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* EU approval paves way for first shots to be delivered in a
month
* Johnson & Johnson's COVID-19 vaccine is 4th endorsed by EU
* Norway, Denmark temporarily suspend use of AstraZeneca's
shot
*
(Adding details)
By Muvija M and Pushkala Aripaka
March 11 (Reuters) - Europe approved Johnson & Johnson's
single dose COVID-19 vaccine on Thursday, paving the way
for the first shots to be delivered in a month 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 European Union 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
COVID-19 vaccine.
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 after the agency gave its
conditional approval.
The official nod came from the European Commission shortly
after, the final step to allowing its use across the bloc.
The region is having difficulty taming a spike in 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.
The first shipments will start in the second half of April,
the company said, adding it is committed to delivering at least
200 million doses to the EU this year.
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 55 million doses due in the
second quarter in full.
J&J's factory in Leiden in the Netherlands and a plant in
Baltimore in the United States run by Emergent BioSolutions
have both been authorised by the drugs' regulator as a
manufacturer of ingredients for the vaccines.
Earlier this year, some EU countries raised questions about
J&J's production network and contract with the EU, which would
require it to send vaccines made at the Dutch factory to the
United States for bottling before being shipped back to the EU.
News that the EU had approved Johnson & Johnson's vaccine
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 instructions for human cells to
manufacture immunity-building proteins, using a weakened version
of a common-cold virus to carry them in, similar to
AstraZeneca's shot, which uses a chimpanzee cold virus. J&J has
also used the technology in its EU-approved Ebola vaccine.
EU conditional marketing authorisation allows a treatment to
be sold for a year without full data on its efficacy and
side-effects being available.
(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,
Kevin Liffey and Susan Fenton)
