Tagged Drugs (Pharmaceuticals)

Don’t Let the Pandemic Stop Your Shots

the new old age

Don’t Let the Pandemic Stop Your Shots

Even as older adults await the coronavirus vaccine, many are skipping the standard ones. That’s not wise, health experts say.

Credit…Chris Lyons

  • Dec. 28, 2020, 12:12 p.m. ET

Peggy Stein, 68, a retired teacher in Berkeley, Calif., skipped a flu shot this year. Her reasoning: “How could I get the flu if I’m being so incredibly careful because of Covid?”

Karen Freeman, 74, keeps meaning to be vaccinated against shingles, but hasn’t done so. A retired college administrator in St. Louis, she quipped that “denial has worked well for me these many years.”

Sheila Blais, who lives on a farm in West Hebron, N.Y., has never received any adult vaccine. She also has never contracted the flu. “I’m such an introvert I barely leave the farm, so where’s my exposure?” said Ms. Blais, 66, a fiber artist. “If it’s not broke, don’t fix it.”

While older adults await vaccination against Covid-19, public health officials also worry about their forgoing, forgetting, fearing or simply not knowing about those other vaccines — the ones recommended for adults as we age and our immune systems weaken.

“There’s a lot of room for improvement,” said Dr. Ram Koppaka, associate director for adult immunization at the Centers for Disease Control and Prevention.

Every year, campaigns urge older adults to protect themselves against preventable infectious diseases. After all, influenza alone has killed 12,000 to 61,000 Americans annually over the past decade, most of them 65 or older, and has sent 140,000 to 810,000 people a year to hospitals.

The coronavirus pandemic has introduced another imperative. Those hospitals are filling fast with Covid-19 patients; in many places they are already swamped, their staffs overworked and exhausted.

“Knowing how stressed the health care system is, prevention is key,” said Dr. Nadine Rouphael, a vaccine researcher and infectious disease specialist at Emory University. “When we have record numbers of deaths, why would you go to a hospital for a vaccine-preventable illness?”

Yet the nation has long done a better job of vaccinating its children than its elders. The most recent statistics, from 2017, show that about one-third of adults over 65 had not received a flu shot within the past year. About 30 percent had not received the pneumococcus vaccine.

The proportion receiving the shingles vaccine, a fairly recent addition to the list, has inched up, but by 2018 only 34.5 percent of people over 60 had been vaccinated.

Moreover, Dr. Koppaka pointed out: “When you look deeper, there are longstanding, deep, significant differences in the proportion of Black and Hispanic adults getting vaccines compared to their white counterparts. It’s really unacceptable.”

Close to 40 percent of non-Hispanic whites had been vaccinated against shingles, for instance, compared with fewer than 20 percent of Blacks and Hispanics.

One might expect a group who can recall polio fears and outbreaks of whooping cough to be less hesitant to get vaccinated than younger cohorts. “You’ll probably have a different concept of vaccination from someone who never experienced what a serious viral illness can do,” Dr. Koppaka said.

When it comes to the Covid-19 vaccine, for instance, only 15 percent of those over 65 say they would definitely or probably not get it, compared with 36 percent of those 30 to 49, a Kaiser Family Foundation tracking poll showed earlier this month. (Ms. Stein, Ms. Blais and Ms. Freeman all said they would happily accept the Covid vaccine.)

But for other diseases, vaccination rates lag. Given that older people are more vulnerable to severe illness from them, why the gaps in coverage?

Internists and other doctors for adults don’t promote vaccines nearly as effectively as pediatricians do, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. Older patients, who often see a variety of doctors, may also have trouble keeping track of when they got which shot.

Experts fear that vaccination rates may have fallen further during the pandemic, as they have among children, if older people wary of going to doctors’ offices or pharmacies skipped shots.

Financial and bureaucratic obstacles also thwart vaccination efforts. Medicare Part B covers three vaccines completely: influenza, pneumococcus and, when indicated, hepatitis B.

The Tdap and shingles vaccines, however, are covered under Part D, which can complicate reimbursement for doctors; the vaccines are easier to obtain in pharmacies. Not all Medicare recipients buy Part D, and for those who do, coverage varies by plan and can include deductibles and co-pays.

Still, older adults can gain access to most recommended vaccines for no or low cost, through doctors’ offices, pharmacies, supermarkets and local health departments. For everyone’s benefit, they should.

Here’s what the C.D.C. recommends:

Influenza An annual shot in the fall — and it’s still not too late, because flu season peaks from late January into February. Depending on which strain is circulating, the vaccine (ask for the stronger versions for seniors) prevents 40 to 50 percent of cases; it also reduces illness severity for those infected.

Thus far this year, flu activity has remained extraordinarily low, perhaps because of social distancing and masks or because closed schools kept children from spreading it. Manufacturers shipped a record number of doses, so maybe more people got vaccinated. In any case, fears of a flu/Covid “twindemic” have not yet been realized.

Nevertheless, infectious disease experts urge older adults (and everyone over six months old) to get flu shots now. “Flu is fickle,” Dr. Schaffner said. “It could take off like a rocket in January.”

Tetanus, diphtheria, pertussis. A booster of TD vaccine every 10 years, to prevent tetanus and diphtheria. If you’ve never had the Tdap vaccine — which adds prevention against pertussis — that’s the one you want. Although pertussis, better known as whooping cough, occasionally shows up in adults, newborns are particularly at risk. Pregnant women will ask expectant grandparents to get a Tdap shot. Because it is covered under Part D, a pharmacy is the best bet.

Pneumococcus. “It’s a pneumonia vaccine, but it also prevents the most serious consequences of pneumonia, including meningitis and bloodstream infections,” Dr. Koppaka said.

People over 65 should get the polysaccharide formula — brand name Pneumovax — but there are certain circumstances, such as immune-compromising conditions, to discuss with a health care provider.

