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The 1st Coronavirus Vaccine ‘mRNA-1273’ Ready for Human Experimental Test
The 1st Coronavirus Vaccine has been discovered for experimental testing in United states of America.
The new vaccine is a collaboration between NIAID scientists and the biotechnology company Moderna Inc., based in Cambridge, Massachusetts.
Covid-19 which is the disease caused by Coronavirus has been a threat to human lives and National Economy systems. However, it seems that we are getting close to eliminating this deadly virus.
The vaccine was fast-tracked to human trials, but more time is needed before it’s ready for public use. A healthy volunteer in Seattle is the first person in the U.S.A. to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial announced by the government health officials on March 16th.
Also Read: Coronavirus: Safety Health Measures Beyond the Surgical Mask and Hand Sanitizers
The National Institute of Allergy and Infectious Diseases (NIAID) allowed the new vaccine to be fast-tracked into clinical trials without thorough testing in animal models, which usually stands as a strict prerequisite to human testing. While making the jump to human trials could bring the vaccine to market faster, this is only step one.
In the next 6 weeks, researchers plan to enroll 45 participants in the trial, which will test the safety of the vaccine as well as its ability to induce an immune response in the volunteers. The trial will be taking place at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.
However, NIAID Director Dr. Anthony Fauci told the House Oversight and Reform Committee that this new Vaccine must pass through 3 iterative phases of clinical trials before being deemed safe and effective for widespread use. Assuming the initial tests go well, it may take 12 to 18 months before any vaccine is ready for public use.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Fauci said in a NIAID statement, published March 16. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
PHASE 1 TRIAL:
According to the U.S. Food and Drug Administration (FDA), this trial launched today is known as a “Phase 1 clinical trial,” meaning its main purpose is to provide information about how the vaccine interacts with a healthy human body.
Phase 1 trials examine a small group of people, typically between 20 and 80 individuals, who received different doses of an experimental treatment. Over the course of several months, researchers monitor how each volunteer metabolizes the given treatment and what common side effects emerge in response to different doses.
The 45 volunteers in the new trial will receive varying doses of the new vaccine called ‘mRNA-1273’ and they will be monitored over a 14-month period.
Volunteers will receive two injections of the vaccine in the upper arm, with a 28-day gap between doses. The first participant will receive the lowest dose of the vaccine, at 25 micrograms (mcg) per injection, according to the NIAID statement.
Three others will receive the same initial dose, and four more will each receive a 100-mcg dose of the vaccine and be thoroughly evaluated before any volunteers are given their second dose.
According to ClinicalTrials.gov., if participants’ reactions to the low doses prove acceptable, a third group of participants will receive 250 mcg of the vaccine per injection. In addition to monitoring for side effects, the researchers will test whether the vaccine triggers an immune response by analyzing the volunteers’ blood for antibodies.
However, If the vaccine works as designed, the immune system should generate antibodies that grab hold of a characteristic protein found on the surface of the novel coronavirus SARS-CoV-2.
Kaiser Permanente, the health care company conducting the trial said instead of introducing a dead or weakened virus into the body to prompt this reaction, as conventional vaccines do, the vaccine instructs cells to build the viral protein themselves using a molecule called messenger RNA (mRNA). Once utilized by the body, the mRNA should break down and be eliminated, leaving only protective antibodies behind.
PHASE 2 TRIAL:
According to the U.S. Centers for Disease Control and Prevention (CDC), the drug must then be tested in larger groups of people and over longer periods of time, in Phase 2 and Phase 3 trials.
Phase 2 trials typically examine several hundred people and monitor participants for periods of from several months to two years.
Worthy of note, Phase 2 trials serve as a secondary measure of safety and help researchers to refine the dosing of a particular medication. At this stage, researchers select participants with characteristics, such as age and physical health, that match those of the people who the vaccine is being developed for. (For example, although anyone can contract COVID-19, those of advanced age and those with chronic conditions are more likely to develop severe symptoms, so this could be a consideration in Phase 2 trials.)
PHASE 3 TRIAL:
According to the FDA, Phase 3 trials typically follows 300 to 3,000 volunteers over the course of one to four years; with a larger group of people, researchers can take note of unusual side effects of the drug, and by lengthening the study period, they can catch long-term side effects as they emerge.
