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| How do we know Covid vaccines are safe? | |
| (7 days later) | |
| Scientists hope to tweak coronavirus vaccines to ensure they continue to offer high protection as new variants of the disease emerge. | |
| The UK's drug regulator says new vaccines can be fast-tracked for approval if needed. So, how are vaccines approved? | |
| How do we know a vaccine is safe? | How do we know a vaccine is safe? |
| Safety trials begin in the lab, with tests and research on cells and animals, before moving on to human studies. | Safety trials begin in the lab, with tests and research on cells and animals, before moving on to human studies. |
| The principle is to start small and only move to the next stage of testing if there are no outstanding safety concerns. | The principle is to start small and only move to the next stage of testing if there are no outstanding safety concerns. |
| How will I get a coronavirus vaccine? | How will I get a coronavirus vaccine? |
| Who will get the vaccine first and when can you have it? | Who will get the vaccine first and when can you have it? |
| Your Questions Answered: How do we know the vaccine is safe? | Your Questions Answered: How do we know the vaccine is safe? |
| What role do trials have? | What role do trials have? |
| As long as the safety data from the labs is good, scientists can check the vaccine or treatment is effective too. | As long as the safety data from the labs is good, scientists can check the vaccine or treatment is effective too. |
| That means tests on large numbers of volunteers - about 40,000 in the case of Pfizer-BioNTech, the first to be approved in the UK. | That means tests on large numbers of volunteers - about 40,000 in the case of Pfizer-BioNTech, the first to be approved in the UK. |
| Half are given the vaccine and the other half a placebo jab. The researchers and participants are not told which group is which, until after the results, to avoid bias. | Half are given the vaccine and the other half a placebo jab. The researchers and participants are not told which group is which, until after the results, to avoid bias. |
| BBC's Laura Foster explains the order in which the Covid vaccine will be given | BBC's Laura Foster explains the order in which the Covid vaccine will be given |
| All of the work and findings are checked and verified independently. | All of the work and findings are checked and verified independently. |
| The Covid vaccine trials have happened at breakneck speed, but they haven't skipped any steps. | The Covid vaccine trials have happened at breakneck speed, but they haven't skipped any steps. |
| The Oxford-AstraZeneca Covid vaccine trial was voluntarily put on hold at one stage to investigate why one participant - out of many thousands - had died. It restarted once it was clear it was not related to the vaccine. | The Oxford-AstraZeneca Covid vaccine trial was voluntarily put on hold at one stage to investigate why one participant - out of many thousands - had died. It restarted once it was clear it was not related to the vaccine. |
| What is the fast-track approval for vaccines against new variants? | |
| A similar rapid approval method is already used for annual flu vaccines. No corners will be cut, with safety paramount, says the MHRA, which approves drugs in the UK. | |
| Manufacturers will need to show robust evidence the new shots trigger protective antibodies in the blood. | |
| But lengthy clinical trials with thousands of volunteers will not be needed. | |
| Instead, data from existing studies and ongoing real-world use could be used. | |
| Will the vaccine give me side effects? | Will the vaccine give me side effects? |
| Vaccines do not give you a disease. Instead, they teach your body's immune system to recognise and fight the infection they have been designed to protect against. | Vaccines do not give you a disease. Instead, they teach your body's immune system to recognise and fight the infection they have been designed to protect against. |
| Some people do experinece mild symptoms after being vaccinated. This is not the disease itself, but the body's response to the vaccine. | |
| Common reactions that may affect more than one in 10 people and typically get better within days include: | Common reactions that may affect more than one in 10 people and typically get better within days include: |
| sore arm | sore arm |
| headache | headache |
| chills | chills |
| tiredness | tiredness |
| feeling sick | feeling sick |
| fever | fever |
| dizziness | dizziness |
| weakness | weakness |
| aching muscles | aching muscles |
| Who approves vaccines or treatments? | Who approves vaccines or treatments? |
| Approval is only given in the UK if the regulator is happy that a vaccine is safe and effective. | |
| Checks continue after approval to make sure there are no further side effects or long-term risks. | Checks continue after approval to make sure there are no further side effects or long-term risks. |
| Independent experts on the Joint Committee on Vaccination and Immunisation decide how best to use a vaccine and who should get it. | Independent experts on the Joint Committee on Vaccination and Immunisation decide how best to use a vaccine and who should get it. |
| What's in the Covid vaccines? | What's in the Covid vaccines? |
| Pfizer-BioNTech's vaccine (and Moderna's) uses bits of genetic code to cause an immune response, and is called an mRNA vaccine. | Pfizer-BioNTech's vaccine (and Moderna's) uses bits of genetic code to cause an immune response, and is called an mRNA vaccine. |
| It does not alter human cells, but merely presents the body with instructions to build immunity to Covid. | It does not alter human cells, but merely presents the body with instructions to build immunity to Covid. |
| The Oxford-AstraZeneca vaccine uses a harmless virus altered to look a lot more like the pandemic virus. | The Oxford-AstraZeneca vaccine uses a harmless virus altered to look a lot more like the pandemic virus. |
| Vaccines sometimes contain other ingredients, like aluminium, that make the vaccine stable or more effective. | Vaccines sometimes contain other ingredients, like aluminium, that make the vaccine stable or more effective. |
| What about allergies? | What about allergies? |
| Allergic reactions to vaccines are rare. For any approved vaccine, the ingredients are listed. | Allergic reactions to vaccines are rare. For any approved vaccine, the ingredients are listed. |
| There have been serious but treatable allergic reactions in a very small number of people given the Pfizer-BioNTech vaccine. | |
| As a precaution, the MHRA says people with a history of significant allergic reactions to any of the ingredients in this vaccine should not currently have this vaccine. | |
| Be aware that anti-vaccine stories are spread online through social media. These posts are not based on scientific advice (or blend facts with misinformation). | Be aware that anti-vaccine stories are spread online through social media. These posts are not based on scientific advice (or blend facts with misinformation). |
| What if I've already had Covid? | What if I've already had Covid? |
| People will still be offered the jab even if they have had Covid-19 in the past. | People will still be offered the jab even if they have had Covid-19 in the past. |
| That's because natural immunity may not be long-lived and immunisation could offer more protection. | That's because natural immunity may not be long-lived and immunisation could offer more protection. |
| Guidance says there are no safety concerns about giving jabs to people with "long" Covid either. But people who are currently unwell with Covid-19 should not receive the vaccine until they have recovered. | Guidance says there are no safety concerns about giving jabs to people with "long" Covid either. But people who are currently unwell with Covid-19 should not receive the vaccine until they have recovered. |
| How animal-friendly are vaccines and do they contain alcohol? | How animal-friendly are vaccines and do they contain alcohol? |
| Some vaccines, such as the shingles vaccine and the children's nasal flu vaccine, can contain pork gelatine. | Some vaccines, such as the shingles vaccine and the children's nasal flu vaccine, can contain pork gelatine. |
| The Covid vaccines from Pfizer, Moderna and AstraZeneca do not contain this, or any other animal products. | The Covid vaccines from Pfizer, Moderna and AstraZeneca do not contain this, or any other animal products. |
| The British Islamic Medical Association says there is negligible alcohol in it - no more than in bread, for example. | The British Islamic Medical Association says there is negligible alcohol in it - no more than in bread, for example. |