Those over 65 may choose, again in consultation with a provider, to also get the conjugate pneumococcal vaccine (brand name Prevnar), which provides some additional protection. If so, C.D.C. guidelines specify which vaccine to take when.

Shingles. Social distancing won’t ward off this disease; anyone who had chickenpox, which is just about every senior, still carries the virus.

“If you live to be 80, you stand a 35 to 50 percent chance of having an episode,” Dr. Schaffner said. “And the older you are when you get it, the more apt you are to get the most serious complication” — lingering nerve pain called post-herpetic neuralgia.

The C.D.C. recommends Shingrix, the highly effective shingles vaccine the F.D.A. approved in 2017, for everyone over 50. The previous shingles vaccine has been discontinued. Get Shingrix even if you had the earlier vaccine, Zostavax, and even if you’ve had shingles — it can recur.

The two required shots, given two to six months apart, can total $300 out of pocket. But Medicare Part D beneficiaries will pay an average of $50 for the pair, said a spokesman for the manufacturer GlaxoSmithKline, and people with private insurance even less.

Hepatitis A and hepatitis B. These aren’t age-related; the vaccines are recommended for people with certain health conditions, including chronic liver disease and H.I.V. infection, or for travelers to countries where the diseases are widespread.

The hepatitis B vaccine is also recommended, at a provider’s discretion, for diabetics over 60 who haven’t been previously vaccinated. Talk to a health care professional about your risks.

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

The Risks of Using Steroids for Respiratory Infections

Personal Health

The Risks of Using Steroids for Respiratory Infections

Doctors often prescribe them for sore throats and the common cold, even though evidence of benefit is sorely lacking.

Credit…Gracia Lam
Jane E. Brody

  • Dec. 28, 2020, 5:00 a.m. ET

“Steroid Shots and the Culture of Instant Gratification,” an editorial published Oct. 8 in JAMA Otolaryngology-Head & Neck Surgery online, highlights a chronic ailment in American medical care: a frequent failure to practice evidence-based medicine. Maybe I’ve been living under a rock, but I was surprised to learn that doctors often prescribe oral or injected corticosteroids for acute respiratory tract infections like sore throat, sinusitis, bronchitis and the common cold even though evidence of benefit is sorely lacking and risks of the drugs are widely known.

Yet a recent analysis of nearly 10 million outpatient medical visits in the United States showed that nearly 12 percent of patients with acute respiratory infections were prescribed oral or injected steroids, and this dubious practice is on the rise. The analysis found that prescriptions for steroids like prednisone to treat acute respiratory ailments nearly doubled from 2007 to 2016.

Although steroids can be invaluable, even lifesaving, medications often vital to treating asthma, autoimmune conditions, and chronic pulmonary disease and preventing transplant rejection, their misuse can result in a treatment that is worse than the disease.

The editorial writer, Dr. Edward D. McCoul, otolaryngologist at the Ochsner Clinic Foundation, described a scenario that is apparently replicated hundreds of thousands of times a year in the United States among patients given steroid injections for acute respiratory infections: “Within moments of receiving the intramuscular injection your congestion wanes, the headache vanishes, and your energy level skyrockets.”

Sure, Dr. McCoul told me, you feel better, at least temporarily — steroids, after all, counter inflammation and have a euphoric, energizing effect. But at what price?

The answer to that question is addressed in another commentary published in the Annals of Internal Medicine. Dr. Beth I. Wallace at Michigan Medicine and Dr. Akbar K. Waljee of the V.A. Ann Arbor Healthcare System listed three serious risks that can follow as few as three days of treatment with corticosteroids taken orally even by relatively young, otherwise healthy patients: gastrointestinal bleeding, sepsis and heart failure.

A Danish study found an elevated risk of diabetes and osteoporosis among patients who had received one or more steroid shots a year for three or more years to treat allergic rhinitis, another use of steroids lacking evidence of benefit.

Dr. Evan L. Dvorin, internist at the Ochsner Health System and Dr. Mark H. Ebell of the University of Georgia, writing in the journal American Family Physician, added several other frightening side effects linked to the brief use of steroids: low blood sugar, elevated blood pressure, mood and sleep disturbances, fracture and blood clots.

Dr. Wallace, a rheumatologist whose patients often depend on long-term steroid therapy, said with regard to short bursts of steroids for respiratory infections, “A very large number of young, otherwise healthy patients are receiving a treatment that we know can be harmful for a condition where steroids just aren’t indicated.”

In an interview, Dr. Dvorin said that although steroids may make people euphoric, they can also “make some people feel pretty bad by causing anxiety, jitteriness and manic-like behavior.” In people with pre-existing psychosis, short-term steroid shots can trigger a psychotic episode, Dr. McCoul said.

Drs. Dvorin and Ebell wrote, “Physicians might assume that short-term steroids are harmless and free from the widely known long-term effects of steroids. However, even short courses of systemic corticosteroids are associated with many possible adverse effects.” (“Systemic” refers to both oral and injected steroids, as opposed to topical uses on the skin.)

Furthermore, there is no credible evidence to justify such risks when treating a condition like a cold or sinus infection, the Michigan doctors noted. When any treatment is prescribed, it’s the practitioner’s job to first weigh its expected benefits against possible risks. However, Drs. Wallace and Waljee reported that “corticosteroid bursts are frequently prescribed for self-limited conditions, where evidence of benefit is lacking.” Leading the list of such inappropriate uses of steroids are acute respiratory tract infections that usually resolve without specific treatment within a week or two.

As with antibiotics and opiates, short-term use of injected or oral steroids have “well-defined indications but can cause net harm when used — as they frequently are — when evidence of benefit is low,” they concluded.

