After an afternoon of debate, an FDA panel voted Friday in favor of authorizing J&J’s COVID-19 booster shot.
The FDA has the final say in reviewing J&J’s application to give an extra dose.
A new study suggested Moderna’s or Pfizer’s vaccine also work as a booster for J&J recipients.
The Food and Drug Administration’s expert panel voted Friday in support of Johnson & Johnson’s application to offer a booster shot of its COVID-19 vaccine.
About 15 million people in the US have received the J&J single-dose vaccine, and Friday’s positive recommendation clears a path for the agency to potentially authorize an extra dose those recipients. Unlike the Pfizer and Moderna booster shots, the FDA committee recommended all J&J recipients be offered a booster, regardless of age or risk of severe disease.
J&J is seeking to make a second dose available as early as two months after people got the first shot. The FDA’s group voted unanimously, 19-0, in favor of recommending the additional shot.
The thumbs up comes despite limitations in J&J’s booster data
The committee’s blessing was not without debate. And the FDA is not required to follow the group’s recommendations, although it typically does so.
J&J submitted results from a study that included just 17 volunteers who got a second dose after six months. While that data appeared to meet the FDA’s goals for what a booster should do, the FDA’s review stated the results are limited by the small sample size and were also impacted by a subpar lab test J&J used.
There’s far more evidence supporting a second dose of J&J given two months after the first shot. But that dataset, which includes more than 16,000 volunteers, has yet to be independently reviewed and verified by by FDA scientists.
Mixing-and-matching vaccine boosters could be more effective
That trial enrolled 458 people who had been vaccinated with either Pfizer’s, Moderna’s, or J&J’s vaccine, then offered a boost of one of those three brands. J&J recipients saw a significantly larger jump in neutralizing antibody levels with a Moderna or Pfizer booster – respectively a 76-fold and 35-fold increase in antibodies – compared to another J&J shot, which yielded a 4-fold jump on average.
The FDA has been busy reviewing booster-shot applications from Moderna and Pfizer as well. The FDA’s expert panel voted on Thursday to recommend Moderna’s booster shot for authorization.
Pfizer’s booster shot won emergency use authorization in August, with the FDA making a large swath of Pfizer recipients eligible for an extra dose after six months. This group includes the immunocompromised, people 65 years and older, and younger people at high risk of severe COVID-19.
The Centers for Disease Control and Prevention’s expert panel is set to meet on October 20 and 21 to discuss the US booster policy.
They allow me to enjoy live music and loud events while minimizing potential hearing damage.
Concert Earplugs (small)
Before the coronavirus pandemic put a pause on in-person events, I went to a lot of concerts. But while I loved listening to live music, I never gave much thought to the damage it could cause to my hearing. Now that concerts are making a comeback, I’m turning over a new leaf – I’m going to wear earplugs.
According to the CDC, noises measuring above 70 dB over an extended period of time can start damaging your hearing. In my experience going to concerts, I’ve found that, on average, loud music ranges from 90 dB to 110 dB – as measured by my Apple Watch Series 6. EDM music festivals and raves are even louder.
To test your level of hearing loss, you can try the Mimi app on iOS and Android. It’s not going to be as accurate as a hearing test conducted by a professional, but it’s neat to get an idea.
I’ve been lucky enough to avoid any permanent hearing loss or tinnitus, but I have to be careful to keep it that way. That’s where earplugs come in. I’ve tried a couple of different brands, but the Mumba Concert Earplugs have proven to be a solid combination of comfort, affordability, and effectiveness.
For a sale price of $22 (usually they’re $29), you get the earplugs, keychain case, and two sizes of in-ear shells.
After some trial and error, I’ve found the smaller size shells (left) to be far more comfortable for my ears. Both sizes are a bit finicky to clean, though.
The carrying case gets a second look every time I pass through security, but it’s super convenient to keep on my keys. I have yet to misplace them, too, which is easy with something so small.
They have a low profile and fit in nice and snug. I’ve found that they cut down on sound without muffling it, and I can still hear people nearby talking to me.
These earplugs are designed to reduce noise by up to 24 dB, potentially bringing loud concerts below the harmful level. Exactly how many decibels hit your ears depends on how close you are to the speakers, though.
Should you buy the Mumba Concert Earplugs?
Mumba’s Concert Earplugs have been a good investment for me, and they’re worth considering if you attend a lot of loud events, too.
The Mumba Earplugs are high quality, effective, and comfortable. Compared to Loop brand earplugs that I’ve tried previously, the Mumba earplugs stay in my ears more securely, and muffle less sound. They also make it easier to hear people around me, which I couldn’t do with Loops.
