LONDON, Oct 21 (Reuters) - The European Union's drug
regulator expects to announce the results of its review of
Moderna's COVID-19 booster vaccine next week and also
to start a rolling review of Merck's antiviral oral
pill, a senior official said on Thursday.
The results of the Moderna review will be announced on Oct.
25, Marco Cavaleri, head of vaccines strategy for the European
Medicines Agency (EMA), told a briefing.
Cavaleri also said it was not clear whether Russia would
submit an application for its one-dose coronavirus vaccine,
known as Sputnik Light, in addition to one already submitted for
its two-dose Sputnik V shot.
"We don't have really any clear understanding of whether
(the Russian team) intends to submit an application also for
this vaccine in the European Union, but we will continue the
dialogue to get more clarity on this," he said.
The start of a formal review of the two-dose Sputnik V was
confirmed in March https://www.reuters.com/article/us-health-coronavirus-europe-vaccines-idUSKCN2AW0W8,
but no decision has yet been announced.
Reuters reported on Thursday that the regulator was unlikely
to decide whether to approve the Russian vaccine until at least
the first quarter of 2022 because it still lacked some data
required for the review.
This is in line with what the World Health Organization has
said regarding delays in its Emergency Use Listing process.
BOOSTERS AND PILLS
The EMA's conclusion on boosters of Moderna's vaccine,
Spikevax, is expected for use in people over 12 years of age and
the shot is to be given six months after a second dose.
The EMA said it expected to receive data on boosters of the
single-shot Johnson & Johnson vaccine in the coming
On Oct. 4, the watchdog gave the go-ahead for the
Pfizer-BioNTech boosters and recommended a
third dose of a shot from Pfizer-BioNTech or Moderna for
vulnerable people, leaving it to member states to decide for the
U.S. authorities have authorised on Wednesday booster doses
of Pfizer-BioNTech, Moderna and J&J.
While vaccines are the main weapon against COVID-19, Merck's
experimental pill, which it is developing with partner Ridgeback
Biotherapeutics, could be a game-changer after studies showed it
could halve the chances of dying or being hospitalised for those
most at risk of contracting severe illness.
Britain has already secured a deal https://www.reuters.com/world/uk/britain-secures-covid-19-antivirals-merck-pfizer-2021-10-20
for the drug, molnupiravir, well before any approvals.
(Reporting by Josephine Mason in London and Pushkala Aripaka in
Bengaluru; Editing by Jason Neely, Edmund Blair and Gareth