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EU Reg. to Pick Virus Vaccine Dec. 29  12/01 06:18

   The European Medicines Agency will convene a meeting on Dec. 29 to decide if 
there is enough data about the safety and efficacy of the COVID-19 vaccine 
developed by Pfizer and BioNTech for it to be approved, the regulator said 
Tuesday.

   BERLIN (AP) -- The European Medicines Agency will convene a meeting on Dec. 
29 to decide if there is enough data about the safety and efficacy of the 
COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved, the 
regulator said Tuesday.

   The agency also said Tuesday it could decide as early as Jan. 12 whether to 
approve a rival COVID-19 vaccine developed by Moderna Inc.

   The German pharmaceutical company BioNTech and its U.S. partner Pfizer said 
earlier Tuesday that they had asked the regulator for speeded-up, conditional 
approval of their coronavirus vaccine, concluding the rolling review process 
they initiated with the agency on Oct. 6.

   The move comes a day after rival Moderna said it was asking U.S. and 
European regulators to allow the use of its COVID-19 vaccine.

   BioNTech said if the vaccine, currently named BNT162b2, is approved, its use 
in Europe could begin before the end of 2020.T he companies said last month 
that clinical trials with 44,000 participants showed the vaccine is 95% 
effective. The efficacy rate in particularly vulnerable older age groups was 
more than 94%, they said.

   In a statement, the EU medicines regulator said it had already begun a 
"rolling review" of the Moderna vaccine based on laboratory data previously 
submitted by the company and would now assess data on how well that vaccine 
triggers an immune response and whether it is safe enough for broad use across 
Europe.

   The agency said that "if the data are robust enough to conclude on quality, 
safety and effectiveness," then it could approve the Moderna vaccine at a 
meeting scheduled for Jan. 12.

   BioNTech and Pfizer have already submitted a request for emergency approval 
with the U.S. Food and Drug Administration and the U.K. regulator MHRA, as well 
as rolling submissions in other countries including in Australia, Canada and 
Japan.

   "We have known since the beginning of this journey that patients are 
waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential 
authorizations will allow us," Pfizer's chief executive Albert Bourla said in a 
statement.

   BioNTech said it stands ready to ship stockpiles of vaccines where they are 
needed when the Amsterdam-based agency or the FDA approve the vaccine.

   "Depending on how the authorities decide we can start delivering within a 
few hours," said BioNTech's chief operating officer, Sierk Poetting.

   The European Union's top official said around 2 billion doses of potential 
COVID-19 vaccines have been secured for the bloc's 27 nations, with the first 
deliveries likely to start before the end of the year.

   EU Commission President Ursula von der Leyen said EU nations have started 
working on their vaccination plans and on the logistics for delivering tens of 
millions of doses across the bloc, a major challenge for the EU.

   "If everything goes well, the first European citizens might already be 
vaccinated before the end of December," Von der Leyen said. "And it will be a 
huge step forward toward our normal life. In other words, I just wanted to say 
there is a light at the end of the tunnel."

   The Commission, the EU's executive arm, has secured deals allowing to 
purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, 
BioNTech-Pfizer and CureVac.

   Von der Leyen however urged EU citizens to remain "disciplined till we have 
reached finally a vaccination that is appropriate to eradicate this virus."

   Germany's science minister said Tuesday that the same safety standards are 
being applied in the approval process for coronavirus vaccines as for other 
drugs and that this would be key to gaining the widest possible public 
acceptance for COVID immunization.

   Anja Karliczek cited the fact that Europan regulators plan to hold a public 
hearing on Dec. 11 about the approval request by BioNTech and Pfizer.

   Speaking to reporters in Berlin, Karliczek stressed that the vaccine will be 
voluntary and that authorities will work hard to inform the public about 
possible side effects that a small percentage of recipients might experience 
after immunization, such as headaches, exhaustion and fever.

   Marylyn Addo, a doctor at Hamburg's UKE hospital who is involved in the 
trials for a rival vaccine, said the rapid development of a vaccine was the 
result of enormous efforts by scientists, early funding and experience from 
previous vaccines.

 
 
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