Moderna plans to use a half-strength dose for its third shot. The initial two injections were 100 micrograms; the third shot would be 50 micrograms. The company said this smaller dose still produced good immune responses and would increase how many doses Moderna can produce.
Even with a smaller dose, people who received the booster shot still experienced common side effects. These were predominantly mild or moderate in intensity and resolved on their own within a few days, according to clinical trial results presented by Moderna.
People under 65 years old recorded more side effects, although the frequency was typically slightly lower than rates after the second dose. For younger people, here are the most common side effects.
These are from 129 study volunteers who received a half-strength booster shot after being fully immunized:
Injection site pain: 86%
Muscle pain: 50%
Joint pain: 42%
Injectionarm swelling or tenderness: 25%
Moderna also included safety data in its application for 38 study volunteers who were 65 years and older. Their most common side effects were:
Injection site pain: 76%
Muscle pain: 47%
Joint pain: 40%
The FDA still needs to officially authorize Moderna’s booster shot. The Centers for Disease Control and Prevention would then need to also sign off on its use before it can be rolled out.
Former President Bill Clinton was admitted to hospital on Tuesday for an infection unrelated to COVID-19.
His physicians said he is responding well to treatment in the last two days, and that his white blood cell count is trending down.
Clinton, 75, has a medical history involving two heart procedures.
Former US President Bill Clinton was admitted to the University of California Irvine Medical Center on Tuesday evening for an infection unrelated to COVID-19, according to his spokesperson, Angel Urena.
“He is on the mend, in good spirits, and incredibly thankful to doctors, nurses, and staff providing him with excellent care,” said Urena in a statement.
Having an accurate thermometer on hand can help tell you how severely the body is in distress – whether it’s confirming that you or your baby is ill enough to need a doctor or the hospital, or if your systems are safe after being exposed to dangerous weather.
Luckily, getting a quick temperature reading is remarkably easy and safe these days. But the biggest variable among thermometers you can buy is really just: Is it accurate? That’s why I tested 10 leading thermometers, in addition to speaking with many experts and parents on which type of home thermometer is best and other FAQs on therometers and fevers.
Here are the best thermometers to check for a fever:
I reached out to a number of pediatricians for their expert opinion on thermometers and read journal articles, “Consumer Reports,” customer reviews, and even spoke with 20 parents about their temperature-taking experiences.
I narrowed it down to the top 10 thermometers and tested each myself nine times over the course of three days on myself and my two kids, as well as a handful of times on my sister and two of my nieces, one of whom is an infant. I also handed off two of the infrared thermometers to Cindy Mrotek, owner of A.C.E Behavior Solutions, an essential business screening adults and children with special health care needs upon entry, for testing over the course of one week.
I looked at each product’s speed, size of display, mute options, memory recall, batteries, warranty options, and storage containers. I also looked hard look at:
Accuracy, precision, and readability of thermometer instructions: You have to use a thermometer correctly for an accurate reading, so I evaluated the information on each product’s box and inside its user manual from a health literacy perspective, including how helpful and easy to read the instructions were. Models varied, with some having a quick guide with pictures (great), information in Spanish (big bonus), or a QR code for video instructions, while others had print so tiny you need a magnifying glass to read it.
Pros: User friendly, easy to read, nice storage pouch, precise, can be used either contactless or in-ear
Cons: Cap to change methods difficult to snap on, no probe covers
The iProven DMT-511 infrared therometer is two-in-one, as it allows you to switch from reading via an in-ear probe or a forehead setting, the latter of which is safer for infants under 3 months old.
It was highly accurate in my tests, reading within 0.5-1.0 degrees again and again for forehead readings and within 0.5-0.8 degrees for ear mode. It also displays the temperature within one second.
There are separate buttons for “head” and “ear,” and to change from one to the other, you need to snap on or off the top cap of the thermometer, which I found a little difficult but still doable.
To get an accurate ear temperature, you have to insert and place the probe top correctly, so be sure to read the instructions thoroughly. It took me a couple of tries to feel confident taking my own temperature this way.
I liked that it has a fever alarm and color temperature indication to take the guesswork out of interpreting the readings. The manual also includes a very comprehensive comparison table on how to interpret measurements based on age and method. The thermometer can also store up to 20 past readings for easy comparison.
The devices comes with two AA batteries, a soft pouch for storage (great for travel and diaper bags), and cleaning instructions. It also comes with a two-year limited warranty and the option of an extended year warranty for free.
