world headquarters in New York is seen on November 9, 2020. –
Pfizer stock surged higher on November 9, 2020 prior to the opening
of Wall Street trading after the company announced its vaccine is
“90 percent effective” against Covid-19 infections. The news
cheered markets worldwide, especially as coronavirus cases are
spiking, forcing millions of people back into lockdown. (Photo by
Kena Betancur / AFP)
The European Medicines Agency is still reviewing the
safety of a Covid-19 vaccine submitted by Pfizer and BionNTech and
has not received clinical trial data, EU sources said
Monday.
A “rolling review” of several potential vaccines is underway
and, for now, Brussels is sticking by its forecast that one may be
approved and available “early next year”, one source said.
Earlier, the companies said that ongoing trials had found that
their vaccine was 90 percent effective in preventing Covid-19
infections, sending hopes soaring for an end to the epidemic.
The European Medicines Agency (EMA) has begun an expedited
procedure to examine potential vaccines, and did nothing to pour
cold water on reports of a breakthrough.
But a spokeswoman for the Amsterdam-based agency said they had
yet to receive the results of clinical trials.
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“Through rolling reviews, EMA can exceptionally evaluate data as
it becomes available, ahead of a formal marketing-authorisation
application,” she said.
“We evaluated the first batch of data on the vaccine, which came
from laboratory studies (non-clinical data).
“The agency is currently assessing a second batch of data which
relate to the quality of the vaccine, including data related to its
ingredients and the way it is produced.
“Any new data available for this vaccine will be reviewed in the
same way. We have not received nor assessed the emerging clinical
data at this point and can therefore not comment further.”
Separately, in Brussels, a European source confirmed this and
added “any prediction would be risky, but we have good indications
that the first vaccine may be available early next year.”
European officials, including the president of the European
Commission Ursula von der Leyen have previously used this timeline
when talking about a future vaccine.
And Brussels has put funding aside to reserve tens of millions
of doses of future vaccines from several companies, including that
from US giant Pfizer and its German partner BioNTech.
AFP
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