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FDA Approves Export of Covid-19 Vaccine Doses From Troubled Baltimore Plan -- Update

06/11/2021 | 01:39pm EDT

By Thomas M. Burton and Sabrina Siddiqui

WASHINGTON -- The Food and Drug Administration is making millions of Johnson & Johnson Covid-19 vaccine doses available for export from a Baltimore factory that had been beset by contamination problems.

A review determined that two batches of vaccines produced at the Baltimore plant run by Emergent BioSolutions Inc. were suitable for use, the FDA said Friday.

The agency also said that it wasn't yet ready to designate the plant as an authorized manufacturing facility, and "continues to work through issues there" with J&J and Emergent.

The two batches cleared for use will provide about 10 million doses, according to people familiar with the situation. About 60 million doses were rejected for potential contamination, one of these people said, confirming a report in the New York Times.

With those rejections, there are about 120 million vaccine doses and unbottled substance made for J&J and AstraZeneca PLC at the Baltimore plant that could be cleared in coming weeks and be available for export, according to this person, a senior U.S. official.

The J&J shots are one-dose vaccines that can immunize about 10 million people. AstraZeneca's are part of a two-shot regimen, so those shots can immunize half as many people as doses available.

The Emergent plant made vaccine for J&J and for AstraZeneca, before an April 30 FDA inspection report concluded that the facility didn't take proper measures to avoid cross-contamination between the two companies' vaccine lines.

Kathy Wengel, chief officer of J&J's global supply chain, said in a statement that Friday's decisions "represent progress in our continued efforts to make a difference in this pandemic on a global scale."

Emergent said in a statement that it looks forward to "continuing to work with the FDA and Johnson & Johnson toward the release additional doses and resuming production at our Bayview facility."

The release of the vaccines will help advance President Biden's plan to export American-made vaccines to poor nations. In England ahead of the Group of Seven summit Thursday, Mr. Biden announced a plan to make 500 million doses of a third vaccine available to other countries. That vaccine, from Pfizer Inc. and BioNTech SE, also is given as a two-shot regimen.

Those donations are slated to take place over approximately the next 12 months. The doses of Pfizer/BioNTech vaccine will be provided through Covax, the global initiative to aid developing countries in their struggle against the Covid-19 pandemic.

Mr. Biden had previously committed to export a total of 80 million doses by the end of June in a bid to increase global vaccinations.

The White House said roughly 75% of those 80 million vaccine doses will be shared through Covax. The remaining 25% will be distributed to countries where cases are surging and to their neighbors, as well as to partners who requested assistance from the U.S. government.

The administration initially said 60 million doses would come from AstraZeneca following an FDA review, since the vaccine had not been authorized in the U.S., while the other 20 million doses would be a combination of vaccines from Moderna Inc., Pfizer and Johnson & Johnson, all of which are being administered domestically.

Under the Biden plan, the biggest chunk of the first batch of doses will go to South and Central American countries, including Brazil, Argentina, Peru, Ecuador and Guatemala; countries in Asia, including India, Nepal, Bangladesh, Pakistan and Sri Lanka; and to Africa, with countries that will be selected in coordination with the African Union.

Roughly six million doses will go to partners and regional priorities such as Mexico, Canada, South Korea, the West Bank and Gaza, and United Nations front-line workers.

White House press secretary Jen Psaki said earlier this week the administration still planned to export all 80 million doses by the end of the month.

"We remain committed to that. And obviously if the FDA approves AstraZeneca doses, then that will be a component of that supply," she said.

Mr. Biden has said the U.S. will be a global leader in vaccine diplomacy, which emerged as a top issue at the G-7 summit in Cornwall, England. British Prime Minister Boris Johnson, who had called on G-7 leaders to commit to vaccinating the rest of the world by the end of 2022, said the U.K. will donate more than 100 million surplus doses globally in the next year.

Some of the world leaders in attendance have disagreed with Mr. Biden's call to waive intellectual property rights for Covid-19 vaccines as a means of accelerating production in developing countries.

The U.S. has also faced criticism from some lawmakers and international aid groups for giving priority to the vaccinations of Americans and being slow to share its supply globally.

Mr. Biden's move to export doses comes as U.S. demand for the vaccine has waned following a mid-April peak of nearly 3.4 million doses administered daily. The number of daily doses administered over the past week averaged 1.1 million, according to the Centers for Disease Control and Prevention.

--Peter Loftus contributed to this article.

Write to Thomas M. Burton at tom.burton@wsj.com and Sabrina Siddiqui at Sabrina.Siddiqui@wsj.com

(END) Dow Jones Newswires

06-11-21 1539ET

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