Best budget thermometer
The Vicks Comfort Flex Thermometer was the most affordable of the thermometers tested, easy to use, and has a large digital screen with color-coded readings to indicate fever.
Pros: Affordable, multiuse, precise, large digital display, comes with probe covers
Cons: Very loud beep, must turn off and on between readings, colored fever alerts misleading, coin cell battery is more annoying to replace
The Vicks Comfort Flex Thermometer is easy to use right out the box: There’s only one button and you have the option to use the device orally, rectally, or under the arm. Its runs on an included coin cell button battery.
I found the large digital display to be the easiest to read of all the thermometers I tested. It also beeps the loudest of the group, which is especially helpful for seniors with visual and hearing impairments, but also could be a nuisance for some considering the beeping lasts a full eight seconds.
The LCD screen uses a color temperature indication alongside displaying the actual number, which is generally helpful but fever isn’t the same for everyone so this could be alarmist if you run hot.
The precision and repeatability of the thermometer was quite good in my tests and only varied by about 0.5 degrees. Although the box says the Vicks Comfort Flex Thermometer takes 10-12 seconds to read your temperature, I found it was actually much quicker with a response time of 5 to 6 seconds orally and 6 to 7 seconds rectally.
It is a little annoying that you have to turn it off and back on to take a second reading, and it is only able to recall the last reading you took. But I did like that this model comes with 100 disposable probe covers and a protective holder, along with a one-year limited warranty and instructions in English and Spanish.
Pros: Fast reading, precise, no beeping, helpful content in user manual
Cons: Vibration may be missed, prone to user error, doesn’t work well for kids that won’t sit still
Prior to testing the iHealth No-Touch Forehead Thermometer PT3 myself, I’d already seen it in action for pre-screening at both my dentist’s office and my daughter’s daycare. It seemed like a good product that offered quick readings.
When I tested it myself, I found that first impression held up. Instead of a beeping alarm, the device vibrates once it has a reading, which also lights up the LED display. This is nice if you don’t want a loud noise, and upon testing, I found the precision and repeatability varied only by 0.5 degrees.
I also had Cindy Mrotek, whose business A.C.E Behavior Solutions screens people upon entry, try it out and she said the iHealth was a faster read compared to other infrared thermometers. However, she added it was a bit difficult to use on kids that can’t sit still. I myself found the device woudn’t read if it was too far away from the skin.
The iHealth comes with a user manual in English and Spanish, a quick guide with pictures, two AAA batteries, and cleaning instructions. It also has a one-year limited warranty.
Best thermometer for daily testing
If you’re tech-savvy and looking for a great smart thermometer, the Kinsa Quick Care Smart Thermometer can be used three ways and even allows you to contribute to public health research.
Pros: Diverse way to read temps, can support multiple family members and keep temperature records separate, has great app features, contributes to public health research
Cons: Needs app to work, does not include probe covers,
Every morning, I have to self-certify that my kids are free of COVID-19 symptoms before sending them off to school. A smart thermometer like the Kinsa — which stores all the readings for each individual family member on my phone and helps me monitor their baseline temperature — makes that daily routine much easier to manage.
The Kinsa Quick Care Smart Thermometer connects to your smartphone via Bluetooth and uses an app, which I found easy to set up. I then created profiles for each member of my family, which includes inputting their birthdays to help the app’s algorithm provide appropriate care instructions person to person. You can also add notes, symptoms, and track medication doses within the app.
After each reading, the thermometer displays not only the temperature but a happy, neutral, or sad-face emoji corresponding with fever status.
You can check the temperature orally, under the armpit, or rectally (they also make a separate model specific for in-ear use). Although the box says the response time is 8 seconds, I found it to read a temperature between 2 to 3 seconds when used orally. The precision varies between 0.8 and 0.5 degrees.
Kinsa sits in a really unique space for both thermometers and smart equipment contributing to public health: As Hilary Brueck, Insider’s Senior Health and Science reporter, has laid out, the smart thermometer has helped forecast outbreaks of both the coronavirus and the flu, including detecting fever spikes weeks before hospitals and clinics start to see an influx of patients.
It’s an added bonus that using this stellar, versatile, and accurate thermometer can help contribute to predicting COVID hotspots.
Pros: Most precise tested, suitable for all ages older than three months
Cons: Unintuitive, dim display, plastic cap to protect the sensor easy to lose
Next to rectal thermometers, temporal artery thermometers are the most reliable way to get an accurate reading on children and babies over 3 months of age. (Use a rectal thermometer on infants under 3 months.)
