Month: January 2021

Lately it seems like everywhere I look, someone is vaping as they walk by, stand outside a store, or roll up in the car next to me at a stoplight. It’s not surprising: e-cigarette use, or vaping, has become remarkably popular in recent years. About 6% of adults in the US now report vaping. That’s about 15 million people, double the number from just three years ago. Of course, regular cigarettes are known to cause cancer and a host of other health problems.

While considered less harmful than smoking tobacco, vaping isn’t risk-free. We know some, but not all, of its risks. We also know vaping is increasingly popular among teens and young adults, and this makes the recent FDA announcement authorizing sales of three additional vaping products surprising.

A surprise announcement from the FDA

In its announcement, the FDA authorized the R. J. Reynolds Vapor Company to market and sell its Vuse Solo device with tobacco-flavored vaping liquid to adults.

The FDA denied marketing authorization for 10 flavored products made by the same company. It also reports having denied more than a million flavored vaping products from other companies.

By the way, the agency emphasizes it is not actually approving these vaping products, or declaring them safe. The announcement states that marketing authorization will be reversed if

• the company directs advertising to younger audiences
• there is evidence of “significant” new use by teens or by people who did not previously smoke cigarettes
• R. J. Reynolds does not comply with extensive monitoring requirements.

Why did the FDA take this action?

The decision was reportedly based on data from the company — unfortunately not provided in the press release — demonstrating these products would benefit individuals and public health. How? By helping smokers quit.

Some studies have suggested that e-cigarette use can be modestly helpful for smokers trying to quit. For example, an analysis of 61 studies found that e-cigarette use was more effective than other approaches to quitting smoking. The study authors estimated that out of every 100 people who tried to quit smoking by vaping, nine to 14 might be successful. When only using other methods, such as nicotine patches or behavioral counselling, only four to seven smokers out of 100 might quit. A separate study suggests vaping may help smokers who aren’t able to quit reduce the number of cigarettes smoked per day — at least for six months, the duration of the study.

Does vaping harm health less than smoking cigarettes?

Despite claims that vaping is less harmful than smoking cigarettes and that it might help smokers quit, concern about its risks is well deserved.

• Nicotine addiction. Whether in cigarettes or vapes, nicotine is highly addictive. And the amount of nicotine in many vaping products is much higher than in regular cigarettes. Side effects include reduced appetite, increased heart rate and blood pressure, nausea, and diarrhea.
• Harm to lungs and heart. Vapors from e-cigarettes may contain cancer-causing toxins, metals, and lung irritants. Vaping raises risk for lung diseases, such as emphysema, asthma, chronic bronchitis, and chronic obstructive pulmonary disease. It’s also linked to an increased risk of heart attacks. Even secondhand exposure to e-cigarette vapors may trigger asthma.
• Severe, potentially fatal lung injury. In 2019, doctors began seeing people who had recently vaped and developed shortness of breath, cough, fever, and extensive lung damage. Dubbed EVALI (e-cigarette or vaping product use-associated lung injury), more than 2,800 cases and 68 deaths were reported. The condition has been linked to vapors containing THC and a form of vitamin E (called vitamin E acetate) used as a thickening agent when vaping THC. Cases have fallen markedly since 2020. Possibly because of falling case numbers, the FDA announcement of new vaping products didn’t even mention EVALI, which seems odd. If you do vape, see these recommendations to reduce the risk of EVALI.
• Health risks during pregnancy. Nicotine can damage a baby’s developing brain and lungs; some flavorings may be harmful as well. As a result, experts recommend that people who are pregnant not vape.

For teens and children, vaping has additional risks

An alarming number of middle-school and high-school age kids report vaping, despite the nationwide prohibition against selling e-cigarette products to anyone under age 18 (21 in some states). Its popularity is partly related to the marketing of flavors known to appeal to minors, such as bubblegum and berry-flavored products. According to one national survey, approximately 85% of teen vaping involved non-tobacco flavored products.

It’s important to know that

• nicotine negatively affects the developing brain
• the high exposure to nicotine and other toxic chemicals through vaping may be particularly harmful to kids because of their smaller body size
• the addictive potential of nicotine may mean that kids who vape are more likely to become cigarette smokers.

The bottom line

For nonsmokers and teens, there is no controversy: don’t start smoking and don’t vape.

If you’re an adult smoker trying to quit, be aware that the balance of risks and benefits and the long-term health consequences of vaping are uncertain. We need more solid research to help people make decisions. Meanwhile, the FDA has come down on the side of a limited authorization to help adult smokers quit. We’ll know only in retrospect if that was the right move.

Last week, the FDA authorized the Pfizer/BioNTech COVID vaccine for children ages 5 to 11. After conducting their own review, the CDC now recommends this vaccine for children in this age range, who can begin receiving their first dose within the week.

