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EU regulators approve Moderna’s COVID vaccine as pressure builds to speed up immunizations



Moderna raises 2021 vaccine output outlook to at least 600 million doses

Moderna Inc.’s COVID-19 vaccine won the backing of the European Union drugs regulator, clearing the way for a second weapon in the bloc’s fight to stem the pandemic.

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

EU leaders are facing growing pressure to speed up clearance and deployment of vaccines to tame a virus resurgence across the continent. The 27-nation bloc began immunizations last week with the vaccine developed by Pfizer Inc. and BioNTech SE, but the pace of the rollout has been uneven, prompting unfavorable comparisons with the U.K. and U.S.

France had vaccinated fewer than 10,000 people so far, compared with more than 300,000 in Germany, heaping pressure on President Emmanuel Macron to accelerate the deployment. The U.S., by contrast, has immunized more than 5 million people, and Britain more than 1.3 million.

Moderna shares rose 2.6% before U.S. exchanges opened. The vaccine was developed with the National Institutes of Health and is given in a two-dose regimen. Like the Pfizer-BioNTech shot, it’s based on messenger RNA technology that previously hadn’t been used in immunizations. The Moderna shot was cleared for emergency use by U.S. regulators on Dec. 18.

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

The EU recently announced that it would trigger an option for 100 million additional doses of the Pfizer-BioNTech vaccine, raising the total from the companies to 300 million. It’s also negotiating a deal that could as much as double that amount, people familiar with the talks said Tuesday.

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

Moderna will likely start delivering doses within the next week, German health minister Jens Spahn said Wednesday. Germany expects to get more than 50 million doses, he said.

Shots from AstraZeneca Plc and the University of Oxford are also anticipated, though it may be some weeks before they’re approved. After the EMA said last week it hadn’t received enough information to review the Astra-Oxford vaccine, Astra submitted a “substantial” data package and said it would work closely with the EMA to support the start of a formal application process.

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 shots into people’s arms presents a huge logistical challenge and will take months, leaving governments little choice but to impose restrictions on public life to keep 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 jab that goes into our arms, we are tilting the odds against Covid,” U.K. Prime Minister Boris Johnson said a televised address late Monday. “The weeks ahead will be the hardest yet, but I really do believe that we are entering the last phase of the struggle.”

More health care and Big Pharma coverage from Fortune:

  • The biggest conspiracy theories of 2020 (and why they won’t die)
  • Timeline: From the first coronavirus cases to the first vaccinations
  • Trump hyped Verily’s coronavirus testing tool. It led to less than 1% of all tests in 2020
  • Commentary: Cracking the code of biological aging could solve America’s health care crisis
  • Data delays aren’t slowing the global rollout of a Chinese COVID-19 vaccine


Biden’s inauguration was good news for our world



Biden's inauguration was good news for our world

Good morning. David Meyer here in Berlin, filling in for Alan.

I’m a South-African-British dual citizen living in Germany. So, while I’ve been saddened by the rancor that’s infected American politics over recent years, and while I naturally have personal opinions on the issues that divide the country, I’m not an American voter, and my family and I have no direct stake in the choices that American voters make.

Except when it comes to one particular issue: the climate emergency.

The world is heating up due to human actions, and there is strong scientific consensus that this will have terrible outcomes if not mitigated. We’re seeing them already, in the U.S., in Germany, in the U.K., in South Africa—everywhere. We all share this world, we are all suffering from its degradation, and we must all act to save it.

That responsibility lies with every country, but there’s no getting around the fact that the greatest onus to cut carbon emissions rests on the biggest emitters, namely China, the U.S., the EU, India and Russia. The fifth entry on that list is dragging its heels—and shame on the Putin regime for that. But China, the EU and India are all taking this challenge seriously, and it is of the utmost importance that the U.S., the second-biggest emitter, does the same.

