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Medically Necessary: Europe hopes mRNA vaccines will speed rollout after delays

This is an excerpt from the April 20, 2021 edition of Medically Necessary, a health care supply chain newsletterSubscribe here.

Europe hopes mRNA vaccines will speed rollout after delays

New strategy: The European Union is turning to Pfizer’s mRNA vaccine to speed up the vaccine rollout after doses from AstraZeneca and Johnson & Johnson were delayed by health concerns and production problems, according to reporting from The New York Times.

  • Pfizer will deliver 50 million doses to the EU a few months early. The EU is also negotiating with Pfizer to secure 1.8 billion doses over the next two years, according to a press release
  • This week, Pfizer announced that it would supply an additional 100 million doses to the EU. The company now hopes to supply 600 million doses by the end of the year. 
  • “We need to focus on technologies that have proven their worth; mRNA vaccines are a clear case in point,” European Commission President Ursula von der Leyen said, according to the press release.

Last week, Reuters reported that the EU did not plan to renew vaccine contracts with AstraZeneca and Johnson & Johnson, which both use a different kind of technology.

Supply problems: Europe was initially relying heavily on doses from AstraZeneca, but the company failed to deliver promised doses earlier this year.

  • AstraZeneca was supposed to deliver 80 million doses to Europe by the end of March, but cut that number to 31 million doses because of production issues, according to The Guardian.
  • In March, the company told the EU it would only be able to provide 100 million doses — down from the 270 million it originally promised — by the end of June because of problems with export restrictions, according to The Wall Street Journal

The European Union started ordering more shots from Moderna and Pfizer soon after AstraZeneca reported those supply problems, according to Fierce Pharma. But Pfizer also had problems supplying Europe early on.

  • In February, Reuters reported that Pfizer hadn’t yet delivered millions of doses it had promised to the EU.

Health concerns: On top of that, European regulators say there’s a possible connection between AstraZeneca’s vaccine and blood clots, which has caused further delays. A similar concern paused the rollout of Johnson &  Johnson’s vaccine.   

  • Germany, France, Italy and many other European countries suspended administration of the AstraZeneca vaccine after because of reports that the vaccine caused blood clots, according to the Associated Press.
  • Many of those countries resumed administration a few days later after the European Medicines Agency determined that the benefits outweighed the risks, according to CNBC.
  • Last week, Denmark stopped using the AstraZeneca vaccine because of the risk of blood clots, according to NPR.

Johnson & Johnson delayed the rollout of its vaccine in Europe for several days because of reports about similar blood clots

The latest: On Tuesday morning, the European Medicines Agency’s safety committee concluded that the benefits of Johnson & Johnson’s vaccine outweighed the risks. 

What’s next? The German vaccine manufacturer CureVac says it’s weeks away from publishing results about the efficacy of its own mRNA vaccine, according to Bloomberg.

  • The company says it could get approval for use in the European Union by May, Bloomberg reports.

CureVac is focused on providing shots to Europe and the company’s vaccine is also easier to store. That’s good news for European countries that have struggled to get shots in arms.

Johnson & Johnson leaders say they’re still on track to supply doses despite setbacks

The rosy view: Despite a major manufacturing mishap and questions about serious side effects, leaders at Johnson & Johnson are optimistic about the future of their vaccine.

  • “We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for the emerging pandemic,” Johnson & Johnson Chief Scientific Officer Paul Stoffels said on a conference call with investors Tuesday morning.

The money: The company reported $100 million in sales of the COVID-19 vaccine during the first quarter of 2021. 

  • Chief Financial Officer Joe Wolk reminded investors on Tuesday morning that Johnson & Johnson is providing the vaccine on a not-for-profit basis “during the crisis period.”

Side effects: Concerns about blood clots caused a delay in vaccine administration in the U.S. and Europe, but executives seemed to indicate that those pauses wouldn’t cause major disruptions to supply.

  • “We’re cautiously hopeful that there is a very viable path forward. We’ll learn a lot more in the next couple of days through the regulators,” Wolk said.

A CDC panel is set to meet on Friday to determine whether to resume administration of the Johnson & Johnson vaccine in the U.S.

  • “I would be surprised if they did not have a decision by Friday,” White House medical adviser Anthony Fauci told NPR. “I doubt very much whether they would just cancel it. … So you have either come back with no inhibitions or you come back with some sort of restrictions.” 

Johnson & Johnson says it will still be able to provide 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland and 100 million doses to the U.S. However, it failed to specify a specific timeline for delivery.

  • In March — before the problems with blood clots and the mix-up at a Maryland manufacturing facility — Reuters reported that Johnson & Johnson was already struggling to provide the 55 million doses it had promised the EU by the end of June.

Manufacturing update: In April, the FDA told contract manufacturer Emergent Biosolutions to stop producing Johnson & Johnson’s COVID-19 vaccine at a Maryland manufacturing plant while the agency is investigating the plant. 

  • The order to stop production follows a mishap at the plant where workers ruined up to 15 million doses of the vaccine, according to The New York Times.
  • After the mishap, Johnson & Johnson assigned extra manufacturing, quality and technical operations staff to oversee the plant.
  • The plant hasn’t received FDA approval, so the plant can’t contribute to the company’s vaccine supply yet. 

On Tuesday’s call, executives said they were still confident that they could provide 100 million doses to the U.S. but were reluctant to provide more details.

  • “At this time, as we continue in discussions with the FDA, it is premature to speculate on any potential impact that this may have on our timing of our vaccine deliveries,” Stoffels said.

Stoffels said he expected the FDA to close its investigation into the facility this week and then the company would work to address any issues the inspection finds.

Half of U.S. adults have one shot and all are eligible

A milestone: Half of all adults in the U.S. have received at least one dose of a COVID-19 vaccine and all are now eligible to receive a vaccine.

  • As of Tuesday, more than 130 million adults in the U.S. — half the adult population — had received at least one dose of a COVID-19 vaccine, according to data from the Centers for Disease Control and Prevention.
  • About 85 million adults are now fully vaccinated, representing about one-third of the U.S. population.

In some states, more than 60% of the adult population has received at least one dose. Mississippi and Alabama are farther behind, with fewer than 40% of adults vaccinated.

Source: CDC

Your turn: All U.S. adults are now eligible to receive a shot, according to The New York Times.

  • Hawaii, Massachusetts, New Jersey, Oregon, Rhode Island and Vermont were the last states to expand eligibility to all adults, according to NPR.
  • In early April, President Joe Biden said he wanted states to open up vaccine eligibility to all adults by Monday, according to Axios.  

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