COVID-19 Roundup: Pharmacists Prescribing Paxlovid, Maternal Mortality, Impact of Maternal Vaccination on Infants, COVID and Influenza Vaccination Rates
FDA Authorizes Pharmacists to Prescribe Nirmatrelvir and Ritonavir1
The US Food and Drug Administration (FDA) revised the emergency use authorization (EUA) for nirmatrelvir and ritonavir (paxlovid) to authorize state-licensed pharmacists to prescribe the medication for certain patient populations. Pharmacists should refer patients for clinical evaluation if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function or to assess for a potential drug interaction.
- Modification of other medications is needed because of a potential drug interaction.
- The medication is not an appropriate therapeutic option based on the FDA’s current Fact Sheet for Healthcare Providers or because of potential drug interactions for which recommended monitoring would not be feasible.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” commented Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research.
FDA Authorizes New COVID-19 Vaccine2
The FDA has authorized the use of the Novavax COVID-19 vaccine, adjuvanted, via EUA for use in individuals aged 18 years or older.
The vaccine is administered in a 2-dose primary series. The doses are given 3 weeks apart.
The EUA was based on preliminary results from an ongoing clinical trial that included approximately 17,200 individuals who received the vaccine. The results indicated that the vaccine was 90.4% effective in the prevention of mild, moderate, or severe COVID-19 symptoms. Additionally, the vaccine was 78.6% effective in the subset of patients who were aged 65 years or older.
Spike in All-Cause Maternal Mortality During COVID-19 Pandemic3
Maternal mortality in the United States increased significantly during the COVID-19 pandemic, following an 18.4% increase in US maternal mortality between 2019 and 2020, prior to the pandemic.
The researchers compared maternal mortality rates and percentages with a secondary COVID-19 code by time of death, race and ethnicity, and underlying cause and assessed differences by using a z test of proportions.
They found that 18.8 maternal deaths per 100,000 live births had occurred before the pandemic from 2018 through the first quarter of 2020. In contrast, 25.1 maternal deaths per 100,000 live births had occurred during the pandemic from April 2020 to December 2020. This change in mortality constitutes a relative increase of one-third from the prepandemic to the pandemic period.
Moreover, late maternal mortality increased by 41%, and increases were highest for Hispanic and non-Hispanic Black women. A secondary code for COVID-19 was listed in 15% of maternal deaths in the last 3 quarters of 2020, and this percentage was highest (32%) among Hispanic women.
“In the US, maternal deaths increased substantially (33.3%) after March 2020, corresponding to COVID-19 onset, a figure higher than the 22% overall excess death estimate associated with the pandemic,” the researchers noted. “Change in maternal deaths during the pandemic may involve conditions directly related to COVID-19 (respiratory or viral infection) or conditions exacerbated by COVID-19 or other health care disruptions (diabetes or cardiovascular disease) but could not be discerned from the data.”
Maternal Vaccination Reduced Risk of Hospitalization in Infants4
Maternal vaccination against COVID-19 may reduce the risk of hospitalization and critical illness in infants younger than 6 months of age.
The researchers conducted a case-control study that enrolled 537 infants hospitalized with COVID-19 and 512 infants hospitalized without COVID-19 between July 1, 2021, and March 8, 2022.
They found the following rates of effectiveness of maternal vaccination against hospitalization for COVID-19 in their infants:
- Overall: 52% (95% CI, 33% to 65%)
- During the delta period: 80% (95% CI, 60% to 90%)
- During the omicron period: 38% (95% CI, 8% to 58%)
In addition, overall effectiveness was 38% (95% CI, 3% to 60%) when maternal vaccination occurred during the first 20 weeks of pregnancy but was 69% (95% CI, 50% to 80%) when maternal vaccination occurred after 20 weeks of pregnancy.
Low COVID-19 Vaccination Rates Are Associated With Low Influenza Vaccination Rates5
To better understand the relationship between vaccination against COVID-19 and vaccination against influenza, the researchers calculated the change in influenza vaccine uptake at the statewide level after COVID-19 vaccines became widely available (from September 2021 through January 2022) relative to uptake prepandemic (from September 2019 through January 2020).
They found that influenza vaccine uptake was stable during the first influenza season of the pandemic. However, after COVID-19 vaccines became widely available, adult influenza vaccine uptake decreased in states at the lowest 2 quartiles of COVID-19 vaccine uptake, whereas it increased in states at the top 2 quartiles.
“[O]ur findings suggest that after the widespread availability of COVID-19 vaccines, factors associated with COVID-19 vaccination rates (e.g., safety concerns and mistrust of COVID-19 vaccines or government) may have spilled over to affect influenza vaccination rates,” the researchers concluded.
- U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. News release. US Food and Drug Administration; July 6, 2022. Accessed July 13, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations
- Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 vaccine, adjuvanted. News release. US Food and Drug Administration; July 13, 2022. Accessed July 15, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted
- Thoma ME, Declercq ER. All-cause maternal mortality in the US before vs during the COVID-19 pandemic. JAMA Network Open. 2022;5(6):e2219133. doi:10.1001/jamanetworkopen.2022.19133
- Halasa NB, Olson SM, Staat MA, et al. Maternal vaccination and risk of hospitalization for Covid-19 among infants. N Engl J Med. Published online June 22, 2022. doi:10.1056/NEJMoa2204399
- Leuchter RK, Jackson NJ, Mafi JN, Sarkisian CA. Association between Covid-19 vaccination and influenza vaccination rates. N Engl J Med. 2022;386:2531-2532