Based on this, I can only applaud yesterday’s inauguration of President Joe Biden. I’d do the same for a Republican president who took the climate emergency seriously—on this side of the pond, it’s much less of a partisan issue, and I hope that will soon become true in the U.S. as well.

As soon as he took office, Biden was a whirlwind of climate-defending activity. Most importantly, he recommitted the U.S. to the Paris Agreement, which aims to keep global warming well below 2 degrees Celsius. The significance of this is enormous.

Before yesterday, countries producing half of all global carbon emissions had committed to carbon neutrality or net-zero emissions. “Today’s commitment by President Biden brings that figure to two-thirds,” said United Nations Secretary-General António Guterres as he welcomed the move.

But, Guterres warned, “there is a very long way to go. The climate crisis continues to worsen, and time is running out to limit temperature rise to 1.5 degrees Celsius and build more climate-resilient societies that help to protect the most vulnerable.”

I have no doubt that the U.S. will be rewarded for bringing its considerable heft to this fight, not only in terms of national security—climate change is a far more fundamental threat than terrorism—but also when it comes to international standing. The country will find it easier to achieve its foreign-policy aims when others see it as a partner rather than a holdout.

It should also go without saying that clean-energy investors will find the new administration’s policies rewarding. Solar stocks are on a tear, thanks to the prospect of more stimulus and subsidies, and the likely continuation of low interest rates that aid financing for new projects. Unsurprisingly, with a green-hued infrastructural push on the way, a BofA note this morning points out that fund managers are throwing money into energy and materials.

All in all, yesterday’s transition provides grounds for climate optimism around the world. But now there’s work to do. More news below.

David Meyer

[email protected]

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Do government deficits matter?



Do government deficits matter?

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In support of political contributions



A deluge of feedback in a turbulent week

Good morning.

Most Americans don’t want CEOs involved in politics. A poll conducted last week by Golin and Ipsos found only 41% favored CEOs weighing in on disputed elections, and only 43% wanted them speaking out on impeachment. On the other hand, 74% say CEOs should call for unity and a peaceful transfer of power, and 57% believe it was appropriate for CEOs to speak out after the January 6 insurgency at the Capitol. That pretty well tracks with the way most CEOs and business groups have behaved since election day. They kept their powder dry until all legitimate avenues for disputing the election were exhausted, then came out strongly endorsing the election results and attacking efforts to undermine them. Relatively few have backed impeachment. (You can see the poll results here.)

But how about political contributions? That’s the question raised last week, as a host of companies—Marriott, AT&T, American Express, Best Buy, Cisco, Comcast, Dow and Amazon among them—suspended campaign contributions to members of Congress who challenged the election results. Another large group—Microsoft, Boeing, Blackrock, Coca-Cola, JP Morgan, Ford, GM, UPS, Goldman Sachs and Citigroup—temporarily halted all political contributions to members of both parties. (Quartz has a more comprehensive list of what companies did here.)

Some business leaders are even contemplating permanently shutting their political action committees and exiting the money game altogether. But absent a broader overhaul of campaign finance—which is unlikely anytime soon—I think that’s a mistake. Most big companies remain balanced players in the money game, dividing their dollars roughly equally between members of each party. Walmart, for instance, has kept its contributions at exactly 50-50. Their strategies have less to do with trying to influence outcomes, and more to do with assuring they have access to whoever wins.

The more important question for 2021 is how big business uses that access. There are a host of issues where business has the potential to help broker positive outcomes for the U.S. economy and society: economic stimulus, infrastructure, worker training, climate change. On each of these, business leaders occupy the center, and can help bring the parties together to solve urgent problems.

But on tax and regulatory issues, in particular, corporations will be playing defense. And they’ll be tempted to use what influence they can muster to seek tax breaks and regulatory exemptions that aren’t in the broader public interest. That’s where the commitment to stakeholder capitalism will be tested. The nation desperately needs business involved in government. But business, now more than ever, needs to use its influence to focus on solving long-term challenges.

News below.

Alan Murray

[email protected]

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