The FDA’s Vaccine Expert Panel Recommends Approval of a J&J Booster for Anyone Who Had an Initial Shot

The expert committee has now recommended booster doses for all three COVID-19 vaccines available in the US

The FDA’s Vaccine Expert Panel Recommends Approval of a J&J Booster for Anyone Who Had an Initial Shot
boosters for all three vaccines currently available in the US.

J&J’s vaccine is the only one authorized in the U.S. (and globally) that requires only a single dose. If the FDA accepts the committee’s decision, which it is expected to do, the Centers for Disease Control will then outline which specific groups should receive the additional dose.
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The recommendation comes a day after the committee recommended a booster of the Moderna vaccine, which uses a different technology than J&J and requires two doses initially. The FDA is expected to make a formal decision soon about whether to follow the committee’s advice on that vaccine. The FDA and CDC have previously authorized the Pfizer-BioNTech booster for people over age 65 and for adults who are at higher risk of severe COVID-19 and its complications, such as people with underlying health conditions, as well as health care and other essential workers whose jobs may put them at increased risk of exposure and therefore more severe COVID-19.

Read more: FDA Panel Votes to Recommend Moderna COVID-19 Booster Shot

J&J’s request was a complex one, and the committee had to decide whether to recommend the booster two months or six months after the single dose. From the start, J&J’s was less efficacious than the ones from Pfizer-BioNTech and Moderna, but the committee supported the vaccine because it provided practical benefits in the middle of a pandemic—unlike the Pfizer-BioNTech and Moderna vaccines, J&J’s requires only a single shot, and the vaccine does not need to be shipped and stored in ultra-cold conditions, but can be kept frozen at normal freezer temperatures. Those are significant advantages for reaching a large part of the world’s population, especially in in lower-resource countries.

At the committee meeting, J&J presented data showing that after the comparatively lower immune response generated after its single dose, a second, booster dose given two months later enhanced that response. That data prompted most of the members to question whether the J&J shot should have been a two-dose vaccine to begin with. “I think this was always a two-dose vaccine,” said Dr. Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia and a member of the committee. “It’s hard to recommend the single-dose [now] given the two-month data.” He noted that had the two-month data on immune responses to the second dose been available at the time that the companies originally requested an emergency use authorization (EUA) back in February, the committee likely would have recommended the vaccine be given in two doses, rather than one. That’s why the committee ultimately voted in favor of authorizing a booster dose beginning at two months for anyone after getting a first shot of the J&J vaccine.

The data get more complicated, however. At the FDA meeting on Friday, J&J researchers presented studies showing that their vaccine provides strong and persistent protection against COVID-19 disease that lasts up to eight months following the single vaccination. According to J&J’s studies, while the efficacy of their vaccine starts out lower—at around 74%, compared to the 94% and 95% efficacy recorded for the Pfizer-BioNTech and Moderna vaccines, respectively—J&J’s efficacy remains stable for months while both Pfizer-BioNTech and Moderna have documented drops in virus-fighting antibody levels starting about six months after the second dose.

One of the committee members, Dr. Hayley Gans, professor of pediatrics at Stanford University, noted the apparent paradox inherent in J&J’s request for an authorization of a booster: if a single dose of J&J provided this sort of consistent protection, especially against severe disease, why would a booster be needed?

In response, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, noted that the data on J&J’s efficacy might not be as robust as the companies suggested, citing recent CDC studies indicating vaccine efficacy as low as 50% a few months after vaccination. “There is more data out there than what we are seeing,” Marks said. “All of the data do not fully align with this being a vaccine that retains excellent activity over time against all forms of disease, or even against severe forms of disease.”

Finding the balance between the rigorous scientific evidence that regulatory agencies like FDA require and the real-world urgency of meeting the threat of an ongoing pandemic has been the recurring theme of the review of booster shots. Committee members have consistently raised questions about what the goal of boosters should be, given that the existing regimens do seem to continue to provide adequate protection against severe disease, based on currently available data. The question for the committee was to weigh how comfortable they are with the protection provided by original dosages, and how preemptive they want to be in having boosters ready for the public to head off waning immunity before it hits the point where more vaccinated are getting infected and getting severely ill—especially in the context of variants like Delta.

In theory, one goal of the additional shots could be to raise immunity levels to the point where people are less likely to transmit the virus if they do get infected, but there aren’t strong enough data to show that vaccines actually do that. Another goal would be to throw up a higher wall of immunity against new variants of SARS-CoV-2, especially the now-dominant Delta strain, which accounts for nearly all new infections around the world—booster shots raise the level of antibodies against the virus, and under the idea that a rising tide raises all ships, the more antibodies that the body makes against SARS-CoV-2, the more likely that some of those will be able to block different variants.

Indeed, the J&J team presented data showing that adding a second dose, especially six months after the first, raised vaccine efficacy to around 90%.

