Aislinn Antrim

The FDA has approved Adacel (tetanus toxoid, reduced diptheria toxoid, and acellular pertussis vaccine; Tdap) during the third trimester of pregnancy to help protect against pertussis in infants younger than 2 months of age.

The Adacel vaccine is FDA-approved for active booster immunization against tetanus, diphtheria, and pertussis in individuals ages 10 through 64 years. It was the first vaccine globally to have a licensed indication for use in pregnancy to help prevent pertussis in young infants.

Pertussis is a highly contagious respiratory infection. Very young infants are at the highest risk of complications due to pertussis because of their still developing immune systems, and nearly half of babies ages 6 months and younger who get pertussis may need care in the hospital. Additionally, 1 out of 100 infants hospitalized for pertussis dies.

Although it can be prevented with vaccination, pertussis often goes undiagnosed. It can lead to severe and sometimes life-threatening health problems, such as exacerbation of chronic medical conditions such as asthma. For children and adults, initial symptoms typically develop between 7 and 10 days after exposure and are the same as a common cold. The next stage of illness is characterized by frequent bouts of paroxysmal cough and inspiratory whooping.

The CDC recommends Tdap vaccination during every pregnancy. When given during the third trimester, Adacel can help pregnant individuals create antibodies against the bacteria that cause pertussis, which are passed to the infant before birth. These antibodies help protect the infant against whooping cough during the first few months of life.

The efficacy of Adacel when administered during the third trimester to prevent pertussis among infants younger than 2 months of age was established in a clinical study using innovative real-world data, according to a press release. In that study, the efficacy of the vaccine at preventing pertussis was found to be 88%.

Available safety data in the retrospective passive surveillance study and ongoing pregnancy registry during the third trimester of pregnancy did not reveal any vaccine-related adverse effects on pregnancy or on the fetus or infant.

“We are pleased to receive the FDA’s approval for use of Adacel vaccine specifically during pregnancy to help protect young infants against pertussis, a potentially life-threatening disease,” said Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi, in the press release. “We pursued the label expansion to align fully with the long-standing health agency recommendations to provide Tdap vaccination to every woman in every pregnancy. We hope for higher and higher rates of Tdap vaccination in pregnancy so that fewer and fewer infants are likely to get pertussis.”

FDA approves Adacel for immunization during pregnancy to help protect young infants against pertussis. News release. Sanofi; January 17, 2023. Accessed January 17, 2023. 

https://www.news.sanofi.us/2023-01-17-FDA-approves-Adacel-R-for-immunization-during-pregnancy-to-help-protect-young-infants-against-pertussis

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The vaccine was 88% effective at preventing pertussis among infants younger than 2 months when administered during the third trimester of pregnancy.

FDA Approves Adacel Vaccine During Pregnancy to Protect Infants Against Pertussis

For individuals driving with groups outside their households or using ride-share services, keeping the windows rolled down and wearing masks can decrease the risk of spreading COVID-19, according to research results from the University of Surrey in the United Kingdom.

A team at the university’s Global Centre for Clean Air Research (GCARE) used sensors to monitor the concentration of pollution particles to map how those particles varied during different settings in the vehicle and to evaluate exposure doses for 3 different ventilation settings. They evaluated scenarios with the air conditioning on and using fresh air, with air conditioning on and using air recirculation, and the windows open.

The team found that maintaining a continuous intake of fresh air by keeping the windows open while also wearing a mask is the best way to guard against the transmission of COVID-19, according to a statement.

However, this scenario also increases occupants’ exposure to toxic air pollution particles.

This creates a dilemma because guarding against air pollution in turn increases the risk of COVID-19. The study results showed that the probability of transmission increased by 28.5% when windows were closed and air recirculation was switched on.

To balance both these issues, the team found that the best chance of remaining safe from both air pollution and COVID-19 was to keep the windows closed while running the air conditioning on ambient mode, in which it draws in fresh air from outside. This approach avoids external air pollution while minimizing exposure to COVID-19.

Lead author Prashant Kumar, PhD, founding director of GCARE at the University of Surrey, said in the statement research like this is essential to end the COVID-19 pandemic.

“It’s vital that the scientific community provides society with the data it needs so we can learn from the painful experience of the past 2 years,” he said. “Our research found that if your priority is to reduce the risk of contracting COVID-19, wearing a mask and keeping car windows open is the ideal approach.”