With the Exergen Temporal Artery Thermometer, a gentle stroke across a child’s forehead captures the naturally emitted heat waves coming from the skin over the temporal artery to give a reading in 2 to 3 seconds. It can store up to eight readings.
When tested repeatedly, the Exergen thermometer delivered the most consistent and precise results of any model tested on myself and my kids — within 0.3 degrees.
However, unlike other models with backlight displays, the Exergen has a relatively small LCD display screen with a dim readout. It may be hard to see if you are in a dark room.
However, unlike others, this thermometer wasn’t as intuitive to use, despite having instructions printed directly on the back of the device, I wasn’t sure if I was correctly stroking the top of the unit across the forehead. But the instruction manual had a QR code which led to videos demonstrating how to use it, which was helpful.
The model comes with a 9V battery already installed, cleaning instructions, and a five-year limited product warranty.
Braun Thermoscan 7 Ear Thermometer ($38): This is a fantastic in-ear thermometer with much peer-reviewed research to back it up, and not only do we recommend it but many parents I spoke with already own it. The downsides are it takes 10 seconds to read a temp, and it’s the most expensive option I tested — especially when you factor in the disposable lens filters that need replacing for accuracy and hygiene.
Dr. Talbot’s Infrared Forehead Thermometer, Non-Contact($19.89): This device has comparable precision and speed to the iHealth and is designed for contactless reading of infants over 3 months, including adults. I liked this device and it was easy to operate, but it’s more expensive than the iHealth and was difficult to change the settings using only the trigger.
Kinsa Smart Ear Thermometer($39.99): The Kinsa is super sleek and easy to use on yourself, which can be tricky for the ear. I also found the app to be tremendous in terms of content with very helpful instructions. Even though the readings only took a second, the precision tended to vary by 1.5 degrees.
Your basic digital thermometer options to choose from are:
Single-use stick thermometer (marketed for rectal only)
Multiuse stick thermometer (rectum, mouth, or armpit)
Tympanic thermometer (ear)
Temporal artery thermometer (forehead)
Tympanic and temporal thermometer (ear and forehead)
Infrared non-contact thermometer (forehead)
Though there’s plenty of apprehension about no-contact thermometers, a column in Ask a Pediatrician by Dr. Elizabeth Murray, an official spokesperson for the AAP, addresses those concerns directly. Murray says that “the claims about their danger are false … It is the infrared energy coming from the person that is being gathered by the thermometer, not infrared light being projected to the person.”
All thermometers sold in the United States must meet federal standards and are already calibrated for home use at the time of purchase.
Which type of thermometer is the most accurate?
Dr. John Vann, a pediatrician in Omaha, told Insider that only a rectal temperature offers a true outpatient reading. “Everything else is an estimate,” he said.
“Luckily, the exact number is not usually as important as how the patient looks,” he adds. Which is to say, there are other indicators of how severe someone’s illness or condition is other than an optimally-accurate temperature reading. There are also reliable methods for checking your temperature even if you don’t have access to a thermometer.
No matter if you opt for an infrared thermometer or a strictly ear-based model, it’s important to know fever isn’t the same for everyone and that it varies by age, gender, and time of day, among other variables. Using a thermometer at various times of the day when you’re feeling well gives you an idea of what’s normal for you, or your baseline temperature.
Which is the best thermometer for home use?
Among at-home thermometers, medical research hasn’t determined an exact correlation between oral, rectal, ear, armpit, and forehead temperature measurements. But Kaiser Permanente notes that an ear (tympanic) temperature is 0.5 to 1 degree higher than an oral temperature and a forehead (temporal) scanner is usually 0.5 to 1 degree lower than an oral temperature.
What is the best thermometer to use for COVID?
The best thermometer for COVID is really just one that is accurate and reliable. That means any of the thermometers on our list are great for checking for COVID symptoms. That being said, if you’re using the thermometer on more than one person, it’s best to use a contactless reader to not cross-contaminate. In that case, we highly recommend the iHealth No-Touch Forehead Thermometer PT3 or the Exergen Temporal Artery Thermometer with Smart Glow, both of which proved to be accurate and reliable in my tests.
Can I use my HSA/FSA funds to buy a thermometer?
If you have an HSA or an FSA account, know that over-the-counter digital thermometers are eligible for reimbursement without a prescription.
