EU Medicines Agency starts review of Merck's oral Covid-19 drug

Studies show molnupiravir could reduce the risk of hospital admission by half

European health regulators are reviewing an oral Covid-19 drug from US pharmaceutical firm Merck after studies showed it could halve the chances of dying or being admitted to hospital.

The experimental pill, known as molnupiravir, could be a game-changer for those most at risk of contracting severe illness.

Given to patients within days of a positive test, the treatment halves the risk of hospital admission, according to a clinical trial conducted by Merck. Its trial also indicated it prevented 100 per cent of deaths compared with a placebo.

The sample size, however, was relatively small and the figure cannot yet be reliably extrapolated.

The European Medicines Agency will now assess whether molnupiravir complies with European standards of efficacy, safety and quality under a “rolling review".

It can take several months between the start of a rolling review by the EMA and any eventual green light, but the review is being conducted as soon as data becomes available, thereby speeding up the process.

A simple pill to treat the coronavirus has been sought since the start of the pandemic and Merck's announcement was hailed as a major step towards that goal.

Until now, Covid therapeutics such as monoclonal antibodies and Gilead's remdesivir, authorised for use in the EU under the name Veklury, have been administered intravenously.

But experts have said it is not a miracle cure and should complement vaccines, not replace them.

They have also cautioned it would be critical to administer the drug early for it to be effective.

It comes as Moderna said on Monday its Covid-19 vaccine generated a strong immune response and was generally well tolerated in children aged 6 to 11. The company plans to submit the data to regulators soon.

The company, which has its headquarters in the US, said its two-dose vaccine generated neutralising antibodies in children and safety was comparable to that previously recorded in clinical trials of adolescents and adults.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged six to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna chief executive Stephane Bancel said.

A panel of US Food and Drug Administration advisers will vote on Tuesday over whether to authorise rival the Pfizer-BioNTech's Covid-19 vaccine for use in children aged 5 to 11.

Sweden has paused the use of the Moderna vaccine for younger age groups after reports of heart inflammation in young adults.

Moderna said the majority of the side effects in the trial, which had 4,753 participants, were mild or moderate in severity, with fatigue, headache, fever and injection site pain the most common.

The company said it planned to submit the data to US, European and other regulators soon.

Updated: October 25th 2021, 2:59 PM