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Last Updated : Sep 19, 2020 07:12 PM IST | Source: Moneycontrol.com

Coronavirus vaccine update | Phase III trial of Oxford's Covishield to begin in Pune next week

The phase-II trials were conducted at Bharti Vidyapeeth Medical College and also KEM Hospital in the city.

Candidate’s trial report finds no major safety issues: Pfizer’s internal COVID-19 vaccine trial report has found no major safety issues with the vaccine candidate, taking into account 12,000 individuals who received their second doses. Pfizer’s chief scientific officer Mikael Dolsten told investors in a virtual meeting that there are “no safety signals reported so far,”
Candidate’s trial report finds no major safety issues: Pfizer’s internal COVID-19 vaccine trial report has found no major safety issues with the vaccine candidate, taking into account 12,000 individuals who received their second doses. Pfizer’s chief scientific officer Mikael Dolsten told investors in a virtual meeting that there are “no safety signals reported so far,”

The phase III human trials of Oxford University's COVID-19 vaccine, manufactured by the Serum Institute of India (SII), will begin at the Sassoon General Hospital in Pune next week.

"The phase III trial of Covishield vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday (September 21). Some volunteers have already come forward for the trial. Around 150 to 200 volunteers will be administered the vaccine candidate dose," Muralidhar Tambe, the Dean of the state-run hospital, told news agency PTI.

"From Saturday (September 18), the hospital started enrolling volunteers for the trial. Those who are willing to volunteer for the vaccination should contact the hospital," he said.

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Phase II trials were conducted at Bharti Vidyapeeth Medical College and also KEM Hospital in the city.

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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The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.

The vaccine, called AZD1222 and under development by AstraZeneca and scientists at Britain's Oxford University, did not prompt any serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal after early-stage clinical trials in healthy volunteers.

Earlier this month, the SII had paused the clinical trials of the vaccine candidate in the country.

The Drugs Controller General of India (DCGI) had on September 11 directed the SII to suspend any new recruitment in phase II and III clinical trial of the vaccine till further orders after AstraZeneca paused the trials in other countries because of "an unexplained illness" in a participant in the study.

However, on September 15, the DCGI gave permission to SII to resume clinical trial of the vaccine.
First Published on Sep 19, 2020 07:11 pm
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