Unprecedented demand for nirsevimab-alip (Beyfortus), the new long-acting monoclonal antibody injection for preventing respiratory syncytial virus (RSV) in newborns, has led to some supply problems, Sanofi said last week in a statement.

Despite an aggressive supply program, demand for Beyfortus has been higher than expected, especially for the 100-mg dose used for babies born before RSV season. Sanofi said it is closely collaborating with the Centers for Disease Control and Prevention (CDC) to ensure doses are equally distributed through the Vaccines for Children (VFC) program. It added that its distribution plan for the private market will be similar and that it is working with AstraZeneca to boost supply.

The American Academy of Pediatrics (AAP) this week said ordering though the VFC program has been put on hold, and the 100-mg formulation is currently not available for ordering through Sanofi. The group added that it has been in touch with the CDC and Sanofi to express concerns about equitable distribution. It said the CDC signaled to state immunization managers that VFC ordering will resume this week with the allocation system in place.

The Food and Drug Administration (FDA) approved the drug in July, and in August the CDC recommended it as a way to protect all newborns and infants entering their first RSV season and for children up to 24 months entering their second season who are at risk for severe disease. Young children are among the groups at greatest risk for severe RSV infection.

Beyfortus is one of two new tools for battling RSV in the youngest children. In August, the FDA approved the use of Pfizer’s new RSV vaccine, called Abrysvo, in pregnant women as a strategy for protecting newborns, and in early September, the CDC’s vaccine advisory group recommended that pregnant women between 32 to 36 weeks' gestation receive the vaccine as a single intramuscular dose.

Another monoclonal antibody, called palivizumab, is available for certain children younger than 2 years old who have underlying conditions such as preterm birth and chronic lung disease that put them at higher risk for severe RSV infection.

Pregnant patients who accepted recommended tetanus, diphtheria, and pertussis (Tdap) and flu vaccines in pregnancy were more likely to also get vaccinated against COVID-19, according to a new study in the Journal of Infection.

Though COVID-19 vaccines are safe and recommended in pregnancy, uptake has been low as vaccine hesitancy and misinformation has overshadowed the use of the vaccines. Several studies have shown the vaccines do not negatively affect pregnancy outcomes or hinder fertility, two claims rampant on social media.

The present study used data from the California Immunization Registry to look at the vaccine history of all pregnant patients who delivered at a single site from December 2020 through March 2022.

According to the authors, of the 7,857 patients who delivered during the study period, 4,410 (56.1%) accepted the COVID-19 vaccine in pregnancy. And of those who accepted the vaccine, 97.6% also received an influenza vaccine in pregnancy, and 88.5% received a Tdap vaccine.

No difference in outcomes

Advanced maternal age, obesity, Asian race, and private insurance were all correlated to COVID-19 vaccine uptake, the authors said. Younger pregnant patients, Black patients, and those on public insurance were less likely to get the vaccine.

Importantly, the study found no difference in pregnancy outcomes among those who did and did not get vaccinated against COVID-19.

There were no differences in preterm birth, low birthweight and NICU admission between patients who received and did not receive the COVID-19 vaccine.

"There were no differences in preterm birth, low birthweight and NICU admission between patients who received and did not receive the COVID-19 vaccine," the authors said. "Efforts to improve vaccination rates for the influenza and Tdap vaccine have the potential to translate to improved vaccination rates for COVID-19."

A new Centers for Disease Control and Prevention-led study finds that people with HIV (PWH) have higher COVID-19 reinfection rates than those without HIV (PWOH).

The study, published yesterday in Emerging Infectious Diseases, involved 453,587 adults in Chicago infected with SARS-CoV-2 from their first infection through May 2022. The investigators matched COVID-19 test results and vaccination data to Chicago's Enhanced HIV/AIDS Reporting System.

"HIV can compromise the immune system; persons with HIV (PWH), especially those not receiving antiretroviral therapy (ART), might be vulnerable to SARS-CoV-2 infection," the researchers wrote. "Understanding how COVID-19 affects PWH is important because approximately half of PWH are >50 years of age and have higher rates of medical comorbidities, compared with persons without HIV (PWOH)." 

6.7% vs 5.2% reinfection rate

A total of 5.3% of the 453,587 COVID-positive residents were reinfected, including 192 of 2,886 (6.7%) PWH and 23,642 of 450,701 (5.2%) PWOH. Reinfection rates among PWH were 66 per 1,000 person-years, compared with 50 of 1,000 person-years among PWOH. PWH had a higher adjusted rate of COVID-19 reinfection (1.46 per 1,000 person-years) than PWOH.

Among reinfected residents, PWH were older (median age, 43 years) than PWOH (36 years). Relative to PWOH, PWH were more likely to be men (79.3% vs 40.9%) and Black (53.7% vs 27.0%) and to have received a primary COVID-19 vaccine series and booster (31.8% vs 22.1%). Of those reinfected, PWH were less likely than PWOH to be unvaccinated at their first infection (87.5% vs 91.0%).

PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections.

Of 131,682 residents vaccinated before their first SARS-CoV-2 infection, 54.2% had completed a primary Pfizer/BioNTech vaccine series. Of 23,834 reinfected residents, 39.6% (9,444 of 23,834) had completed a primary series but had not received a booster before reinfection. 

Regardless of variant wave and calendar quarter, PWH consistently had a higher rate of reinfection than PWOH. The highest incidence for PWH occurred during Omicron strain predominance (50 cases per 1,000 person-years). Overall, an excess of 16 reinfections per 1,000 person-years were reported among PWH.

"PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections," the authors wrote.  

• The Indian Council for Medical Research has confirmed Nipah virus antibodies in 12 bats collected and sampled from a village in Kozhikode district, where the country’s recent outbreak in humans was reported. The results were reported by Kerala state health minister Veena George at a media briefing, Manorama online reported. The outbreak, which began in early September, resulted in six cases, two of them fatal. India has reported two other Nipah virus outbreaks from Kozhikode district in recent years. Fruit bats are known to harbor the virus, which in humans can cause severe infections that have high case-fatality rates of 45% to 75%. There are no specific treatments or vaccines, but development of countermeasures is a high priority for global health groups.
• Pfizer said yesterday that its list price for a 5-day course of Paxlovid once the government supply runs out and the private market takes over will be $1,390 before rebates and other discounts to insurers and pharmacy-benefit managers, Reuters reported. For comparison, the US government paid $530 for a course of Paxlovid, which it has made available to Americans at no cost through the end of the year. The company said the drug will be free for Medicare and Medicaid recipients through 2024, as well as for underinsured and uninsured people through 2028.
• The World Health Organization (WHO) today released an update of its essential diagnostic test list, which adds three tests for hepatitis E. One of them is a rapid test. The WHO said hepatitis E, implicated in outbreaks and sporadic cases, is underreported, and a small proportion of people develop liver failure, especially pregnant women. The WHO said adding the tests will help countries manage outbreaks.