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 systematic review and meta-analysis highlights the deadly impact of infections caused by multidrug-resistant organisms (MDROs) in Latin America and the Caribbean, researchers reported yesterday in Emerging Infectious Diseases.

To assess the lethality of MDRO infections in Latin American and the Caribbean, researchers reviewed studies published from 2000 through March 29, 2022 that estimated the case-fatality rate within 30 days of infection with a drug-resistant organism. Of the 54 studies that met the inclusion criteria, 49 were from Brazil (29), Argentina (8), Colombia (6), and Mexico (6). Of the 49 studies that reported the source of patients, all included hospital patients, 18 consisted of intensive care unit (ICU) patients, 20 included both ICU and non-ICU patients, and 43 included high-risk populations. The most commonly studied MDRO was methicillin-resistant Staphylococcus aureus (MRSA).

The overall unadjusted case-fatality rate related to MDRO infection was 45%, with higher lethality observed among patients infected with MDRO than among patients infected with non-resistant organisms (pooled adjusted odds ratio [OR], 1.93; 95% confidence interval [CI], 1.58 to 2.37). Attributable lethality was two times higher in patients infected with MRSA than with non-MRSA infections, and patients with vancomycin-resistant Enterococcus infections were four times more likely to die than those with vancomycin-susceptible Enterococcus infections.

Higher lethality was also observed in those who did not receive appropriate empirical treatment (OR, 2.27; 95% CI, 1.44 to 3.56) than those who did (OR, 1.59; 95% CI, 0.99 to 2.56).

The study authors say the findings highlight the need for stronger infection-prevention strategies in the region.

"Rather than relying solely on new drug development to address the problem of AMR [antimicrobial resistance], we should focus efforts on preventing the emergence and transmission of these organisms through the One Health initiative, principally in low-income settings," they 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.