12/01/2020 7:37 AM
Updated 12/01/2020 8:52 AM
A day after its competitor, Moderna, German pharmaceutical company
and its American partner Pfizer applied to the European Medicines Agency (EMA) for
of their vaccine against the new coronavirus, the companies announced Tuesday.
The two companies indicated Tuesday that the application, filed Monday, completed the review process started with the agency on October 6.
Rival Moderna had indicated the day before that it had requested the emergency use of its COVID-19 vaccine to regulatory authorities in the United States and the European Union.
If the BioNTech vaccine, which now goes by the name
, it could begin to be used in Europe before the end of 2020, according to the company.
If the BioNTech vaccine, which now goes by the name BNT162b2, is licensed, it could start to be used in Europe before the end of 2020. Photo: AFP
"If the EMA decides that the benefits of the candidate vaccine
outweigh its risks
in protecting against covid-19, it will recommend that it be granted a CMA (conditional authorization to be placed on the market,
) that could potentially allow the use of BNT162b2 in Europe before the end of 2020, "it said in a statement.
In fact, the European Medicines Agency already began on Tuesday to
evaluate the requests
for "conditional" use of the vaccines against Covid-19 developed by the pharmaceutical company Moderna, as well as the one presented by Pfizer and BionNtech.
The study of these applications will take several weeks and the authorization is not expected to be confirmed or rejected
until the end of this month
"at least", due to the time it takes to
study all the documentation
submitted by the pharmaceutical companies that seek to market their vaccine in the EU. .
A week ago, Pfizer and BioNtech had requested an emergency authorization for their vaccine from the US health authorities, where the competent body (the Food and Drug Administration, FDA, in English)
will meet on December 10
to decide on the request.
The distribution and application of the vaccine will imply
a logistical challenge
since it has to be kept at a temperature of minus 70 degrees Celsius and in order to guarantee this, Pfizer and BionTech have developed a transport system with
their own refrigerators.
The Pfizer and BioNtech vaccine, in the third phase of clinical studies, showed
95 percent effectiveness
and has to be applied in two doses to offer protection against the coronavirus.
Before knowing the announcement of the companies, the German Minister for Research, Anja Karliczek, indicated that "vaccines from different laboratories will be needed" and warned that the authorization process is not only about evaluating their effectiveness, but also that it will
not present adverse side
effects, that it will be safe and accessible for everyone.
Source: AP, EFE and AFP
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