COVID News: FDA, Moderna, Sanofi, GSK, Pfizer & More
The latest on COVID-19 vaccines/drugs and manufacturing from the FDA, Moderna, Sanofi, GlaxoSmithKline, Pfizer, BioNTech and Daiichi Sankyo. Highlights below.
Updates on COVID-19 Vaccines and Therapeutics
* FDA Commissioner Tests Positive for COVID-19
* Canada OKs Moderna’s Omicron Bivalent COVID Vaccine Booster
* Sanofi, GSK Get EU OK for COVID-19 Vaccine Booster in Adults
* EMA Advisory Committee Recommends Pfizer’s/BioNTech’s Omicron Vaccine Booster
* Moderna Reports Positive Results for Omicron COVID-19 Vaccine Boosters
* Daiichi Sankyo Reports Positive Results for COVID-19 Vaccine Booster
Updates on COVID-19 Vaccines and Therapeutics
FDA Commissioner Tests Positive for COVID-19
The US Food and Drug Administration (FDA) Commissioner Robert M. Califf tested positive for COVID-19 (as reported on November 7, 2022). The FDA reported that he is up to date on vaccines against COVID-19 and is experiencing mild symptoms and is conducting the FDA’s work virtually at home.
Source: US Food and Drug Administration
Canada OKs Moderna’s Omicron Bivalent COVID Vaccine Booster
Health Canada, the national pharmaceutical regulatory agency of Canada, has authorized Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-BA.5), as a booster dose in individuals 18 years of age and older. The booster dose of mRNA-1273.222 includes mRNA encoding for the spike protein of the Omicron BA.4/BA.5 variant and the original strain of the SARS-CoV-2 virus.
mRNA-1273.222 is the second Moderna bivalent COVID-19 vaccine approved by Health Canada, following the approval of mRNA-1273.214 (Spikevax Bivalent), Moderna’s bivalent vaccine booster against Omicron BA.1, in September 2022.
Source: Moderna
Sanofi, GSK Get EU OK for COVID-19 Vaccine Booster in Adults
The European Commission has approved Sanofi’s and GlaxoSmithKline’s protein-based COVID-19 vaccine booster, VidPrevtyn Beta, for the prevention of COVID-19 in adults 18 years of age and older. Designed to provide broad protection against multiple variants, the booster vaccine is based on the Beta variant antigen and includes GSK’s pandemic adjuvant.
The vaccine is indicated as a booster for active immunization against SARS-CoV-2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of the vaccine are ready to be distributed to European countries as per advance purchase agreements (as reported on November 10, 2022).
EMA Advisory Committee Recommends Pfizer’s/BioNTech’s Omicron Vaccine Booster
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Pfizer’s and BioNTech’s booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for marketing authorization in children aged 5 through 11. The European Commission will review the CHMP recommendation and is expected to make a final decision soon (as reported on November 10, 2022).
The vaccine is currently authorized in the EU as a booster dose for individuals aged 12 years and older.
Moderna Reports Positive Results for Omicron COVID-19 Vaccine Boosters
Moderna reports that both of its bivalent Omicron-targeting booster candidates, mRNA-1273.214 and mRNA-1273.222, have shown positive antibody responses against Omicron (BA.4/BA.5) in Phase II/III clinical trials, compared to a booster dose of mRNA-1273, the company’s prototype vaccine.
Source: Moderna
Daiichi Sankyo Reports Positive Results for COVID-19 Vaccine Booster
Daiichi Sankyo reports its COVID-19 mRNA vaccine candidate, DS-5670, has shown positive results in in a Phase I/II/III trials evaluating the efficacy and safety of booster vaccination against COVID-19.
Based on the trial results, Daiichi Sankyo says it will proceed with preparing a new drug application in January 2023. In addition, Daiichi Sankyo is planning to conduct clinical trials of bivalent vaccines of the original strain and Omicron strains against new coronaviruses.
Source: Daiichi Sankyo
