Government Executive - Authors - Celine Gounder

Will COVID Spike Again This Fall? 6 Tips to Help You Stay Safe

Celine Gounder, KFF Health News — Mon, 17 Oct 2022 10:20:00 -0400

Last year, the emergence of the highly transmissible omicron variant of the COVID-19 virus caught many people by surprise and led to a surge in cases that overwhelmed hospitals and drove up fatalities. Now we’re learning that omicron is mutating to better evade the immune system.

Omicron-specific vaccines were authorized by the FDA in August and are recommended by U.S. health officials for anyone 5 or older. Yet only half of adults in the United States have heard much about these booster shots, according to a recent KFF poll, and only a third say they’ve gotten one or plan to get one as soon as possible. In 2020 and 2021, COVID cases spiked in the U.S. between November and February.

Although we don’t know for sure that we’ll see another surge this winter, here’s what you should know about COVID and the updated boosters to prepare.

1. Do I need a COVID booster shot this fall?

If you’ve completed a primary vaccination series and are 50 or older, or if your immune system is compromised, get a COVID booster shot as soon as possible. Forty percent of deaths are occurring among people 85 and older and almost 90% among people 65 and over. Although people of all ages are being hospitalized from COVID, those hospitalizations are also skewing older.

Unvaccinated people, while in the minority in the U.S., are still at the highest risk of dying from COVID. It’s not too late to get vaccinated ahead of this winter season. The United Kingdom, whose COVID waves have presaged those in the United States by about a month, is beginning to see another increase in cases.

If you’ve already received three or more COVID shots, you’re 12 to 49 years old, and you’re not immunocompromised, your risk of hospitalization and death from the disease is significantly reduced and additional boosters are not likely to add much protection.

However, getting a booster shot provides a “honeymoon” period for a couple of months after vaccination, during which you’re less likely to get infected and thus less likely to transmit the virus to others. If you’ll be seeing older, immunocompromised, or otherwise vulnerable family and friends over the winter holidays, you might want to get a booster two to four weeks in advance to better shield them against COVID.

You may have other reasons for wanting to avoid infection, like not wanting to have to stay home from work because you or your child is sick with COVID. Even if you aren’t hospitalized from COVID, it can be costly to lose wages or arrange for backup child care.

One major caveat to these recommendations: You should wait four to six months after your last COVID infection or vaccination before getting another shot. A dose administered too soon will be less effective because antibodies from the previous infection or vaccination will still be circulating in your blood and will prevent your immune cells from seeing and responding to vaccination.

2. Do kids need to be vaccinated even if they’ve had COVID?

Although children are at lower risk for severe COVID than are adults, the stakes for kids are higher than many diseases already recognized as dangerous. Their risk shouldn’t be measured against the risk that COVID poses to other age groups but against the risk they face from other preventable diseases. In the first two years of the pandemic, COVID was the fourth- or fifth-leading cause of death in every five-year age bracket from birth to 19, killing almost 1,500 children and teenagers. Other vaccine-preventable diseases like chickenpox, rubella, and rotavirus killed an average of about 20-50 children and teens a year before vaccines became available. By that measure, vaccinating kids against COVID is a slam-dunk.

Children who have had COVID also benefit from vaccination. The vaccine reduces their risk of hospitalization and missing days of school, when parents might need to stay home with them.

But it’s precisely because the stakes are higher for kids that many parents are anxious about getting their children vaccinated. As recently as July, just after the FDA authorized COVID vaccines for children as young as 6 months, a KFF poll found that over half of parents of children under age 5 said they thought vaccines posed a greater risk to the health of their child than getting the disease. And in the most recent poll, half said they had no plans to get their children vaccinated. COVID vaccination rates range from 61% among children ages 12 to 17 to 2% among kids younger than 2.

Similar to influenza, COVID is most deadly for the very youngest and oldest. At especially high risk are infants. They’re unlikely to have immunity from infection, and a small share have been vaccinated. Unless their mothers were vaccinated during pregnancy or got COVID during pregnancy — the latter of which poses a high risk of death for the mother and of preterm birth for the baby — infants are probably not getting protective antibodies against COVID through breast milk. And because infants have small airways and weaker coughs, they’re more likely to have trouble breathing with any respiratory infection, even one less deadly than COVID.

3. Will I need a COVID shot every year?

It depends on the targets set by public health officials whether COVID becomes a seasonal virus like the flu, and how much the virus continues to mutate and evade humanity’s immune defenses.

