Washington, October 16: Pfizer Inc, America's leading pharmaceutical giant, is looking forward to file for "emergency use" approval of its COVID-19 vaccine candidate after the presidential elections in the United States. The company has partnered with German drugmaker BioNtech to produce an RNA-based anti-coronavirus vaccine, which is currently in the late-stage trials. COVID-19 Vaccine Development: Major Updates on Oxford-AstraZeneca, Johnson & Johnson, Sputnik V, Bharat Biotech & Sinopharm Candidates.
A letter released by Pfizer CEO Albert Bourla on Friday stated that the emergency use approval from the Food and Drug Administration (FDA) would be sought in third week of November.
The American medicine regulator, as per the guidelines issued to vaccine makers, has said that it would permit the usage of a candidate only after analysing two months of safety data.
Bourla, in his letter that was released on Pfizer website, said the targeted date of filing for regulatory approval may vary, as it depends on whether the data on effectiveness of vaccine would be available by October-end.
"As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates," he said.
If Pfizer succeeds in filing for emergency use approval by third week of November, it would be on the course to emerge as the first drugmaker in the United States to develop a COVID-19 vaccine. It is also possible that the American regulator and health agencies may officially authorise the vaccine for use by the year-end. In that scenario, the roll-out for public use may follow soon.