Development

The scale of the global pandemic means there is no time to waste. Although vaccine development usually takes a decade or longer, timelines were accelerated to develop the vaccine whilst maintaining safety and quality in collaboration with regulators.

Clinical development at pace to meet global demand

Vaccine development usually takes a decade or longer, but when faced with a global pandemic there is no time to waste.

There is some precedent for accelerated delivery of a vaccine, as this is not the first time in history that a vaccine is being developed at a faster pace than usual in order to meet public health demands. Following the Ebola outbreak in Guinea in 2016, a vaccine went from early testing to clinical trials within approximately 10 months, which was unprecedented at that time. When a new outbreak of Ebola emerged in 2018, an adenoviral vector vaccine was administered to approximately 300,000 people, which helped to slow the spread of the disease and save lives.

 

Accelerating timelines whilst maintaining safety and quality

To tackle the global COVID-19 pandemic we are working at a similarly accelerated pace.

While the development program is faster than typical, patient safety is of paramount importance. New ways of working can be introduced to reduce the time it takes for vaccines to reach communities around the world. For example, investing in manufacturing before we have evidence that it works and increasing people resources to enable trials to progress as quickly as possible, including more investigators and sites so that we can recruit more quickly than usual. This allows the highest levels of quality and safety to be maintained, while saving years of time compared to a traditional vaccine manufacturing process.

 

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Real world evidence

As COVID-19 vaccines start to become approved around the world, the effectiveness of the vaccines in the real-world setting is to be determined. This analysis relies on the use of data captured from existing clinical settings and linked to national healthcare systems often allowing population level impact demonstration.

It is clear that to overcome the COVID-19 pandemic, more than one vaccine will be needed. People need vaccines to do different things – to work better in older people or in children, or to alleviate disease severity. Providing broad equitable access of the COVID-19 vaccines to those in need will enable us to truly alter the course of this pandemic and positively impact the real-word effectiveness of this unprecedented vaccination programme.

Developing an effective vaccine

Making sure a vaccine is effective in real world settings, with broad access will allow for wide implementation of vaccination programmes at speed. 

For a vaccine to be effective in a real-world setting you need to consider safety, efficacy, durability of response, ease-of-use within the healthcare setting and uptake.

Learn how these could make a difference in the fight against COVID-19.

 

Ensuring broad, equitable supply around the world: The cornerstone of any successful global vaccination programme

WHO collaborators have demonstrated that the global public health value of a vaccine is only maximised by ensuring equitable access.1

To change the course of the pandemic, COVID-19 vaccines need to be available globally and be accessible to all who need them. To achieve this, the scalability of production and manufacturing capacity are essential.

In addition, to ensure ease of access to vaccines, logistical aspects are crucial. Stability, ease-of-use (i.e., no need for specially trained medical staff) and simplicity of distribution, ideally by using a cold chain that is already in place for other vaccines, should be considered. Manufacturing capacity needs to scale as quickly as possible to enable rapid access to as many countries as possible following approval by the regulators. Furthermore, setting up local and regional supply chains reduces the need for transport and supports the resilience of local vaccine infrastructure.

References

1. World Health Organisation. Emergency use listing of vaccines. Available at: https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/EUL_PQ_Vaccines/en/ (Accessed 18 November 2020)

2. Bernal JL et al. medRxiv 2021.03.01.21252652; doi: https://doi.org/10.1101/2021.03.01.21252652 (Preprint published online)

3. Hyams C et al. Preprint published online. Lancet. 2021

4. Shah ASV et al. Preprint published online. medRxiv. 2021;

5. Vasileiou E et al. Preprint published online. Lancet. 2021;