If the goal of vaccination is to prevent severe disease, hospitalization, and death, then many people will be well protected after their primary vaccination series and may not need additional shots. Public health officials might strongly recommend boosters for older and immunocompromised people while leaving the choice of whether to get boosted to those with lower risk. If the goal of vaccination is to prevent infection and transmission, then repeat boosters will be needed after completing the primary vaccination series and as often as a couple of times a year.

Influenza is a seasonal virus causing infections and disease generally in the winter, but scientists don’t know whether COVID will settle into a similar, predictable pattern. In the first three years of the pandemic, the United States has experienced waves of infection in summer. But if the COVID virus were to become a wintertime virus, public health officials might recommend yearly boosters. The Centers for Disease Control and Prevention recommends that people 6 months and older get a flu shot every year with very rare exceptions. However, as with the flu, public health officials might still place a special emphasis on vaccinating high-risk people against COVID.

And the more the virus mutates, the more often public health officials may recommend boosting to overcome a new variant’s immune evasion. Unfortunately, this year’s updated omicron booster doesn’t appear to provide significantly better protection than the original boosters. Scientists are working on variant-proof vaccines that could retain their potency in the face of new variants.

4. Are more COVID variants on the way?

The omicron variant has burst into an alphabet soup of subvariants. The BA.5 variant that surfaced earlier this year remains the dominant variant in the U.S., but the BA.4.6 omicron subvariant may be poised to become dominant in the United States. It now accounts for 14% of cases and is rising. The BA.4.6 omicron subvariant is better than BA.5 at dodging people’s immune defenses from both prior infection and vaccination.

In other parts of the world, BA.4.6 has been overtaken by BA.2.75 and BF.7 (a descendant of BA.5), which respectively account for fewer than 2% and 5% of COVID cases in the U.S. The BA.2.75.2 omicron subvariant drove a wave of infections in South Asia in July and August. Although the U.S. hasn’t yet seen much in the way of another variant descended from BA.5 — BQ.1.1 — it is rising quickly in other countries like the U.K., Belgium, and Denmark. The BA.2.75.2 and BQ.1.1 variants may be the most immune-evasive omicron subvariants to date.

BA.4.6, BA.2.75.2, and BQ.1.1 all evade Evusheld, the monoclonal antibody used to prevent COVID in immunocompromised people who don’t respond as well to vaccination. Although another medication, bebtelovimab, remains active in treating COVID from BA.4.6 and BA.2.75.2, it’s ineffective against BQ.1.1. Many scientists are worried that Evusheld will become useless by November or December. This is concerning because the pipeline for new antiviral pills and monoclonal antibodies to treat COVID is running dry without a guaranteed purchaser to ensure a market. In the past, the federal government guaranteed it would buy vaccines in bulk, but funding for that program has not been extended by Congress.

Other omicron subvariants on the horizon include BJ.1, BA.2.3.20, BN.1, and XBB, all descendants of BA.2.

It’s hard to predict whether an omicron subvariant or yet another variant will come to dominate this winter and whether hospitalizations and deaths will again surge in the U.S. Vaccination rates and experience with prior infections vary around the world and even within the United States, which means that the different versions of omicron are duking it out on different playing fields.

While this might all sound grim, it’s important to remember that COVID booster shots can help overcome immune evasion by the predominant omicron subvariants.

5. What about long COVID?

Getting vaccinated does reduce the risk of getting long COVID, but it’s unclear by how much. Researchers don’t know if the only way to prevent long COVID is to prevent infection.

Although vaccines may curb the risk of infection, few vaccines prevent all or almost all infections. Additional measures — such as improving indoor air quality and donning masks — would be needed to reduce the risk of infection. It’s also not yet known whether prompt treatment with currently available monoclonal antibodies and antiviral drugs like Paxlovid reduces the risk of developing long COVID.

6. Do I need a flu shot, too?

The CDC recommends that anyone 6 months of age or older get an annual flu shot. The ideal timing is late October or early November, before the winter holidays and before influenza typically starts spreading in the U.S. Like COVID shots, flu shots provide only a couple of months of immunity against infection and transmission, but an early flu shot is better than no flu shot. Influenza is already circulating in some parts of the United States.

It’s especially important for people 65 or older, pregnant women, people with chronic medical conditions, and children under 5 to get their yearly flu shots because they’re at highest risk of hospitalization and death. Although younger people might be at lower risk for severe flu, they can act as vectors for transmission of influenza to higher-risk people in the community.

