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 The news came as the French and British partners said preliminary
data from trials showed the single-dose booster provided strong
immune responses.
The companies said they need more time to test the booster on more
people who have not been infected by the virus before they can
submit data to regulators.
The Phase III trial for the recombinant adjuvanted COVID-19 vaccine
recruited most participants in the third quarter, coinciding with a
significant increase in the number of people infected globally due
to the Delta variant, it said.
"To provide the necessary data to regulatory authorities for the
booster vaccine submission, the trial will continue to accrue the
number of events needed for analysis, with results expected in Q1,
2022."
No safety concerns were identified.
This is the latest delay for the vaccine's development, putting the
companies further behind rivals in the race for COVID-19 shots.
(For a Reuters' vaccine tracker graphic, see https://tmsnrt.rs/3GLZEWI)
They were forced to start a new clinical trial of the vaccine
candidate after trials last year showed an insufficient immune
response in older people.
In May, the companies had said the vaccine could be approved by the
year-end after initially targeting the first half of the year.
Sanofi's shares in Paris were down 0.4%, while GSK in London was
down 0.3% by 0921 GMT.
Jefferies said the initial data was encouraging, but noted the delay
to the trial results.
"Vaccine sales would be almost entirely upside to current
(consensus), so no change to estimates likely, but success could be
a welcome boost to narrative," they said in a note.
The protein-based vaccine uses the same technology as one of
Sanofi's seasonal influenza vaccines coupled with an adjuvant, a
substance that acts as a booster to the shot, made by GSK.
At the end of September, Sanofi dropped its plans for its own
mRNA-based COVID-19 vaccine because of the dominance achieved by
BioNTech-Pfizer and Moderna in using the technology to fight the
pandemic. [L1N2QU0BI]
[to top of second column] |
 BOOSTER SHOT
"The booster was well tolerated, with a safety
profile similar to currently approved COVID-19
vaccines. This is the most comprehensive booster
trial to date to explore boosting across
different vaccine technologies used for primary
vaccination", the companies said in a statement.
The booster shot has been tested for all age
groups and for people who have received four of
the most widely approved shots - AstraZeneca,
Johnson & Johnson, Moderna and Pfizer/BioNTech -
as part of their primary vaccine.
It was administered between four and ten months
after a complete primary vaccination schedule.
The Omicron variant was not circulating during
the trial. "Preliminary results
from the VAT0002 clinical trial investigating the safety and
immunogenicity of the booster showed neutralizing antibodies
increased nine to 43-fold regardless of the primary vaccine received
(AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for
all age groups tested", Sanofi said.
The company said this was the most "comprehensive" booster trial to
date as European countries grapple with a new wave of COVID-19
infections fuelled by the Delta variant of the virus and are gearing
up for the new more contagious Omicron variant.
Sanofi also it was continuing "its contribution to global public
health needs" with the manufacturing of up to half a billion doses
from BioNTech/Pfizer, Moderna, and Johnson & Johnson vaccines.
(Reporting by Benoit Van Overstraeten; Additional reporting by
Silvia Aloisi; Writing by Josephine Mason; Editing by Tom Hogue and
Louise Heavens)
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