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 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
You must be logged in to post a comment.