In Louisiana, where Dr. McCoul practices, steroid shots for upper respiratory infections are shockingly common, he said. “Patients may go to urgent care five or six times a year to get a steroid shot.” Although the drugs themselves are not addictive, getting these shots “is like a behavioral addiction,” he said.

“It’s a pervasive practice for which there’s practically zero evidence of benefit,” Dr. McCoul added. “It’s important for the public to understand that most upper respiratory infections are self-limited; no intervention is required. They resolve on their own if you don’t seek care.”

However, when patients do go to the doctor, they expect something to happen, and doctors are often happy to oblige. They are reimbursed by insurance if they administer an injection but not if they hand patients a prescription for oral steroids.

A single steroid shot provides the equivalent of six days of oral prednisone at 20 milligrams a day, Dr. Dvorin said. But unlike pills that patients can stop taking, once an injection is administered, the drug can’t be removed from the body if it causes an adverse effect or confers no benefit.

Asked how to avoid inappropriate use of steroids, Dr. Dvorin suggested that patients look providers in the eye and ask, “Is this evidence-based? Is it something that’s really going to help me? What are the possible side effects? Are steroids really needed? What else can I do or take to relieve my symptoms?”

Less hazardous options abound, Dr. Wallace said. They include over-the-counter drugs like ibuprofen, acetaminophen (Tylenol and its store brands), and a nighttime cough syrup. Dr. McCoul suggested using an over-the-counter decongestant to reduce mucus production and relieve pressure in the head. Alternatively, try a saline nasal spray, which he said is “one of the best things a person can do for any acute or chronic upper respiratory condition in which inflammation plays a role.”

You can purchase a salt mixture or make your own to use in a nasal irrigation device like a Neti pot. Mix 3 teaspoons of noniodized salt with 1 teaspoon of baking soda. Add 1 teaspoon of the mixture to 8 ounces of distilled (or boiled and cooled) water in the device. Tilt your head over the sink at a 45-degree angle, place the spout in one nostril and gently pour in the salt solution. Repeat in the other nostril.

What People With Allergies Should Know About Covid Vaccines

Here’s What People With Allergies Should Know About Covid Vaccines

Four people so far have had allergic reactions after getting the Pfizer-BioNTech vaccine. Experts say that shouldn’t deter most people from getting a jab.

Vaccinations underway in Orange, Calif., on Wednesday.
Vaccinations underway in Orange, Calif., on Wednesday.Credit…Jenna Schoenefeld for The New York Times
Katherine J. Wu

  • Dec. 18, 2020, 12:27 p.m. ET

Allergic reactions reported in two health workers who received a dose of Pfizer’s vaccine in Alaska this week have reignited concerns that people with a history of extreme immune flare-ups might not be good candidates for the newly cleared shots.

The two incidents follow another pair of cases in Britain. Three of the four were severe enough to qualify as anaphylaxis, a severe and potentially life-threatening reaction. But all four people appear to have recovered.

Health officials on both sides of the pond are vigilantly monitoring vaccinated people to see if more cases emerge. Last week, British drug regulators recommended against the use of Pfizer’s vaccine in people who have previously had anaphylactic reactions to food, medicines or vaccines.

And on Thursday, Dr. Doran Fink, deputy director of the Food and Drug Administration’s clinical division of vaccines and related products applications, addressed the issue during a meeting about the vaccine made by Moderna that contains similar ingredients and is expected to soon receive emergency use authorization, or E.U.A., from the agency.

“We anticipate that there may be additional reports, which we will rapidly investigate,” Dr. Fink said, adding that robust surveillance systems were in place to detect these rare events.

Still, Dr. Fink said that “the totality of data at this time continue to support vaccinations under the Pfizer E.U.A., without new restrictions.”

The F.D.A., he added, would work with Pfizer to revise fact sheets and prescribing information for the vaccine so that the public would understand the risk of allergic reactions and know how to report them.

What do we know about the people who had bad reactions?

The first two confirmed cases of allergic reactions came from two health care workers in Britain. Both had a medical history of serious allergic reactions, but had not previously been known to have trouble with any of the vaccine’s ingredients. After an injection of epinephrine — the typical treatment for anaphylaxis — both recovered.

(A third British incident described as a “possible allergic reaction” was also reported and appears to have been minor.)

On Wednesday, two health workers in Alaska experienced reactions as well. One was too mild to be deemed anaphylaxis. But the other, which occurred in a middle-aged woman with no history of allergies, was serious enough to warrant hospitalization, even after she got a shot of epinephrine.

“What is happening does seem really unusual to me,” said Dr. Kimberly Blumenthal, an allergist, immunologist and drug allergy researcher at Massachusetts General Hospital. Vaccine-related allergic reactions are typically rare, occurring at a rate of about one in a million.

Dr. Blumenthal also pointed out that it was a bit bizarre to see allergic reactions clustering in just two locations: Britain and Alaska. Zeroing in on the commonalities between the two hot spots, she said, might help researchers puzzle out the source of the problem.

Do we know for sure that their reactions were caused by the vaccine?

British and U.S. agencies are investigating the causes, but no official has declared a direct link.

But Dr. Blumenthal suspects they were connected to the shots, because the reactions were immediate, occurring within minutes of injection.

“We have to think it was related because of the timing,” she said.

Nor is it known if a particular ingredient might have been the cause. Pfizer’s vaccine contains just 10 ingredients. The most important is a molecule called messenger RNA, or mRNA — genetic material that can instruct human cells to make a coronavirus protein called spike. Once manufactured, spike teaches the immune system to recognize the coronavirus so it can be fought off in the future. Messenger RNA, which is naturally found in human cells, is unlikely to pose a threat, and degrades within about a day of being injected.

The other nine ingredients are a mix of salts, fatty substances and sugars that stabilize the vaccine. None are common allergens. The only chemical with a history of causing allergic reactions is polyethylene glycol, or PEG, which helps package the mRNA into an oily sheath, protecting it as it goes into human cells.

