The U.S. Food and Drug Administration (FDA) announced yesterday that it will now require everyone receiving the Janssen/Johnson & Johnson vaccine to be informed ahead of time of a small risk of Guillain-Barré syndrome associated with the shot. What does that actually mean for the vaccine rollout, and for those still waiting to be vaccinated?
Here, I dig into some of the biggest questions about the FDA's announcement, with help from reporting by my colleague Alice Park.
Why did the FDA make this announcement?
The FDA and the U.S. Centers for Disease Control and Prevention (CDC) have been closely monitoring reports of side effects and other adverse reactions among people who have gotten coronavirus vaccines. The agencies detected a slightly increased risk of Guillain-Barré syndrome among J&J recipients, leading them to update the fact sheet given to all those receiving it with a relevant warning.
What is Guillain-Barré syndrome?
It's a rare autoimmune syndrome that causes a person's immune system to attack their nerves, which can lead to a tingling sensation or, in the most severe cases, paralysis. Most people diagnosed with it make a full recovery.
How rare is this syndrome?
There have been about 100 reports of Guillain-Barré syndrome among the nearly 13 million Americans who have received the J&J vaccine so far, a rate of about 0.0007%. About 3,000 to 6,000 people in the U.S. are diagnosed with the condition each year; it most commonly shows up following an unrelated infection. Other vaccines, including the flu shot, have also been tied to a very small increased risk of Guillain-Barré syndrome.
Does this affect the other COVID-19 vaccines authorized in the U.S.?
No. There haven't been significant reports of Guillain-Barré syndrome among people who received the mRNA vaccines made by Pfizer-BioNTech or Moderna.
Could this increase vaccine hesitancy?
Possibly. Although the risk of Guillain-Barré syndrome linked to the J&J vaccine is still very low, the announcement will drum up public scrutiny of the shot. This is also the second time the FDA has updated its warnings about the J&J shot; the agency noted in April that, in rare cases, it can cause blood clots.
About 387.2 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this morning, of which nearly 334.9 million doses have been administered thus far, according to TIME's vaccine tracker. About 48.1% of Americans have been completely vaccinated.
More than 187.2 million people around the world had been diagnosed with COVID-19 as of 1 a.m. E.T. today, and more than 4 million people have died. On July 12, there were 424,419 new cases and 7,118 new deaths confirmed globally.
Here's how the world as a whole is currently trending:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
And here's every country that has reported over 3 million cases:
The U.S. had recorded more than 33.8 million coronavirus cases as of 1 a.m. E.T. today. More than 607,300 people have died. On July 12, there were 34,778 new cases and 243 new deaths confirmed in the U.S.
Here's how the country as a whole is currently trending:
Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
All numbers unless otherwise specified are from the Johns Hopkins University Center for Systems Science and Engineering, and are accurate as of July 13, 1 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
Tennessee's former top vaccine official, who was fired yesterday, spoke out against her termination in a statement published by The Tennessean later the same day. The official, Dr. Michelle Fiscus, called the decision to fire her "bizarre," said that she is "afraid for my state," and criticized the Tennessee Department of Health's decision to halt all communications about child vaccination as capitulation to political pressure from state legislators. "It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19," she wrote. "I have now been terminated for doing exactly that."
French President Emmanuel Macron has announced new vaccine requirements as the Delta variant spreads around his country, the Associated Press reports, including a vaccination mandate for healthcare workers and new passes allowing inoculated people to visit restaurants, malls and hospitals or travel via train or plane. "The equation is simple," Macron said at a press conference yesterday. "The more we vaccinate, the less space we leave this virus to circulate." France is reporting a seven-day average of daily new cases of 3,787 as of July 11, compared to just over 2,000 two weeks prior. About 37% of France's population is fully vaccinated, compared to about 45% in the European Union broadly.
Greek Prime Minister Kyriakos Mitsotakis has also mandated new vaccination requirements, Reuters reports. All nursing home staff must be vaccinated by Aug. 16; the requirement extends to all healthcare workers on Sept. 1. Additionally, only vaccinated people will be allowed to visit indoor spaces like bars and movie theaters. "It is not Greece that is in danger, but unvaccinated Greeks," Mitsotakis said in an address yesterday. Greece is reporting a seven-day average of new daily cases of 1,835 as of July 11, compared to 412 just a week before. More than 40% of the population is fully vaccinated.
The European Union has yet to endorse several vaccines in use across much of the rest of the world, including AstraZeneca shots produced in India and other vaccines developed in China and Russia. The upshot: people who received those shots may not be able to travel freely across Europe this summer, the AP reports. Individual European countries are allowed to make their own rules regarding travelers and vaccinations, but that's led to a confusing patchwork—Germany is allowing visitors inoculated with non-EU endorsed shots, but France and Italy are not. Health officials warn that the situation could stoke vaccine hesitancy by stigmatizing some vaccines as low quality.
The White House has recruited a new ally in its mission to get more young people vaccinated: pop star Olivia Rodrigo, whose album Sour topped the charts this week, CNBC reports. Rodrigo will create videos to encourage young people to get vaccinated and answer their questions about the shots. Young people have been among the slowest groups to get vaccinated in the U.S.; only about half of people ages 18 to 24 have been vaccinated, compared to 67.7% of adults overall, per CDC data.
Thanks for reading. We hope you find the Coronavirus Brief newsletter to be a helpful tool to navigate this very complex situation, and welcome feedback at coronavirus.brief@time.com. If you have specific questions you'd like us to answer, please send them to covidquestions@time.com.
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Today's newsletter was written by Tara Law and edited by Alex Fitzpatrick.
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