Nina Cosdon

Birth outcomes, cardiovascular outcomes, mental health, and self-rated health were all lower in communities that had higher levels of racism and racial prejudice, according to research published by the American Psychological Association.

 was a systematic literature review that sought to identify any correlation between area-level racial prejudice and health. The investigators stratified the results by race and ethnicity, noting any significant outcomes that merited future study.

The investigators utilized various sources to measure community-level racial prejudice, analyzing data from internet searches, social media, and large-scale surveys. Using 4 interdisciplinary databases, they systematically reviewed 14632 articles, 14 of which met the inclusion criteria and were used in the study. Data extraction followed PRISMA guidelines.

“The majority of research on racial discrimination and health to date has focused on experiences at the individual level, said Amani M. Allen, PhD, MPH, a senior author of the study. “The emerging body of work examined in this review is an important step in going above the level of the individual to capture the context of place and how it may impact the health of people living in those places.”

The 14 papers contained data conglomerated from big-data sources like Google and Twitter. Some of the papers analyzed how often users included a racial slur in their Google searchers, while others monitored tweets that expressed prejudice toward people of color.

Eli Michaels, MPH, the study’s lead author, said, “Racism is gaining recognition as a fundamental driver of health inequities. Leveraging big data to capture area-level racial prejudice is one innovative approach to measuring the overall racial climate in which people live, work, play and pray. The studies included in this review revealed that living in an area with high levels of racial prejudice may harm health and widen racial health inequities.”

After establishing markers of racial prejudice from the 14 papers, the Michaels and his team coded the data by geographic area. They measured area-level racial prejudice health outcomes among residents of those areas.

All of the studies found a correlation between area-level racial prejudice and worsened health outcomes among racial and ethnic minority populations. Specifically, the negative health outcomes were all-cause (n = 4) and cause-specific (n = 4) mortality, birth outcomes (n = 4), cardiovascular outcomes (n = 2), mental health (n = 1), and self-rated health (n = 1). A few of the studies even found areas with more racial prejudice also negatively impacted the health of white residents.

The investigators concluded that people living in communities with more prejudice may experience more stressful and harmful interactions. Racial prejudice may also damage social capital, breaking down mutual reliance in communities and leading to less support for reforms that could enhance an area’s health and wellbeing.

“As we see from this review, living in an environment with an overall climate that is prejudiced against people of color is not only bad for racially marginalized groups, but for everyone. Area-level racial prejudice is a social determinant of population health,” Allen said.

Originally published on our sister brand, 

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All studies included in this research found a correlation between area-level racial prejudice and adverse health outcomes among racial and ethnic minority populations.

Communities with more racial prejudice have worse health outcomes

The Omicron variant led to COVID-19 infections spiking in young children. As such, it is necessary to determine whether children are adequately protected 

The highly infectious Omicron strain has since continued to mutate, retaining its status as the predominant COVID-19 variant. In a study published tonight in 

, investigators determined the real-world effectiveness of the Pfizer-BioNTech (BNT162b2) vaccine against Omicron infection in children 5-11 years of age.

The investigators utilized available data from the largest healthcare organization in Israel. They identified a study cohort of children aged 5-11 years who were vaccinated on or after November 23, 2021. The children were matched with unvaccinated controls to compare vaccine efficacy during the Omicron wave.

After the first and second Pfizer-BioNTech doses, the investigators documented vaccine effectiveness against SARS-CoV-2 infection and symptomatic COVID-19 disease. The study ran until January 7, 2022, after which the cumulative incidence of these 2 outcomes of interest was determined with a Kaplan-Meier estimator. Vaccine effectiveness was calculated as 1 minus the risk ratio, and was also estimated in age subgroups.

A total of 136127 vaccinated children were included in the study cohort, and they were matched with 94728 unvaccinated controls. At 14-27 days after the first dose of Pfizer-BioNTech, estimated vaccine efficacy against documented COVID-19 infection was 17% (95% confidence interval [CI], 7 to 25). A7 7-21 days after the second dose, vaccine efficacy was estimated to be 51% (95% CI, 39 to 61).

