Covid-19 Vaccine – Covovax is the 11th vaccine to receive an emergency use authorization (EUA) from the Food and Drug Administration (BPOM) on Thursday (11/18/2021).
It is manufactured by Serum Institute of India Pvt Ltd, India (SII). This company also produces Novovax vaccine products. The vaccine was made using recombinant glycoprotein spike protein subunit platform technology using the Matrix-M1 adjuvant vaccine.
As Covid-19 vaccine, Covovax has also met the evaluation requirements issued by the World Health Organization (WHO).
Avalibility in Indonesia
India has approved the export of 20 million doses of Covovax Covid-19 vaccine to Indonesia.
SII told Reuters last month it could produce up to 100 million doses of Covovax by December.
SII’s chief executive said that they expect to export 20-30 million doses of Covishield to COVAX in November. They also expect the same amount in December once India’s needs of vaccines are nearly met.
One source said the government first wanted to ensure sufficient doses to completely inoculate nearly all of India’s 944 million adults, possibly by January. The tentative target is to have around 1.7 billion doses in total.
The efficacy will show after 7 days of giving two doses in adults aged above 18 years. The dose is 5 micrograms per dose twice and with an interval of 21 days.
The results of the Phase 2/3 clinical trial in India showed a good immune response from the measurement 14 days after the second shoots.
This covid-19 vaccine is stored at 2-8 degrees Celsius and can be stored using the standard cold chain available in tropical countries.
According to the research, here are the efficacy level of Covovax vaccine:
- 89.7-90.4 percent in all Covid-19 cases of varying severity.
- Moderate and severe severity is around 86.9-100 percent.
- Eldery group based on a phase 3 clinical trial in the UK was 88.9 percent.
Side effects Based on the results of a detailed evaluation of the safety aspect, the side effects reported from the Covovax Vaccine clinical trial were mild to moderate.
The most frequently reported side effects are :
- local pain (23.9-32 percent),
- tenderness (9.9-11.4 percent),
- headache (15.5-19,9 percent),
- fatigue (8 ,7-17.9 percent),
- muscle pain/myalgia (8.5-15.5 percent), and
- fever (3.5-14.4 percent).
Clinical trials in 5 countries The evaluation results from aspects of safety, immunogenicity, and efficacy of the Covovax vaccine refer to data from pre-clinical trials and clinical trials conducted in
- the United States,
- the United Kingdom (UK), and
- South Africa.
SII has also conducted a phase 2/3 clinical trial in India.
Quoted from the official website of the Serum Institute of India Pvt Ltd, India (SII), from the third phase of clinical trials in the United States and Mexico, the Covovax vaccine provides 100 percent protection against COVID-19 cases, both moderate and severe symptoms.
Meanwhile, a third clinical trial in the UK showed this vaccine had an efficacy rate of 96.4 percent against the Wuhan coronavirus and 86.3 percent against the Alpha or B188.8.131.52 variant.
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Source: Kompas, tempo