Nov 18 (Reuters) - There are no approved vaccines and
only one drug in the United States for respiratory syncytial
virus (RSV), a common respiratory virus that usually causes
mild, cold-like symptoms but can also lead to serious illness
Sanofi SA and AstraZeneca Plc's drug
nirsevimab recently became the second to get Europe's approval
to prevent RSV infections in infants, after Swedish drugmaker
Orphan Biovitrum's Synagis. Nirsevimab does not have
U.S. approval yet.
There are a handful of companies developing drugs and
vaccines for the infections, some of which could become
available as soon as early next year:
The company is developing an RSV shot for older adults as
well as for infants when given to expectant mothers, and plans
to apply for approval for the maternal vaccine by year-end.
Earlier in November, Pfizer Inc 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. However, the vaccine did not meet the study's second
main goal of preventing less severe respiratory illness.
The vaccine in August was shown to be 85.7% effective in a
different trial among participants aged 60 and above with three
or more symptoms.
GSK Plc's vaccine was 82.6% effective against RSV
infection in a late-stage study involving adults aged 60 and
over, data showed in October.
U.S. and Europe authorities are yet to approve the vaccine.
The U.S. Food and Drug Administration (FDA) is expected to
announce the decision on the vaccine's marketing application by
May next year. If approved, the shot is expected to generate
billions in sales for the British drugmaker.
SANOFI AND ASTRAZENECA
Earlier this month, Sanofi SA and AstraZeneca Plc
gained the European Commission's marketing authorization
for their antibody treatment nirsevimab for preventing disease
caused by RSV in infants.
In March, nirsevimab 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. Monoclonal antibodies
are synthetically manufactured copies of the human body's
natural infection-fighting proteins and are already being used
to treat some types of cancers.
Nirsevimab received a breakthrough therapy designation in
the United States and is under review by the FDA.
JOHNSON & JOHNSON
Johnson & Johnson began a late-stage study of its
RSV vaccine in 2021 for adults aged 60 years and older, with
data expected by the end of this year.
COVID vaccine-maker Moderna Inc began a late-stage
trial of its RSV vaccine earlier this year in people aged 60
years and above, based on messenger RNA (mRNA) technology used
for the development of its coronavirus shot.
Interim data from the study is expected this winter.
Merck & Co Inc is currently conducting a late-stage
study testing its experimental antibody drug clesrovimab to
prevent RSV infections in infants and children. It expects to
complete the trial in 2024.
Denmark-based Bavarian Nordic in April 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; Editing by Devika Syamnath)