Here’s how it works:
If you pay with cash or credit card in a store or online, you can request a reimbursement from your HSA/FSA account. Different plans have different requirements on what’s needed for reimbursement but usually, a copy of your thermometer receipt will be enough.
There are HSA and FSA-specific retailers, like the HSA Store and the FSA Store that make shopping for items that qualify for reimbursement really simple. According to both websites, when shoppers use an HSA or FSA card to pay, they typically don’t have to submit receipts; purchases on these websites automatically substantiate. It is worth noting, however, that the thermometer options available on these websites are limited and cost more than other retailers.
What counts as a fever?
Many Americans think anything over 98.6 degrees Fahrenheit is a problem, but what constitutes a fever is actually different person to person.
Rik Heller, a biomedical engineer and thermographic expert, tells Insider, “Age, gender, and even time of day impact normal body temperatures.”
Some children’s temperatures especially run higher than others, points out Dr. Jesse Hackell, a practicing pediatrician with New York-based Pomona Pediatrics. Any reading of 100.4 F or higher in a baby younger than 3 months is reason to call the pediatrician. “Another reason to call is if the fever persists for more than 24 hours in children younger than two and more than three days in a child 2 years of age or older,” he said.
Meanwhile, older adults tend to have lower baseline temperatures than younger adults; sometimes fevers in the elderly are completely absent.
To figure out what’s a fever for you, you want to find your baseline temperature (i.e., what’s normal for you) by checking your temperature at various times of the day when you are feeling well.
At the end of the day, how you or your child is acting and feeling is the best indicator of a fever over the number on a thermometer, multiple of our doctors say.
Our expert sources
Jesse Hackell MD, FAAP, chair of the American Academy of Pediatrics Committee on Practice and Ambulatory Medicine and a practicing pediatrician with New York-based Pomona Pediatrics, a division of Boston Children’s Health Physicians
People who got the J&J vaccine may get a better immune response from a Moderna or Pfizer booster, a major new study suggests.
J&J recipients generated far more antibodies after a Moderna or Pfizer shot, instead of a second J&J jab.
However, higher levels of antibodies do not necessarily mean a person is more protected from the coronavirus.
The first US study to mix and match boosters of Moderna, Pfizer, and Johnson & Johnson’s COVID-19 shots is out, and it looks like you can boost any US-authorized vaccination with any other vaccine safely – though boosting J&J with Moderna or Pfizer may prompt a stronger immune response, at least initially.
The new study, funded by the US National Institutes of Health, showed first and foremost that mixing and matching COVID-19 vaccines is a perfectly safe thing to do.
“What the study shows is that regardless of what an individual received originally, getting boosted with one of the three vaccines that we evaluated, the one from Moderna, the one from Janssen, the one from Pfizer, led to good antibody responses in each of the groups,” lead study author Dr. Robert Atmar from Baylor College of Medicine told Insider, shortly after his new data was released on Wednesday.
The mix-and-match study enrolled 458 people from 10 different medical centers across the US who were each fully vaccinated with Moderna’s, Pfizer’s, or J&J’s [Janssen] vaccine. Volunteers then got boosted with one of those three shots, yielding nine different mix and match combinations. Researchers tested the blood of those volunteers periodically throughout the next month, comparing their levels of virus-fighting proteins called neutralizing antibodies.
The study provides some of the clearest evidence yet that all the booster shots – Pfizer, Moderna, and J&J – increase antibody levels, but that a booster from Moderna’s or Pfizer’s vaccine yields a stronger response than another J&J jab. (It’s similar to what researchers in Europe have found boosting AstraZeneca‘s vaccine with Pfizer.)
People who got their first shots from J&J saw the strongest responses from Pfizer or Moderna boosts
In this group, a J&J booster shot raised neutralizing antibody levels by 4.2-fold on average. But J&J recipients who got a Moderna shot instead saw a 76-fold increase in antibodies, and a Pfizer booster yielded a 35-fold jump. The differences between these groups were statistically meaningful, meaning it’s highly unlikely they are a product of chance.
The researchers warn that with only roughly 50 people in each group, this study is too small to fairly compare different vaccine booster combinations side by side, and the trial’s limited follow-up time (of just one month) doesn’t tell us how durable each booster’s protection may be in the long run.
Atmar cautioned that this study was “not designed to really make comparisons between different groups,” but instead “to provide data rapidly for public health decisions.”
Still, he acknowledged, “the natural thing” people do “is to want to make comparisons.” And the tables show stark differences:
The same trends above held true for neutralizing antibody titers, a more durable (though still not perfect) picture of vaccine-induced immunity.