But PEG is, generally speaking, inert and widespread. It’s found in ultrasound gel, laxatives like Miralax and injectable steroids, among other drugs and products, Dr. Blumenthal said. Despite the chemical’s ubiquity, she said, “I’ve only seen one case of a PEG allergy — it’s really, really uncommon.”

It’s still possible that something else could be causing the reactions — perhaps a factor related to how the vaccines are transported, thawed or administered, Dr. Blumenthal said.

Did the volunteers in Pfizer’s clinical trials have any bad reactions?

A small number of volunteers in Pfizer’s clinical trials experienced allergic reactions. Just one of the 18,801 participants who received the vaccine in a late-stage trial had anaphylaxis, and the incident was deemed unrelated to the vaccine, said Steven Danehy, a spokesman for Pfizer. No severe reactions were found in people who got a placebo shot.

Pfizer excluded people with a history of anaphylaxis to vaccines from its clinical trials.

What does the F.D.A. say about these reactions?

Several experts raised concerns about the allergic reactions in meetings convened to discuss both Pfizer’s and Moderna’s vaccines. The agency has advised caution, noting that health care providers should not administer the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine — a standard warning for vaccines.

Should people with mild allergies wait to get vaccinated?

There’s no evidence that people with mild allergies, which are quite common, need to avoid the vaccine. Allergies are, simply put, the product of an inappropriate immune response against something harmless — pollen, peanuts, cat dander and the like. In many cases, the results of this overreaction are mild symptoms such as a runny nose, coughing or sneezing.

But allergies are specific: A reaction to one substance does not guarantee a reaction to another. On Monday, the American College of Allergy, Asthma and Immunology released guidance stating that people with common allergies “are no more likely than the general public to have an allergic reaction to the Pfizer-BioNTech Covid-19 vaccine.”

William Amarquaye, a clinical pharmacist at Brandon Regional Hospital, said he wouldn’t let his asthma or allergies stop him from taking the vaccine when it is offered to him in the next few weeks. He’s also never had trouble with other vaccines he has taken in the past.

“It should still be OK to take the vaccine,” Dr. Amarquaye said. “I’m actually excited about it.”

What about people with a history of severe allergies?

Most people in this category should be good to go, too, said Dr. Eun-Hyung Lee, an expert in allergy and immunology at Emory University.

Guidelines released by the Centers for Disease Control and Prevention identify only one group of people who might not want to get Pfizer’s vaccine: those with a known history of severe allergic reactions to an ingredient in the injection.

People with a history of anaphylaxis to any other substance, including other vaccines or injectable drugs, can still get the vaccine, but should consult their health care providers and be monitored for 30 minutes after getting their shots. Everyone else, like people with mild or no allergies, need to wait only 15 minutes before leaving the vaccination site.

“In general, the immediate reactions that require epinephrine are those that happen within the first 30 minutes,” said Dr. Merin Kuruvilla, an allergist and immunologist at Emory University.

Some people will understandably be concerned. Dr. Taison Bell, a critical care physician at UVA Health in Charlottesville, Va., said he worried about his 7-year-old son, Alain, who is severely allergic to several foods, including wheat, peanuts and cow’s milk. Alain has about two bouts of anaphylaxis each year.

It’s a bit of a relief that Alain is “later in the prioritization schema,” Dr. Bell said. By the time a vaccine is ready for him, he said, “we’ll get a better sense for how serious this is.” The family plans to discuss their situation with Alain’s doctor.

Ultimately, it’s unlikely that any of the ingredients in a coronavirus vaccine would cause Alain any issues. Alain has tolerated other vaccines, including the flu shot, in previous years, and is looking forward to his own shot at immunization to the coronavirus, said Dr. Bell, who received his first dose of Pfizer’s vaccine on Tuesday.

What about Moderna’s vaccine?

Two volunteers in Moderna’s late-stage clinical trial developed anaphylactic reactions, the company reported at the F.D.A. committee meeting on Thursday. Neither was deemed to be linked to the company’s vaccine, which also contains mRNA, because they occurred weeks or months after the participants received their shots. One of these volunteers also had a history of asthma and a shellfish allergy.

Moderna, unlike Pfizer, did not exclude people with a history of anaphylaxis from its trials.

Dr. Tal Zaks, the company’s chief medical officer, said that while Moderna’s vaccine recipe was similar to Pfizer’s, key molecular differences existed that could set the two products on different paths. He said that bad reactions to Pfizer’s vaccine did not guarantee that similar events would happen in relation to the Moderna shots.

Both vaccines do, however, include a version of PEG.

Dr. Blumenthal and others said that anyone concerned about having an allergic reaction to a vaccine should seek the advice of a health care provider.

For anyone getting the vaccine, it’s all about “balancing out the risks,” Dr. Lee, of Emory, said. Allergic reactions can be dangerous. But they are rare and treatable, and the tools to combat them should be available at all vaccination sites. The coronavirus, on the other hand, can have far graver consequences.

“When it’s my turn in line, I think weighing these odds is what I would do,” Dr. Lee said.

Moderna to Begin Testing Its Coronavirus Vaccine in Children

Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children

The company said the trial would involve children ages 12 through 17.

The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.
The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.Credit…Cody O’Loughlin for The New York Times

By

  • Dec. 2, 2020, 2:13 p.m. ET

The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.

But the posting says the study is “not yet recruiting,” and Colleen Hussey, a spokeswoman for Moderna, said it was not certain when the testing sites would be listed or start accepting volunteers. A link on the website to test centers is not yet working, and Ms. Hussey said she was not sure when it would become active.

