Matching articles for "Spikevax"

COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary...
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Oct 31;64(1662):e1-2 | Show Full IntroductionHide Full Introduction

COVID Update: Bivalent Vaccine Booster Doses Authorized for Children ≥5 Years Old (online only)

   
The Medical Letter on Drugs and Therapeutics • October 17, 2022;  (Issue 1661)
The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these...
The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children as young as 5 years old (Pfizer) or 6 years old (Moderna). The bivalent Pfizer vaccine had previously been authorized for use in persons ≥12 years old and the bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for primary immunization against COVID-19. The monovalent Pfizer and Moderna COVID-19 vaccines are no longer authorized for use as booster doses in any age group.
Med Lett Drugs Ther. 2022 Oct 17;64(1661):e1 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization

   
The Medical Letter on Drugs and Therapeutics • October 3, 2022;  (Issue 1660)
The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the...
The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the products as a single booster dose in persons ≥12 years old (Pfizer) or ≥18 years old (Moderna) whose most recent COVID-19 vaccine dose was a monovalent product given ≥2 months previously as a booster or for completion of a primary series. The bivalent formulations are not authorized for primary immunization. Monovalent Pfizer and Moderna COVID-19 vaccines are no longer authorized for use as booster doses in persons ≥12 years old.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):159-60 | Show Full IntroductionHide Full Introduction

COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent...
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured by Johnson & Johnson (Janssen) is available under an EUA for use in adults who are unable or unwilling to receive another COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):121-2 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old

   
The Medical Letter on Drugs and Therapeutics • July 11, 2022;  (Issue 1654)
The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as...
The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.
Med Lett Drugs Ther. 2022 Jul 11;64(1654):110-2 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old

   
The Medical Letter on Drugs and Therapeutics • June 13, 2022;  (Issue 1652)
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who...
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):94 | Show Full IntroductionHide Full Introduction

COVID-19 Update: FDA Narrows EUA for the Johnson & Johnson Vaccine

   
The Medical Letter on Drugs and Therapeutics • June 13, 2022;  (Issue 1652)
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19...
The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.
Med Lett Drugs Ther. 2022 Jun 13;64(1652):94-5 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • April 18, 2022;  (Issue 1648)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose...
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose ≥4 months after a first booster dose in adults ≥50 years old and in persons aged ≥12 years (Pfizer) or ≥18 years (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent.
Med Lett Drugs Ther. 2022 Apr 18;64(1648):63-4 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • March 21, 2022;  (Issue 1646)
The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product...
The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.
Med Lett Drugs Ther. 2022 Mar 21;64(1646):47-8 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):31-2 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • January 24, 2022;  (Issue 1642)
On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody...
On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):16 | Show Full IntroductionHide Full Introduction

In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults

   
The Medical Letter on Drugs and Therapeutics • December 27, 2021;  (Issue 1640)
On November 19, the FDA expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of...
On November 19, the FDA expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a booster dose for all adults ≥18 years old after primary immunization with either the same COVID-19 vaccine or a different one. Booster doses of these vaccines were previously authorized only for select populations (age ≥65 years or persons at high risk for severe COVID-19). The EUA for the adenovirus-based vaccine manufactured by Johnson & Johnson was amended in October 2021 to include administration of a booster dose for all adults ≥18 years old after primary immunization with the Johnson & Johnson vaccine.
Med Lett Drugs Ther. 2021 Dec 27;63(1640):201-2 | Show Full IntroductionHide Full Introduction

Booster Doses of COVID-19 Vaccines

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based vaccine manufactured by Johnson & Johnson/Janssen to include administration of a booster dose in select populations after primary immunization with either the same COVID-19 vaccine or a different one.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):186-8 | Show Full IntroductionHide Full Introduction

Drugs for Rheumatoid Arthritis

   
The Medical Letter on Drugs and Therapeutics • November 15, 2021;  (Issue 1637)
Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were...
Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.
Med Lett Drugs Ther. 2021 Nov 15;63(1637):177-84 | Show Full IntroductionHide Full Introduction

Booster Dose of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)

   
The Medical Letter on Drugs and Therapeutics • October 18, 2021;  (Issue 1635)
On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine...
On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty for all persons ≥16 years old, citing a lack of adequate data.
Med Lett Drugs Ther. 2021 Oct 18;63(1635):161-2 | Show Full IntroductionHide Full Introduction

In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons

   
The Medical Letter on Drugs and Therapeutics • September 20, 2021;  (Issue 1633)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose...
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18 years old (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent (see Table 1).
Med Lett Drugs Ther. 2021 Sep 20;63(1633):145-6 | Show Full IntroductionHide Full Introduction