The combination of mask wearing and keeping windows open is best for reducing COVID-19 risk in cars, finds a new study. University of Surrey. News release. August 24, 2021. Accessed August 27, 2021. 

https://www.surrey.ac.uk/news/combination-mask-wearing-and-keeping-windows-open-best-reducing-covid-19-risk-cars-finds-new-study

Guarding against external air pollution while reducing the risk of infection when driving presents a challenge. 

Keeping Windows Down, Wearing Masks Reduces COVID-19 Risk in Cars

New research has found that shelter-in-place (SIP) orders during the COVID-19 pandemic had a significant impact on the population’s weight, with the average American gaining 2 pounds per month over the last year.

Despite common discussions about the “quarantine 15,” researchers have struggled to quantify the exact impact of the pandemic on physical health and fitness levels. In the study, researchers noted that surveys asking people about their weight are typically unreliable, and because many Americans have postponed their routine medical appointments, physicians may not have been able to catch these issues.

According to the study authors, 45 state governments issued SIP orders between March 19 and April 6, 2020, to slow transmission of COVID-19. These initial orders coincided with a decrease in daily step counts, likely due to changes in physical activity and daily habits, as well as self-reported increases in snacking and overeating, according to the study.

To investigate the possible down-stream health implications of prolonged SIP orders, investigators performed a longitudinal analysis of data obtained from participants in the Health eHeart Study who volunteered to report weight measurements from their Bluetooth-connected smart scale or iHealth. Demographic characteristics and medical conditions were obtained via online surveys.

According to the study authors, 7444 weight measurements from 269 unique study participants were collected during the study period, with a mean of 28 weight measurements per participant. Of the 269 participants, 130 were men and 207 were white, and the group had a mean age of 51.9 years.

According to their findings, post-SIP participants experienced steady weight gain of 0.27 kg every 10 days, irrespective of geographic location of comorbidities. This translates into approximately 1.5 pounds of weight gain every month.

These findings could have significant implications, as weight is a clinically relevant health outcome and is independently associated with all-cause mortality. It is also a helpful proxy for physical activity, which the study authors said is also associated with all-cause mortality.

When they analyzed weight trends around the initial SIP orders, the investigators found a significant increase in weight over the post-SIP period. Although 1.5 pounds over a month may not appear clinically important, it could lead to substantial weight gain over the prolonged pandemic, the authors said.

Lin A, Vittinghoff E, Olgin J, et al. Body Weight Changes During Pandemic-Related Shelter-in-Place in a Longitudinal Cohort Study. 

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777737?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=032221

Although 1.5 pounds over a month may not appear clinically important, it could lead to substantial weight gain over the prolonged pandemic.

Study: Average American Gained 1.5 Pounds Per Month During COVID-19 Pandemic

The FDA has issued a letter to JUUL Labs Inc, requesting more information about the company&#39;s outreach and marketing practices of electronic nicotine delivery systems (ENDS) and related products. The letter specified concerns around marketing targeted at students. The FDA also issued a simultaneous warning letter regarding JUUL&#39;s marketing and advertising practices.

According to FDA policies, companies must scientifically demonstrate that their products pose less risk than traditional products before they are able to market products for reduced risk. Acting FDA Commissioner Ned Sharpless, MD, said JUUL has ignored this law in marketing their products.

The warning letter cited several statements examined during a July 2019 Congressional hearing on JUUL products. According to the testimony, a JUUL representative speaking with students at a school made statements that identified JUUL products as "much safer than cigarettes," and that a student "should mention JUUL to his [nicotine-addicted] friend...because that&#39;s a safer alternative than smoking cigarettes, and it would be better for the kid to use."

"The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes," said the FDA statement.

E-cigarette use has been under increasing scrutiny over the past year. The FDA conducted a

in October 2018, after concerns were raised regarding e-cigarette sales to minors.

was recorded in August 2019, according to the Illinois Department of Public Health.

According to the CDC, JUUL sales have rapidly increased since 2016. Between 2016 and 2017, JUUL sales increased from 2.2 million devices sold to 16.2 million devices, a total increase of 641%. The CDC expressed concern that 74% of youth who used JUUL said they bought the device directly from a retail store.