Moderna announced on Monday that data from its study in 30,000 adults had found its vaccine to be 94.1 percent effective, and that it had applied to the Food and Drug Administration for emergency authorization to begin vaccinating adults. If approval is granted, certain groups of high-risk adults, including people in nursing homes, could receive shots late in December.

But no vaccine can be widely given to children until it has been tested in them. Vaccines meant for both adults and children are generally tested first in adults to help make sure they are safe for pediatric trials.

Moderna’s vaccine has not yet been studied in children or pregnant women. In the new clinical trial in adolescents, girls past puberty will be tested before each injection to make sure they are not pregnant.

“Everyone anticipates that when we test this first in adolescents, then older children, then the real small kids, that the Covid vaccine will work,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and an adviser on vaccines to the Centers for Disease Control and Prevention.

But children have more active immune systems than adults, and may have stronger reactions, including more fever, muscle and joint aches, and fatigue, Dr. Schaffner said.

“They may be more out of sorts than adults for a day or two,” he said. “You really do want to know, if it’s given in adolescents, what can parents expect? You really want to be able to tell them clearly how you might feel for 24 or 48 hours after you receive the vaccine. And obviously, we really want to be able to tell parents it works.”

If a child had intense side effects and parents were not prepared for it, they might be reluctant to go back for the second shot, Dr. Schaffner said.

Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, said that vaccines “for the most part” work equally well in children and adults. Occasionally, as with the hepatitis B vaccine, different doses are required, he said. Moderna will study the same dose in children that it has tested in adults.

Pfizer began testing its coronavirus vaccine in children as young as 12 in October. A large clinical trial found its vaccine to be 95 percent effective in adults, and the company has requested emergency authorization from the F.D.A. Britain approved the Pfizer vaccine for adults on Wednesday, the first country to do so.

AstraZeneca has also tested its vaccine in children, but not in the United States.

As vaccine studies have moved forward, rumors have spread on social media, particularly among people who oppose vaccines in general, that President-elect Joseph R. Biden Jr. plans to require vaccination for everyone, including children. His team has denied those claims, and Mr. Biden has said that he will rely on scientists’ advice for the best way to end the pandemic.

Who Will Get the Coronavirus Vaccine First?

After months of deliberation and debate, a panel of independent experts advising the Centers for Disease Control and Prevention is set to decide on Tuesday which Americans it will recommend to get the coronavirus vaccine first, while supply is still short.

The panel, the Advisory Committee on Immunization Practices, will vote in a public meeting on Tuesday afternoon, and it is expected to advise that health care workers be first in line, along with residents of nursing homes and other long-term care facilities. If the C.D.C. director, Dr. Robert R. Redfield, approves the recommendations, they will be shared with states, which are preparing to receive their first vaccine shipments as soon as mid-December, if the Food and Drug Administration approves an application for emergency use of a vaccine developed by Pfizer.

States don’t have to follow the C.D.C.’s recommendations, but most probably will, said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. The committee will meet again soon to vote on which groups should be next to receive priority.

Here are answers to some common questions about the vaccine and its distribution.

Who will get the vaccine first?

Based on its recent discussions, the C.D.C. committee will almost certainly recommend that the nation’s 21 million health care workers be eligible before anyone else, along with three million mostly elderly people living in nursing homes and other long-term care facilities.

A staggering 39 percent of deaths from the coronavirus have occurred in long-term care facilities, according to the committee. But there won’t be enough doses at first to vaccinate everyone in these groups; Pfizer and Moderna, the two companies closest to gaining approval for their vaccines, have estimated that they will have enough to vaccinate no more than 22.5 million Americans by January. So each state will have to decide which health care workers go first.

They may choose to prioritize critical care doctors and nurses, respiratory therapists and other hospital employees, including cleaning staff, who are most likely to be exposed to the coronavirus. Or they may offer the vaccine to older health care workers first, or those working in nursing homes, who are at higher risk of contracting the virus. Gov. Andy Beshear of Kentucky said on Monday that most of his state’s initial allocation would go to residents and employees of long-term care facilities, with a smaller amount going to hospital workers.

It’s important to remember that everyone who gets a vaccine made by Pfizer or Moderna will need a second shot — three weeks later for Pfizer’s, four weeks for Moderna’s.

Who gets it next?

The C.D.C. committee hinted last week that it would recommend essential workers be next in line. About 87 million Americans work in food and agriculture, manufacturing, law enforcement, education, transportation, corrections, emergency response and other sectors. They are at increased risk of exposure to the virus because their jobs preclude them from working from home. And these workers are disproportionately Black and Hispanic, populations that have been hit especially hard by the virus.

Individual states may decide to include in this group employees of industries that have been particularly affected by the virus. Arkansas, for example, has proposed including workers in its large poultry industry, while Colorado wants to include ski industry workers who live in congregate housing.

After essential workers, the priority groups likely to be recommended by the C.D.C. committee are adults with medical conditions that put them at high risk of coronavirus infection, and people over 65. But again, some states might diverge to an extent, choosing, for example, to vaccinate residents over 75 before some types of essential workers. All other adults would follow. The vaccine has not yet been thoroughly studied in children, so they would not be eligible yet.

If the C.D.C. director, Dr. Robert R. Redfield, approves the panel’s recommendations, they will be shared with states.
If the C.D.C. director, Dr. Robert R. Redfield, approves the panel’s recommendations, they will be shared with states.Credit…Stefani Reynolds for The New York Times

Who will make state-level decisions about priority groups?

Each state has a working group, composed largely of public health officials, that has been planning for months and making decisions about vaccination campaigns. Each state’s top health official and governor will probably sign off on final plans.

How long will states focus on one priority group before moving to the next in line?

States don’t need to reach everyone in one priority group before moving on to the next, according to the C.D.C. advisory committee. But more federal guidance is expected on the subject.

When will the first doses of a vaccine be shipped, and where will they go?