Antibodies are not everything when it comes to immunity
Atmar cautioned that this does not mean we all need mRNA boosters.
“I don’t think we’re going to want to end up boosting people every six months,” he said.
While antibodies are a key part of the body’s initial immune response, there are other long-term components of immune memory, like the cellular immune response, which weren’t measured in this study.
As far as side effects are concerned, by far the most common complaint post-booster was some mild arm pain, which more than 70% of patients in all mix and match groups experienced.
Health regulators will vote on boosters this week and next
The highly-anticipated study is some of the most compelling research on the safety and immunogenicity of boosters. And it comes at a critical time, too: An FDA expert panel will meet Thursday and Friday to discuss Moderna and J&J boosters, while a CDC panel convenes on the same issue next week. (Third doses of Pfizer were OK’d by both last month.)
J&J’s booster shot application has already fallen under FDA scrutiny, with the agency’s scientists highlighting a lack of robust clinical trial results supporting a booster at six months.
A Japanese drugmaker plans to submit data for a plant-based COVID-19 vaccine to Canadian regulators.
The vaccine is made using a relative of the tobacco plant.
Medicago, which is making the vaccine, is part-owned by tobacco giant Philip Morris International.
The world’s first plant-based COVID-19 vaccine could reach Canada’s drug regulator by the end of the year.
Leading Japanese drugmaker Mitsubishi Tanabe Pharma said Tuesday that Medicago, its Quebec-based subsidiary that developed the shot, would apply for Canadian approval by the end of 2021, the Financial Times reported.
Marlboro cigarette brand manufacturer Philip Morris International part-owns Medicago, according to the Financial Times.
US market intelligence company Transparency Market Research predicted in September that the plant-based vaccine market, including non-COVID-19 vaccines, will be worth $2.34 billion by 2031.
Toshifumi Tada, head of vaccine business development at Mitsubishi Tanabe Pharma, told the Financial Times that there was “value in expanding options for vaccinesm” and said that, like seasonal flu, he didn’t expect demand for COVID-19 vaccines to “suddenly disappear.”
“There is still much uncertainty regarding emerging variants,” Tada said, per the Financial Times.
Medicago’s plant-based COVID-19 vaccine has shown promise in trials.
Medicago said in May that, in a trial of 24,000 participants, those given its COVID-19 vaccine had 10 times as many antibodies as those who had previously caught COVID-19. The vaccine also gave no serious side effects in the study, it said.
The vaccine includes an adjuvant – an additive which enhances immune response – made by UK pharma giant GlaxoSmithKline, and was given as two doses, 21 days apart, Medicago said.
Medicago makes the plant-based vaccine by first inserting a genetic code into a bacteria. A close relative of the tobacco plant is then soaked in the modified bacteria. The code teaches the plant, Nicotiana benthamiana, to make a protein, which is then used in the vaccine, per scientific journal Nature.
Its fast manufacturing time could cut costs and make it easy to adapt to emerging coronavirus variants: It takes five to six weeks for Medicago to produce a clinical-grade vaccine this way, compared to four to six months for traditional lab methods, Nathalie Charland, Medicago’s senior director of scientific and medical affairs, told Nature
Plant-based vaccines also don’t require the ultracold storage temperatures, unlike Moderna and Pfizer’s COVID-19 shots.
Medicago said earlier this month that it planned to submit the vaccine to Japanese regulators by March 2022.
Merck now finds itself in a position to make molnupiravir one of its most profitable drugs, with industry analysts forecasting the company will make about $22 billion in revenue from the drug through 2030. At the same time, to be an effective tool in the pandemic, it’ll have to work to make it accessible to the people who need it the most around the world.
Merck hopes to make billions while not leaving behind the most vulnerable populations. While the US government is paying $712 per treatment course, Merck is allowing generic manufacturers to make its pill for lower-income markets, where they will likely charge a fraction of that cost.
Merck has reached agreements with eight generic drug companies, allowing each of them to sell molnupiravir in more than 100 low- and middle-income countries. These generic companies will compete on price, with one report saying they are expected to charge about $12 to $15 per treatment course.
Drug companies have enlisted generic manufacturers before with HIV and hepatitis C medicines, typically after public pressure. For its COVID-19 pill, Merck has set up these partnerships ahead of time, preemptively giving up the monopoly control of the drug that pharma companies so aggressively protect under normal circumstances.
“We’ve been planning to put this strategy in place from the very beginning,” Paul Schaper, Merck’s executive director of global pharmaceutical public policy, told Insider.
