"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. Being alert to potential adverse reactions with any new vaccine is part of the process, he explained. "I still don't see a proper plan on paper to do that [in India] beyond 400 million doses.you don't want a situation with the vaccine where you have capacity for your country but you can't consume it", he told the paper.
The episode shows that care is being taken with the trial, they say.
Oxford said that globally some 18,000 people have received its vaccine so far. Brazil has approved restarting the trials and the Serum Institute of India is awaiting permission from the Drugs Controller General of India. But these trials have already resumed in Britain. Massachusetts-based Moderna and British drugmaker AstraZeneca are among the other candidates that have started late stage Phase III trials.
The Oxford-AstraZeneca study had previously been stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine. Due to their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. "And that's assuming that these vaccines are demonstrated to be safe and effective in these large trials".
Fox News medical contributor Dr. Marc Siegel said Monday that the common flu, unlike coronavirus, is a "moving target" that often changes form from year to year, while COVID-19 is more static. The World Health Organization (WHO) had flagged AstraZeneca's as the most promising.
Italy's health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.