The US Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
Pfizer Inc said on Friday it could apply for US emergency use of its COVID-19 vaccine candidate being developed along with Germany’s BioNTech SE as soon as a safety milestone is achieved in the third week of November.
The US Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
Based on current trial enrollment and dosing pace, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in a statement.
Pfizer had said previously that it expected late-stage trial data in October.
Read all the Latest News and Breaking News here
Comments
0 comment