(Reuters) – Drugmakers Pfizer Inc and GSK are close to bringing the first two vaccines for respiratory syncytial virus (RSV) to the United States after gaining the backing of a panel of advisers to the U.S. Food and Drug Administration (FDA). RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can […]
Factbox-First RSV vaccines inch closer to the finish line
(Reuters) – Drugmakers Pfizer Inc and GSK are close to bringing the first two vaccines for respiratory syncytial virus (RSV) to the United States after gaining the backing of a panel of advisers to the U.S. Food and Drug Administration (FDA).
RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. The market for its vaccines could exceed $10 billion by 2030, analysts have said.
Johnson & Johnson said on Wednesday it will discontinue the late-stage study for its adult RSV vaccine candidate.
The following is a list of companies developing drugs and vaccines for the virus:
The company is developing a RSV shot for older adults as well as for infants when given to expectant mothers. The FDA is set to decide by May this year on the RSV vaccines for adults.
In November last year, Pfizer reported that its RSV vaccine was 81.8% effective in a late-stage study in preventing severe infections in infants when given to expectant mothers.
The vaccine was shown to be 66.7% effective in August in a different trial among participants aged 60 and above with two or more symptoms.
The company expects to launch its RSV vaccine in the U.S. this year.
GSK’s vaccine was 82.6% effective against RSV infections in a late-stage study involving adults aged 60 and over, data showed in October last year.
U.S. and European authorities are yet to approve the vaccine.
Moderna Inc’s experimental messenger RNA vaccine for RSV was 83.7% effective in a late-stage trial at preventing at least two symptoms, such as cough and fever, in adults aged 60 and older.
The company plans to submit the vaccine, mRNA-1345, for approval consideration globally in the first half of 2023.
SANOFI AND ASTRAZENECA
In November last year, Sanofi and AstraZeneca gained the European Commission’s marketing authorization for their antibody drug nirsevimab to prevent RSV-related disease in infants.
Nirsevimab in March last year showed an efficacy of 74.5% against some types of lower respiratory tract infections, compared with a placebo in infants in a late-stage study.
It is under review by the FDA.
Merck & Co Inc is conducting a late-stage study of its experimental antibody drug clesrovimab to prevent RSV infections in infants and children, with the trial expected to be completed in 2024.
Denmark-based Bavarian Nordic in April last year began a late-stage trial for its RSV vaccine in volunteers aged 60 years and older. Study results are expected by mid-2023.
(Reporting by Raghav Mahobe and Nandhini Srinivasan in Bengaluru; Additional reporting by Mariam Sunny and Khushi Mandowara; Editing by Devika Syamnath, Sriraj Kalluvila and Shounak Dasgupta)
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