And, their data also suggested that the immunity generated by its vaccine has a “unique immune profile with antibody titers peaking later, broadly reactive against multiple strains [of the virus] variants, and that persist,” said Dr. Penny Heaton, head of global therapeutics at Janssen Research & Development. That means that the immunity could potentially be longer-lasting, or more durable than that provided by other vaccines. Dr. Dan Barouch, professor of medicine at Harvard Medical School who developed the vaccine in collaboration with J&J, noted that the vaccine “induced a distinct, complex immunologic profile with robust durability.”

As part of that argument the companies highlighted what they see as the defining feature of their vaccine: the triggering of the T-cell response, which is a sort of an immunologic backup to the immediate SWAT team of antibodies that the body deploys when it first encounters a new virus; antibodies can flood the zone quickly but tend to wane after time if the virus isn’t constantly present. The T-cell response, on the other hand, involves memory cells that can remember previous infections, then recognize the threat if it appears again, thus enabling the body to mount reactions more quickly in an ongoing fashion. A booster dose could potentially amplify the size of this process in people immunized with the J&J vaccine.

Before dispersing, the committee also heard results from the just-published and highly anticipated study led by the National Institutes of Health on mixing and matching doses of the three currently authorized vaccines. While the research did not directly compare different combinations, the results support the fact that giving people a booster shot from a vaccine different from the one with which they were originally immunized was both safe and effective. In fact, for the people who initially received the J&J vaccine, getting a boost with an mRNA vaccine—like those made by Moderna and Pfizer-BioNTech—led to levels of virus-neutralizing antibodies around 7-10 times higher than getting a second dose of the same vaccine.

Read more:

Those results highlighted the evolving nature of what scientists know about the protection provided by vaccines, and how best to optimize the shots. Anticipating a steady flow of new studies and new data, some of which may lead to the need to change past recommendations about vaccines, committee members discussed how the FDA will manage expanding the current booster authorizations to the broader population of adults not currently eligible for the boosters (those without health conditions or in high risk settings), and eventually children. With the ever-evolving body of knowledge on vaccines and their effectiveness, the committee stressed that the FDA needs to remain flexible and transparent in how it makes its decisions. Already, for example, each of the three types of boosters are recommended for different populations: anyone who received the J&J vaccine initially is eligible to get a booster, while for those who were immunized with Moderna or Pfizer-BioNTech, only those over age 65, or those 18-64 with health conditions or in high risk jobs are eligible.

Moving forward, “I hope we can present it in a way that’s not confusing to the public,” said committee member Dr. Stanley Perlman, professor of microbiology and immunology at the University of Iowa. “What we do is follow the science, but people who aren’t doing this think the rules are changing all the time. I hope we can do this in a way that doesn’t look like we are just changing the rules all the time.”

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How to sleep better—when nothing helps you sleep better

Believe it: These practices work. The post How to sleep better—when nothing helps you sleep better appeared first on Precision Nutrition.

How to sleep better—when nothing helps you sleep better

Reviewed by Jennifer Martin, PhD

It’s 3:17 am, and you’re awake.

Your bedroom is a cool 65° F, and inky black thanks to your blackout blinds.

You haven’t touched caffeine since 10 am.

You meditated before bed.

And if you count one more stupid lamb, you’re going to scream.

You’ve done everything right. Why can’t you sleep?

As it turns out, good sleep hygiene (habits and routines that reduce sleep disturbances) isn’t always enough.

Meanwhile, sleep loss can become a nightmarish loop. The more nights you spend tossing and turning, the more you might:

  • Associate your bed with anxiety and sleeplessness
  • Sleep in, withdraw from daytime activities, and/or obsess about sleeping
  • Develop a belief that you’re doomed to be a “bad sleeper”

The good news: There’s help.

You have more tools than ever to improve sleep quality.

For this story, we used insights from CBT-I, a research-supported form of cognitive behavioral therapy developed to treat insomnia.

We also worked with Dr. Jennifer Martin, sleep scientist and professor of medicine at UCLA, and Dr. Chris Winter, sleep researcher, neurologist, leading sleep expert, and author of The Sleep Solution. (They’re both contributing experts in our new .)

If you’re having trouble sleeping, the following strategies have the potential to transform your sleep life.

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1. Train yourself to believe you can handle less-than-ideal sleep.

“I have to fall back asleep, or tomorrow is ruined.”

“I need a solid night’s sleep, or I’m going to blow my presentation.”

“If I don’t sleep well, my inflammation levels are going to skyrocket, and I’m going to get cancer.”

Sound familiar?

Frustratingly, it’s often your thoughts that turn one bad night into a pattern of bad nights.

When you worry, your body becomes alert and vigilant. This state of physiological arousal interferes with sleep, and—if it  continues over time—you may even begin to define yourself as “a bad sleeper.”

