studio in Paris on November 16, 2020. (Photo by JOEL SAGET / AFP) /
The EU’s medicines watchdog said on Thursday that it
had brought forward the date for a decision on authorising
Moderna’s coronavirus vaccine by nearly a week to January
6.
The Amsterdam-based European Medicines Agency has been under
growing pressure to speed up, and earlier this week accelerated the
timeframe for Pfizer/BioNTech’s jab.
The EMA had originally been due to decide on US-based Moderna’s
vaccine on January 12, but said the company had submitted extra
data on Thursday “ahead of schedule”.
“Taking due account of the progress made, the Committee has
scheduled an extraordinary meeting on 6 January 2021 to conclude
its assessment, if possible,” the EMA said, referring to the
medicines committee that decides on such issues.
“The meeting planned for 12 January 2021 will be maintained if
needed.”
A clinical trial of 30,400 people found the Moderna vaccine was
94.1 percent effective in preventing Covid-19 compared to a
placebo, performing slightly better in younger adults compared to
the elderly.
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EMA chief Emer Cooke said the under-fire agency had shown it was
able to respond.
“We have been able to revise the timetables for the evaluation
of the Covid-19 vaccines due to the incredible efforts of everybody
involved in these assessments,” Cooke said in a statement.
“The number of infections is increasing across Europe and we are
aware of the huge responsibility we have to get a vaccine to the
market as quickly as is feasible, whilst maintaining the robustness
of our scientific review.”
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With Britain and the United States having pushed through
emergency authorisation of the Pfizer/BioNTech vaccine, the EMA has
been under pressure to speed up, notably from Germany.
The watchdog, which moved from London last year after Brexit,
will decide on a year-long “conditional marketing authorisation”
for Pfizer/BioNTech on Monday, having brought the date forward from
December 29.
Read more https://swordpress.com.ng/2020/12/18/eu-agency-fast-tracks-moderna-vaccine-decision-to-jan-6/