More than 60 scientists from Pfizer and its vaccine partner firm BioNtech have proposed to halt the COVID19 vaccine until the end of November. However, Pfizer CEO Albert Bourla and other scientists from BioNtech have said that they will submit the data of the phase 3 trial by end of October. They have informed that they will soon apply for approval at the US Food and Drug Administration (FDA). On the other hand, some of the experts have claimed that there is a need for more safety data before applying for approval of the vaccine at the FDA. They have urged Pfizer to at least wait until the end of November to file for approval.
Experts have said that filling for approval in late November will give experts more time to compile the data of at least two months after the volunteers receive their second dose of the vaccine. Pfizer has said that they will be able to conclude whether their program works or not by the end of October. Experts opposing the submission of the vaccine at the FDA before November end have said that for the success of the vaccine, people need to have the utmost trust in it. Submission of the vaccine before thorough safety checks and trials will break the trust of the people. It will ruin the effort to achieve a widespread vaccination as well.
The phase-3 trial of the Pfizer vaccine has enrolled around 35000 volunteers so far. Nearly 24000 participants have received their second doses of the vaccine as well. The firm has been aiming to include 44000 participants for the trial. The officials of the Pfizer have appreciated experts’ input. They have said that they will provide the safety data along with the median of two months’ safety records to the FDA after the second dose on a rolling basis. Pfizer and BioNtech have signed a joint safety and efficacy undertaking early this month to ensure the complete safety and efficiency of the COVID19 vaccine, which they are developing in partnership.
