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Moderna seeks European and US approval for coronavirus vaccine

Results suggest the vaccine gives high levels of protection against the virus.

Image: Shutterstock/LookerStudio

MODERNA IS FILING for regulatory approval of its coronavirus vaccine after trials showed no serious safety concerns.

Results from phase three of the study suggest high levels of protection against the virus, and there is no evidence efficacy is worse at older ages, according to primary analysis.

The UK has secured seven million doses of the jab from the US firm – enough for around 3.5 million people.

Announcing the results today, Moderna said it plans to request emergency use authorisation from the US Food and Drug Administration (FDA).

The company is also applying for a conditional marketing authorisation with the European Medicines Agency (EMA) and plans to progress with the rolling reviews which have already been initiated with international regulatory agencies.

Moderna said the analysis of the phase three COVE study of the vaccine candidate, called mRNA-1273, involving 30,000 participants included 196 cases of Covid-19, of which 30 cases were severe.

Vaccine efficacy against the disease was 94.1% and vaccine efficacy against severe Covid-19 was 100%, the company reported.

It added that the jab is generally well tolerated with no serious safety concerns identified to date.

Stephane Bancel, chief executive of Moderna, said: “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.

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.

The analysis released on Monday was based on 196 cases, of which 185 cases of Covid-19 were observed in the placebo group, versus 11 cases observed in the vaccinated group.

This resulted in a point estimate of vaccine efficacy of 94.1%.

A secondary endpoint analysed severe cases of the virus and included 30 severe cases.

All 30 cases occurred in the placebo group and none in the vaccinated group.

The company said there was one Covid-19-related death in the study to date, which occurred in the placebo group.

Moderna reports that efficacy was consistent across age, race and ethnicity, and gender demographics.

The 196 coronavirus cases included 33 adults aged 65 and over, and 42 participants identifying as being from diverse communities.

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Based on prior analysis, the most common adverse reactions included injection site pain, fatigue, myalgia (muscle pain), arthralgia (joint pain), headache, and redness at the injection site.

The company said these solicited adverse reactions increased in frequency and severity in the vaccinated group after the second dose.

Dr Gillies O’Bryan-Tear, chairman of policy and communications at the Faculty of Pharmaceutical Medicine, said: “Although we await the full details of these results in published form, we can now assume that this vaccine will be approved for use in December.”

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