Johnson & Johnson asks FDA for emergency use authorization of coronavirus vaccine
Johnson & Johnson asked U.S. regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies.
J&J’s vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study.
It didn’t appear quite as strong as two-dose competitors made by Pfizer and Moderna — a finding that may be more perception than reality, given differences in how each was tested.
But the Food and Drug Administration is asking its independent advisers to publicly debate all the data behind the single-dose shot — just like its competitors were put under the microscope — before it decides whether to green light a third vaccine option in the U.S.
This same regulatory process for Pfizer took a little over three weeks. For Moderna it was a little more than two.
Meanwhile, despite its world-class medical system and its vaunted Centers for Disease Control and Prevention, the U.S. fell behind in the race to detect dangerous coronavirus mutations. And it’s only now beginning to catch up.
The problem has not been a shortage of technology or expertise. Rather, scientists say, it’s an absence of national leadership and coordination, plus a lack of funding and supplies for overburdened laboratories trying to juggle diagnostic testing with the hunt for genetic changes.
In other developments:
- Coronavirus deaths in the United States surpassed 450,000 on Thursday, and daily deaths remain stubbornly high at more than 3,000 a day, despite falling infections and the arrival of multiple vaccines.
- Even as President Joe Biden meets with senators and works the phones with Capitol Hill to push for a $1.9 trillion COVID-19 relief package, his team is increasingly focused on selling the plan directly to voters.
- The Biden administration is reviewing whether it can take steps to provide student debt relief through executive action, even as it continues to call on Congress to pass legislation to help borrowers and their families.
- A new survey says people who moved because of the pandemic in the fall were more likely to cite financial stress as their top reason compared with those who moved in the spring, when fear of catching the virus was the most important reason.
- Wisconsin’s Republican-controlled Legislature on Thursday repealed Democratic Gov. Tony Evers’ mask mandate, brushing aside warnings from health experts against making Wisconsin one of only 10 states without a statewide order.
- An Associated Press investigation has found that scores of Roman Catholic dioceses in the U.S. had more than $10 billion in cash and other readily available funds when they received at least $1.5 billion from the federal government’s small business emergency relief program.
- Iran has received its first batch of foreign-made coronavirus vaccines ― 500,000 doses of the Russian-made Sputnik V ― as the country struggles to stem the worst outbreak of the pandemic in the Middle East.
- With COVID-19 problems cropping up and four teams currently idled, the NHL has revised its virus protocols in a bid to keep the shortened season on track.
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