Pfizer-BioNTech also revealed that they submitted an amended protocol to the US FDA seeking approval for expanding the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. Sources told Reuters that enrollment of new patients and other trial procedures for the pivotal United States trial were being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.
From the ramparts of Red Fort, he had said three vaccines were in different stages of testing, and the plan for production was ready.
"Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, now plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021", the companies had said in a statement earlier this week.
The university said in large trials such as this "it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety".
Sinopharm said in July that its vaccine could be ready for public use by the end of this year after the conclusion of Phase 3 trials. "Hopefully they'll work it out and be able to proceed along with the remainder of the trial".
Russian Federation has said that over one billion people would receive its vaccine in 2020-21. Brazil has approved restarting the trials and the Serum Institute of India is awaiting permission from the Drugs Controller General of India. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
Pauses in drug trials are commonplace but the temporary hold led to a sharp fall in AstraZeneca's share price following the announcement Tuesday.
The firm said it expects to begin trials of the two-dose vaccine in December. The World Health Organization (WHO) had flagged AstraZeneca's as the most promising.