Phase 3 trials must demonstrate that a given drug provides the medical benefits it’s intended to; if this coronavirus vaccine passes that test, the FDA could approve the drug for widespread use.
PHASE 4 TRIAL:
Following approval by the FDA, drugs undergo Phase 4 clinical trials, otherwise known as “post-marketing surveillance trials.” Once a drug enters public use, researchers monitor several thousand volunteers to spot side effects not seen in earlier trials and to track how well the vaccine works over extended periods of time, according to the National Cancer Institute.
Although this coronavirus vaccine may or may not reach Phase 4 trials in the coming years, limited studies have shown promising results. In the meantime, research groups around the world will continue to develop alternate vaccines to combat the spread of COVID-19.
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CBN Sells Polaris Bank To SCIL
The Central Bank of Nigeria (CBN) has announced the completion of the sale of shares in Polaris Bank to Strategic Capital Investment Limited (SCIL), a new core investor.
In a statement signed by its Director, Corporate Communications Department, Osita Nwanisobi, the CBN said that SCIL has paid an upfront consideration of N50 billion to acquire 100% of the equity of Polaris Bank and has accepted the terms of the agreement, including the full repayment of the sum of N1.305 trillion, being the value of the bonds, which as part of its intervention, in 2018, to revoke the licence of the former Skye Bank Plc. and establish Polaris Bank to assume its assets and certain liabilities, the banking industry regulator injected into Polaris through the Asset Management Corporation of Nigeria (AMCON) and is to be repaid over a 25-year period.
The statement reads: “The Central Bank of Nigeria (CBN) and the Asset Management Company of Nigeria (AMCON) are pleased to announce the completion of a Share Purchase Agreement (SPA) for the acquisition of 100% of the equity in Polaris Bank by Strategic Capital Investment Limited (‘SCIL’).
“Polaris has been operating as a bridge bank since 2018 when the Central Bank of Nigeria intervened to revoke the licence of the former Skye Bank Plc. and established Polaris Bank to assume its assets and certain liabilities. As part of the CBN intervention, consideration bonds with a face value of N898 billion (future value of N1.305 trillion) was injected into the bridge bank through AMCON, to be repaid over a 25-year period.
“These actions were taken to prevent the imminent collapse of the bank, enable its stabilisation and recovery, protect depositors’ fund, prevent job losses and preserve systemic financial stability. SCIL has paid an upfront consideration of N50 billion to acquire 100% of the equity of Polaris Bank and has accepted the terms of the agreement which include the full repayment of the sum of N1.305 trillion, being the consideration bonds injected.
“The CBN thus received an immediate return for the value it has created in Polaris Bank during the stabilisation period, as well as ensuring that all funds originally provided to support the intervention are recovered. The sale was coordinated by a Divestment Committee comprising representatives of the CBN and AMCON, and advised by legal and financial consultants. The Committee conducted a sale process by ‘private treaty’, as provided in Section 34(5) of the AMCON Act to avoid negative speculations, retain value and preserve financial system stability.
“In the process, parties who had formally expressed an interest in acquiring Polaris Bank, subsequent to the CBN intervention in 2018, were invited to submit financial and technical proposals. Invitations to submit proposals were sent to 25 pre-qualified interested parties, out of which three parties eventually submitted final purchase proposals following technical evaluation. All submissions were subject to a rigorous transaction process from which SCIL emerged as the preferred bidder having presented the most comprehensive technical/financial purchase proposal as well as the highest rated growth plans for Polaris Bank.”
The CBN Governor, Mr. Godwin Emefiele, was quoted in the statement as saying that: “This sale marks the completion of a landmark intervention in a strategic institution in the Nigerian banking sector by the CBN and AMCON. We commend the outgoing board and management for their vital role since the bridge bank was established; in stabilising the Bank’s operations, its balance sheet and implementing strong governance structures to address the issues that led to the intervention.
“This process has provided the CBN with an unprecedented opportunity to recover its intervention funds in full and promote financial stability and inclusive growth. We wish SCIL well as they implement growth plans to build the bank from the strong foundations that have been established.”
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