Wednesday, April 14, 2021

Axios Vitals: The new vaccine threat is fear itself

1 big thing: The new vaccine threat is fear itself | Wednesday, April 14, 2021
 
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Vitals
By Caitlin Owens ·Apr 14, 2021

Good morning.

Today's word count is 1,046, or a 4-minute read.

 
 
1 big thing: The new vaccine threat is fear itself
Data: CDC and Simon Willison; Chart: Danielle Alberti/Axios

The FDA's decision to pause the use of Johnson & Johnson's coronavirus vaccine has set off a chain reaction of fear — about the safety of the vaccine, and about whether the FDA is overreacting — that's causing unnecessary drama just as the vaccine effort is finally picking up speed, Axios' Sam Baker reports.

The big picture: Throughout the pandemic, the public and the media, and sometimes even regulators, have struggled to keep risks in perspective — to acknowledge them without exaggerating them, and to avoid downplaying them because other people will exaggerate them.

Reality check: The FDA did not say that the Johnson & Johnson vaccine's risks outweigh its benefits, and it certainly did not cast any doubt on the other two vaccines available in the U.S.

  • At the same time, the FDA also is not obligated to keep potentially serious side effects a secret because they will affect fewer people than the coronavirus. Discovering and responding to new safety information is how this system is supposed to work.

Details: The number of reported blood clots is low — just six patients out of the roughly 7 million who have gotten a J&J shot.

  • Several other common medications, including birth control, carry a higher risk of blood clots than that. And the coronavirus causes a far higher incidence of blood clots than any of them, in addition to the many other ways in which it is highly dangerous.
  • You wouldn't know that from the immediate reaction to yesterday's announcement.

That's part of the reason critics feared the FDA was overreacting, allowing a very small number of adverse events to potentially undermine a very large number of people's confidence in all-important vaccines.

  • But that criticism is missing some context of its own.

What's next: A federal vaccine advisory committee will meet today to discuss the safety issues.

Go deeper.

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2. How it's playing locally
Illustration of a shadow hovering over a giant red button with syringes in the shape of a pause symbol

Illustration: Sarah Grillo/Axios

 

The J&J pause has complicated Iowa's pandemic recovery, Axios Des Moines' Jason Clayworth reports.

Why it matters: The single-dose vaccine was critical in helping inoculate communities that are sometimes difficult to reach or schedule for two shots, including college students and homeless populations.

  • It's too early to fully assess the local ramifications since the majority of vaccines provided in the DSM area have been Moderna or Pfizer, Polk County Health Department spokesperson Nola Aigner Davis told Axios.
  • Some good news: Finding an appointment in the metro for Moderna and Pfizer has been getting easier in recent days, Aigner Davis told Jason.

The pause isn't expected to have a significant impact on Minnesota's vaccine rollout, Axios Twin Cities' Torey Van Oot reports.

  • "We'll see about a 5% or so drop off [in supply] but it will not impact our desire and our nation-leading efforts to get 80% vaccinated," Gov. Tim Walz told reporters.
  • The vast majority of doses administered in Minnesota — more than 90% — are Moderna or Pfizer.
  • Yes, but: Minnesota Health Department commissioner Jan Malcolm acknowledged that while the pause is a sign the public health system is working, the headlines could present more challenges for officials' efforts to overcome vaccine hesitancy.

In Charlotte, the pause will likely only cause a hiccup in the overall rollout, Axios Charlotte's Paige Hopkins and Katie Peralta Soloff report.

  • "My biggest concern is that vaccine hesitancy just skyrocketed," Katie Passaretti of Atrium Health told reporters Tuesday.
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3. Another blow to the EU

In Europe, where all of AstraZeneca's problems may have already led to higher vaccine hesitancy, the J&J news could be yet another roadblock, NYT reports.

The big picture: European officials had been confident they had shored up enough alternative doses to make up for the shortfalls caused by AstraZeneca's problems, and would be able to fully vaccinate 70% of European Union adults by the end of the summer.

  • But that was before yesterday's news that blood clots may be linked to a second vaccine.
  • "Today's developments with the J&J vaccine in the US are under close monitoring" by the bloc's medicines regulator, tweeted Stella Kyriakides, the European commissioner for health.

Where it stands: Two-thirds of the at least 300 million doses arriving from now through June are from Pfizer, and only 55 million are from J&J. Another 70 million are from AstraZeneca.

Yes, but: "There is mounting evidence that the concerns are eroding Europeans' willingness to get the AstraZeneca vaccine in particular, and threatening to elevate already high levels of vaccine hesitancy generally," NYT writes.

Go deeper: What's going on with the AstraZeneca vaccine

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A message from PhRMA

Instead of breaking what works, let's fix what's broken
 
 

America's unique R&D ecosystem delivered multiple COVID-19 medical breakthroughs in recordbreaking time.

As we continue our work to help end the pandemic, we have a common sense plan for better, more affordable health care — for everyone.

 
 
4. A spotlight on Black maternal health

The White House on Tuesday issued its first-ever presidential proclamation marking Black Maternal Health Week as part of an effort to highlight racial gaps in pregnancy and childbirth-related deaths, Axios' Shawna Chen reports.

Why it matters: The U.S. retains the highest maternal mortality rates in the developed world, largely due to high mortality rates among Black mothers, according to research by Commonwealth Fund. Black women in the U.S. are 2.5 times more likely to die from pregnancy-related complications than white women.

The administration said it has taken initial actions to help reduce maternal mortality and morbidity, including:

  • Investing $200 million to implement implicit bias training and create state pregnancy medical home programs, among other things.
  • Increasing funding for the Health and Human Services' Office for Civil Rights and for the Title X Family Planning program.
  • Offering states the option to extend postpartum coverage to one year instead of the 60-day minimum through a Medicaid waiver that provides an easier process for states.
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5. Catch up quick
Illustrated collage of a cut up coronavirus cell.

Illustration: Aïda Amer/Axios

 

Moderna's COVID-19 vaccine is more than 90% effective against the coronavirus approximately six months after the second dose is administered, according to preliminary data published in the New England Journal of Medicine.

Moderna released a statement Tuesday reassuring people of the safety of its coronavirus vaccine hours after the FDA recommended pausing the administration J&J vaccines due to reported cases of "extremely rare" blood clots.

Pfizer CEO Albert Bourla on Tuesday announced the company has ramped up production of its coronavirus vaccine and can deliver 10% more doses to the U.S. by the end of May than it previously agreed to produce.

The NFL outlined in a memo sent to all 32 teams that support staff, including coaches and trainers, should be vaccinated against COVID-19 "unless they have a bona fide medical or religious ground for not doing so."

The Food and Drug Administration on Tuesday announced that patients seeking abortion pills will not be required to obtain the drug from hospitals or medical facilities in person while the coronavirus pandemic persists.

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A message from PhRMA

Instead of breaking what works, let's fix what's broken
 
 

America's unique R&D ecosystem delivered multiple COVID-19 medical breakthroughs in recordbreaking time.

As we continue our work to help end the pandemic, we have a common sense plan for better, more affordable health care — for everyone.

 
 

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