Tag Archives: European Medicines Agency

J&J stands ready to roll out COVID-19 vaccine in Europe as regulators weigh risks

By Manas Mishra and Carl O’Donnell

(Reuters) -Johnson & Johnson said on Tuesday it stands ready to resume rolling out its COVID-19 vaccine in Europe, where the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.

Use of the company’s one-dose vaccine was temporarily halted by U.S. regulators last week after the 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.

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

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

“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,” said J&J’s Chief Scientific Officer Paul Stoffels.

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,” Edward Jones analyst Ashtyn Evans said, 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 a call to discuss quarterly results. 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 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 Anil D’Silva and Bill Berkrot)

EU urged to review remdesivir supply deal after COVID trial results

By Francesco Guarascio

BRUSSELS (Reuters) – The European Union should renegotiate a 1 billion euro ($1.17 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir after it showed poor results in a large trial, experts said on Friday.

In a blow to one of the few drugs being used to treat people with COVID-19, the Solidarity Trial conducted by the World Health Organization showed on Friday that remdesivir appeared to have little or no effect on mortality or length of hospital stays among patients with the respiratory disease.

The trial results were disclosed a week after the EU’s executive Commission announced its largest contract to date with Gilead for the supply of 500,000 courses of the antiviral drug at a price of 2,070 euro per treatment, which Gilead said was the standard for wealthy nations.

The Commission “needs to present the reasons behind the rush to conclude the latest contract with Gilead and move to review it in light of the Solidarity Trial findings,” said Yannis Natsis, who represents patients’ organizations on the board of the European Medicines Agency (EMA), the EU drug regulator.

The EU announced on Oct. 8 that it had signed the supply contract with the U.S. company on behalf of its 27 member states and 10 partner countries, including Britain.

Gilead had known about the results of Solidarity since Oct. 6, the WHO said, citing disclosure rules under the Solidarity Trial.

Gilead told Reuters it had received in late September an “heavily redacted manuscript” from the WHO which contained different information from the final document published on Friday.

“TIME IS OF THE ESSENCE”

The Commission’s decision was made after EU countries warned of shortages of remdesivir in their hospitals amid a new surge of COVID-19 infections across Europe.

The contract does not oblige countries to buy remdesivir, although it ties them to the agreed price.

Gilead did not comment on whether remdesivir’s price for wealthy countries could change after the WHO trial, and the company questioned its results.

“As time is of the essence – we are in a situation of a public health emergency – we have to not only invest up-front in vaccine development but also in access to therapeutics,” a spokesman for the European Commission said.

He added the EMA would look into the Solidarity results and data available from other studies on COVID treatments “to see if any changes are needed to the way these medicines are used”.

But the spokesman did not comment on whether the EU was aware of the Solidarity results before it signed the contract with Gilead. He also did not reply to questions on whether the price agreed with Gilead could be renegotiated.

“The EU should revisit the prices to be paid for Remdesivir. Why pay 1 billion euros for a drug with no effects on survival?” said Andrew Hill, a senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

He said generic versions of the drug manufactured in India were sold at 200 euros per course.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller; Editing by Gareth Jones)