StageDuration Who the vaccine is tested on Purpose Lab testing 1 year The vaccine will first be tested in the lab on human cells and on animals to make.

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Presentation transcript:

StageDuration Who the vaccine is tested on Purpose Lab testing 1 year The vaccine will first be tested in the lab on human cells and on animals to make sure it is not toxic. Submit proposal to Ethics Committee. Phase 1 part one 4 months Start of human trial. Very small doses of the vaccine will be given to a small group of healthy people to see how the human body reacts to it and check it is safe for humans. Phase 1 part two 6 months Larger doses of the vaccine will be given to a bigger group of healthy people. Is it still safe for humans? Are there any side- effects? Phase 2 3 years A larger group of people will be given the vaccine and their health will be monitored every month at their local hospital. Continue to assess safety in humans and record any new side-effects. Does it work in humans? Does it protect people against the disease? What is the most effective dosage? Can the vaccine be improved? Decide whether to continue testing this vaccine with a bigger group, or start again and develop a new one.

StageDuration Who the vaccine is tested on Purpose Phase 3 3 years Large groups of thousands of people in several countries will be given the vaccine to build up lots of data. How well does it work? Does it protect everyone against the disease, or just some people? How long does the protection last? What is the best age to give the vaccine? Continue to record information about side- effects. Work out best way to manufacture the vaccine. Submit trial data to regulatory bodies who decide whether to approve the vaccine for general use. Vaccine approved for general use 1 year Start manufacturing the vaccine and let the NHS and other health authorities know about it. Phase 4 ongoing Vaccine is made available to the public. Ongoing monitoring of the vaccine. Data will be collected all the time for as long as the vaccine is available. This is to confirm the vaccine is safe and effective over a person’s whole lifetime, to make sure all side-effects are well-known and understood, and to see if any booster jabs are needed.

30 healthy volunteers in UK 15 given vaccine 15 not given vaccine nobody given vaccine / no testing Human cells in test-tubes Animal tests (e.g. rats, dogs, pigs) 800,000 + people per year across the world everyone given vaccine 12,000 people in UK 12,000 people in France 14,000 people in Germany 9,000 people in Finland half in each group given vaccine, other half not given vaccine 10 healthy volunteers in UK 5 given vaccine 5 not given vaccine 400 volunteers in UK 200 given vaccine 200 not given vaccine

StageDuration Who the vaccine is tested on Purpose Lab testing 1 year Human cells in test-tubes Animal tests (e.g. rats, dogs, pigs) The vaccine will first be tested in the lab on human cells and on animals to make sure it is not toxic. Submit proposal to Ethics Committee. Phase 1 part one 4 months 10 healthy volunteers in UK 5 given vaccine 5 not given vaccine Start of human trial. Very small doses of the vaccine will be given to a small group of healthy people to see how the human body reacts to it and check it is safe for humans. Phase 1 part two 6 months 30 healthy volunteers in UK 15 given vaccine 15 not given vaccine Larger doses of the vaccine will be given to a bigger group of healthy people. Is it still safe for humans? Are there any side- effects? Phase 2 3 years 400 volunteers in UK 200 given vaccine 200 not given vaccine A larger group of people will be given the vaccine and their health will be monitored every month at their local hospital. Continue to assess safety in humans and record any new side-effects. Does it work in humans? Does it protect people against the disease? What is the most effective dosage? Can the vaccine be improved? Decide whether to continue testing this vaccine with a bigger group, or start again and develop a new one.

StageDuration Who the vaccine is tested on Purpose Phase 3 3 years 12,000 people in UK 12,000 people in France 14,000 people in Germany 9,000 people in Finland half in each group given vaccine, other half not given vaccine Large groups of thousands of people in several countries will be given the vaccine to build up lots of data. How well does it work? Does it protect everyone against the disease, or just some people? How long does the protection last? What is the best age to give the vaccine? Continue to record information about side- effects. Work out best way to manufacture the vaccine. Submit trial data to regulatory bodies who decide whether to approve the vaccine for general use. Vaccine approved for general use 1 year nobody given vaccine / no testing Start manufacturing the vaccine and let the NHS and other health authorities know about it. Phase 4 ongoing 800,000 + people per year across the world everyone given vaccine Vaccine is made available to the public. Ongoing monitoring of the vaccine. Data will be collected all the time for as long as the vaccine is available. This is to confirm the vaccine is safe and effective over a person’s whole lifetime, to make sure all side-effects are well-known and understood, and to see if any booster jabs are needed.