discomfort, headache, injection site tenderness, hyperaemia, swelling, nausea, and dyspepsia.
Ø ZyCoV-D Vaccine
The ZyCoV-D vaccine may lead to pain at the injection site, redness, swelling, itching, headache, fever, muscle pain, fatigue, arthralgia, back pain, muscle spasms, myalgia, and musculoskeletal pain. Other potential side effects include neck pain, vertigo, diarrhea, gastritis, gastroesophageal reflux disease, nausea, vomiting, asthenia, chills, eye irritation, abdominal distension, abdominal pain, and more. It is essential to be aware of these side effects and seek medical attention if necessary.
Vaccines Safe for Pregnancy
The National Technical Advisory Group on Immunization (NTAGI) recommends that pregnant women may take either Covishield or Covaxin COVID-19 vaccines. Lactating women are also eligible for vaccination any time before and after delivery. The benefits of COVID-19 vaccination during pregnancy are believed to outweigh the risks associated with contracting COVID-19 infection during pregnancy.
Fight against the war
The Vaccines emphasizes the safety and efficacy of COVID-19 vaccines used in the country, highlighting the rigorous clinical trial processes followed to ensure public health safety. It underscores the importance of continuing COVID-appropriate behavior even after vaccination and addresses concerns related to vaccine-induced immunity, protection against new strains, and vaccination for specific populations like pregnant women and children.
Overall, the document provides comprehensive information on vaccine development, safety, efficacy, and recommendations, aiming to guide informed decision-making and public health measures during the ongoing pandemic.