(Reuters) – British drugmaker GSK Plc on Wednesday became the first to receive approval for its respiratory syncytial virus (RSV) vaccine in the United States, putting it ahead of rivals Pfizer Inc, Moderna Inc and Bavarian Nordic.
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.
The following is a list of companies developing drugs and vaccines for the virus:
GSK
U.S. health regulator approved GSK’s RSV vaccine, Arexvy, in May, while Europe’s health regulator recommended authorization for the shot in late April.
The company expects the vaccine to be available before the next RSV season in the United States.
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.
PFIZER
The company is developing an RSV shot for older adults as well as for infants when given to expectant mothers. The FDA is set to decide by this month on the use of its 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.
MODERNA
Moderna’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 its application for U.S. approval of its vaccine, mRNA-1345, in the second quarter of 2023 for those aged 60 and older.
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
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.
BAVARIAN NORDIC
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, Khushi Mandowara and Bhanvi Satija; Editing by Devika Syamnath, Sriraj Kalluvila, Shounak Dasgupta and Maju Samuel)