While many families have been eagerly awaiting the opportunity for their children to be immunized, others are hesitant. And most parents have questions about how COVID-19 affects younger children, vaccine safety in this age range, and whether the benefits outweigh potential risks. As a pediatric infectious disease specialist, I hear certain questions crop up repeatedly. Here’s what we know so far.

How does COVID-19 affect children in this age range?

While children continue to be much less likely than adults — especially adults 65 and older — to get severely ill from COVID-19, some children do get very sick. Thousands of children 5 to 11 have been hospitalized or need ICU-level support to recover from this infection. Almost 150 children in this age range have died from COVID-19. Additionally, over 5,000 cases of a serious inflammatory condition known as MIS-C that can follow COVID-19 infection have been reported. The majority of cases of MIS-C have occurred in children in this age range.

How has the Delta strain of the virus affected children?

The Delta strain of the virus that causes COVID spreads easily, particularly among people who haven’t received the vaccine. Children ages 5 to 11 remain more susceptible to infection, given their ineligibility to be vaccinated. In fact, more than one in five new cases recorded over the past two months while Delta infections surged in the US occurred in this age group, according to weekly reports from the American Academy of Pediatrics and the Children’s Hospital Association.

Can children spread the virus to others?

Several detailed reports describing outbreaks associated with settings such as summer camps, daycares, and schools, and those tracing transmission of COVID-19 within households, clearly demonstrate that children can spread this virus and infect others with whom they come into close contact.

Which COVID vaccines and doses are authorized for children ages 5 to 11?

Pfizer/BioNTech is the first COVID vaccine authorized by the FDA for this age group, based on results from a randomized controlled trial evaluating safety and immune responses. A separate trial launched by Moderna is being considered separately.

In a small number of children, the Pfizer/BioNTech trial compared three doses:

• 30 micrograms (the dose adults receive)
• 20 micrograms
• 10 micrograms.

This part of the trial showed that 10 micrograms, the smallest dose, resulted in fewer side effects while still generating robust immune responses similar to responses achieved with higher doses.

In the next part of the trial, more than 2,200 children ages 5 to 11 were randomly assigned to receive either a 10-microgram dose of the vaccine (two-thirds of participants) or a placebo dose (one-third of participants). All received two shots, spaced three weeks apart.

Those given the vaccine had similar immune responses as 16-to-25-year-olds who had received the full-dose series of two shots.

When Pfizer/BioNTech submitted data to the FDA, there were not many cases of symptomatic COVID-19 infections in trial participants. Out of 19 documented cases, most had received the placebo shots. Estimates suggest the efficacy rate of the vaccine is 90%. (Efficacy measures how much a vaccine reduces infection in a controlled trial.) Tests confirmed that the Delta viral strain had caused the infections.

What do we know about side effects for children this age?

Most children had no side effects other than pain at the injection site. Those who did have side effects most commonly experienced fatigue, headaches, and/or muscle aches after the second dose rather than the first dose. For example, only 6% of children had fever after the second vaccine dose. There were no cases of severe allergic reaction to the vaccine.

What is not yet known?

In very rare instances, the Pfizer/BioNTech COVID-19 vaccine is linked to myocarditis, which is an inflammation of the heart. When this occurs, it is mostly seen in young males following their second dose of an mRNA vaccine (Pfizer/BioNTech or Moderna). Most cases are mild, and children show no signs of long-term injury to the heart.

Among the 5-to-11-year-olds who received the Pfizer vaccine during the trial, there were no cases of myocarditis. However, this side effect is very rare and might not be noted until the number of children receiving the vaccine is much higher. The FDA and Pfizer/BioNTech will continue to closely monitor this age group for any occurrence of this rare side effect.

Can children get vaccinated against COVID-19 and influenza at the same time?

Yes. Children and adults can safely get both vaccines at the same time. The CDC urges everyone to get flu shots to help stay healthy during this flu season.

A randomized, controlled trial in the UK evaluated adults who received a flu shot or placebo shot in one arm and their second dose of the Pfizer/BioNTech vaccine in the other arm. The researchers reported in Preprints with The Lancet that side effects and immune responses were similar, whether the flu shot or a placebo shot was given at the same time as the COVID vaccine.

What other steps can parents take to protect children against COVID-19?

Parents should remember that an individual is not fully immunized and protected by the vaccine until 14 days after the second dose of the Pfizer vaccine. Masks are recommended for anyone who is unvaccinated, or not fully immunized, when indoors with people outside of their household. If rates of COVID-19 are high where you live, masks may be recommended indoors for vaccinated individuals as well.

Parents can continue to encourage other simple habits that help prevent colds, flu, and COVID-19, such as washing hands often, coughing or sneezing into an elbow, throwing away used tissues quickly, and avoiding crowded places and people who are ill when possible.