Even some drug-pricing advocates applaud Merck’s strategy.
“Merck is among the better actors in the pandemic compared to other companies,” said Jamie Love, head of the drug-access advocacy group Knowledge Ecology International.
The US is paying $712 per patient for Merck’s drug
Merck is expected to reap billions from its new drug, fueled by supply deals with rich countries like the US.
In June, the US government agreed to pay $1.2 billion in a supply deal for molnupiravir, if the drug wins an OK from the Food and Drug Administration. Merck declined to provide details on how that price was negotiated; the Department of Health and Human Services did not respond to Insider’s request for comment on the price.
Analysts expect molnupiravir to turn into a top-selling drug for Merck. The Bernstein analyst Ronny Gal projected in an October 6 research note that Merck will make $5.3 billion in 2022 sales for the drug, with about 80% of that coming from the US market. Gal forecasted $22 billion in total molnupiravir revenue for Merck through 2030.
Investors appear to see that potential as well: Merck’s stock price rose as much as 10% after the company announced the positive study results on October 1.
The US is effectively paying about $712 per treatment course from the June deal. That price strikes some experts as too high, particularly given federal grant money that has been invested in the drug. The drug’s early development was funded with $35 million in taxpayer grants, Axios reported.
“Unfortunately, in the US, we allow manufacturers to set whatever price they want, and as a result, we get situations like this,” Dr. Aaron Kesselheim, a professor at Harvard Medical School said in an email, adding the government’s negotiations factor into the public investment.
But patients won’t face that bill directly. The US government negotiated a supply deal for 1.7 million treatment courses, which will then be distributed to patients for free.
Even at that price, molnupiravir is cheaper than other COVID-19 treatments. A pill is much simpler to produce than other medicines, given as IV infusions. The government is paying $2,100 per infusion of Regeneron’s antibody cocktail and $3,200 for a five-day IV course of Gilead Sciences’ antiviral remdesivir. The COVID-19 vaccines, on the other hand, are far cheaper, ranging from $10 to $40 per shot in the US.
Merck hasn’t set a commercial price for molnupiravir yet but said it will use different prices in countries by their income level.
Even with access plan, some say Merck should do more
Advocates pointed out a few steps Merck could take that would improve access.
Dzintars Gotham, an independent researcher and a physician at King’s College Hospital, said it would be useful to know how much it costs Merck to produce the pills. That information can help countries negotiate fair prices, he said.
Gotham and Melissa Barber, a doctoral candidate in population health sciences at Harvard University, released their own analysis, estimating it costs $17.74 to produce a course of molnupiravir.
Merck declined to say how much it costs to make molnupiravir. Schaper said the marginal cost isn’t the right question to ask on pricing, saying that doesn’t consider the societal benefit of the drug.
This lack of transparency is common in the drug industry, Gotham said.
“A lot of drug pricing relies on very dramatic pricing asymmetry between the buyer and the seller,” Gotham said, “which is a fancy term for the seller knowing a lot of information about what they could or couldn’t afford in terms of pricing and the buyer not knowing much in terms of what’s possible.”
Gotham and Love also both said they’d like to see Merck publicly release the contracts with generic suppliers. This would include information on the list of 105 included countries, how long the licenses last, and what royalties Merck receives from those sales.
“Licenses should be public,” Gotham said. “I don’t see a logical argument why they wouldn’t be.”
Democrat-led states had stricter COVID-19 responses and better health outcomes, a new study found.
States with stricter COVID-19 rules saw 8% fewer cases, on average, than models would have predicted.
The results show that politics shouldn’t influence public-health policy, researchers say.
After nearly two years of politically charged battles over whether strict COVID-19 restrictions work – and whether they’re worth the consequences – scientists awarded a point to Democratic governors this week.
A study published in the American Journal of Preventive Medicine on Monday found that COVID-19 rules in states with Democratic governors were, on average, linked to 8% fewer daily COVID-19 cases in 2020 than a mathematical model would have predicted otherwise.
Republican-led states, by contrast, had 8% more cases than the model would have expected.
To assess the strength and effectiveness of various states’ COVID-19 policies, the researchers behind the study created a system they called the “Public Health Protective Policy Index.” The index factored in daily COVID-19 case counts in 2020, a range policies enacted at the state level, and governors’ political affiliations, then assigned quantitative values to these many factors. Then the team compared the resulting scores.
Those results showed that the public-health measures Democratic governors put in place last year were, on average, 10 percentage points more stringent than those put in place by Republican governors. And that had an observable effect on how many people got sick.
