Companies say shot, if authorized for use, could be rolled out before end of year; German science minister says safety standards are being maintained
BERLIN Media www.rajawalisiber.com — The German pharmaceutical company BioNTech and its US partner Pfizer say they have submitted an application for conditional approval of their coronavirus vaccine with the European Medicines Agency.
The two companies said Tuesday that the submission, which occurred Monday, completes the rolling review process they initiated with the agency on October 6.
The move comes a day after rival Moderna said it was asking US and European regulators to allow emergency 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.
Israel has ordered millions of units of the vaccine and set up a special storage and distribution center in the south of the country equipped to store the shots in their necessary deep freeze.
The companies said last month that clinical trials with tens of thousands of participants showed the vaccine had an efficacy rate of 95%. The success rate in particularly vulnerable older age groups was more than 94%, they said.
BioNTech and Pfizer have already submitted a request for emergency approval with the US Food and Drug Administration and the UK 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.
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 told reporters in Berlin that the EMA will be holding a public hearing on December 11 on the approval request by BioNTech and Pfizer.
She added that the vaccine will be voluntary and that authorities will work hard to inform the public about possible side effects that might be expected after immunization, such as headaches, localized pain 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.
Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the US.
Israel is reportedly expected to receive up to half a million doses of the Pfizer Inc. vaccine against the coronavirus as early as December, one month earlier than originally hoped for.
As part of the agreement with Pfizer, Israel is to eventually receive 8 million doses of the vaccine, enough to inoculate 4 million Israelis.
Israel is thought to have also purchased 1-2 million doses of the Moderna vaccine as well as negotiated with other companies for rival vaccines.
Israel’s domestically produced coronavirus vaccine will likely be ready for the public by the summer, according to a report earlier this month. However, on Monday, the head of the Defense Ministry’s Institute for Biological Research griped that regulation was slowing down testing on the vaccine that it’s developing.
Health Ministry figures published Tuesday morning showed that 1,227 infections had been diagnosed the previous day, the highest daily number since October 19. It came after the country’s active cases on Monday night went above 10,000 for the first time in a month. Tuesday’s figures put that tally at 10,513, the highest since October 31. The total number of confirmed cases since the pandemic began earlier this year stood at 337,373. The death toll stood at 2,865.