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UPDATE 6-J&J to resume roll out of COVID-19 vaccine in Europe after regulatory review

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Manas Mishra and Carl O'Donnell
·3 min read
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(Updates to include J&J resuming Europe vaccine rollout, updates shares)

By Manas Mishra and Carl O'Donnell

April 20 (Reuters) - Johnson & Johnson said on Tuesday it will resume rolling out its COVID-19 vaccine in Europe after the region's medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.

Europe's health regulator, the European Medicines Agency (EMA), on Tuesday recommended adding a warning about rare blood clots with low blood platelet count to the vaccine's product label and said the benefits of the one-dose shot outweigh its risks.

J&J shares were up 2.6%

Use of the J&J vaccine was temporarily halted by U.S. regulators last week after rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

J&J said it will adjust the package label on its vaccine to warn of the risk of the rare side effect and provide instructions on how to recognize and treat it. The company said it would resume shipments to the European Union, Norway and Iceland.

"It's an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine," J&J Chief Scientific Officer Paul Stoffels said during a conference call to discuss the company earnings.

Similar rare blood clot issues were reported with use of AstraZeneca's COVID-19 vaccine in Europe.

J&J earlier on Tuesday said it was working with European countries to resume ongoing clinical trials for its shot.

The United States is also reviewing a handful of potential cases of severe side effects in addition to those that led to the pause.

"The outcome of the vaccine review is important for overall global vaccination efforts, given J&J's vaccine does not have the extreme cold storage requirements of the mRNA vaccines," said Edward Jones analyst Ashtyn Evans, referring to vaccines from Moderna Inc and Pfizer Inc with partner BioNTech SE.

Meanwhile, J&J is working with U.S. regulators to get clearance for its Baltimore-based vaccine production plant, owned by Emergent BioSolutions Inc, and expects feedback in the coming days. Emergent shut down production at its plant earlier this month after manufacturing errors ruined millions of J&J doses in March. "We are remediating what we need to remediate. We think that will lend itself to a positive outcome," said J&J Chief Financial Officer Joseph Wolk during the call. He said J&J "should know more in the next couple of days."

Nearly 8 million people had received the J&J vaccine in the United States prior to the halt.

J&J said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.

The company also said it recorded $100 million in COVID-19 vaccine sales. J&J has said the vaccine will be available on a not-for-profit basis until the end of the pandemic.

An advisory committee to the U.S. Centers for Disease Control and Prevention is expected to meet on Friday to address the pause after it delayed making any recommendations in a meeting last week and called for more data.

Johnson & Johnson reported first-quarter earnings that exceeded Wall Street expectations and raised its dividend payouts to shareholders.

The company said it expects a big improvement in sales from its medical device business in the second quarter of 2021 compared with a year earlier, when COVID-19 lockdowns took a toll.

J&J slightly raised its full-year adjusted profit forecast and now sees earnings of $9.42 to $9.57 per share, up from its prior view of $9.40 to $9.60 per share.

Total sales rose 7.9% to $22.32 billion, beating estimates of $21.98 billion.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Carl O'Donnell in New York; Editing by Bill Berkrot)