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Here’s What You Need To Know About Covaxin

Covaxin has been originally developed as well as manufactured in India’s Bharat Biotech located in Hyderabad jointly with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The vaccine is made up of Coronavirus in dead form and cannot infect the person but still doesn’t allow the virus to get multiplied in the person’s body. It also increases the immunity to fight against the virus as per various hypotheses. According to the mathematical calculations, it can provide immunity for 9 to 12 months says All India Institute of Medical Sciences(AIIMS). A booster shot may be given after this period of time. Also, the effectiveness of Covaxin has been found to be more than 50% which is needed for a regulator to approve a drug and it costs around Rs. 290 for a shot.

Working Of Covaxin

It does not require to be reconstituted, requires no sub-zero storage, and is stable at 2 to 8oC. It comes in multi-dose vials and is in liquid form. 2 doses of it are to be given 28 days apart. The Drug Controller General of India(DCGI) approved the vaccine for Phase I and II Human Clinical Trials in July 2020. However, fever, body ache, abdominal pain, nausea, injection site pain, headache, vomiting are some of the adverse effects following immunization(AEFIs).

In Phase I, 375 healthy volunteers were enrolled. The study groups consisted of participants aging between 18 to 55 years(both inclusive) of either gender. After the 14 days of the 2nd dose, i.e. on the 28th day, the participants who got vaccinated intramuscularly had remarkably increased IgG antibodies and Neutralizing Antibody titers. Also, the study consisted of a 12-month follow-up after the last vaccine administration. Only 15% was the percentage after combining all the side effects in the people who received the vaccine.

In Phase II, 380 random children and adults belonging to age group 12 to 65(both inclusive) of either gender were enrolled. The study consisted of a 6-month follow-up after the last vaccine administration. After 4 weeks, two intramuscular doses of vaccine were administered. Minimal adverse effects in both the vaccine groups were found after 2 doses and most of them were solved within 24 hours of onset.

Further, Prime Minister Narendra Modi got his first shot of Covaxin at All India Institute of Medical Sciences(AIIMS) by sister P. Nivedita from Pondicherry. Now people above 45 and 60 years of age will be given the COVID-19 vaccine at government facilities for free of cost but will have to pay at private hospitals. NCP Chief Sharad Pawar got his first shot accompanied by his wife Pratibha Pawar and daughter Supriya Sule. Union ministers Amit Shah, External Affairs Minister Dr. S Jaishankar, and Odisha's CM Naveen Patnaik are some of the recipients of the shots.

Controversy Of Covaxin

Experts doubted how a vaccine whose trials were still in progress was allowed to use for emergency use by millions of vulnerable candidates. Also, there was no efficacy data. In medical terms, 'Efficacy' of a product or treatment is its ability to provide beneficial effects. For Covaxin clinical trial, 25 locations were chosen and Mumbai’s Sion and JJ Hospitals were amongst them. Many candidates dropped out after the first dosage whereas, the hospitals were supposed to a thousand candidates each for the trial. The candidates cannot be forced but counseled.

Conducting Phases Of Clinical Trials

These phases are conducted only when they aim to improve the care of patients. Before that, preclinical research has to be done but not with the people. It can be done in a laboratory by taking small samples of human cells. Then clinical trials are done to check whether the tests work. Here come the 4 phases :

1.   Phase 0: Here the studies are not used widely. Candidates consist of people around 15 or less. The drug is given for a short time with a small dosage.

2.   Phase 1: Drug safety is tested here. Doctors initially give low doses of the drug and then give higher doses are given to other patients until they get the expected results or the side effects increase much.

3.   Phase 2: Includes more candidates mostly in hundreds than the previous phase who are monitored for several months. If the drug is still promising and has to be used for more people then, this may lead to the next phase.

4.   Phase 3: These studies can be done all across the country or even the world. Double-blind trials are conducted where investigators and the candidates both don’t know which medication the candidate is taking. Candidates can be more than hundreds.

5.   Phase 4: This can last for many years. Drugs used here are approved by FDA first. Thousands of candidates are included here.

Some Other Vaccines In India

·  Biological E. Limited(BE) which is a Hyderabad-based vaccination and pharmaceutical company that has developed a vaccine along with US-based Dynavax and Baylor College of Medicine.
·   Bharat Biotech has developed a nasal vaccine.
·  Pune-based Genova in along with Seattle-based HDT Biotech Corporation developed India's first mRNA vaccine HGCO19. It uses bits of genetic code to get an immune response.
·   Ahmedabad-based Zydus-Cadila developed ZyCov-Di.
·  Dr. Reddy's Lab and Gamaleya National Centre in Russia developed the Sputnik V vaccine. 

Conclusion

The attempts of Indian medical teams to fight against COVID-19 through Covaxin as well as other such vaccines are bearing fruit. On one hand, there are still many people getting infected by the virus while on the other hand, the large number of people fighting successfully against it also cannot be ignored. The increasing number of candidates for the intake of Covaxin surely proves to be appreciable.

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