This is an adaptation of a recipe in Charmaine Solomon’s classic “The Complete Asian Cookbook” first published in 1976 and remains in publication.
Phases of clinical trials
Many clinical trials to develop new interventions are conducted in phases. In the early phases, the new intervention is tested in a small number of participants to assess safety and effectiveness.
Phase I Clinical Trial
Phase I clinical trials are done to test a new biomedical intervention for the first time in a small group of people (e.g. 20-80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).
Phase II Clinical Trial
Phase II clinical trials are done to study an intervention in a larger group of people (several hundred) to determine whether it works as intended and to further evaluate its safety.
Phase III Clinical Trial
Phase III studies are done to determine whether it works as intended in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care). Phase III studies are also used to monitor adverse effects and to collect information that will allow the intervention to be used safely.
There are currently five Phase III Trials listed on the WHO website. Read about each one below and the full list is shown below these.
University of Oxford/AstraZeneca
A vaccine in development by the British-Swedish company AstraZeneca and the University of Oxford is based on a chimpanzee adenovirus called ChAdOx1. A study on monkeys found that the vaccine provided them protection. In May, the United States awarded the project $1.2 billion in support. Their Phase I/II trial reported that the vaccine was safe, causing no severe side effects. It raised antibodies against the coronavirus as well as other immune defenses. The vaccine is now in a Phase II/III trial in England, as well as Phase III trials in Brazil and South Africa. The project may deliver emergency vaccines by October. AstraZeneca has said their total manufacturing capacity for the vaccine, if approved, stands at two billion doses. The study completion date is listed at Oct 2021
Sinovac
The private Chinese company Sinovac Biotech is testing an inactivated vaccine called CoronaVac. In June the company announced that Phase I/II trials on 743 volunteers found no severe adverse effects and produced an immune response. Sinovac then launched a Phase III trial in Brazil in July. The company is also building a facility to manufacture up to 100 million doses annually. The study indicates a completion date of Sept 2021
Wuhan Institute of Biological Products/Sinopharm
After finding that an inactivated virus vaccine was safe and provoked an immune response, the state-owned Chinese company Sinopharm launched Phase III trials in July in the United Arab Emirates. Abu Dhabi’s health minister was the first volunteer to be injected, and 15,000 people were scheduled to participate in total. In July, the chairman of Sinopharm told Chinese state media that the vaccine could be ready for public use by the end of the year. Expected completion July 2021
Moderna/NIAID
Moderna develops vaccines based on messenger RNA (mRNA) to produce viral proteins in the body. They have yet to bring one to the market. In partnership with National Institutes of Health, they found that the vaccine protects monkeys from the coronavirus. In March, the company put the first Covid-19 vaccine into human trials, which yielded promising results, After carrying out a Phase II study they launched a Phase III trial on July 27. The final trial will enroll 30,000 healthy people at about 89 sites around the United States. The government has bankrolled Moderna’s efforts with nearly $1 billion in support. Completion date for study indicated as July 2022
BioNTech/Fosun Pharma/Pfizer
The German company BioNTech has entered into collaborations with Pfizer, based in New York, and the Chinese drug maker Fosun Pharma to develop their mRNA vaccine. In July, they posted preliminary results from their Phase I/II trials in the United States and Germany. They found that the volunteers produced antibodies against SARS-CoV-2, as well as immune cells called T cells that respond to the virus. Some volunteers experienced moderate side effects such as sleep disturbances and sore arms. On July 27, they announced the launch of a Phase II/III trial with 30,000 volunteers in the United States and other countries including Argentina, Brazil, and Germany. Study indicates a primary completion date of April 2021.
If approved, Pfizer said they expect to manufacture over 1.3 billion doses of their vaccine worldwide by the end of 2021.
Beijing Institute of Biological Products/Sinopharm
After finding that an inactivated virus vaccine was safe and provoked an immune response, the state-owned Chinese company Sinopharm launched Phase III trials in July in the United Arab Emirates. Abu Dhabi’s health minister was the first volunteer to be injected, and 15,000 people were scheduled to participate in total. In July, the chairman of Sinopharm told Chinese state media that the vaccine could be ready for public use by the end of the year. Expected completion July 2021
A new case has been confirmed in South Gippsland. The postcode area data for Active cases has not been updated since July 31st, the day it was first publicized. 6 active cases in total.
Daniel Andrews to Impose $5000 Fine for Isolation Breaches. Update from Council CEO Kerryn Ellis
The following is from South Gippsland Shire Council CEO, Kerryn Ellis:
Sunday’s announcement that regional Victoria will be returning to stage three restrictions has been a blow for all of us. Although the news was perhaps not entirely unexpected considering the increasing number of COVID-19 cases across Victoria, the restrictions mean that our movement and our ability to socialise with friends and family will again be limited.