Estimated vaccine effectiveness against symptomatic COVID-19 infection was 18% (95% CI, −2 to 34) at 14-27 days after the first dose of Pfizer-BioNTech, and 48% (95% CI, 29 to 63) at 7-21 days after the second dose.

The investigators noted that vaccine efficacy was higher in the younger children, such as those 5-6 and 7-9 years of age. Among the oldest children in the cohort, those 10-11 years, vaccine efficacy was lowest.

This study was conducted right as Omicron was becoming the dominant variant and causing unprecedented rates of COVID-19 in children, including severe and even fatal infection. These findings suggest 2 doses of the Pfizer-BioNTech mRNA vaccine were moderately protective against documented and symptomatic COVID-19 infection in children 5-11 years of age.

More research is certainly merited to determine whether other COVID-19 vaccines or alternative dosages would prove more effective in young children.

In children 5-11 years old, 2 doses of the Pfizer-BioNTech COVID-19 vaccine were moderately effective against documented, symptomatic Omicron infection.

Pfizer-BioNTech vaccine efficacy against Omicron in children 5-11 years

Recently, Verrica Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for VP-102, their molluscum contagiosum treatment.

This is Verrica’s second time filing a New Drug Application (NDA) for VP-102, and their second time receiving a CRL in response to manufacturing concerns.

In the CRL, the FDA cited deficiencies identified at Sterling Pharmaceuticals Services, LLC (Sterling), the contract manufacturing organization that produces VP-102. A pre-approval inspection (PAI) had been conducted at Sterling. Verrica said their NDA review was completed and they were set to be notified of their label, had it not been for Sterling’s Official Action Indicated (OAI) status.

“Based on the successful PAI of VP-102 at Sterling and our understanding that the Division was ready to communicate our label, we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy, or safety of VP-102,” said Ted White, Verrica’s president and CEO.

Verrica had aspired for VP-102 to become the first FDA-authorized treatment for the common and highly contagious skin disease molluscum contagiosum (

). Verrica shared their CRL yesterday, May 25, on what had been their Prescription Drug User Fee Act (PDUFA) target action date.

Molluscum affects approximately 6 million people in the US alone, most of whom are children. Verrica remains hopeful that they can address the manufacturing concerns and “We look forward to potentially bringing treatment and relief to thousands of patients, primarily children, suffering from molluscum, starting with a sales focus in Dermatology, Pediatric Dermatology and key academic centers and health systems,” said Ted White, Verrica president and CEO.

 a Complete Response Letter (CRL) from the FDA on September 16, 2021. The CRL noted the FDA formally delayed consideration of VP-102 due to deficiencies at a Sterling manufacturing facility. The quality issues were not directly connected to VP-102, but the agency wanted additional time to review requested information from Verrica.

“More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls deficiencies related to VP-102,” Verrica said at the time they received notice of the initial delay.

The FDA classified Sterling as Voluntary Action Indicated (VAI) after a facility reinspection on November 17, 2021, leading Verrica to believe no further action or reinspection was required. Thus, Verrica resubmitted an NDA for VP-102 on November 24, 2021.

The resubmission came after positive results from the identical phase 3 randomized, double-blind, multicenter clinical trials, CAMP-1 and CAMP-2. The trials evaluated the safety and efficacy of VP-102 versus placebo in persons diagnosed with molluscum. Of the 500 participants, aged 2 years and older, a clinically and statistically significant number met the primary endpoint of complete clearance of treatable molluscum lesions.

VP-102 was well-tolerated in both trials, treating nearly 8000 lesions with bulk solution manufactured at Sterling. There were no serious adverse events reported, and the dropout rate was under 2%.

VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidin (0.7% w/v). Its single-use applicator enables precise, targeted administration of the topical treatment. If approved, VP-102 would be marketed under the brand name Ycanth.