“Eight percent is not huge, but it’s there. If you’re wondering if policies actually matter, apparently they do,” Olga Shvetsova, a political science professor at Binghamton University who led the study, told Insider.
Shvetsova said her team did not do state-specific analyses, opting instead to look at trends across multiple states. A clear political pattern emerged – one that likely would look even more dire for Republican-led states if it included data from 2021, Shvetsova added.
“What we see in Republican states is really tragic right now. They squandered their initial good fortune – badly,” she said.
The link between Democratic leadership and lower COVID-19 infections does not necessarily mean that governors’ actions directly drove down COVID cases, however – it’s just a correlation. The new study also did not examine the relationship between political leadership and hospitalizations or deaths from the virus. Nor did it assess the degree to which states enforced governors’ policies or how much residents actually complied.
What’s more, a governor’s politics didn’t always predict the degree of strictness in a state’s COVID-19 policies. In Vermont, Massachusetts, and Maryland – which have Republican governors but tend to be more liberal – GOP governors pursued more aggressive COVID-19 policies and restrictions that were more similar to Democrat-led states.
Other studies also found links between political affiliations and health outcomes
The new study builds on previous research, published in the American Journal of Preventive Medicine in July, that found a link between the political leanings of US governors and the number of COVID-19 infections and deaths by state. The researchers behind that study pointed to differences in state policies as one of the reasons Republican-led states have seen more per-capita infections since June 2020.
Up to that point, Republican-led states were recording fewer per capita COVID-19 cases, deaths, and positive tests than Democrat-led states. But from June 3, 2020 on, Republican-led states had 1.1 times more daily cases per 100,000 people, on average.
A handful of other studies have also found that overall, Democratic states had lower test-positivity rates between May and December 2020, a metric that suggests more rigorous testing and infection containment. Republican governors were also slower to issue stay-home orders and mask mandates, while Democratic leaders were both more likely to implement those rules and to leave them in place. Republican governors, meanwhile, were quicker to roll back COVID-19-related restrictions in 2020.
“Governors’ political affiliation might function as an upstream progenitor of multifaceted policies that in unison impact the spread of the virus,” the authors of the July study wrote. (They noted, however, that Maryland and Massachusetts bucked the trend.)
In both studies, researchers came to a similar conclusion: If politicians’ priority is to keep their constituents from getting sick, they should delegate public-health policy decisions to medical and public-health professionals.
Or, as Shvetsova put it: “Politicians are creatures of their public. The public cannot be its own doctor.”
Immunity from COVID-19 vaccines starts to wane after about five months, according to real-world data, so eventually most people will likely need an extra dose.
But Dr. Akiko Iwasaki, immunologist at Yale University, told The Wall Street Journal that people who had been fully vaccinated and have previously caught the virus were “likely to be the last group that really needs the booster” because their immune system had had “three exposures” – two vaccine doses and one infection, all of which trigger an immune response.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said that people who were infected and vaccinated “just won the game,” per The Journal.
“I wouldn’t ask them to get a booster dose. I think they just got it,” he said, referring to the immune system boost from an infection. Offit, who is a member of the Food and Drug Administration’s advisory panel on vaccines, supports boosters for older adults but not for the general public at this time, The Journal reported.
Gary McClean, professor in molecular immunology at London Metropolitan University, told Insider that, theoretically, vaccinated people who previously had COVID-19 may not need a booster at all.
Vaccines produce an immune response to one part of the virus, called the spike protein, so you get “spike-specific” immunity, McClean said. Getting COVID-19 triggers an immune response to more than one part of the virus, which means your immune system should later be better prepared to fight variants that have mutations, he said.
But McClean also warned it would be “dangerous” for anybody to deliberately try to catch COVID-19 because of the risk of severe disease. Boosters are “generally safe” if given months after vaccination, he added.
Determining who needs a booster
Emerging evidence suggests that people who caught COVID-19 and were then fully vaccinated have the strongest antibody response of any group – stronger than people who have only been infected, or only been fully vaccinated, for example.
Paul Bieniasz, virologist at the Rockefeller University, said that catching COVID-19 after vaccination may not have the same effect. “It’s more variable,” Bieniasz told Insider.
In the future, we may need antibody tests to determine who needs extra vaccine doses, Bieniasz said.
We can’t yet reliably detect whether people have had an antibody response to COVID-19 either before or after vaccination. Protection also wanes over time, so the timing of an infection or vaccination matters too – people who had COVID-19 prior to vaccination may eventually need a booster.