Current Affairs


September 8, 2020
*WORLD Vaccines in Phase-3 Trail Stage
* INDIA — 2 Vaccines in Phase -2 Trial Stage
* At least three vaccine candidates developed by the Western World are expected to be available in this year itself.
1.Russia released its vaccine for public use yesterday.
2. ‘Covishield’ by University of Oxford-AstraZeneca:
2.1.1. What remains–Final Approval
2.2. One of the most closely watched candidates globally, this vaccine works on a mechanism that uses a weakened and non-replicating version of a common cold virus that infects chimpanzees to carry a code that will tell cells to build just the spiky outer layer of the SARS-CoV-2 virus (the spike protein).
2.3. The body’s immune system is expected to recognise this as a threat and develop antibodies to fight the spike protein so that it will be ready in case the real virus tries to infect it.
2.4. AstraZeneca has reported that it has obtained ‘good data so far’ on its Covid-19 vaccine candidate, which was licensed from the University of Oxford and is currently in large-scale clinical studies.
2.5.The potential vaccine has entered its final trial in Brazil, with
studies ongoing in the UK and South Africa.
2.6. In the Phase I/II COV001 trial conducted in the UK, the vaccine was tolerated and generated strong immune responses in all evaluated participants.
2.7.Findings were published in The Lancet journal.
2.8.Study results showed that a single dose of the vaccine led to a four-fold increase in antibodies to the SARS-CoV-2 spike protein in 95% of participants one month following vaccination.
2.9. Furthermore, a T-cell response that peaked by day 14 and maintained two months after injection was observed in all subjects.
2.10. AstraZeneca signed deals with multiple countries to produce more than two billion doses of the investigational Covid-19 vaccine and hopes to secure approval by the end of this year.
2.11.The India trials started on August 26, with two volunteers in Pune’s Bharati Vidyapeeth Medical College receiving the first shots.
2.12. As of August 27, at least 10 of the 17 clinical trial sites across the country expected to conduct these trials were still awaiting approvals from their ethics committees, without which they would not be able to begin enrolling participants.
2.13.The phase II/III trials in India are expected to take seven months–potentially until March 2021–according to CTRI.
3. THE PFIZER VACCINE–Status–in Phase–3 Trials
3.1. Pfizer has adopted the “Investigational Vaccine Route”.
3.2. It is called the “mRNA” Vaccine.
3.3. The investigational vaccine is an mRNA vaccine.
3.3.1. It is a kind of vaccine that gives a body’s cells instructions to make viral proteins that can be recognized by the immune system. 3.3.2.It contains a small part of the genetic code for the SARS-CoV-2 spike protein.
3.3.3. By delivering the mRNA to the body’s cells, the viral protein is expressed and an immune system response is generated against it, with the goal of preventing COVID-19 disease.
3.3.4.The vaccine does not contain any live virus or the parts of the virus that can make a person sick.
3.3.5. mRNA vaccines are different because they contain information about the infectious agent to give a body’s cells instructions to make a viral protein that can be recognized by the immune system.
3.3.6. Pl see the images of the trial locations and trial details of Pfizer attached below.
4. MODERNA–mRNA 1273–Phase -3 Trials started on July 27
4.1. The Phase 3 study protocol follows the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies.
4.2.The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg.
4.3.The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomatology.
4.4. SARS-CoV-2 is the virus that causes COVID-19.
4.5. With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study. 4.6. The clinical research sites, with the support of the Company, are working within their local communities to reach a diverse population.
4.7. Working together with collaborators, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.
4.8.The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 because of the Company’s internal U.S. manufacturing capabilities and strategic collaboration with Lonza, Ltd.
4.9. In addition, Moderna recently announced a collaboration with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility for the U.S., and with ROVI of Spain for fill-finish manufacturing outside the U.S.
4.10. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine
Research Center.
1. BHARAT BIOTECH– In Phase–2 Trials Stage
1.1. Bharat Biotech is expected to move to phase II trials of ‘Covaxin’, its Covid-19 vaccine candidate, this week
1.2. The Centre has given approval to Hyderabad-based Bharat Biotech’s coronavirus vaccine Covaxin to conduct phase 2 of clinical trials from September 7.
1.3.The trials will be conducted on 380 volunteers, according to a letter issued to Bharat Biotech International by Dr S Eswara Reddy, the Joint Drugs Controller of India.
1.4. In the first phase of the Covaxin trial, around 375 participants were studied across 12 sites.
2. ‘ZyCov-D’ by Zydus Cadila:– In Phase-1/2 trials
2.1.One of the indigenously produced frontrunners in the Covid-19 vaccine race, this uses a genetically engineered DNA molecule coded with the DNA sequence of the SARS-CoV-2 virus, against which the immune response is expected to be developed.
2.2. Zydus Cadila announced early in August that phase I trials of the candidate showed it was “safe and well tolerated”, allowing it to move to the second phase of human trials on August 6.
2.3. While company chairman Pankaj Patel earlier said that the phase I and II trials would take around three months–until October–CTRI shows that the trials, conducted on over 1,000 participants, are expected to take around a year to complete.
2.4.The firm is reportedly looking at building a capacity to produce 100 million doses if phase II trials are successful.
2.5.The phase II/III trials in India are expected to take seven months–potentially until March 2021–according to CTRI.
Ramdas Iyer
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