EU regulator verdict on Moderna COVID-19 booster shot next week

LONDON, Oct 21 (Reuters) – The European Union’s drug regulator expects to announce the outcomes of its overview of Moderna’s (MRNA.O) COVID-19 booster vaccine subsequent week and in addition to start out a rolling overview of Merck’s (MRK.N)antiviral oral capsule, a senior official mentioned on Thursday.

The outcomes of the Moderna overview can be introduced on Oct. 25, Marco Cavaleri, head of vaccines technique for the European Medicines Company (EMA), instructed a briefing.

Cavalerialso mentioned it was not clear whether or not Russia would submit an utility for its one-dose coronavirus vaccine, often called Sputnik Mild, along with one already submitted for its two-dose Sputnik V shot.

“We do not have actually any clear understanding of whether or not (the Russian staff) intends to submit an utility additionally for this vaccine within the European Union, however we’ll proceed the dialogue to get extra readability on this,” he mentioned.

The beginning of a proper overview of the two-dose Sputnik V was confirmed in March, however no determination has but been introduced.

Reuters reported on Thursday that the regulator was unlikely to determine whether or not to approve the Russian vaccine till not less than the primary quarter of 2022 as a result of it nonetheless lacked some information required for the overview. read more

That is consistent with what the World Well being Group has mentioned concerning delays in its Emergency Use Itemizing course of. read more

BOOSTERS AND PILLS

The EMA’s conclusion on boosters of Moderna’s vaccine, Spikevax, is anticipated to be used in folks over 12 years of age and the shot is to be given six months after a second dose.

The EMA mentioned it anticipated to obtain information on boosters of the single-shot Johnson & Johnson (JNJ.N) vaccine within the coming weeks.

On Oct. 4, the watchdog gave the go-ahead for the Pfizer-BioNTech (PFE.N) (22UAy.DE) boosters and really useful a 3rd dose of a shot from Pfizer-BioNTech or Moderna for weak folks, leaving it to member states to determine for the remainder. read more

U.S. authorities have authorised booster doses of Pfizer-BioNTech, Moderna and J&J.

Whereas vaccines are the primary weapon in opposition to COVID-19, Merck’s experimental capsule, which it’s creating with accomplice Ridgeback Biotherapeutics, could possibly be a game-changer after research confirmed it may halve the possibilities of dying or being hospitalised for these most prone to contracting extreme sickness. read more

Britain has already secured a deal for the drug, molnupiravir, nicely earlier than any approvals.

Reporting by Josephine Mason in London and Pushkala Aripaka in Bengaluru; Enhancing by Jason Neely, Edmund Blair and Gareth Jones

Our Requirements: The Thomson Reuters Trust Principles.