Federal officials have said they plan to ship the first 6.4 million doses within 24 hours after the F.D.A. authorizes a vaccine, and the number each state receives will be based on a formula that considers its adult population. Pfizer will ship special coolers, each containing at least 1,000 doses, directly to locations determined by each state’s governor. At first, almost all of those sites will probably be hospitals that have confirmed they can store shipments at minus 94 degrees Fahrenheit, as the Pfizer vaccine requires, or use them quickly.

When will a vaccine be available to the general public, and where will people receive it?

Federal officials have repeatedly suggested that people who are not in the priority groups — healthy adults under 65 who don’t work in health care or otherwise qualify as essential workers — should have access to the vaccine by May or June, because there will be enough supply by then. But a lot will have to go right for that to happen. One factor is whether, or when, other vaccines besides Pfizer’s and Moderna’s are approved.

Can employers like hospitals or grocery stores require their employees to be vaccinated?

Employers do have the right to compel their workers to be vaccinated. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation”; with a coronavirus vaccine, a worker might be allowed to wear a mask in the office instead, or to work from home.

Three companies have announced preliminary data indicating their vaccines are effective, and there are dozens of additional candidates in clinical trials. Can I choose which vaccine I get?

This depends on a number of factors, including the supply in your area at the time you’re vaccinated and whether certain vaccines are found to be more effective in certain populations, such as older adults. At first, the only choice is likely to be Pfizer’s vaccine, assuming it is approved. Moderna asked the F.D.A. for emergency authorization on Monday; if approved, it would most likely become available within weeks after Pfizer’s.

Are there any side effects from the shot?

Some participants in both Pfizer’s and Moderna’s trials have said they experienced symptoms including fever, muscle aches, bad headaches and fatigue after receiving the shots, but the side effects generally did not last more than a day. Still, preliminary data suggests that, compared with most flu vaccines, the coronavirus shots have a somewhat higher rate of such reactions, which are almost always normal signs that the body’s immune response is kicking in. At the meeting of the C.D.C. advisory committee last week, some members said it would be important for doctors to warn their patients about possible side effects and assure them of the vaccines’ safety.

How do I know it’s safe?

Each company’s application to the F.D.A. includes two months of follow-up safety data from Phase 3 of clinical trials conducted by universities and other independent bodies. In that phase, tens of thousands of volunteers get a vaccine and wait to see if they become infected, compared with others who receive a placebo. By September, Pfizer’s trial had 44,000 participants; no serious safety concerns have been reported.

The F.D.A. will also review the data for each vaccine seeking authorization and share it with its advisory committee, which will meet publicly — in the case of the Pfizer vaccine, on Dec. 10 — to ask questions and make a recommendation to the agency. The F.D.A. will then decide whether to approve the vaccine for emergency use.

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

New Guidelines Cover Opioid Use After Children’s Surgery

Opioids are very effective drugs for managing pain, but they can also be scary drugs, with their potential for misuse and abuse. Given the current opioid epidemic in the United States, some parents worry about whether they are safe for children, while many pain experts worry that fear of opioids among parents and among physicians may contribute to the undertreatment of pediatric pain.

In new guidelines published in November in the journal JAMA Surgery, a panel convened by the American Pediatric Surgical Association Outcomes and Evidence-based Practice Committee set out some guidelines for how to think about — and prescribe — opioids for children to relieve pain after surgery. “It’s important to understand that children undergo a lot of painful procedures,” said Dr. Lorraine Kelley-Quon, a pediatric surgeon at Children’s Hospital Los Angeles, who was the lead author on the guidelines. “They have real pain; opioids can help.”

Matthew Kirkpatrick, an addiction expert who is an assistant professor in the department of preventive medicine at the Keck School of Medicine at the University of Southern California, and who was one of the authors of the new guidelines, said, “We don’t want to contribute to scaring parents and to scaring physicians about undertreating pain.” From the data they reviewed, he said, “kids that use these medications as prescribed are at very low risk for abuse and dependence either in the short term or the long term.”

However, the first six statements in the guidelines discuss the risks of adolescents misusing prescription opioids (misuse is anything other than use exactly as directed by the prescriber, or use without a prescription), diverting them (giving them away or selling them), and possibly having a higher risk of problems with opioids in the future. Dr. Kelley-Quon pointed out that many health care practitioners may not be familiar with the addiction literature. But some pain experts warn that heavy emphasis on that risk as a way of framing the issue may frighten both parents and doctors.

Dr. Elliot Krane, the chief of pediatric pain management at Stanford Children’s Health, who was not an author of the new guidelines, said, “the concern is that the paper is going to discourage the appropriate use of opioids, though I know that wasn’t the intent of the authors — the reason I think that’s the risk is they set up their recommendations with a premise which I think is untrue, that kids are dying and becoming addicts” at an increasing rate.

Dr. Krane disputed some of the statements about the risk: “I think the evidence that opioid abuse is increasing in children is very weak; I think the evidence in children that prescription opioids lead to later abuse isn’t there at all.”

Dr. Scott Hadland, a pediatrician and addiction specialist at Boston Medical Center, who was not involved with the guidelines, said, “While I agree with the recommendations, I agree also with the concern from the pain community that risk may be overstated — may not be as large as some of the earlier studies have suggested.”

The guidelines recommend non-opioid medications as first-line postoperative drugs, including the use of regional anesthesia.

But when opioids are used, the guidelines stress careful supervision. “It all boils down to access,” Dr. Kirkpatrick said, and the imperative is to make sure that parents and physicians get the right information “to manage the dispensing of the medication to their kids and the access that their kids have to the medication.” Parents should not be afraid of managing the child’s pain with opioids when they are needed, but should understand the importance of controlling that access in children and through adolescence.

“The parent should be highly engaged in managing the child’s pain, in making sure the child gets the medication to manage the pain, but the child does not have access to the drug on their own.”