High-dose flu vaccines and “adjuvanted” flu vaccines are recommended for people 65 and older. Adjuvants strengthen the immune response to a vaccine.

It is safe to get vaccinated for COVID and the flu at the same time, but you might experience more side effects like fevers, headache, or body aches.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Subscribe to KHN's free Morning Briefing.

]]>

Did the U.S. Jump the Gun With the New Omicron-Targeted Vaccines?

Celine Gounder and Elisabeth Rosenthal, KFF Health News — Mon, 12 Sep 2022 14:00:00 -0400

Last month, the FDA authorized omicron-specific vaccines, accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original covid vaccines. The message to a nation still struggling with the covid-19 pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.

The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the omicron-specific vaccines significantly more protective — and in what ways — than the original covid vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be pulled from other covid response efforts, like testing and treatment.

Several members of the CDC advisory committee that voted 13-1 for the recommendation voiced similar questions and concerns, one saying she only “reluctantly” voted in the affirmative.

Some said they set aside their desire for more information and better data and voted yes out of fear of a potential winter covid surge. They expressed hope that the new vaccines — or at least the vaccination campaign that would accompany their rollout — would put a dent in the number of future cases, hospitalizations, and deaths.

That calculus is, perhaps, understandable at a time when an average of more than 300 Americans are dying of covid each day.

But it leaves front-line health care providers in the impossible position of trying to advise individual patients whether and when to take the hot, new vaccines without complete data and in the face of marketing hype.

Don’t get us wrong. We’re grateful and amazed that Pfizer-BioNTech and Moderna (with assists from the National Institutes of Health and Operation Warp Speed) developed an effective vaccine in record time, freeing the nation from the deadliest phase of the covid pandemic, when thousands were dying each day. The pandemic isn’t over, but the vaccines are largely credited for enabling most of America to return to a semblance of normalcy. We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.

But as society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and in all likelihood raising the price later.

This last point is concerning because the government no longer has funds to purchase covid vaccines after this autumn. Funding to cover the provider fees for vaccinations and community outreach to those who would most benefit from vaccination has already run out. So updated boosters now and in the future will likely go to the “worried well” who have good insurance rather than to those at highest risk for infection and progression to severe disease.

The FDA’s mandated task is merely to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical vaccine effectiveness data from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters.

Yet the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which populations? And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original covid vaccines except for a tweak in the mRNA code to match the omicron BA.5 virus. Studies by Pfizer showed that its updated omicron BA.1 booster provides a 1.56 times higher increase in neutralizing antibody titers against the BA.1 virus as compared with a booster using its original vaccine. Moderna’s studies of its updated omicron BA.1 booster demonstrated very similar results. However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5% and 1% respectively. Pfizer and Moderna are just starting to study their updated omicron BA.5 boosters in human trials.

Though the studies of the updated omicron BA.5 boosters were conducted only in mice, the agency’s authorization is in line with precedent: The FDA clears updated flu shots for new strains each year without demanding human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That’s not the case with covid vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now.

As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally. In 2022, the U.S. has seen covid hospitalization rates among people 65 and older increase relative to younger age groups. And while covid vaccine boosters seem to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.

Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: Many people with money and insurance will demand it whether data ultimately proves it is necessary for them individually or not.

We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where significant portions of at-risk populations remain unvaccinated and unboosted, the fear of a winter surge is legitimate.

But will the widespread adoption of a vaccine — in this case yearly updated covid boosters — end up enhancing protection for those who really need it or just enhance drugmakers’ profits? And will it be money well spent?

The federal government has been paying a negotiated price of $15 to $19.50 a dose of mRNA vaccine under a purchasing agreement signed during the height of the pandemic. When those government agreements lapse, analysts expect the price to triple or quadruple, and perhaps even more for updated yearly covid boosters, which Moderna’s CEO said would evolve “like an iPhone.” To deploy these shots and these dollars wisely, a lot less hype and a lot more information might help.

Subscribe to KHN's free Morning Briefing.

]]>

What You Need to Know About Monkeypox

Celine Gounder, KFF Health News — Fri, 01 Jul 2022 08:00:00 -0400

The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S. And with public health officials unable to follow all chains of transmission, they’re likely undercounting cases. Everyone should be aware of its symptoms, how it spreads, and the risks of it getting worse.

Q: Should I be worried about monkeypox?