Molluscum is caused by a pox virus that produces sin-toned-to-pink-colored raised lesions. These bumps can cause pain, inflammation, itching, and bacterial infection. Molluscum is easily transmitted, through both skin-to-skin contact or via objects and surfaces. Without treatment, the infection lasts for an average of 13 months, and in some cases can linger for several years.

In addition to treating molluscum, VP-102 has demonstrated ability to treat common warts and external genital warts in phase 2 studies. Verrica is also developing its second cantharidin-based product, VP-103, to treat plantar warts.

Verrica is reportedly working with Sterling to present multiple options to satisfy the deficiencies to the FDA. At the same time, Verrica is recruiting an additional contract manufacturing organization to serve as an alternative supplier of VP-102.

“Verrica is extremely disappointed in the Agency’s issuance of the CRL under the totality of these circumstances,” White said. “However, as Verrica weighs all its options to bring the first FDA-approved treatment for molluscum, one of the largest unmet needs in dermatology, to the market as soon as possible, it will continue to work collaboratively with the Agency.” Verrica is planning to file a Type A meeting request by the end of this week.

Verrica received a Complete Response Letter from the FDA regarding their New Drug Application for the topical molluscum contagiosum treatment, VP-102.

FDA Cites Manufacturing Deficiencies in Second Complete Response Letter for Verrica’s VP-102

 diagnostic tests, once a luxury at the beginning of the pandemic, are thankfully now more accessible in the US. Naso-pharyngeal RT-PCR tests are highly accurate, but for rapid results at home, some opt for rapid lateral flow antigen tests.

The need for inexpensive, reliable, rapid 

 is augmented by the relatively large proportion of children who are unvaccinated. One study, presented at this week’s 40th Annual Meeting of the European Society for Pediatric Infectious Diseases (

), assessed the performance of the “COVID-VIRO ALL IN” COVID-19 rapid test in children.

This cross-sectional, prospective, multicenter, real-life study was conducted from September 1, 2021-January 3, 2022. Children 0-15 years old were recruited after presenting to emergency departments and ambulatory settings. The children were either symptomatic for COVID-19 or had been exposed to an infected person.

All children were given a SARS-CoV-2 RT-PCR or rapid antigen test, and a self-test. Above the age of 6, the children could easily perform the self-tests themselves, whereas younger children required the help of a parent or other adult.

The COVID-VIRO ALL IN (AAZ-LMB, Boulogne Billancourt, France) test was used for this study, due to its short sampling device and soft sponge swab. The comfort of use allowed for long sampling (15 seconds per nostril). The investigators compared self-collected nasal swabs to RT-PCR tests, estimating the accuracy and acceptance of these tests for pediatric populations.

A total of 836 pediatric patients, aged an average of 4 years, completed the COVID-19 diagnostic tests. A total of 92.6% of the children were symptomatic, and the prevalence of COVID-19 was 18.4%.

In comparison to the RT-PCR test, the sensitivity of the self-collected nasal swab test was 72.6% during the period when the Delta variant was predominant, and 87.0% during the Omicron wave.

False negative self-tests were largely aligned with low viral loads. Low viral load was established by RT-PCR with a cycle threshold ≥33 and/or a SARS-CoV-2 rapid antigen test positive in more than 3 minutes. The youngest child confirmed positive with a self-test was 1 month old.

On a scale from 1-10, with 1 being “very pleasant” and 10 being “very unpleasant,” 77.9% of children rated the test ≤ 3.

The investigators concluded that the nasal self-test used in this study was reliable, particularly in more contagious children. They noted that it is vital to provide highly accurate tests that are less invasive and unpleasant to encourage families to test their children for COVID-19.

This study, “Diagnostic Accuracy of SARS-CoV-2 Antigen Detection Self-Test in Children: Vigil Study 3,” was presented during the 

40th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID)

, held online and in Athens, Greece from May 9-13, 2022.

