This University of Maryland School of Medicine file photo dated May 4, 2020 shows the first patient to participate in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine, Baltimore. The German pharmaceutical company BioNTech and its US partner Pfizer have submitted an application to the European Medicines Agency for conditional approval of their coronavirus vaccine. (Courtesy University of Maryland School of Medicine via AP, file)
The German pharmaceutical company BioNTech and its US partner Pfizer have submitted an application to the European Medicines Agency for conditional approval of their coronavirus vaccine.
The two companies announced on Tuesday that the filing on Monday would complete the rolling review process they initiated with the agency on October 6.
The move comes a day after rival Moderna asked U.S. and European regulators to approve the use of its COVID-19 vaccine in an emergency.
BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.
The companies said last month that clinical studies involving tens of thousands of participants showed the vaccine had a 95% effectiveness rate. The success rate in particularly vulnerable older age groups was over 94%.
BioNTech and Pfizer have previously filed an emergency authorization application with the US Food and Drug Administration and UK regulatory agency MHRA, as well as ongoing applications in other countries including Australia, Canada and Japan.
“We have known since the beginning of this journey that patients are waiting and we are ready to ship COVID-19 vaccine doses as soon as possible approvals allow us,” said Albert Bourla, Pfizer chief executive officer, in a statement.
The German science minister said on Tuesday that the same safety standards are used in the approval process for coronavirus vaccines as for other drugs, and that this would be the key to achieving the broadest possible public acceptance for COVID immunization.
Anja Karliczek told reporters in Berlin that the EMA would hold a public hearing on December 11th on BioNTech and Pfizer’s application for approval.
She added that the vaccine will be voluntary and that authorities will work hard to educate the public about possible side effects to be expected after immunization, such as headache, localized pain and fever.
Marylyn Addo, a doctor at Hamburg’s UKE Hospital who is involved in trials for a competing vaccine, said the rapid development of a vaccine was the result of tremendous efforts by scientists, early funding and experience from previous vaccines.
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