The American public is currently at low risk for monkeypox. It is spreading among men who have sex with men, but it is only a matter of time before it spreads to others. As of June 27, the European Centre for Disease Prevention and Control had reported 10 cases among women. Monkeypox is generally a mild disease but can be serious or even deadly for people who are immunocompromised, pregnant women, a fetus or newborn, women who are breastfeeding, young children, and people with severe skin diseases such as eczema.

But monkeypox could become endemic in the U.S. and around the world if it continues to spread unchecked.

Q: How does monkeypox spread?

Monkeypox is a viral infection, a close cousin of smallpox. But it causes a much milder disease.

It is transmitted through close contact, including sex, kissing, and massage — any kind of contact of the penis, vagina, anus, mouth, throat, or even skin. In the current outbreak, monkeypox has primarily been transmitted sexually.

Condoms and dental dams will reduce but won’t prevent all transmission because they protect only against transmission to and from the skin and mucosal surfaces that are covered by those devices. It’s important to know that the virus can enter broken skin and penetrate mucous membranes, like in the eyes, nose, mouth, genitalia, and anus. Scientists don’t know whether monkeypox can be transmitted through semen or vaginal fluid.

Monkeypox can be transmitted through respiratory droplets or “sprays” within a few feet, but this is not thought to be a particularly efficient mode of transmission. Whether monkeypox could be transmitted through aerosols, as covid-19 is, is unknown, but it hasn’t been documented so far.

It is not known whether monkeypox can be transmitted when someone doesn’t have symptoms.

Q: What are the common symptoms of monkeypox?

Symptoms of monkeypox may develop up to 21 days after exposure and can include fevers and chills, swollen lymph nodes, rash, and headaches.

It is not known whether monkeypox always shows any or all of those symptoms.

Experts currently think monkeypox, like smallpox, will always cause at least some of these symptoms, but that belief is based on pre-1980 science, before there were more sophisticated diagnostic tests.

Q: What does the monkeypox rash look like?

The monkeypox rash usually starts with red spots and then evolves into fluid-filled and then pus-filled bumps that may look like blisters or pimples. The bumps then open into sores and scab over. People with monkeypox should be considered infectious until after the sores scab over and fall off. Monkeypox sores are painful. The rash was often seen on palms and soles in the past, but many people in this outbreak have experienced external and internal lesions of the mouth, genitalia, and anus. People may also experience rectal pain or the sensation of needing to have a bowel movement when their bowels are empty.

Q: How do I get tested for monkeypox?

If you have symptoms of monkeypox, including oral, genital, or anal lesions, go to your nearest sexual health clinic for testing. A medical professional should swab any suspicious lesion for testing. There’s also emerging evidence that throat swabs may be useful in screening for monkeypox, but health officials in the U.S. are so far not recommending them.

Q: Is there a vaccine for monkeypox?

Yes. Two vaccines are effective in preventing monkeypox: the Jynneos vaccine and the ACAM2000 vaccine. The FDA has approved the Jynneos vaccine for preventing monkeypox and smallpox among people 18 and older. The ACAM2000 is FDA-approved to prevent smallpox. The U.S. is currently using only the Jynneos vaccine because it’s safer and has fewer side effects.

The Jynneos vaccine is safe. It has been tested in thousands of people, including people who are immunocompromised or have skin conditions. Common side effects of the Jynneos vaccine are similar to those of other vaccines and include fevers, fatigue, swollen glands, and irritation at the injection site.

The Jynneos vaccine is effective in preventing monkeypox disease up to four days after exposure and may reduce the severity of symptoms if given up to 14 days after exposure.

Q: Can I be vaccinated against monkeypox?

The Centers for Disease Control and Prevention currently recommends vaccination against monkeypox only for those at heightened risk: people who have had close contact with someone with monkeypox; men who have sex with men and trans women who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading; and some health care workers, laboratory staffers, first responders, and members of the military who might come into contact with the affected.

Supplies of the Jynneos vaccine are currently limited. The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response will release 56,000 doses from the strategic national stockpile immediately. An additional 240,000 doses will be made available in the coming weeks, 750,000 doses later this summer, and 500,000 this fall, for a total of more than 1.5 million doses.

Q: What are other ways to lower the risk of monkeypox transmission?

The best way is to educate yourself and your sex partners about monkeypox. If you’re worried you might have monkeypox, get tested at a sexual health clinic. Many emergency rooms, urgent care centers, and other health care facilities may not be up to date on monkeypox. The CDC link to find the nearest sexual health clinic is https://gettested.cdc.gov/.

