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Coronavirus vaccine: Pfizer and BioNTech ask the European Union to authorize the sale

2020-12-01T22:19:59.279Z

If approved, it could start to be used in Europe before the end of 2020, the labs reported.12/01/2020 7:37 AM Clarín.com World Updated 12/01/2020 8:52 AM A day after its competitor, Moderna, German pharmaceutical company BioNTech and its American partner Pfizer applied to the European Medicines Agency (EMA) for conditional approval of their vaccine against the new coronavirus, the companies announced Tuesday. The two companies indicated Tuesday that the application, filed Monday, comp



12/01/2020 7:37 AM

  • Clarín.com

  • World

Updated 12/01/2020 8:52 AM

A day after its competitor, Moderna, German pharmaceutical company

BioNTech

and its American partner Pfizer applied to the European Medicines Agency (EMA) for

conditional approval

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

BNT162b2

, is

licensed

, 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,

ndlr

) 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

ap

Look also

The appearance of the vaccine will not stop the evolution of the coronavirus

Moderna calls on US and European regulators to urgently approve its coronavirus vaccine

Source: clarin

All news articles on 2020-12-01

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