The announcement is a huge setback in efforts to fight the
pandemic, which first emerged in China last December and has killed over 1.5
million people worldwide.
Sanofi and GSK said the delay in their adjuvanted
recombinant protein-based COVID-19 vaccine programme was to “improve immune
response in older adults.”
The vaccine’s potential availability had been pushed back
“from mid-2021 to Q4 2021,” they said in a statement.
American pharmaceutical giant Pfizer and its German partner
BioNTech have said their vaccine had proven 90 percent effective in preventing
Covid-19 infections in ongoing Phase 3 trials involving more than 40,000
people.
US experts voted Thursday to recommend granting emergency
approval for the Pfizer-BioNTech vaccine, paving the way for America to become
the next country to move ahead with mass immunisation after the UK. Canada,
Bahrain and Saudi Arabia have also approved it.
The Sanofi-GSK candidate is based on technology that Sanofi
has used to produce seasonal influenza vaccines and on immunological agents
developed by GSK.
“Phase 1/2 study interim results showed an immune response
comparable to patients who recovered from COVID-19 in adults aged 18 to 49
years, but a low immune response in older adults likely due to an insufficient
concentration of the antigen,” the statement said.
It said a recent study in non-human primates using an
improved antigen formulation demonstrated that the candidate could “protect
against lung pathology and lead to rapid viral clearance from the nasal
passages and lungs, within 2 to 4 days.”
“These results increase the companies’ confidence in the
capacity of the adjuvanted recombinant platform to deliver a highly efficient
vaccine for all adults,” it said.
The hunt for a vaccine brings up questions like whether
unexpected safety issues may arise when the number of people vaccinated grows
to millions and possibly billions of people.
– ‘More than one vaccine needed’ -Also unknown is whether
more side effects will emerge, how long the vaccine remains effective, whether
it will limit transmission and how it will work in children, pregnant women,
and immunocompromised patients.
“We care greatly about public health which is why we are
disappointed by the delay announced today, but all our decisions are and will
always be driven by science and data,” said Thomas Triomphe, Executive Vice
President and Head of Sanofi Pasteur.
“We have identified the path forward and remain confident
and committed to bringing a safe and efficacious COVID-19 vaccine,” he said.
“There is no question of abandoning the vaccine,” he told
AFP.
Both Russia and China have already begun inoculation
campaigns with domestically produced vaccines despite far less vetting, while
several other vaccines are being developed in the West.
Japan has formalised a deal with UK drugmaker AstraZeneca to
receive 120 million doses of its coronavirus vaccines, the health ministry said
Friday.
Tokyo has also secured Covid-19 vaccines for 60 million
people from pharmaceutical giant Pfizer, and for a further 25 million people
from biotech firm Moderna. Vaccination could start as early as March 2021,
Kyodo News agency reported this week.
“No single pharma company can make it alone; the world needs
more than one vaccine to fight the pandemic,” Triomphe said.
Roger Connor, President of GSK Vaccines added: “The results
of the study are not as we hoped. Based on previous experience and other
collaborations, we are confident that GSK’s pandemic adjuvant system, when
coupled with a COVID-19 antigen, can elicit a robust immune response.”
The companies plan a Phase 2b study expected to start in
February. If the data is positive, a global Phase 3 study could start in the
second quarter of next year.
“Positive results from this study would lead to regulatory
submissions in the second half of 2021, hence delaying the vaccine’s potential
availability from mid-2021 to Q4 2021,” the statement said.
AFP