Coronavirus Vaccine News: BioNTech and Pfizer Call on Europe to Grant Vaccine for Emergency Use | World News – Times of India

BERLIN: German pharmaceutical company BioNTech and its American partner Pfizer say they have submitted an application for conditional approval of their coronavirus vaccine with the European Medicines Agency.
The two companies said on Tuesday that the submission, which took place on Monday, completes the ongoing review process they launched with the agency on October 6.
The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow emergency use of its Covid-19 vaccine.
BioNTech said that 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 trials with tens of thousands of participants showed the vaccine to have a 95% effectiveness rate. The success rate in particularly vulnerable older groups was over 94%, they said.
BioNTech and Pfizer have already submitted a request for emergency approval to the United States Food and Drug Administration and the UK regulator MHRA, as well as ongoing submissions in other countries including Australia, Canada and the United States. Japan.
“ We have known from the start of this journey that patients are waiting and we are ready to ship doses of the COVID-19 vaccine as soon as potential clearances permit, ” Pfizer chief executive Albert Bourla said in a statement.
Germany’s science minister said on Tuesday that the same safety standards were applied in the approval process for coronavirus vaccines as with other drugs and that this would be the key to achieving the widest possible public acceptance for the COVID vaccination.
Anja Karliczek told reporters in Berlin that the EMA will hold a public hearing on December 11 on BioNTech and Pfizer’s request for approval.
She added that the vaccine will be voluntary and that authorities will work hard to educate the public about possible side effects one might expect after vaccination, such as headache, localized pain and fever.
Marylyn Addo, a doctor at UKE Hospital in Hamburg who is involved in trials of a rival vaccine, said the rapid development of a vaccine was the result of huge efforts by scientists, funding early and experience with previous vaccines.

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