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Federal health agencies in the United States on Tuesday will call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination, officials briefed on the decision said.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition, the officials said.
Nearly 7 million people in the US have received Johnson & Johnson shots so far and about 9 million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention (CDC).
While the move is framed as a recommendation to health practitioners in the US, the federal government is expected to pause administration of the vaccine at all federally-run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
Scientists with the Food and Drug Administration (FDA) and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday, officials said.
An FDA spokeswoman declined to comment.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.
Regulators in Europe and elsewhere are concerned about a similar issue with the AstraZeneca vaccine, leading to the Republic restricting the use of the AstraZeneca jab to people aged over 60 only. Janssen, Johnson & Johnson’s European subsidiary, is expected to administer 605,000 doses to the Republic.
Most of the vaccine supply in the US comes from two other manufacturers, Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. There have been no significant safety concerns about either of those vaccines.
But while shipments of the Johnson & Johnson vaccine have been much more limited, the Biden administration had still been counting on using hundreds of thousands of doses every week. In addition to requiring only a single dose, the vaccine is easier to ship and store than the other two, which must be stored at extremely low temperatures.
It is unclear to what degree the pause in the use of the Johnson & Johnson vaccine will set back the Biden administration’s plans to deliver enough vaccine to be able to inoculate all adults in the US by the end of May.
In the US alone, 300,000 to 600,000 people a year develop blood clots, according to CDC data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous thrombosis, is extremely rare. All of the women developed the condition between six and 16 days of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause.
The decision is a fresh blow both to Johnson & Johnson and to the administration’s plans. Late last month, the company discovered that workers at a Baltimore plant run by its subcontractor had accidentally contaminated a batch of vaccine, forcing the firm to throw out the equivalent of 13 million to 15 million doses. That plant was supposed to take over supply of the vaccine to the US from Johnson & Johnson’s Dutch plants, which were certified by federal regulators earlier this year. – New York Times