The agency also said Tuesday it could decide as early as
In a statement the EU medicines regulator said it had already begun a “rolling review” of the vaccine based on laboratory data previously submitted by
The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the vaccine at a meeting scheduled for
THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.
The two companies said Tuesday that the submission, which occurred Monday, completes the rolling review process they initiated with the agency on
The move comes a day after rival
The companies said last month that clinical trials with 44,000 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.
“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
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
“Depending on how the authorities decide we can start delivering within a few hours,” said
The
“If everything goes well, the first European citizens might already be vaccinated before the end of December,”
The Commission, the EU’s executive arm, has secured deals allowing to purchase doses with
Karliczek, the German science minister, 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.
Petrequin reported from
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