Like the CDC, the FDA also expressed concern regarding youth&#39;s perceptibility to marketing of e-cigarette products.

"Referring to your ENDS products as &#39;99% safer&#39; than cigarettes, &#39;much safer&#39; than cigarettes, &#39;totally safe,&#39; and &#39;a safer alternative than smoking cigarettes,&#39; is particularly concerning because these statements were made directly to children in school," the warning letter said. "Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL&#39;s products, and evidence that ENDS products contribute to use of, and addiction to, nicotine, to which youth are especially vulnerable."

The FDA requested documents and information on several issues, including JUUL&#39;s use of nicotine salts in its e-liquids and the concentration of nicotine in its products. Nicotine salts were described at the Congressional hearing as a tool to mask the harshness of nicotine.

The FDA also asked JUUL to provide information on why they use a nicotine concentration of 5% in their products, which could potentially increase addictiveness.

The FDA has requested that JUUL provide the requested documents and information within 30 days of the letter.

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth [news release]. Silver Spring, MD; September 9, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth. Accessed September 9, 2019.

FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More than 1300 Retailers and 5 Major Manufacturers for their Roles Perpetuating Youth Access [news release]. Silver Spring, MD; September 11, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM620184.htm. Accessed September 9, 2019.

Illinois Resident Experiencing Respiratory Illness After Vaping Dies. Springfield, Illinois [news release]. Springfield, IL; August 23, 2019: IDPH website. https://www.dph.illinois.gov/news/illinois-resident-experiencing-respiratory-illness-after-vaping-dies. Accessed August 26, 2019.

Sales of JUUL E-cigarettes Skyrocket, Posing Danger to Youth [news release]. Atlanta, GA; October 2, 2018: CDC Newsroom. https://www.cdc.gov/media/releases/2018/p1002-e-Cigarette-sales-danger-youth-html. Accessed October 2, 2018.

Sharpless N. JUUL Labs, Inc. - 509050 - 09/09/2019. Silver Spring, MD; September 9, 2019: FDA website. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/juul-labs-inc-590950-09092019. Accessed September 9, 2019.

The FDA has issued a letter to JUUL Labs Inc, requesting more information about the company's outreach and marketing practices of electronic nicotine delivery systems (ENDS) and related products. The letter specified concerns around marketing targeted at students. The FDA also issued a simultaneous warning letter regarding JUUL's marketing and advertising practices.

FDA Warns E-Cigarette Company of Advertising, Marketing Concerns

Health officials in New Jersey, Michigan, and Massachusetts are warning of mosquitoes carrying Eastern equine encephalitis (EEE), a virus that can potentially cause brain swelling leading to death.

The virus has approximately a 30% mortality rate, and many survivors continue to have neurological problems. Spread by infected mosquitoes, the incubation period ranges from 4 to 10 days, and infection can result in either systemic or encephalitic illness. Symptoms for systemic infection include an abrupt onset of chills, fever, malaise, arthralgia, and myalgia. Symptoms for encephalitic patients include fever, headache, irritability, restlessness, drowsiness, anorexia, vomiting, diarrhea, cyanosis, convulsions, and coma.

Only a few cases are reported each year. The highest number of reported cases in the last decade was in 2012, with 15 reported cases. While there is a vaccine for horses, no human vaccine against EEE currently exists.

The New Jersey Department of Health confirmed the summer&#39;s first case of EEE in August, and urged residents to take precautions against mosquitoes. The statement also urged clinicians to consider patients with compatible symptoms and contact their local health department for testing. Laboratory testing for EEE is currently only available at the State Public Health and Environmental Laboratories.

As of the statement&#39;s release on August 16, EEE was detected in 22 mosquito samples and in 3 horses in the southern and eastern regions of the state.

The Michigan Department of Health quickly released their own statement regarding residents with the virus. According to their statement, 3 cases of EEE are suspected in residents of Kalamazoo and Berrien counties, in southwest Michigan.

"These cases, along with confirmed cases in horses and deer in the state, stress the importance of taking precautions against mosquito bites," said Dr. Mary Grace Stobierski, MDHHS state public health veterinarian, in the Michigan Department of Health&#39;s statement.

As of the statement&#39;s release on August 26, 6 cases of EEE have been confirmed in horses across three southwestern counties. None of those animals were vaccinated against the virus and all have since died.