Dr. Kirkpatrick said that overprescribing by physicians has contributed to opioid use and misuse in adults. In data from a national survey on drug use and health, he said, kids were most likely to get medication they had misused from friends or family members, but when they were asked where that person had gotten it, it was often from a doctor.

Dr. William Zempsky, the division head of pain and palliative medicine at Connecticut Children’s Medical Center, who was not an author of the guidelines, said that while opioids have been prescribed inappropriately to adults in some settings, there is no clear evidence that it has been a problem in pediatrics.

“We need to do things right, but we don’t need to scare people,” Dr. Zempsky said. “Kids continually are at risk for lack of appropriate postoperative surgical management because of fear of opioid addiction.”

Dr. Eugene Kim, the chief of the division of pain medicine at Children’s Hospital Los Angeles, who was one of the authors of the guidelines, said, “I am aware of the caution that certain pain management experts have,” regarding the dangers of underprescribing and undertreating pain. The guidelines should be the basis for ongoing conversations, he said, as well as for responsible prescribing.

“Parents of children who are undergoing surgeries should be educated as to when to use the medications, how to use the medications, and we, as providers, should be involved in that process from the get-go as far as the education process, as far as responsible prescribing, as far as follow up.”

Some adolescents may be particularly at risk for problems with opioids, especially those who have had substance use problems in the past, and those who have mental health problems.

With patients at higher risk, Dr. Hadland said, such as those with anxiety or depression or those who have had substance abuse issues, opioids can still be prescribed when they’re needed, but “we should take great care.”

When a patient of his, a young adult who had alcohol use disorder, needed surgery, Dr. Hadland said, “I and the patient themselves were both concerned about the potential misuse of opioids because of the history of addiction.” He and the surgeon partnered, he said, and agreed that Dr. Hadland would do the postoperative pain management because he was more readily available and more comfortable working with a patient who had this history. He prescribed very small amounts of oxycodone, he said, discussing at every stage with the patient how it felt to be taking the medication. “We had open communication around it and things went really well.”

The guidelines go beyond the discussion of when opioids should be used and cover the importance of educating both children and their parents and caregivers about the possible side effects of opioids (oversedation and respiratory depression), about the importance of following medical instructions carefully, about the need for storing these medications securely (that is, in a locked area) and getting any unused doses out of the home in a safe and secure way (they should be returned to a secure opioid disposal bin).

None of the other specialists I spoke with suggested changing the specific recommendations for multimodal pain relief, for using opioids when other drugs are insufficient for effective pain control, and for good parent education leading to careful oversight, locked storage and safe disposal of unused doses.

“The spirit behind these guidelines is correct,” Dr. Hadland said. “Prescribing the lowest effective dose for the shortest period of time, use only short acting formulations, and talk to families about risks and monitoring dosing and locking up medication.”

Parents and physicians can feel safe that if kids are using these medications as prescribed to manage their pain, Dr. Kirkpatrick said, they are “not at significantly greater risk for developing opioid use related problems.”

“If your child needs surgery, talk to your doctor, ask questions about what pain should be expected,” Dr. Kelley-Quon said. Ask if opioids will be used, and if so, how should they be used, and how can they be safely disposed of, she said. “We want to be at the sweet spot, treating pain appropriately, maximizing benefit and minimizing risk.”

Can Statins Cause Diabetes?

Photo

Credit Stuart Bradford

Do you have a health question? Submit your question to Ask Well.

Related:

For more fitness, food and wellness news, follow us on Facebook and Twitter, or sign up for our newsletter.

Drug Company Lunches Have Big Payoffs

Photo

A free lunch may be all it takes to persuade a doctor to prescribe a brand-name drug instead of a cheaper generic, a new study suggests.

Using Medicare’s Open Payments data, researchers collected information on 279,669 doctors who received 63,524 payments reported by drug companies. They concentrated on specific drugs in four categories: cholesterol lowering statins, two types of blood pressure drugs and antidepressants.

The study, in JAMA Internal Medicine, found that 95 percent of the payments were for meals sponsored by drug companies, worth about $12 to $18 each.

Doctors who were treated to a single meal, where drug companies present information about their medications, were 18 percent more likely to prescribe Crestor, a brand-name cholesterol-lowering medicine. They were 70 percent more likely to prescribe Bystolic, a brand-name beta blocker for high blood pressure, and 52 percent more likely to prescribe Benicar, also for hypertension.

The more meals doctors had, the more likely they were to prescribe the promoted drug.

Think Like a Doctor: Drowning on Dry Land Solved

On Thursday we challenged Well readers to unravel the case of a 67-year-old healthy retiree who suddenly developed knife-like chest pain and a worsening cough. Maybe this case was too easy because more than a quarter of you figured it out.

The correct diagnosis is:

Eosinophilic pneumonia, caused by the antibiotic daptomycin (brand name Cubicin)

The first reader to make this not-quite-as-tough-as-I-thought diagnosis was Francis Graziano, a second-year medical student at Georgetown University School of Medicine. He had just learned about daptomycin and recalled that there were some pretty dramatic side effects linked to it. And the time course seemed right. So he went to the Wikipedia page on the drug and saw that this type of pneumonia was a known adverse reaction to it. Francis is another two-time winner, having solved another tough case two years ago. Well done, Francis.

The Diagnosis

Daptomycin is an antibiotic used primarily to treat drug-resistant staph infections. It was approved by the Food and Drug Administration in 2003.

The first report suggesting a link between this antibiotic and pneumonia was made in 2007. An 87-year-old man who, like this patient, was being treated with daptomycin for an infection after knee surgery lost 15 pounds over the course of just a few weeks and became increasingly fatigued. A CT scan of his chest revealed multiple nodules, and when these nodules were biopsied, the patient was found to have a pneumonia.

