Thursday, March 30, 2023

EU regulators approve Moderna’s COVID vaccine as pressure mounts to speed up vaccinations

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Moderna Inc.’s COVID-19 vaccine has won support from the European Union’s medicines regulator, paving the way for a second weapon in the bloc’s fight to stem the pandemic.

The recommendation was announced Wednesday by the European Medicines Agency. The European Commission is working “at full speed” on the final stage of the authorization, President Ursula Von Der Leyen said in a tweet.

EU leaders are facing increasing pressure to speed up the clearance and deployment of vaccines to tame a viral resurgence across the continent. The 27-nation bloc began vaccination last week with the vaccine developed by Pfizer Inc. and BioNTech SE, but the pace of deployment has been uneven, leading to unfavorable comparisons with the UK and US

France had so far vaccinated less than 10,000 people, compared to more than 300,000 in Germany, pressuring President Emmanuel Macron to speed up the deployment. The United States, on the other hand, has immunized over 5 million people and Britain over 1.3 million.

Moderna shares rose 2.6% before the US stock exchanges opened. The vaccine was developed with the National Institutes of Health and is given in two doses. Like the Pfizer-BioNTech shot, it is based on messenger RNA technology that had not previously been used in immunizations. The Moderna shot was cleared for emergency use by US regulators on December 18.

“This vaccine provides us with another tool to overcome the current emergency,” Emer Cooke, EMA executive director, said in a statement. “We will closely monitor the data on the safety and efficacy of the vaccine to ensure continued protection of the EU public. Our work will always be guided by scientific evidence. “

The EU recently announced that it trigger an option for an additional 100 million doses of the Pfizer-BioNTech vaccine, bringing the company total to 300 million. He is also negotiating a deal that could up to double that amount, people familiar with the talks said on Tuesday.

The bloc has ordered 160 million doses of the Moderna vaccine, the company said last month.

Moderna will likely begin administering doses within the next week, German Health Minister Jens Spahn said on Wednesday. Germany expects to receive more than 50 million doses, he said.

Shots from AstraZeneca Plc and the University of Oxford are also expected, although it could bea few weeksbefore they are approved. After the EMA said last week that it had not received enough information to review the Astra-Oxford vaccine, Astra submitted a “substantial” data set andsaidit would work closely with the EMA to support the launch of a formal application process.

No more restrictions

Vaccines are considered the ultimate weapon against the coronavirus, which has infected more than 86 million people worldwide and killed more than 1.86 million. But getting shot in the arms of people is a huge logistical challenge and will take months, leaving governments the choice to impose restrictions on public life to prevent the pathogen from spreading out of control.

Britain, Germany and Italy all announced tougher measures to contain the spread of the virus this week.

“With every blow that goes into our arms, we tip the scales against Covid,” British Prime Minister Boris Johnson said in a televised speech Monday evening. “The coming weeks will be the toughest yet, but I really believe we are entering the last phase of the fight.”

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