More than 280.4 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of last Monday evening, January 3, 2022, including more than 5.41 million deaths. Healthcare officials in the United States have reported more than 53.2 million positive COVID-19 cases and more than 837,000 deaths. Source: www.worldometers.info/coronavirus
More than 8.81 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday afternoon, including at least 495 million in the United States. Source: GitHub
Pfizer and Merck antivirals receive Emergency Use Authorizations
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for novel COVID-19 oral antiviral treatments manufactured by Pfizer and Merck.
Pfizer’s PAXLOVID™ (nirmatrelvir and ritonavir tablets), an at-home therapy, is indicated for mild-to-moderate disease in adults and pediatric patients who are at least 12 years old and weighing at least 88 pounds who have tested positive and are at high risk for severe disease. The EUA is effective as of Dec. 22, according to Pfizer officials.
The treatment includes nirmatrelvir, a novel main protease inhibitor that was specifically designed to block the activity of the SARS-CoV-2 main protease, an enzyme that allows coronavirus to replicate.
“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths, and can be taken at home, will change the way we treat COVID-19 and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, chairman and chief executive officer at Pfizer.
The FDA reportedly based its decision on clinical data from a Phase 2/3 trial involving non-hospitalized adults ages 18 and older at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in the risk of COVID-related hospitalization or death from any cause in adults treated with PAXLOVID within three days of symptom onset compared to placebo.
No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28, according to Pfizer officials. Similar results were seen in those treated within five days of symptom onset, with an 88% reduction in risk and no deaths observed in the treatment group.
Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild. While PAXLOVID clinical trials did not include patients younger than age 18, the authorized adult dosing regimen is expected to result in comparable blood concentration levels of PAXLOVID in EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) pediatric patients approved for treatment by the EUA.
Additional trials are ongoing in adults at standard risk of disease progression and in those who have been exposed to the virus through household contacts.
Pfizer has also submitted applications for regulatory approval or authorization to other global regulatory agencies and anticipates further regulatory decisions to follow, officials said. The company also plans to file a New Drug Application (NDA) with the FDA in 2022 for potential full regulatory approval.
More information can be found online.
According to a recent report from NBC Health, the pills could pose risks when used with other medications.
Merck’s molnupiravir is authorized to treat mild-to-moderate disease in adults who test positive and who are at high risk for severe disease, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate, according to officials with Merck and Ridgeback Biotherapeutics, two companies that have collaborated on COVID-19 treatments.
Molnupiravir should be administered as soon as possible after diagnosis and within five days of symptom onset. The recommended dose is 800 mg taken every 12 hours for five days, with or without food. Completion of the full five-day treatment course is important to maximize viral clearance and minimize transmission. Molnupiravir is not recommended for use in pregnant patients and it should be assessed whether an individual of childbearing potential is pregnant before initiating treatment.
The authorization is based on a Phase 3 trial that evaluated non-hospitalized adult patients who were unvaccinated with at least one risk factor associated with poor disease outcomes. In analyses from all randomized patients, molnupiravir reduced the risk of hospitalization or death. 9.7% of patients in the placebo group were hospitalized or died compared to 6.8% of patients who received molnupiravir. Nine deaths were reported in the placebo group while one was reported in the molnupiravir group.
The determination of primary efficacy was based on a planned interim analysis of 762 subjects. In the interim analysis, treatment with molnupiravir significantly reduced hospitalizations and death through Day 29 following randomization: 14.1% of patients in the placebo group were hospitalized or died compared to 7.3% of patients who received molnupiravir.
The most common adverse reactions for molnupiravir in the clinical study (incidence ≥1%) were diarrhea (2% for molnupiravir, 2% for placebo), nausea (1% for molnupiravir, 1% for placebo), and dizziness (1% for molnupiravir, 1% for placebo). Discontinuation of study intervention due to an adverse event occurred in 1% of subjects receiving molnupiravir and 3% of subjects receiving placebo. Serious events occurred in 7% of subjects receiving molnupiravir and 10% receiving placebo; most serious events were COVID-19 related.
More information can be found online.
CDC initiates new guidance for face masks
With the ongoing increase of COVID-19 infections due to the Omicron variant, officials with the U.S. Centers For Disease Control and Prevention (CDC) are stressing the need for more specific masking guidelines.
Patients should be instructed to assess if their masks meet the specifications set by the American Society for Testing and Materials (ASTM). The CDC also supports guidelines from the National Institute for Occupational Safety and Health (NIOSH), specifically for use in the workplace.
Some general specifics include:
- A filtration efficiency of at least 50%
- Breathability standards
- A leakage ratio of 5 or higher
Workplace specifics include:
- At least 80% filtration efficiency
- Breathability standards
- A leakage ratio of 10 or greater
The CDC offers a list of masks approved by the NIOSH online.