But it was an unusual pneumonia. Instead of finding bacteria or the usual infection-fighting white blood cells in the lungs, the sample showed a handful of eosinophils (or eos), a type of white blood cell that normally fights off parasites (like intestinal worms) but can also be seen in allergic reactions. The doctors suspected that the pneumonia was an allergic reaction to the daptomycin. They stopped the drug, and the pneumonia resolved.

As a result of this case report, the F.D.A. put eosinophilic pneumonia on the list of possible adverse reactions. By 2011, 11 cases had been reported, enough to convince the F.D.A. that the link was real.

Eosinophilic pneumonia is an unusual disorder and is usually caused by exposure to certain drugs or toxins or radiation therapy. The most common trigger is cigarette smoke, and the illness may occur in those who recently started or restarted smoking. More than 300 different medications have been linked to eosinophilic pneumonia; antibiotics and nonsteroidal anti-inflammatory drugs such as ibuprofen are most commonly cited.

How or why this pneumonia develops is not clear. Men are more likely to be affected than women. In the cases of eosinophilic pneumonia associated with daptomycin, patients were all over age 60.

How the Diagnosis Was Made

Dr. Robert Centor was the doctor on call when the patient was admitted to the hospital. The patient was seen by the resident on his team, who called to tell him about the 67-year-old man with the infected knee and a week-long pneumonia.

Dr. Centor was intrigued. Why would a pretty healthy guy on antibiotics for one infection develop a second infection? He was getting his antibiotics through an intravenous catheter than ran from a vein in his arm into his heart. Could some type of skin bug have traveled up the catheter into his heart, and from there into his lungs?

He asked the resident to make sure that the patient had a CT scan of his chest to look for tiny pieces of infection, known as septic emboli, which might be clogging up the blood vessels in his lungs. The patient got the scan, which showed only the fluffy clouds dotted throughout his lungs.

The next morning, Dr. Centor went to the radiology suite to review the chest X-ray and CT scan with the radiologist. No septic emboli were present. After confirming what he’d already heard the night before, the internist headed up to see the patient with his team.

Looking for Answers

After talking to the patient and examining him, Dr. Centor was certain of two things. First, that the patient was seriously ill. Second, that he wasn’t sure why. It didn’t make any sense at all that this youthful 67-year-old retiree should suddenly develop a whopping double pneumonia.

Certainly bad things can happen to healthy people, but Dr. Centor liked to understand why. In this case, “I was completely befuddled,” Dr. Centor told me in his thoughtful Southern twang. We were old friends; he had been a wonderful teacher and mentor to me. “But whenever I am befuddled, I just talk to other people,” he told me.

I know from my own experience that often enough, just posing a case to a colleague as a question can prompt you to see it in a different light and reveal an answer you hadn’t considered. And if you’re really lucky, the answer comes from asking someone who has previously come across a similar case. So Dr. Centor, who was the dean of his residency program, headed to the cafeteria, where he grabbed a cup of coffee and scanned the room for familiar faces. He settled down at a table full of doctors and residents and quickly outlined the case.

The Right Place, the Right Time

Mohamed Raja, a resident in his second year of training, listened carefully to the case. “It was a matter of being in the right place at the right time,” he told me. Because as soon as Dr. Centor mentioned the name of the antibiotic the patient had been getting, the resident realized with a jolt that he knew the diagnosis.

Well, he said to Dr. Centor, he had been reading up on Cubicin just the week before. And there was this rare complication associated with the drug that had caught his attention. It was an allergic reaction that manifests itself as a terrible and painful pneumonia, caused not by an infection but by the patient’s own white blood cells, the eosinophils.

Hearing of this unusual reaction, Dr. Centor quickly pulled out his cellphone and looked up Cubicin and eosinophilic pneumonia. Sure enough, this unusual side effect, first described just a few years earlier, seemed to fit his patient exactly.

The only way to know for certain was to get a lung doctor to put a scope into the patient’s lungs and see if these specialized cells, the eosinophils, were there. They shouldn’t be. But first he had to stop the medication.

Dr. Centor called the nurses to make certain the patient didn’t get his next scheduled dose. Then he went upstairs to tell his team and the patient.

Waiting for Watson

It is the nature of medical knowledge that no one knows everyone. We doctors all learn the same basics, and what we add depends on the patients we see and the interests we pursue. One of the key skills all doctors must hone is how to recognize and supplement these almost inevitable gaps.

The Internet has made this kind of supplementation much, much easier. For example, when Dr. Centor first told me about this case, he gave me the outline and asked what I thought was going on – a game we often play. I didn’t know, but what I call “test logic” told me that if he was telling me the name of the antibiotic, it had to be part of the answer. So I Googled the terms “daptomycin” and “pneumonia” and whammo, I got the answer immediately.

Last fall, IBM announced that it is developing a health care business based on its supercomputer, Watson. Using the same data-accumulating skills that allowed Watson to conquer “Jeopardy!” in 2011, the goal is to master all medical knowledge – new and old – so that we won’t have to. But until then, doctors must continue to rely on their own data accumulating skills.

Dr. Centor turned first to the traditional method, the who-wants-to-be-a-millionaire option of phoning a friend, before turning to other sources. Will Watson – or any of the other emerging databases – fully replace human recall and thought? They haven’t so far.

How the Patient Fared

The patient had the bronchoscopy the next day. He had eosinophils and no signs of infection. He was started on high-dose steroids to calm the allergic reaction, and the Cubicin was replaced with another antibiotic for the last weeks of treatment.

It’s been four months since his scary pneumonia episode, and the patient tells me he feels just fine. He’s resigned to the fact that his knee may never be perfect. But breathing? No problem.

As for his fishing camp, it’s closed for the winter. But he’ll be back as soon as the weather, and his knee, allow.