The EUA follows a unanimous recommendation from the FDA’s
Vaccines and Related Biological Products Advisory Committee (VRBPAC) based on
data provided by the Company, including efficacy, safety and immunogenicity
data from its clinical trials and real-world evidence data. When administered
as a primary or booster dose, following initial vaccination with the Company’s
COVID-19 single-shot vaccine, it provided protection against symptomatic
disease and was generally well-tolerated, highlighting the favorable benefit-risk
profile of a booster dose in light of the ongoing pandemic.
“We welcome the FDA’s decision to authorize emergency use of
our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., Vice Chairman of
the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“Our data support a schedule that provides benefit to individuals based on
their risks associated with COVID-19, whether administered as a single dose for
an efficient response to the pandemic, or as a booster dose after at least two months
– to protect against symptomatic COVID-19. We also welcome the FDA’s decision
to include a heterologous boosting option as part of this authorization. The
ability to boost immune responses regardless of the primary vaccine regimen an
individual has received provides more flexibility in protecting those already
immunized, and is very beneficial to global public health as we look to curb
this pandemic.”
“Today’s authorization by the FDA is yet another positive
step toward the goal of curbing the COVID-19 pandemic,” said Mathai Mammen,
M.D., Ph.D., Global Head, Janssen Research & Development, Johnson &
Johnson. “It is now even clearer that Johnson & Johnson’s vaccine booster
can play an important role in maintaining protection against COVID-19. We look forward
to sharing our robust safety, efficacy and immunogenicity data in support of a
booster dose with other regulatory bodies and advisory groups around the world
to address the continued threat of COVID-19.”
“We welcome the FDA’s decision to authorize emergency use of
our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., Vice Chairman of
the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“Our data support a schedule that provides benefit to individuals based on
their risks associated with COVID-19, whether administered as a single dose for
an efficient response to the pandemic, or as a booster dose after at least two
months – to protect against symptomatic COVID-19. We also welcome the FDA’s
decision to include a heterologous boosting option as part of this
authorization. The ability to boost immune responses regardless of the primary
vaccine regimen an individual has received provides more flexibility in
protecting those already immunized, and is very beneficial to global public
health as we look to curb this pandemic.”
“Today’s authorization by the FDA is yet another positive
step toward the goal of curbing the COVID-19 pandemic,” said Mathai Mammen,
M.D., Ph.D., Global Head, Janssen Research & Development, Johnson &
Johnson. “It is now even clearer that Johnson & Johnson’s vaccine booster
can play an important role in maintaining protection against COVID-19. We look
forward to sharing our robust safety, efficacy and immunogenicity data in
support of a booster dose with other regulatory bodies and advisory groups
around the world to address the continued threat of COVID-19.”
A single booster dose of the Johnson & Johnson COVID-19
vaccine may also be administered as a heterologous booster dose following
completion of primary vaccination with another authorized or approved COVID-19
vaccine. The eligible population(s) and dosing interval for the heterologous
booster dose are the same as those authorized for a booster dose of the vaccine
used for primary vaccination.
The Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) will provide a potential
recommendation on October 21.
In the U.S., there is sufficient supply to support boosting
to those who have received the Johnson & Johnson COVID-19 vaccine. More
than 15.2 million doses of the Company’s COVID-19 vaccine have been
administered as primary vaccinations in the U.S.
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