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By Muvija M and Pushkala Aripaka
March 11 (Reuters) - The European Union's drugs regulator on
Thursday approved Johnson & Johnson's single dose
COVID-19 vaccine, as the bloc seeks to speed up a stuttering
inoculation campaign and boost its supplies.
The COVID-19 shot is the fourth to be endorsed for use in
the EU after vaccines from Pfizer-BioNTech ,
AstraZeneca-Oxford University and Moderna, and
is recommended for those over 18 years of age, the European
Medicines agency (EMA) said. It's the first single-dose shot.
The United States, Canada and Bahrain have also approved the
shot. South Africa is carrying out an expedited review.
"With this latest positive opinion, authorities across the
European Union will have another option to combat the pandemic
and protect the lives and health of their citizens," EMA's
Executive Director Emer Cooke said.
Final approval by the European Commission is expected soon.
EU conditional marketing authorisation allows a
treatment to be sold for a year without full data on its
efficacy and side-effects being available.
The region is having difficulty taming a spike cases driven
by a more contagious variant of the coronavirus, with countries
including Italy and France imposing fresh lockdowns.
J&J chief scientific officer Paul Stoffels described it as a
"landmark moment" for the U.S. drugmaker and the world as
governments struggle to control the pandemic which has crushed
economies and killed more than 2.7 million.
The shot, called COVID Vaccine Janssen after the J&J unit
that developed it, will help bulk up EU vaccine supplies after a
faltering rollout due to delivery delays from Pfizer and
AstraZeneca.
J&J has agreed to deliver at least 200 million doses to the
EU this year, including 55 million in the second quarter, with
the first shipments expected next month.
Exact volumes are not clear though and the U.S. drugmaker
has told the European Union it is facing supply issues that may
complicate plans to deliver the second quarter doses in
full.
The news came as Norway and Denmark temporarily suspended
the use of AstraZeneca's vaccine after reports of the formation
of blood clots in some who have been vaccinated.
TRIAL DATA
In J&J's 44,000-person global trial, the vaccine was found
to be 66% effective at preventing moderate-to-severe COVID-19
four weeks after inoculation. It was 100% effective in
preventing hospitalization and death due to the virus.
In its statement on Thursday, the EMA said the vaccine was
found to be 67% effective two weeks after inoculation.
The side effects were usually mild or moderate and cleared
within a couple of days after vaccination, it said. The most
common ones were pain at the injection site, headache,
tiredness, muscle pain and nausea.
Though many rival shots have reported a higher protection
rate, J&J's vaccine could help boost thin EU supplies and
simplify inoculation campaigns because it does not require a
second dose or need to be shipped frozen.
Direct comparison between headline numbers reported by
different drugmakers is difficult because their trials had
different goals, and J&J's study was conducted while new, more
contagious variants of the virus were circulating.
Its vaccine delivers immunity-building proteins through a
weakened version of a common cold virus, similar to
AstraZeneca's shot. J&J has also used the technology in its
EU-approved Ebola vaccine.
(Reporting by Muvija M and Pushkala Aripaka in Bengaluru;
additional reporting by Francesco Guarascio in Brussels and Bart
Meijer in Amsterdam; Editing by Josephine Mason, Mark Potter and
Kevin Liffey)