Massachusetts has also seen more EEE activity than normal, with four reported infections

and one death this month as a result of the virus.

The state has issued an informational alert on their website, which said increased activity of mosquitoes at dusk makes those outside at that time more likely to contract the virus.

All of the states issued similar suggestions to avoid mosquito bites and lower risk of contracting the virus. Using insect repellent, wearing protective clothing, and installing screens on doors and windows can also reduce risk of contraction.

Symptoms & Treatment | Eastern Equine Encephalitis | CDC. Centers for Disease Control and Prevention. https://www.cdc.gov/easternequineencephalitis/tech/symptoms.html.

J Fleming. Department of Health Confirms This Summer&#39;s First Human Case of Eastern Equine Encephalitis. Department of Health | News | Department of Health Confirms This Summer&#39;s First Human Case of Eastern Equine Encephalitis. https://www.nj.gov/health/news/2019/approved/20190816a.shtml. Published August 16, 2019.

MDHHS. MDHHS - Cases of mosquito-borne disease suspected in Michigan residents, Eastern Equine Encephalitis continues to be a threat in Southwest Michigan. https://www.michigan.gov/mdhhs/0,5885,7-339--505643--,00.html. Published August 26, 2019.

EEE in Massachusetts. Mass.gov. https://www.mass.gov/guides/eee-in-massachusetts.

Health officials in New Jersey, Michigan, and Massachusetts are warning of mosquitos carrying Eastern equine encephalitis (EEE), a potentially deadly virus characterized by chills, fever, malaise, arthralgia, and myalgia. 


Eastern Equine Encephalitis Detected in Three States

Researchers in Australia have successfully completed a human trial for a vaccine that could effectively eliminate the risk of severe allergic reactions to European honeybee stings, according to an article published in the

Journal of Allergy and Clinical Immunology.

The trial took place at Flinders University and the Royal Adelaide Hospital, and included 27 adults with a history of allergic reactions to bee stings.

While most people will experience a mild to moderate reaction to a bee sting, including localized redness and swelling, approximately 5 to 7.5% of people will experience a severe allergic reaction to insect stings in their lifetimes.

Bee venom contains proteins that affect the skin cells and immune system, resulting in pain and swelling even if a person is not allergic. In those who are allergic, the venom triggers the immune system to produce Immunoglobulin E, which in the case of a bee sting causes an inappropriate immune response such as hives, swelling, and respiratory problems.

The vaccine itself contains a unique sugar-based ingredient called the Advax adjuvant, which can help the body neutralize the bee venom at a faster rate. According to Professor Nikolai Petrovsky, the Advax adjuvant has now been successfully given to over a thousand individuals across a range of vaccines, including those in the current bee sting allergy trial.

The Advax adjuvant was developed by Vaxine Pty Ltd in Australia, and has already been used to develop vaccines for seasonal and pandemic influenza, hepatitis, malaria, Alzheimers disease, cancer, and other diseases.

Associate professor and lead investigator of the trial Robert Heddle, RAH, said the goal was to see whether or not the adjuvant would safely accelerate and improve bee sting immunotherapy.

"The results of the study were very promising and confirmed the safety of this approach to improving bee sting immunotherapy," Heddle said in a statement.

While a commercial bee venom therapy is already avaialble, it currently requires patients to receive over 50 injections during a 3-year period in order to build up their immune system.

Anthony Smith, MBBS, PhD, FRACP, and an investigator on the trial, said in a statement that he&#39;s hopeful this immunotherapy could transform the venom therapy landscape.

"The current treatment option for serious bee venom allergies is lengthy and cumbersome, so I hope this enhanced bee venom therapy brings about faster but longer lasting protection to bee stings for allergic individuals," Smith said.

Heddle R, Smith A, Woodman R, Hissaria P, et al. Randomized controlled trial demonstrating the benefits of delta inulin adjuvanted immunotherapy in patients with bee venom allergy.

Journal of Allergy and Clinical Immunology

Lillis C. Bee sting allergy: Symptoms, causes, and treatment. Medical News Today. https://www.medicalnewstoday.com/articles/322075.php. Accessed August 19, 2019.

Researchers in Australia have successfully completed a human trial for a vaccine that could effectively eliminate the risk of severe allergic reactions to European honeybee stings. 