WIREDGOV

Vaccine could be delivered to the UK from Spring 2021.

• Government concludes negotiations with Moderna to secure access to 5 million doses of its promising coronavirus vaccine
• vaccine could be delivered to the UK from Spring 2021, if approved by the medicines regulator
• deal increases total number of doses secured by the UK to 355 million, as part of government’s strategy to build a diverse portfolio of promising vaccines

The UK government has completed negotiations with biotech company Moderna to secure access to 5 million doses of its promising vaccine, enough for around 2.5 million people, the Business Secretary announced yesterday (Monday 16 November).

If it meets robust standards of safety and effectiveness and approved by the medicines regulator, the vaccine could be delivered to the UK and Europe as early as Spring 2021 with the potential for the government to procure more doses next year.

This would follow the first deliveries of the Pfizer/BioNTech and the Oxford University/AstraZenece vaccines which, once final data from their phase 3 clinical trials has been published and if they receive regulatory approval, could be available before the end of the year.

The agreement is part of the government’s strategy to develop a diverse portfolio of vaccines, increasing the UK’s chances of securing access to a promising vaccine. Yesterday’s deal means the government has put in place agreements with 7 different developers and has secured 355 million vaccine doses, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible.

The news comes as Moderna yesterday published initial data showing that its candidate is nearly 95% effective in protecting against COVID-19, with no safety issues identified to date. The safety data is still to be released by Moderna to show whether the vaccine is both safe and effective.

Until a vaccine is found to meet robust standards of safety and effectiveness, the public must continue to take necessary actions to keep themselves and their loved ones safe, including following the Hands, Face, Space guidance and other public health advice.

Business Secretary Alok Sharma yesterday said:

Today’s announcement is on top of the 350 million doses the UK has already secured from a range of other vaccine developers, putting us towards the front of the international pack on a per capita basis.

The speed at which scientists around the world have worked on a vaccine has been incredible, and it is thanks to their ingenuity that we are on the cusp of one of the biggest scientific breakthroughs in recent years.

While this is exciting news, I urge the public to not be complacent – we are at a critical point in the pandemic and in order to save lives we must continue to follow guidance by maintaining social distancing, wearing face masks and washing our hands regularly.

Health Secretary Matt Hancock yesterday said:

Today’s announcement is excellent news and an encouraging step forward in our fight against COVID-19.

We have moved swiftly to secure 5 million doses of this hugely promising vaccine meaning we are even better placed to vaccinate everyone who will benefit should the rigorous safety standards be met.

But we are not there yet. Until science can make us safe, we must remain vigilant and keep following the rules that we know can keep this virus under control.

Moderna is currently conducting phase 3 clinical trials of its vaccine and is using mRNA vaccine technology.

The Medicines and Healthcare products Regulatory Agency (MHRA) has started a rolling review of Moderna’s vaccine. MHRA will carefully and scientifically review the safety, quality and effectiveness data once it has all been submitted to determine how it protects people from COVID-19 and the level of protection it provides.

The data must include results from the lab and clinical trials; manufacturing and quality controls, product sampling, and testing of the final product.

Once they have thoroughly reviewed the data, the MHRA will seek advice from the government’s independent advisory body, the Commission on Human Medicines. They will critically assess the data too before advising the government on the safety, quality and effectiveness of any potential vaccine.

The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.

Chair of the government’s Vaccine Taskforce Kate Bingham yesterday said:

Today’s news from Moderna is very encouraging. The Moderna mRNA vaccine has posted excellent efficacy data to date from its initial phase 3 readout. The vaccine uses mRNA technology demonstrating that these novel vaccines are showing early promise in being effective against COVID-19.

The government has now signed agreements with seven vaccine developers to secure the most promising vaccines for the UK. The government’s Vaccine Taskforce are pursuing a portfolio approach to obtaining vaccines for the UK across different vaccine formats, to maximise the chances of finding safe and effective vaccines.

We will continue to monitor the field of promising vaccines, and are very encouraged by the effectiveness shown by these early frontrunners, but we must remain vigilant to the fact that no vaccine is yet approved for use by regulators.

Notes to Editors

We have secured early access to over 355 million vaccines doses through agreements with several separate vaccine developers at various stages of trials, including:

• 100 million doses of University of Oxford/AstraZeneca vaccine – phase 3 clinical trials
• 40 million doses of BioNTech/Pfizer vaccine – phase 3 clinical trials
• 5 million doses of Moderna vaccine – phase 3 clinical trials
• 60 million doses of Novavax vaccine – phase 3 clinical trials
• 60 million doses of Valneva vaccine – pre-clinical trials
• 60 million doses of GSK/Sanofi Pasteur vaccine – phase 1 clinical trials
• 30 million doses of Janssen vaccine – phase 2 clinical trials

We have invested over £230 million into manufacturing any successful vaccine and an enormous amount of planning and preparation has taken place across government to be able to quickly roll out the vaccine, including ensuring we have adequate provision, transport, PPE and logistical expertise to do so. We are also working at pace to prepare for the delivery of any potential COVID-19 vaccination programme as quickly as possible.