EMA provides advice on using molnupiravir; will soon render decision on J&J’s COVID vaccine booster

Regulatory NewsRegulatory News | 22 November 2021 |  By 

The European Medicines Agency (EMA) on 19 November issued advice to member states on how to use Merck Sharp & Dohme’s and Ridgeback Biotherapeutics’ antiviral drug Lagevrio (molnupiravir), an oral antiviral drug for treating patients with COVID-19, prior to its formal EU authorization. This action was taken to combat “rising rates of infection and deaths due to COVID-19 across the EU," EMA said.
In related developments, the European regulator also announced that it was evaluating data on booster doses of the COVID-19 vaccine from Janssen, the vaccine arm of Johnson & Johnson; and reviewing Pfizer’s application for Paxlovid, another oral antiviral drug for COVID-19.
The molnupiravir announcement follows up on an earlier notice EMA would be reviewing the drug in an accelerated time frame to facilitate the drug’s emergency use on a national level. (RELATED: EMA to offer recommendation on national use for Merck’s molnupiravir, Regulatory Focus 8 November 2021)
The medicine can be used to treat adults with COVID-19 who do not require supplemental oxygen and are at increased risk of developing severe COVID-19. EMA said the drug should be administered within five days of the start of symptoms and taken twice a day for five days.
“EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in light of rising rates of infection and deaths due to COVID-19 across the EU,” said the announcement.
The advice follows a review of clinical data of non-hospitalized, unvaccinated patients with at least one underlying condition putting them at risk of severe COVID-19.
The clinical data showed that the drug, administered at an 800 mg dose twice a day, reduced the risk of hospitalization and death when treatment started within five days of the start of symptoms.
Results from the data also showed that 7.3% of patients who took Lagevrio were hospitalized or died compared to 14.1% who took a placebo. The most common side effects of the drug were diarrhea, nausea, dizziness and headaches, with all the symptoms reported as being either mild or moderate.
EMA evaluating booster doses
EMA also announced on Monday that it was evaluating data on booster doses of the COVID-19 vaccine from Janssen and expects to arrive at a decision “within weeks” under an accelerated assessment of data submitted by the company.
The company is seeking approval for a booster shot vaccine or people aged 18 and older to be given at least two months after the first dose; the primary vaccination consists of a single dose.
The regulator will be reviewing data from more than 14,000 adults who received a second dose of the J&J vaccine or placebo two months after the initial dose.
The US Food and Drug Administration approved the COVID-19 Johnson & Johnson booster on 20 October. (RELATED:  FDA okays Moderna, J&J, ‘mix and match’ boosters Regulatory Focus, 20 October 2021)
The EU has already authorized four vaccines, including two that rely on messenger RNA (mRNA): Pfizer/BioNTech’s vaccine and Moderna’s mRNA vaccine, and two that rely on adenovirus vectors: Janssen’s single-dose vaccine and AstraZeneca’s two-dose vaccine.
The European regulator has already cleared Pfizer/BioNTech’s and Moderna’s requests for booster shots.
EMA starts review of Paxlovid
In a related action, EMA also announced on 19 November it is starting to review Pfizer’s application for Paxlovid (PF-07321332/ritonavir) an antiviral oral treatment for COVID-19.
The review will compare the effect of Paxlovid with a placebo in non-hospitalized patients with mild to moderate COVID-129 who are at “high risk of progressing to severe disease.”
EMA announced that “the preliminary results indicate that Paxlovid reduced the risk of hospitalisation or death compared with placebo when treatment was given withing three or five days of the start of symptoms.”
Paxlovid is an oral antiviral medicine that reduces the ability of the SARS-CoV-2 coronavirus to multiply in the body. The active substance PF-07321332 “blocks the activity of an enzyme needed by the virus to multiply.” Ritonavir is a protease inhibitor “which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus.”
The medicine is expected to reduce the need for hospitalization in patients with COVID-19.
In the US, the Biden administration recently announced plans to buy 10 million courses of Paxlovid, making a $5.3 billion investment in the pills contingent upon their authorization for emergency use. (RELATED: This Week at FDA: mRNA boosters for most; Blood lancets reclassified, Regulatory Focus, 19 November 2021)
EMA’s announcement on molnupiravir
EMA’s announcement on booster doses
EMA’s announcement on Paxlovid


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