Coronavirus: Moderna seeks approval in Europe and the US while UK secures an extra 2 million doses of Moderna COVID-19 vaccine

Biotech company Moderna said it will today ask for approval of its COVID-19 vaccine in both Europe and the US.

The firm made the announcement as it said that the most recent trial results showed its vaccine was 94.1% effective. Moderna said the vaccine was 100% effective against severe COVID-19. This was largely in line with preliminary results earlier this month.

Regulators will look at trial data for the mRNA vaccine and decide if it is safe and effective enough to recommend for roll out.

Clinical studies show the jab is more than 94% effective at protecting people from becoming ill with Covid-19.

Pfizer, which has a similar jab, has already filed for the same US approval.

UK government secures additional 2 million doses of Moderna COVID-19 vaccine

The UK now has access to a total of 357 million doses of vaccines from 7 different developers.

The UK government on (Sunday 29 November) signed a deal for a further 2 million doses of Moderna’s promising vaccine candidate, bringing the total to 7 million doses for the UK.

Following the deal, the UK now has access to enough doses of Moderna’s vaccine candidate for around 3.5 million people.

• UK government has now secured 7 million doses of Moderna vaccine, which will be available in Europe as early as spring 2021
• trials show the vaccine is almost 95% effective
• the deal means the UK now has access to a total of 357 million doses of vaccines from 7 different developers

To be approved for use in the UK, the Moderna vaccine must meet the strict standards of safety and effectiveness of the independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). If it is approved, 7 million doses could start to be delivered to the UK as early as spring 2021 – the same timetable as other countries in Europe.

The latest agreement is part of the government’s strategy to develop a diverse portfolio of promising vaccine candidates. The government has now secured 357 million vaccine doses from 7 different developers, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible.

Business Secretary Alok Sharma said:

It is essential that we continue to bolster our portfolio of vaccine candidates to ensure we’re in the best possible position to protect the public once we see that breakthrough.

The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted we have been able to secure a further 2 million doses of their promising candidate for the British public.

Moderna says it hopes to gain UK approval soon, now that it has trial data from 30,000 volunteers – including high risk groups like the elderly – that suggests it works.

UK regulators are also reviewing data on the Pfizer vaccine, as well as another type of Covid vaccine from AstraZenca and Oxford University for emergency approval.

In those studies, 15,000 people received the real vaccine while the other participants got placebo injections. No serious side effects were reported.

During the studies, 185 people in the placebo group fell ill with Covid-19, and some severely so.

In comparison, there were 11 cases in the vaccine group and none were severe.

Full trial data has not been released but will be published in a peer-reviewed journal in due course.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, chief executive officer of Moderna.

Bancel goes on to say: “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” he continued.
It came after results showed that 196 of the 30,000 participants in Moderna’s phase three trials contracted COVID-19. Just 11 of those cases were among people who received the Moderna candidate vaccine.

The company, which worked with the US National Institutes of Health (NIH), has said it expects an advisory committee meeting with the US FDA on December 17.

It is just behind US pharmaceutical company Pfizer, which is working with German biotech company BioNTech, which filed for US authorisation on November 20. The European Medicines Agency is also doing a rolling review of the vaccine candidate.

The vaccine’s side effects were generally “mild or moderate” and included pain at the injection site, fatigue, muscle pain and headache, the company said earlier this month.

There was one COVID-19-related death in the study which occurred in the group that did not receive the candidate vaccine.

The company said there were no serious safety concerns identified related to the vaccine.

The vaccine is based on new technology that contains mRNA or genetic instructions that help the body to recognise the coronavirus’ spike protein — which it uses to enter the body’s cells.

Two other companies Pfizer and AstraZeneca recently released efficacy information about their vaccines, as well, fuelling hopes that a vaccine could be approved by the end of this year or early next year.