What it takes to develop a Covid vaccine – and why it’s different to normal
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The development of a Covid-19 vaccine has been different to the normal processes – but officials have stressed standards are 'no lower' despite the public health emergency.
The timetable for developing and approving a vaccine has been condensed.
Processes that would normally take several years have instead taken months or even weeks. With Covid, the clinical trial phases have overlapped instead of taking place sequentially.
But England's deputy chief medical officer Jonathan Van-Tam has said the standards are "no lower" because this is a public health emergency.
In a Downing Street data briefing on November 11, Professor Van-Tam set out how the timetables for developing and approving a vaccine both during "peace time" and during the crisis.
Traditionally vaccine development would take several years and include various processes (stock photo)
Vaccines can take traditionally take years to develop
Traditionally vaccine development would take several years and include various processes including: design and development stages followed by clinical trials – which in themselves need approval before they even begin.
The trials take place in three sequential stages – also known as phases. Once the trials are complete, they are sent to regulators for review before being approved for widespread use.
Phase one clinical trials are small studies focusing on safety and dosage, medium-sized phase two studies which determine whether vaccines can generate an immune response.
Some phases of development have overlapped (stock photo)
(Image: Getty Images/Tetra images RF)
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And if these stages are successful the trials move on to phase three, which are real world trials involving thousands of participants.
These will show whether a vaccine generates antibodies but also protect people form disease. Safety assessments take place throughout.
If successful at every stage, vaccine creators can send their trial data for review by regulators.
Once approved large scale production and distribution begins.
Processes overlap for Covid vaccine – but safety not compromised
But in the trials for a Covid vaccine, things look slightly different.
A process which usually takes years has been condensed to months.
While the early design and development stages look similar, the clinical trial phases overlap – instead of taking place sequentially.
And pharmaceutical firms have begun manufacturing before final approval had been granted – taking on the risk that they may be forced to scrap their work.
A health care worker injects the a syringe of the phase 3 vaccine trial
(Image: Anadolu Agency via Getty Images)
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The new way of working means that regulators around the world can start to look at scientific data earlier than they traditionally would do.
This means that data from each phase of the clinical trial can be put to regulators in what has been called a "rolling review" – instead of regulators going through reams of information at the conclusion of the trials.
Once approved by regulators, people can start to receive the vaccine.
Professor Jonathan Van-Tam has said the vaccine will be safe
(Image: Pippa Fowles / No 10 Downing Street)
"This is a public health emergency"
Prof Van-Tam said: "Everyone knows that this is a public health emergency. We are in a much more difficult position."
But he said that the three phases of clinical trials were no smaller and "the standards are no lower just because this is a public health emergency".
British regulators said the safety of the public always come first.
Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), told the November 11 briefing: "A Covid-19 vaccine will only be approved once it has met robust standards of effectiveness, safety and quality."
High hopes for UK Oxford/AstraZeneca vaccine
Hopes have been raised today that the UK could produce a successful coronavirus vaccine after data from the University of Oxford showed its jab provokes a strong immune response in older people.
The ChAdOx1 nCov-2019 vaccine, developed with pharmaceutical giant AstraZeneca, has been shown to trigger a robust immune response in healthy adults aged 56-69 and people over 70.
How the Oxford Covid-19 vaccine works
(Image: Press Association Images)
Phase two data, published in The Lancet, suggests one of the groups most vulnerable to serious illness and death from Covid-19 could build immunity, researchers say.
Study found vaccine better tolerated in older people
According to the researchers, volunteers in the trial demonstrated similar immune responses across all three age groups (18-55, 56-69, and 70 and over).
The study of 560 healthy adults – including 240 over the age of 70 – found the vaccine is better tolerated in older people compared with younger adults.
Volunteers received two doses of the vaccine candidate, or a placebo meningitis vaccine.
No serious adverse health events related to the vaccine were seen in the participants.
The early results are consistent with phase one data reported for healthy adults aged 18-55 earlier this year.