US company seeks approval for vaccine

UK secures enough doses of jab for around 3.5 millon people as Moderna’s trials show no serious safety concerns

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 yesterday, 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.”

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.

Based on prior analysis, the most common adverse reactions included injection site pain, fatigue, muscle pain or 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 Gi l l i e s O’ Br ya n-te a r, 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.”

While the Government has secured seven million doses of the Moderna vaccine, it is not expected to be rolled out in the UK until the spring.

In the meantime the NHS is preparing to start rolling out a Covid-19 vaccine from next month.

The UK has placed orders for 100 million doses of the Oxford vaccine — enough to vaccinate most of the population — with a rollout expected in weeks if the jab is approved by the MHRA.