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The F.D.A. tells Johnson & Johnson to discard about 60 million doses made at troubled US plant

 

The F.D.A. tells Johnson & Johnson to throw out about 60 million doses made at troubled plant

WASHINGTON — After weeks of review of a troubled Baltimore factory, federal regulators have decided that about 60 million doses of the Johnson & Johnson coronavirus vaccine produced there must be discarded because of possible contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices. The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.

For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the site.

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COMMENTARY: Epidemiology, not geopolitics, should guide COVID-19 vaccine donations

With COVID-19 vaccine supplies shifting from scarcity to abundance in high-income settings, such as Canada, the EU, the USA, and the UK, the June 11–13, 2021, Group of Seven (G7) summit in Cornwall, UK, is the time when leaders from those countries should act on their promises to send surplus COVID-19 vaccine supplies to the many other countries where doses remain scarce.
 
Vaccine donations are not the only solution to the gap that has emerged between countries with and without sufficient doses of COVID-19 vaccines. Yet, the potential number of surplus vaccine doses purchased by G7 nations is likely to be in the hundreds of millions or more.
 

Vaccine manufacturers based in those countries have also offered to sell more than a billion doses at cost for use in low-income and middle-income countries (LMICs) in 2021, which G7 governments could buy and donate.

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U.S. expected to provide additional 500 million Pfizer-BioNTech doses to 100 nations over the next year

 

The U.S. is expected to provide 500 million Pfizer-BioNTech doses to 100 nations over the next year

The White House has reached an agreement with Pfizer and BioNTech to provide 500 million doses of coronavirus vaccine to about 100 countries over the next year, a pact that President Biden plans to announce as early as Thursday, according to multiple people familiar with the plan.

Under intense pressure to do more to address the global vaccine shortage and the disparities in vaccination between rich and poor nations, the president hinted at the plan Wednesday morning, when he was asked if he had a vaccination strategy for the world.

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J&J COVID-19 vaccine protects against virus variants--new study

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