Page 26 - rp-may-2020

NEWS ETHICAL 24
RET AIL PHARMA C Y • MA Y 2020
IMMUNISATION PROGRAM EXTENDED TO KIDS UNDER FIVE
Under the 2020 National Immunisation
Program (NIP) more than one million
Australian children aged six months
to five years can now be immunised
against influenza for free.
Dr Sarah Chu, GP at the Turbot Street
Medical Centre in Brisbane, says that
as Australia works to contain and
cope with the COVID-19 pandemic,
the community needs to do all it can
to minimise avoidable hospitalisations,
reduce transmission of flu, and deal
with the “double whammy of infection
with influenza and the coronavirus”.
A nationwide approach to flu
vaccination, she adds, is particularly
important in young children, as they’re
at increased risk of hospitalisation
caused by flu. Last year, in children
under five years, more than 36,570
cases of laboratory-confirmed flu were
reported, with an estimated 5,000
related hospitalisations.
“There’s been a lot of focus on
influenza in older Australians, but
hospitalisation rates in children are
too high for a virus that’s preventable,”
Dr Chu said. “Vaccination remains the
most effective way to protect children
against influenza.”
In previous years, free flu shots under
the NIP were available only to children
at high risk of complications, including
those with underlying health conditions
and children from Aboriginal and Torres
Strait Islander communities.
Since 2018, state and territory
authorities have offered broader
access to the flu vaccine, but despite
their best efforts, only one in four
children aged under five years has
been vaccinated. The extension of the
NIP age range follows a submission
by Sanofi Pasteur, maker of Vaxigrip
Tetra (one of the flu vaccines available
in Australia), to the government’s
advisory committee.
“A national approach to vaccinating
children against influenza is a positive
step for families, the community and
our health system,” Sanofi Pasteur
Australia and New Zealand Medical
Director Dr Christian Felter said.
“We hope the move to a national
influenza vaccination program will
improve immunisation rates in young
children and help reduce the number of
people who contract the virus,” he said.
“This is not the year to be complacent
about the influenza vaccine. It can
protect you, safeguard people around
you and hopefully ease the pressure
on our overburdened medical system.”
COVID-19 VACCINES APPROVED FOR CLINICAL TRIAL
Pfizer and German biotech firm
BioNTech have received regulatory
approval from German authority
Paul-Ehrlich-Institut to begin their first
human clinical trial of four COVID-19
vaccine candidates from a program
named BNT162.
The trial is the first clinical trial of a
COVID-19 vaccine candidate to start
in Germany and is part of a global
development program. Pfizer and
BioNTech will also conduct BNT162
trials in the US on regulatory approval.
The four vaccines are the first
candidates from BioNTech’s COVID-
19-focused project ‘Lightspeed’,
each representing different mRNA
(messenger RNA) formats and
target antigens.
Two of the four include a nucleoside
modified mRNA (modRNA), one
includes a uridine containing mRNA
(uRNA), and the fourth utilises self-
amplifying mRNA (saRNA). Each
mRNA format is combined with a
lipid nanoparticle (LNP) formulation.
The larger spike sequence is included
in two of the vaccine candidates, and
the smaller optimised receptor binding
domain (RBD) from the spike protein is
included in the other two candidates.
The RBD-based candidates contain the
piece of the spike that is thought to be
most important for eliciting antibodies
that can inactivate the virus.
The dose escalation portion of the
phase I/II trial will include about 200
healthy subjects between the ages
of 18 and 55 and will target a dose
range of 1μg to 100μg, aiming to
determine the optimal dose for further
studies as well as evaluate the safety
and immunogenicity of the vaccine.
The study will also evaluate the effects
of repeated immunisation for three
of the four vaccine candidates, which
utilise uRNA or modRNA. Subjects with
a higher risk for a severe COVID-19
infection will be included in the second
part of the study.
“We’re pleased to have completed
preclinical studies in Germany and to
have received this important regulatory
approval to initiate this first-in-human
trial. The speed with which we were
able to move from the start of the
program to regulatory approval to
initiate this first-in-human trial speaks
to the high level of engagement from
everyone involved,” BioNTech CEO
and co-founder Ugur Sahin said.
Pfizer Chair and CEO Albert Bourla
said: “Pfizer and BioNTech’s partnership
has mobilised our collective resources
with extraordinary speed in the face of
this worldwide challenge.
“Now that the work in Germany can
commence, we’re looking forward
to and actively preparing for the
potential start of this unique and
robust clinical study program in the
US in the near future.”
During the clinical development
stage, BioNTech will provide its
partners clinical supply of the vaccine
from its mRNA manufacturing facilities
in Europe.
BioNTech is also collaborating with
China based Fosun Pharma to develop
BNT162 in China, where the companies
expect to conduct trials.