Pfizer CEO Predicts Covid Vaccine EUA Filing in November
Pfizer CEO Albert Bourla says the company and its development partner BioNTech should be able to tell that their Covid-19 vaccine is effective by the end of the month, and an emergency use authorization (EUA) request could be filed as early as the third week of November. In a 10/16 open letter, Bourla noted that “all the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.” Based on this information, the vaccine could be granted its EUA before the end of the year.
Meanwhile, senior FDA officials offered their perspective on the confidence in any Covid-19 vaccine granted an EUA, which “will depend on the rigor of the clinical criteria, including the duration of follow-up, used to evaluate it.” Writing in the New England Journal of Medicine, CBER vaccine research director Marion F. Gruber and deputy director Philip R. Krause noted that a “favorable benefit–risk determination cannot be made for vaccines that might have only modest benefit or for which there are insufficient data to assess the safety profile. At stake is public confidence in America’s response to the pandemic, in Covid-19 vaccines, and in vaccines in general, all of which are essential to achieving desired public health outcomes.”
The authors stressed thet continued follow-up of vaccine trial participants to “further refine efficacy estimates, further evaluate the potential for enhanced disease and waning of immunity, and obtain additional active safety follow-up will be essential in order to ensure public confidence in a broadly administered vaccine. The quality of the data available to inform ongoing assessment of a vaccine’s benefits and risks will depend on the ability to continue evaluating the vaccine against a placebo comparator in clinical trials for as long as feasible. Moreover, evaluation of other potentially superior vaccines will depend on the ability to continue to maintain placebo controls in ongoing trials. Thus, issuance of an EUA should not, in and of itself, require unblinding of a Covid-19 vaccine trial and immediate vaccination of placebo recipients, since doing so may jeopardize approval of these products.”
Additionally, Gruber and Krause defend the agency’s requirement for a median two-month follow-up after completion of the vaccine regimen and that it will provide the necessary safety and effectiveness data to support distribution of an investigational vaccine under an EUA. “Curtailment of this minimum follow-up could destroy the scientific credibility of the decision to authorize any vaccine for use under an EUA in the U.S. Appropriate conditions for issuing EUAs for Covid-19 vaccines are expected to be discussed further at the October 22, 2020, meeting of the FDA Vaccines and Related Biological Products Advisory Committee.”