By Michelle Roberts
Health editor, BBC News online

Doctor administering injection to young womanimage copyrightGetty Images

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?

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.

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.

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.

media captionBBC’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.

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.

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?

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:

  • sore arm
  • headache
  • chills
  • tiredness
  • feeling sick
  • fever
  • dizziness
  • weakness
  • aching muscles

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.

Independent experts on the Joint Committee on Vaccination and Immunisation decide how best to use a vaccine and who should get it.

Chart shows vaccination programme on course to reach 15m people by mid Feb. Updated 4 Feb.

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.

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.

Vaccines sometimes contain other ingredients, like aluminium, that make the vaccine stable or more effective.

What about allergies?

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).

How the vaccines compare?

What if I’ve already had Covid?

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.

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?

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 British Islamic Medical Association says there is negligible alcohol in it – no more than in bread, for example.

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