Published on Dec. 26th, 2021

SARS-CoV-2 is the virus responsible for the COVID-19 global pandemic. Countries are seeing a new surge of the virus due to Omicron variant (B.1.1.529 lineage). The Omicron variant has quickly become the dominant strain.

Vaccines:

COMIRNATY (mRNA vaccine produced by Pfizer/BioNTech)

• COMIRNATY was issued an EUA for the primary vaccine series (two shots given 21 days apart) for ages 5 years to 15 years old.
• COMIRNATY has FDA received FDA approval for individuals 16 years and older to receive the primary series of COVID-19 vaccine (two shots given 21 days apart).
• COMIRNATY was issued an EUA approval for individuals 16 years and older to receive the COVID-19 booster shot (at least 6 months apart after receiving the last dose of the primary series).
• COMIRNATY has been associated with rare cases of myocarditis and pericarditis in males under the age of 30 years after the 2nd The cases of myocarditis and pericarditis have been mild, and the individuals recovered. Long-term data is being collected.
• Preliminary laboratory data shows that 3- doses of COMIRNATY neutralizes the Omicron variant.
• COMIRNATY reduces hospitalization and progression to severe illness due to COVID-19 by 90%.

Spikevax (Moderna mRNA vaccine)

• Moderna’s mRNA vaccine was issued an EUA for the primary vaccine series (two shots given 28 days apart) for ages 18 years and older.
• Moderna’s mRNA vaccine was issued an EUA for booster shots in individuals 18 years and older (at least 6 months apart from the last dose of the primary series).
• Moderna reports the third dose of its mRNA vaccine provides adequate protection against the Omicron variant.
• Moderna’s mRNA vaccine has been associated with rare cases of myocarditis and pericarditis in males under the age of 30 years after the 2nd The cases of myocarditis and pericarditis have been mild, and the individuals recovered. Long-term data is being collected.
• Moderna’s mRNA vaccine reduces hospitalizations and progression to severe illness due to COVID-19 by 90%.

Janssen/Johnson and Johnson viral vector vaccine

• Janssen’s viral vector COVID-19 vaccine was issued an EUA for the primary vaccine series (one shot) for ages 18 years and older.
• Janssen’s COVID-19 vaccine was issued an EUA for the vaccine booster (a second shot given at least 2 months apart of the primary vaccine) for ages 18 years and older.
• There is a plausible causal relationship between Janssen’s COVID-19 vaccine and a rare and serious adverse event due to blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS). This event was rare (rate 7 per 1 million vaccinated women) but occurred mostly in women 18 years to 49 years old. This adverse event was rare in women over 50 years old and men of all ages.
• Janssen continues to research whether its vaccine is effective against the Omicron variant of COVID-19.
• Janssen’s COVID-19 vaccine reduced hospitalizations and progression to severe illness due to COVID-19 by 67%.

Monoclonal Antibodies:

The US FDA has issued EUA for 3 anti-SARS-CoV-2 monoclonal antibody products for the treatment of mild to moderate COVID-19 infection in non-hospitalized patients who are at high risk of progressing to severe disease and/or hospitalization.

• Bamlanivimab plus etesevimab (intravenous infusion): Neutralizing mAbs that bind to different, but overlapping, epitopes in the spike protein RBD of SARS-CoV-2.
• Casirivimab plus imdevimab (Intravenous infusion and subcutaneous injection): Recombinant human mAbs that bind to nonoverlapping epitopes of the spike protein RBD of SARS-CoV-2.
• Sotrovimab (Intravenous infusion): This mAb was originally identified in 2003 from a SARS-CoV survivor. It targets an epitope in the RBD of the spike protein that is conserved between SARS-CoV and SARS-CoV-2

Currently, the distribution of bamlanivimab/etesevimab and casirivimab/imdevimab for the treatment of COVID-19 is paused due to decreased effectiveness against the Omicron variant. However, data shows that sotrovimab is effective against the Omicron variant. The sotrovimab’s availability is limited.

The Alabama Department of Public Health has launched a website to assist individuals in finding locations for COVID-19 vaccines and monoclonal antibody treatment: https://alpublichealth.maps.arcgis.com/apps/MapSeries

Oral Medications:

Molnupiravir- (information adapted from https://www.phe.gov/emergency/events/COVID19/investigation-MCM/molnupiravir)

The U.S. Food and Drug Administration (FDA) has issued an EUA for the emergency use of the unapproved molnupiravir, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. Molnupiravir is not FDA-approved for any use including for use for the treatment of COVID-19.

Molnupiravir is not authorized:

- for use in patients less than 18 years of age

- for initiation of treatment in patients requiring hospitalization due to COVID-19. Benefit of treatment with molnupiravir has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19.

- for use for longer than 5 consecutive days.

- for pre-exposure or post-exposure prophylaxis for prevention of COVID-19

Dosage and Administration of Molnupiravir:

Molnupiravir is given as 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food.

• Take molnupiravir as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset.
• Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2.
• Molnupiravir is not authorized for use for longer than 5 consecutive days because the safety and efficacy have not been established.

Molnupiravir and Potential for Toxicity:

• Embryo-Fetal Toxicity: Molnupiravir is not recommended for use during pregnancy.
• Bone and Cartilage Toxicity: Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth.

Molnupiravir and Drug Interactions:

No drug interactions have been identified based on the limited available data on the emergency use of molnupiravir authorized under this EUA.

Molnupiravir and Use in Specific Populations:

• Pregnancy: The use of molnupiravir is not recommended during pregnancy. Advise individuals of childbearing potential to use effective contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
• Lactation: Breastfeeding is not recommended during treatment and for 4 days after the last dose of molnupiravir. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of molnupiravir

Paxlovid (Nirmatrelvir/ritonavir)

(Information adapted from https://www.covid19oralrx-patient.com)

The U.S. Food and Drug Administration has issued an EUA for the emergency use of the unapproved PAXLOVID which includes nirmatrelvir, a SARS-CoV-2 main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor, for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid and Limitations of Use:

• PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19.
• PAXLOVID is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
• PAXLOVID is not authorized for use longer than 5 consecutive days

Dosage and Administration of Paxlovid:

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. Nirmatrelvir must be co-administered with ritonavir.

• Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
• Administer orally with or without food.
• Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days.
• Dose reduction for moderate renal impairment (eGFR ≥30 to <60 ml/min)
• Paxlovid is not recommended for use in individuals with severe renal impairment (eGFR < 30 ml/min)
• PAXLOVID is not recommend in patients with severe hepatic impairment (Child-Pugh Class C)

Paxlovid and Potential for Drug Interactions:

PAXLOVID (nirmatrelvir co-packaged with ritonavir) is an inhibitor of CYP3A and may increase plasma concentrations of drugs that are primarily metabolized by CYP3A. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated [see Contraindications (4) and Table 1]. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring.

In short, consult your physician or pharmacist prior to use.

Paxlovid and Use in Specific Populations:

• Paxlovid has not been approved for use in pregnancy or lactating women.
• The use of contraception is advised in men and women when taking this medication.
• Paxlovid is not authorized for use in pediatric patients under the age of 12 years old
• Paxlovid is not authorized for use in individuals weighing less than 40 kg/88 pounds.

References:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines

Anti-SARS-CoV-2 Monoclonal Antibodies | COVID-19 Treatment Guidelines (nih.gov)

Comirnaty (Pfizer), Spikevax (Moderna) and cardiac inflammation | Australian Government Department of Health

Monoclonal Antibodies for High-Risk COVID-19 Positive Patients | combatCOVID.hhs.gov

https://www.phe.gov/emergency/events/COVID19/investigation-MCM/molnupiravir