This closure will be difficult for many people. Stage three restrictions were hard the first time but this time it is even more important that we work together, that we reach out to others and that we “be kind” to all. Many in our community are still struggling with the impacts of isolation from the first lockdown and our local businesses are only just in the process of getting back on their feet. They will need our support. The one benefit we have is that we have been through this already, we know we can get through it and we know how we can do better.
Here is a summary of some of the changes that will be in place from Thursday:
·There will be only four reasons to leave your home: necessary goods and services; medical care or compassionate reasons; exercise; work and education if necessary. Exemptions include visiting a person with whom you are in an intimate personal relationship, including inside metropolitan Melbourne. Face coverings are mandatory.
·You cannot enter metropolitan Melbourne for exercise or recreation.
·You are unable to have visitors in your home. Meeting in public can be with up to two people or household members only. Social distancing measures apply.
·Council’s customer service centre and offices will remain closed. However, we are still here to support you and customer service is available via telephone, online and email.
·Outdoor sporting facilities will close except for facilities where public gathering and physical distancing limits can be adhered to and there is no use of shared equipment or communal facilities (except toilets), eg: tennis courts, golf courses.
·Outdoor sports will only be allowed with one other person, or household members, providing 1.5 metre distance can be maintained, eg: activities such as fishing, golfing, boating, tennis, surfing.
·Swimming pools and playgrounds will close.
·Libraries will close. Caring Calls, Tech Talks, Online Chat, home deliveries, online programs and events and other online resources including ebooks, eaudiobooks, emagazines, kids’ reading and activities will all still be available. More details are available at wgrlc.vic.gov.au
·Community venues including halls will close other than to host an essential public support service (such as Alcoholics Anonymous), or a wedding or funeral. This covers Memorial Hall and its associated meeting rooms. The immunisation session planned for tomorrow (Wednesday 5 August) at Memorial Hall will proceed.
·Community Transport and the L2P program will be put on hold.
·All buildings and facilities managed by Council or through Section 86 Committees will close. This includes SPLASH and many halls and recreation reserves. The outdoor facilities can still be used for casual activities – such as walking the dog or having a kick of the footy – but planned gatherings are not permitted. However please remember to respect the current social distancing guidelines to keep yourself and those around you safe.
·Travel within regional Victoria is allowed for work and education (if necessary), necessary goods and services and care or compassionate purposes only.
·Visitor Information Centres, Coal Creek Community Park and Museum and Council-run caravan parks will remain closed.
For more information I would encourage you to view the DHHS website: https://www.dhhs.vic.gov.au/coronavirus
Council will continue to work on ways to assist our community via the COVID-19 Community Support Fund and community feedback is encouraged via our COVID-19 Impact and Recovery Survey which can be found at: https://www.southgippsland.vic.gov.au/covidsurvey
It goes without saying, that our community needs to come together right now. Please take the time over the next six weeks to regularly check in on your family, friends, neighbours or any people you think might need a hand in these trying circumstances. Buy local where you can and please stay safe. Together we can get through this.
Kerryn Ellis CEO South Gippsland Shire Council
Animals and birds seem to be the predominant theme for me this week. If I’m not attempting to rescue a seagull with fishing wire wrapped around it’s leg, I’m trying to hustle koalas and echidnas to safety off the middle of main country roads.
BREAKING NEWS. Daniel Andrews Announcement on Business Closures, Reduced Hours, and Unchanged. South Gippsland Stays on 5 Active Cases-update. Dan Foreshadows stage 5 restrictions if these don’t work.
The South Gippsland Shire Council have a well-practised art of starting things that make it look like they are doing something except they seem to never achieve any growth for us.
South Gippsland has one additional Active Case- 5 total
Bass Coast steady on 4, Baw Baw steady on 3.
Today’s full DHHS repost shown below.
760 mystery cases-untraceable-no idea where they caught the virus-these cases are not just in Melbourne, they are also from regional areas. State of Disaster Declared-Curfews from 8pm today in Melbourne for 6 weeks
Twenty-Four days after Melbourne was put back into lockdown, the recent highest daily tally of 783 new cases in Victoria makes for dispiriting reading. Why have the numbers stubbornly refused to go down, despite Melburnians being confined to their homes for all but non-essential trips?
You may mock the national anthem by singing “Our land abounds in nature strips” but what you might not know is how true that is.
The daily coronavirus data issued by the State Government now shows cases by postcode and not just by Shire.
Horses, like our dogs and cats, are familiar to many of us, be they racehorses, police horses, or much-loved pony club mounts. So it might surprise you that horses, in Australia, are more deadly than snakes , and indeed all venomous animals combined.
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