The F.D.A. will warn that Johnson & Johnson's vaccine can increase risk of a rare condition.
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 | | The New York Times |
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A Johnson & Johnson warning |
My colleagues Sharon LaFraniere and Noah Weiland report that the Biden administration could announce the new warning as early as Tuesday. European regulators may soon follow suit. (No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer or Moderna, which rely on a different technology.) |
Out of nearly 13 million Johnson & Johnson doses administered in the U.S., federal officials have identified roughly 100 suspected cases of Guillain-Barré syndrome, which occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis. |
Although the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general U.S. population. Most people who develop the condition fully recover from even the most severe symptoms. |
"It's not surprising to find these types of adverse events associated with vaccination," said Dr. Luciana Borio, a former acting chief scientist at the F.D.A. under President Barack Obama. The data collected so far by the F.D.A., she added, suggested that the vaccine's benefits "continue to vastly outweigh the risks." |
The new safety concern comes at a precipitous moment in the nation's fight against Covid-19. The pace of vaccinations has slowed, even as the Delta variant quickly spreads in areas with low rates of vaccination and the national caseload ticks up again. |
 | | The New York Times |
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Johnson & Johnson played a minor role in the U.S. vaccination effort because of manufacturing problems and a link to a rare but serious blood clotting disorder in women. Millions of Johnson & Johnson doses that have been distributed by the U.S. government are sitting unused and will expire this summer. |
The company has promised up to 400 million doses to the African Union. Separately, Covax, the global vaccine-sharing program, is supposed to receive hundreds of millions of doses. |
Covid treatment rationing |
Throughout the pandemic, American doctors have been forced to limit a last-resort Covid-19 treatment that serves as a mechanical substitute for badly damaged lungs. The treatment, known as ECMO, requires expensive equipment and specially trained staff. |
Close to 8,000 patients have received ECMO to date, including nearly 5,000 in North America. Despite the progress the U.S. has made against the virus, some doctors are still having to ration ECMO, which is offered in less than 10 percent of hospitals in the U.S. |
In the absence of a system to ensure fairness, hospitals were left to apply their own criteria, with insurance coverage, geography and even personal appeals playing a role in deciding who received life-saving treatment. |
"Patients died because they could not get ECMO," said Dr. Lena M. Napolitano, co-director of the Surgical Critical Care Unit at the University of Michigan. This spring, she said she was overwhelmed with requests to accept patients considered good candidates for the therapy, but "we could not accommodate all of them." |
- A lockdown in Sydney, Australia, looks likely to be extended as an outbreak of the highly contagious variant shows no signs of slowing down.
- Thailand will give health workers a mix of Chinese and Western vaccines as concerns grow about more transmissible variants as well as about the waning immunity provided by Sinovac.
- Is the variant too contagious for hotel quarantines? Australia and China are designing special quarantine centers to stop the variant from leaking out, The Wall Street Journal reports.
- An investigation by The Kansas City Star revealed that inaction by state officials allowed the variant to spread in Missouri.
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What else we're following |
As things are opening up, I feel more obligated to go out and do things. On the one hand, I'm excited. There's this building feeling that I'm missing out on my youth (I recently celebrated my 21st birthday at home; I didn't drink). But on the other hand, I'm terrified. I'm an anxious and introverted person. Quarantine gave me an excuse to fall back on my instincts to stay in my shell — to stay safe. Now I have to go back to learning how to be an adult and I'm not sure I have the confidence to do it. — Andrea, Arizona |
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