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Coronavirus vaccine update: Serum Institute starts phase 2, 3 clinical studies on over 1,600 volunteers

A written form of consent will have to be filled by the participants and they have to reside in the study area.

August 19, 2020 / 07:58 PM IST

Serum Institute of India (SII) has initiated phase two and three clinical trials of its COVID-19 vaccine to evaluate its safety and immune response on healthy Indian adults, news agency ANI reported. 

The pharmaceutical giant received approval from the Drugs Controller General of India (DCGI) earlier this month.

According to the report, a total of 1,600 participants, aged 18 and above, will be enrolled in the study, which will be conducted on 17 sites in India.

These sites include the Andhra Medical College in Visakhapatanam, Seth GS Medical College and KEM Hospital in Mumbai, BJ Medical College and Sassoon General Hospital in Pune, All India Institute of Medical Sciences (AIIMS) in Delhi, among others.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Of the total participants, according to the report, 400 will be a part of immunogenicity cohort and will be randomly assigned, in a 3:1 ratio, to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19.

The remaining participants will be assigned, again in a 3:1 ratio, to receive either COVISHIELD or the placebo, respectively.

According to the Clinical Trial Registry India, Covishield will be administered as two doses on day one and 29 as a 0.5 ml dose intramuscularly.

"Placebo will be administered as two doses on scheduled days one and 29 as 0.5 ml dose intramuscularly," it added.

A written form of consent will have to be filled by the participants and they have to reside in the study area while also complying with the study protocol requirements. Participants, according to the report, will be excluded if they have acute illness with or without fever at the time of vaccine administration.

Those with a history of laboratory-confirmed COVID-19 disease will not be enrolled for the study, according to the report. Moreover, female participants of childbearing potential are required to have a negative urine pregnancy test 24 hours prior to the vaccine administration.
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first published: Aug 19, 2020 06:38 pm
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