Abstain from sex if you or your partner has monkeypox. And remember that condoms and dental dams can reduce but not eliminate the risk of transmission. The CDC also warns about the risk of going to raves or other parties where lots of people are wearing little clothing and of saunas and sex clubs. It has other suggestions like washing sex toys and bedding.

Q: Is there a treatment for monkeypox?

There is no proven, safe treatment specifically for monkeypox. Most cases of monkeypox are mild and improve without treatment over a couple of weeks. Medications like acetaminophen and ibuprofen can be used to reduce fevers and muscle aches, and medications like acetaminophen, ibuprofen, and opioids may be used for pain. In rare cases, some patients — such as immunocompromised people, pregnant women, a fetus or newborn, women who are breastfeeding, young children, and people with severe skin diseases — will develop more severe illness and may require more specific treatment. Doctors are trying experimental therapies like cidofovir, brincidofovir, tecovirimat, and vaccinia immune globulin. If administered early in the course of infection, the Jynneos and ACAM2000 vaccines may also help reduce the severity of disease.

Q: What misinformation is circulating about monkeypox?

Conspiracy theories about monkeypox abound. Monkeypox is not a hoax. Monkeypox is real. Covid vaccines can’t give you monkeypox. Monkeypox was not invented by Bill Gates or pharmaceutical companies. Monkeypox didn’t come from a lab in China or Ukraine. Migrants crossing the U.S.-Mexico border haven’t brought monkeypox into the U.S. Monkeypox isn’t a ploy to allow for mail-in ballots during elections. There is no need for a monkeypox vaccine mandate or lockdowns due to monkeypox.

Subscribe to KHN's free Morning Briefing.

]]>

The Future of Getting Paid to Be Healthy

Celine Gounder — Mon, 03 Jun 2013 14:28:00 -0400

When a 2014 portion of the Affordable Care Act comes into effect, employers will be able to use financial rewards and penalties to encourage healthier behaviors. Last week the Obama administration released its final rulesregarding these employer-based wellness programs.

Still, critics are concerned that an annual premium adjustment isn't likely to change behavior, and will just end up penalizing those with poorer health.

According to Dr. Kevin Volpp, Director of theCenter for Health Incentives and Behavioral Economics at the University of Pennsylvania, it isn't as simple as just paying someone for doing the right thing. People tend to respond to immediate, short-term rewards (e.g. the satisfaction of eating one more piece of pizza) more readily than to delayed consequences (weight gain). The science of "behavioral economics" has found that when people are offered immediate incentives and penalties to do the healthy thing, they are more likely to make the right decision, sort of like having a swear jar for healthy living.

But not all incentives are created equal, and some behaviors are harder to change (e.g. quitting smoking) than others (taking your kid for a routine check up). The impact of an incentive depends a lot on how it is framed, and the context in which it's offered.

How Exercising at Work Saves Money

Celine Gounder, The Atlantic — Tue, 21 May 2013 16:00:00 -0400

Ever since Karen Straub had her thyroid removed because of cancer in 1999, she has struggled with her weight. She became diabetic and suffered from terrible acid reflux. So when her boss, California State Controller John Chiang, started a worksite wellness program for his staff, Straub decided to give it a try. She joined new Weight Watchers at Work meetings during lunch on Thursdays. She beams activity data from her accelerometer to the Healthrageous website, which allows her to track her activity and interact with her co-workers through a social media platform. She and her colleagues now compete to see who will be the top walker each week. She walks during her work breaks and for 15 minutes at lunch on most days. Since starting the program, Straub has lost 27 pounds. She doesn't have to take pills for her diabetes anymore. Her acid reflux has disappeared.

Chiang's job is to make sure California's tax dollars are well spent -- to root out waste, fraud, and abuse of public funds. Recognizing that the healthcare costs of state employees and retirees were among several threats to the state's fiscal health, Chiang commissioned a study to determine the proportion of costs that were due to modifiable factors such as diet, exercise and smoking. "We all understand that healthcare costs are spiraling out of control," Chiang said.

The California Public Employee's Retirement System health program covers nearly 1.3 million active and retired government employees and their families. Of $1.6 billion spent on healthcare for state employees in 2008, 22 percent was on high blood pressure, heart disease, stroke and kidney disease -- much of which could have been prevented through diet and exercise. The Urban Institute, which conducted the study, estimated that if changes in diet and exercise could reduce the prevalence of these diseases by 5 percent to 15 percent, it would save the state $18 to $54 million per year.