Often, the best approach isn’t medication, supplements, or even some otherwise great sleep hygiene.

Rather, it’s addressing the underlying thoughts and emotions.

Build the skill: Reframe your thoughts.

Write down the thoughts or beliefs that come up when you don’t sleep well.

For example:

  • I’ll never sleep well again.
  • I can’t work out / think clearly / be in a good mood because I’m so tired.
  • My bad sleep is going to cause me to get some terrible illness, like cancer or heart disease.

Notice how worried thoughts tend to:

  • Use absolutes (like “always” or “never”)
  • Predict the future (even though you’re not a licensed fortune-teller)
  • See things as “all-or-nothing” (“If I don’t sleep well, I can’t do ANYTHING.”)

Now, reframe those beliefs using a nuanced perspective.

For example:

  • I might lose sleep occasionally, but other nights will probably be okay.
  • I’m not feeling my best, but I can do some exercise / work and maybe find a few moments of joy in my day.
  • Sleep is just one aspect of good health. If I don’t sleep well, I can still make sure I eat nutritious foods, drink enough water, and maybe get outside for a few deep breaths.

Compassion in particular can activate your calming nervous system. Imagine: all those people, just like you, staring at the ceiling. Send them some imaginary kindness for their suffering, and mentally reassure them that they’ll be okay too.

Consider also what a growth mindset about sleep might look like. Nobody is doomed to be a “bad sleeper” forever.

For example:

  • I’m frustrated right now, but I believe in my ability to find solutions if I keep exploring.
  • It feels like I’ve tried all the strategies, but I wonder if there are things I could practice more consistently? Maybe someone can give me some feedback and coaching here.

Knowing a bit about sleep physiology can also be comforting.

For example:

  • You probably drift into light sleep without realizing it. Ever caught someone snoozing during a movie, and when you called them on it, they swore they were awake?
  • Your brain will eventually make you sleep. Often, even if it doesn’t FEEL like you’ve slept, you probably have. And although some nights you may sleep less, over time, your body will generally fall into a pattern of sleeping at least 5-6 hours a night.

With a little trust in your body, and some intentional reframing of your thoughts, you can train yourself to go from feeling like crappy sleep is a disaster, to feeling like it’s about as devastating as finding a small hole in your underwear.

Not ideal, but you’ll get over it.

2. Have a consistent sleep-wake schedule.

Informal poll:

Who loves a good sleep-in to catch up on extra winks?

[Everyone raises a hand.]

We’re with you. However, delaying your wake time or hastening your bedtime can lead to problems long term.

That’s because oversleeping can reduce your sleep drive.

Your sleep drive is a biological hunger for sleep that accumulates while you’re awake. When you sleep in, you delay that hunger… which is why you might still be wide awake at 2 am the following night.

(To learn more about sleep drive, read: )

The solution? Spend only as much time in bed as you need (for most adults, that’s 7-9 hours) and stick to the regular sleep-wake programming, even on weekends when you could lounge in bed until noon.

Build the skill: Find a sleep schedule that works for YOU (and stick to it).

Different people have different cycles of sleep and wakefulness.

You may know this as being either an “early bird” or a “night owl.”

(This inclination to sleep and wake during particular phases of a 24-hour cycle is also called chronotype.)

Check in:

  • If your energy is highest in the mornings, and you’re often the first one to leave a party (yawning), you’re probably an “early bird.”
  • If your energy is higher later in the day, and you have a mug that says, “But first, coffee,” you’re probably a “night owl.”

Once you understand your individual patterns, you can try to work with them—waking when you’re more likely to feel energetic and going to bed when you’re more likely to feel sleepy—rather than fight them.

See if you can shift your schedule (as much as you can control) to wake and sleep at a time that feels more natural YOUR body. As a result, you may find you fall asleep—and wake up—more easily.

This table shows some sample schedules, based on chronotype:

Wake time Pre-bed ritual starts Sleep time
Early bird (or early-morning job requirements) 5:30 AM 8:30-9 PM 9:30 PM
Middle of the road (or average 9-5er) 7:30 AM 10:30-11:00 PM 11:30 PM
Night owl (or late-starting work requirements) 10 AM 1:00-1:30 AM 2 AM

Depending on work and/or home obligations, you may not be able to start your day at 10:30 am even if that’s what’s ideal for your body.

So, work with what you’ve got. Can you shift your sleep/wake time by an hour? Half an hour? Great. Even small changes can help.

Stick to your new schedule consistently.

Waking up at the same time, even on weekends and off days, is a well-established way to create a strong sleep cycle.

To do this, you can set a bedtime alarm to go off 30-60 minutes before your scheduled bedtime to remind you to start relaxing.

