JUST IN—FDA decided that ~60 million doses of the Johnson & Johnson #COVID19 vaccine produced at Emergent (Baltimore factory) must be discarded because of possible contamination. But 10 million doses can be used with a disclosure warning. 🧵
nytimes.com/2021/06/11/us/…
2) FDA cannot guarantee that Emergent BioSciences, 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
3) 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.
4) More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s.
5) Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.
6) the loss of 60 million J&Jdoses puts a dent in the Biden plan to distribute vaccines to other countries. Biden WH had been counting on sharing doses of both Johnson & Johnson and AstraZeneca but had to delay its plan while the F.D.A. completed a review of the facility.
7) The World Health Organization estimates that 11 billion doses are needed globally to stamp out the epidemic.
The F.D.A.’s action is disappointing news for Emergent and Johnson & Johnson, which hired the firm as a subcontractor.
8) Inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until later this month. Regulators are also continuing to cast doubt on whether the company, paid hundreds of millions of dollars, adhered to manufacturing standards.

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More from @DrEricDing

12 Jun
“Terribly scary” epidemic of blindness and deaths in birds—phenomenon is spreading—increasing reports in DC-metro of sick, blind, injured, dead birds. I’m also seeing reports as far as New York of dead/blind birds—many 🐦species affected. Unknown cause.🧵
birdwatchingdaily.com/news/birdwatch… Image
2) “Eye issues were reported in what otherwise looked like healthy juvenile birds, causing blindness and the birds to land and stay on the ground,” said the Animal Welfare League of Arlington in a statement. awla.org/animal-control…
3) “Animal Control is now seeing additional species of birds affected. Other agencies and localities across the region and state are reporting similar issues.”
Read 27 tweets
12 Jun
📍Nearly 2/3 of Russians say they do not plan to get the Sputnik vaccine. Analysts attribute hesitancy to: widespread distrust of 🇷🇺 authorities, & frequent state television reports that #COVID19 as mostly defeated or not dangerous… And now a new surge.🧵
nytimes.com/2021/06/12/wor… Image
2) “Russian officials scrambled on Saturday to slow the spread of a new wave of the coronavirus, ordering workers in Moscow to take next week off and pleading with the populace to make use of widely available vaccines.
3) “The biggest spike appeared to be in Moscow, the Russian capital, which reported 6,701 new cases on Saturday — more than double the rise five days ago, and the highest single-day total since December. “
Read 6 tweets
12 Jun
Nobody could have predicted this: 2 passengers on Celebrity Millennium cruise ship 🛳 test positive for #COVID19. cnn.com/travel/article…
2) The ship set sail Saturday "with fully vaccinated crew and guests and following comprehensive protocols that align with our destination partners and exceed CDC guidelines to protect the health and safety of our guests," the release said.
3) So-called "breakthrough" coronavirus cases, in which people get infected after vaccination, are expected. Such cases result in milder Covid-19 illness than in unvaccinated people, a Centers for Disease Control and Prevention study published this week shows.
Read 5 tweets
12 Jun
Bitcoin + #COVID19 + Florida = obvious 2021 headline waiting to happen.

Thousands flocked to Miami last week for Bitcoin 2021–the largest-ever cryptocurrency conference. Now, days later, some conference attendees say they’ve tested positive for COVID. 🤦🏻‍♂️
miamiherald.com/news/coronavir…
2) Larry Cermak, research director at the Block, a cryptocurrency news and information website, tweeted that he has not fallen ill but that “everyone” he was with while in Miami did.
3) Eric Wall, chief investment officer at investment firm Arcane Assets, said he tested positive for COVID-19 after attending the conference and that he was “not vaccinated,” before making his account private, Vice reported.
Read 7 tweets
11 Jun
Vaccinations not required? Two #COVID19 cases on a Mediterranean cruise ship. CDC is also not requiring cruise 🛳 to sail with vaccinated passengers. Some cruises will, but Florida prohibits vaccine requirements & will fine cruise companies for asking 🔥
washingtonpost.com/travel/2021/06…
2) The first cruise from U.S. with paying passengers scheduled to sail in June. Celebrity Cruises ship will require everyone age >=16 to be fully vaccinated—which conflicts with a Florida law that says businesses can’t ask for proof of vaccination status. washingtonpost.com/travel/2021/05…
3) MSC Cruises recently got approval from the CDC to conduct a test cruise on that vessel. The company said it will “welcome both vaccinated and non-vaccinated guests,” with those who are not vaccinated subject to additional testing and restrictions. mscpressarea.com/en_US/press-re…
Read 4 tweets
10 Jun
PAY ATTENTION—the #DeltaVariant is the biggest worry & becoming more dominant worldwide. Why?

📍More contagious

📍More severe (⬆️hospitalization risk)

📍Lower vaccine efficacy/neutralization—1 dose just not enough.

Video 📺 part 1 of 2 #COVID19

HT @VickiGSP @IndependentSage
2) It’s critical to recognize that the #DeltaVariant is rising underneath the decrease of the #AlphaVariant #B117. Many have been complacent about this. But Delta is doubling every week now in 🇬🇧! Image
3) India 🇮🇳 doctors have been sharing concerns that #DeltaVariant is more severe / affecting more kids. Singapore 🇸🇬 MOH is also warning it is affecting children a lot. Image
Read 29 tweets

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