A comparison of COVID-19 PCR tests and rapid self-tests found self-tests to be highly accurate and user-friendly for children.

Self-tests for COVID-19 are accurate and tolerable for children

 vertically (from their mothers) has not been thoroughly evaluated. One study, presented at this week’s 40th Annual Meeting of the European Society for Pediatric Infectious Diseases (

 neutralizing antibody titers against the Delta and Omicron variants in children with vertically transmitted HIV infection. The children received the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and were monitored through the Pediatric Infectious Disease Unit at the Luigi Sacco Hospital in Milan, Italy.

The primary study cohort included 22 children with vertically transmitted HIV infection. The children were simultaneously undergoing antiretroviral therapy (ART).

Neutralizing antibody titers were assessed at 1 day before vaccination (T0), 25 days after the second vaccine dose (T1), and 6 months after the second dose (T2). After 6 months, antibody titers were compared to an age-matched cohort of 20 Pfizer-vaccinated, HIV-negative children.

Among the children living with HIV, the percentage of waning neutralizing antibody titers from T1 to T2 was 87.5% during Omicron and 82% during Delta. Notably, Delta displayed a moderate immune escape; Omicron titers were 456 during T1 while Delta titers were 144.

The pediatric HIV patients who had a previous COVID-19 infection had higher levels of neutralizing antibody titers during T1 and T2, and their titers dropped less than those with no COVID-19 infection history. There was no significant difference between the pediatric cohorts with and without vertically transmitted HIV.

The investigators concluded that Pfizer-BioNTech mRNA vaccination had a high immunogenicity profile for children living with HIV. They noted that neutralizing antibody titers are considered representative of COVID-19 protection, concluding by recommending a booster vaccine to maintain high levels of protection.

This study, “Humoral Immune Response in SARS-CoV-2 Vaccinated HIV-Vertically Transmitted Patients,” was presented during the

Children living with HIV had a similar immune response to mRNA COVID-19 vaccination as children without HIV.



COVID-19 vaccine immune response in children with HIV

Pregnant women and their newborns are at increased risk of severe or fatal 

 disease. To prevent this, the US Centers for Disease Control and Prevention (CDC) 

 expecting mothers to receive a COVID-19 vaccine. There has been a great deal of research establishing that 

 is safe and effective for pregnant women and their unborn babies.

However, there has not been extensive research on how COVID-19 vaccination during different gestational periods affects autoimmune response. One study, presented during this week’s 40th Annual Meeting of the European Society for Pediatric Infectious Diseases (

), analyzed whether there was a correlation between gestational age at vaccination and antibody titer at birth.

The investigators recruited 84 new mothers at the Niguarda Hospital of Milan, Italy from May-November 2021. While pregnant, the women had received either the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine. Of the 84 women, 62 received 2 vaccine doses, while 22 just received 1 dose.

To evaluate serological IgG antibodies anti-S1 RBD, the investigators collected blood samples from the mothers and babies. They also gathered information about the type and timing of COVID-19 vaccination.

Among women who received 1 vaccine dose, the geometric mean titer (GMT) of anti-S IgG was 571.8 (7.4) AU/ml for the mothers and 329.2 (7.6) AU/ml for their babies. Of the mothers who received 2 doses of a COVID-19 vaccine, GMT was 5480.5 AU/ml for mothers and 6271.7 AU/ml for their babies.

Among the mothers who received 2 vaccine doses, the higher the gestational age at last vaccination, the higher the serological titers of the infants at birth.

The investigators concluded that mothers who received 2 doses of an mRNA vaccine passed antibody titer equal to or higher than their own to their babies.

These results imply that expecting mothers wishing to protect their newborns against COVID-19 infection may want to consider getting vaccinated later in their pregnancy.

This study, “Antibody Response Evaluation in SARS-CoV-2 Immunized Mothers and Babies at Birth,” was presented during the 

The higher the gestational age when pregnant women received a COVID-19 vaccine, the higher the serological titers at birth.