Of course, you can also use an alarm if you feel like you can’t trust yourself to wake at a certain time, but many people find when they discover a schedule that works, they naturally wake when they want.

3. Create a safe sleep space.

Sleep is a period of time when your defenses are down.

You’re less able to react to danger, whether that’s someone stealing your wallet or Sharpie-ing a mustache on your face.

That’s why, to sleep, you need to feel safe.

Anything that disturbs that sense of safety can trigger hypervigilance—a constantly elevated state of scanning your environment for potential threats, closely connected to anger and anxiety.1 This includes conflict with your bedmate, feeling overloaded at work, or that swirling anxiety triggered by the nightly news.

And, as you can imagine, being in a constant state of surveillance isn’t great for sleep.

In situations like post-traumatic stress disorder (PTSD), many people even fear sleep, which may come with nightmares, or the fear of being attacked while one isn’t conscious.2,3,4

(Note: Treating conditions like clinical anxiety or PTSD requires the care of a specialist and is beyond the scope of this article.)

Build the skill: Feel safe and secure.

This thought exercise can help you come up with creative solutions that lead to a sense of being cocooned, calm, and connected.

Here’s the general idea:

Imagine you live in a place called Great Sleep Town.

The main attraction of this town: Everyone who lives there gets consistent, excellent sleep. Plus, in each home, you can control all aspects of the environment to optimize sleep, including lighting, decor, noise, bedding, and movement of people.

You also have all the money and resources in the world. Think: Engineers, community mediators, sleep scientists, architects, interior decorators, psychologists, couples counsellors, massage therapists, and yogis.

Remember, you have full control, so get creative!

Use these questions to get started:

  • How do you think Great Sleep Town created such a strong sleep culture? What supports do citizens have that allow them to feel safe and calm when they “power down”?
  • How do residents spend their days? And with whom?
  • What environmental features does a home in Great Sleep Town have? Specifically, what features do the bedrooms have that facilitate such good sleep?

Of course, not all of the things you dream up will be readily accessible to you—or even invented yet. However, your answers might give you some insights into small things you could change.

What you need for better sleep will be specific to your life, but here’s what’s worked for some of our clients:

  • Buying some really soft sheets
  • Installing an alarm system and improved door locks
  • Having something for white noise, or wearing ear plugs
  • Decluttering your bedroom, so it feels peaceful and “zen”
  • Planning one small moment of pleasure or relaxation for the next day to look forward to
  • Resolving that argument with your spouse/friend/mother
  • Leaving the TV and some lights on so potential intruders know that someone’s home
  • Sleeping with your big, protective dog

Note: While this experiment can reveal some helpful changes, if you’re experiencing significant distress over your sleep, consider working with a therapist to directly treat the underlying fears and traumas that might be causing you to feel unsettled.

Sleep is a skill, not an identity.

This article is by no means a comprehensive guide to solving all sleep problems. If your struggles with sleep are persistent or severe, consult with your doctor.

However:

Whatever your sleep is like now, know that you can change.

As Dr. Winter says:

“Sleep is a skill, not a trait. If you have a good coach, you can get better.”

Keep practicing good sleep hygiene, trust in your body’s ability to sleep, and dig up Mr. Snufflesworth—your comforting childhood stuffie—if you need to.

We hope to see you in Great Sleep Town.

References

Click here to view the information sources referenced in this article.

1. Forbes D, Nickerson A, Bryant RA, Creamer M, Silove D, McFarlane AC, et al. The impact of post-traumatic stress disorder symptomatology on quality of life: The sentinel experience of anger, hypervigilance and restricted affect. Aust N Z J Psychiatry. 2019 Apr;53(4):336–49.

2. Hall Brown T, Mellman TA. The influence of PTSD, sleep fears, and neighborhood stress on insomnia and short sleep duration in urban, young adult, African Americans. Behav Sleep Med. 2014;12(3):198–206.

3. Gupta MA, Sheridan AD. Fear of Sleep May Be a Core Symptom of Sympathetic Activation and the Drive for Vigilance in Posttraumatic Stress Disorder. J Clin Sleep Med. 2018 Dec 15;14(12):2093.

4. Werner GG, Riemann D, Ehring T. Fear of sleep and trauma-induced insomnia: A review and conceptual model. Sleep Med Rev. 2021 Feb;55:101383.

If you’re a health and fitness coach…

Learning how to help clients manage stress, build resilience, and optimize sleep and recovery can be deeply transformative—for both of you.

It helps clients get “unstuck” and makes everything else easier—whether they want to eat better, move more, lose weight, or reclaim their health.

And for coaches: It gives you a rarified skill that will set you apart as an elite change maker.

The brand-new PN Level 1 Sleep, Stress Management, and Recovery Coaching Certification will show you how.

Want to know more?

The post How to sleep better—when nothing helps you sleep better appeared first on Precision Nutrition.

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