The European Union's drug regulator ruled today that a warning about unusual blood clots associated with with low levels of blood platelets should be added to the product information for Johnson & Johnson's vaccine – but concluded that the vaccine's benefits outweigh the risk.
The European Medicines Agency found a "possible link" between the one-dose vaccine and eight reports of the blood clots, including one fatality. More than 7 million doses have been administered. The U.S. Food and Drug Administration last week asked states to temporarily pause using J&J’s vaccine “out of an abundance of caution."
Dr. Anthony Fauci has said the FDA could once again clear J&J's vaccine for use as soon as Friday.
The decision comes as world leaders and public health experts struggle to curb vaccine hesitancy and convince the public that the pandemic is far from over. Globally, weekly infections are setting records. In the U.S., while cases and hospitalizations have fallen since January, the United States is still reporting more than 400,000 cases per week.
“While we’re making extraordinary strides in the number of people vaccinated, we still have an extraordinary amount of disease out there,” Centers for Disease Control and Prevention director Dr. Rochelle Walensky said at a White House news conference Monday.
About 1 in 4 Americans say they might decline to be immunized. Among them is rocker, gun rights activist and staunch conservative Ted Nugent, who dismissed vaccines while announcing on Facebook that he tested positive Monday after suffering flu-like symptoms for 10 days.
“I thought I was dying,” the singer said. “I literally could hardly crawl out of bed the last few days, but I did, I crawled.”
Also in the news:
►The Food and Drug Administration has ordered production of the Johnson & Johnson COVID-19 vaccine at a Baltimore plant to be halted, raising questions about the company's ability to deliver the 100 million doses it has pledged to the U.S. government by the end of June.
►Rahul Gandhi, an Indian opposition leader and scion of India’s Nehru-Gandhi family, says he has tested positive for COVID-19 after experiencing mild symptoms. India's surge continues unabated, now with more than 1.6 million cases reported in the week ending Monday. India's surge helped propel the world to another record of more than 5.4 million cases reported in the past week.
►Consumers will be able to buy rapid coronavirus tests without a prescription this week at three national chain retailers, an expansion that comes as the nation's vaccination effort accelerates and states relax distancing requirements and mask mandates.
►New York has become the fourth state to report its 2,000,000th coronavirus case, following California, Florida and Texas. California has more than 3.7 million reported cases, a USA TODAY analysis of Johns Hopkins data shows.
? Today's numbers: The U.S. has more than 31.7 million confirmed coronavirus cases and 567,600 deaths, according to Johns Hopkins University data. The global totals: more than 142 million cases and 3 million deaths.
? What we're reading: As of Monday, COVID-19 vaccines are available to every American over 16 who wants a shot, but a panel of experts convened by USA TODAY remains deeply concerned about the people who say vaccines aren't needed. Read more here.
For almost a year, Americans have been looking forward to herd immunity, when enough people are protected through vaccination or past infection to stop the spread of COVID-19. But with about a quarter of Americans saying they might not want to be immunized, herd immunity is simply not an attainable goal, some experts say. The split has become political. About 79% of self-identified Democrats say they have been vaccinated or intend to do so soon, compared with 46% of Republicans.
Herd immunity is "theoretically possible but we as a society have rejected that," said Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group. “There is no eradication at this point, it’s off the table. The only thing we can talk about is control.”
– Elizabeth Weise
The State Department on Monday said that it is raising the travel alert level for a significant number of countries this week as it factors the CDC's COVID data more heavily into its rating system.
"As travelers face ongoing risks due to the COVID-19 pandemic, the Department of State will begin updating its travel advisories this week to better reflect the Centers for Disease Control and Prevention’s science-based Travel Health Notices that outline current issues affecting travelers’ health,'' the department said in a statement. "Our advisories also take into account logistical factors, including in-country testing availability and current travel restrictions for U.S. citizens.''
The agency said approximately 80% of countries will now carry the "do not travel'' label, a level 4.
Today, just 34 of 209 countries, or about 16% have rated a level 4. Nearly 150 countries, or about 70%, fall into level 3.
The State Department said the pandemic continues to pose "unprecedented risks'' to travelers.
"In light of those risks, the Department of State strongly recommends U.S. citizens reconsider all travel abroad.''
– Dawn Gilbertson, USA TODAY
Even as the U.S. and other countries press ahead with their COVID-19 vaccination programs, infections are increasing faster than ever globally.
A record 5,363,616 new cases were reported in the week ending Saturday, a USA TODAY analysis of Johns Hopkins University data shows. At that pace, nearly nine cases are being reported every second. The growth in cases is being pushed by a stunning spike in India. The United States, which opened vaccination eligibility for all adults Monday, Brazil and Turkey are the other nations reporting more than 400,000 cases per week. Those five countries account for most of the world's new cases, the USA TODAY analysis shows.
COVID-19 deaths are still below the peak of more than 100,000 per week. About 83,000 weekly deaths are now being reported, a pace of about eight people dying every minute.
– Mike Stucka
Contributing: The Associated Press