BERLIN — The European Medicines Agency said it would convene a meeting on Dec. 29 to decide if there is enough data about the safety and efficacy to approve a COVID-19 vaccine candidate developed by Pfizer and BioNTech.
The agency also said Tuesday it could decide as early as Jan. 12 whether to approve an experimental COVID-19 vaccine developed by Moderna Inc.
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 Moderna and would now assess data on how well the vaccine triggers an immune response and whether it is safe enough for broad use across Europe.
Germany’s science minister, Anja Karliczek, said Tuesday that the same safety standards are being applied in the approval process for coronavirus vaccines as for other drugs, adding that ensuring the same standards is key to gaining the widest possible public acceptance for the COVID-19 vaccine.
Karliczek also said that the vaccine will be voluntary and that authorities will work hard to inform the public about possible side effects that might be excepted 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 that the rapid development of a vaccine was the result of enormous efforts by scientists, early funding and experience from previous vaccines.
