In response to the Pfizer-BioNTech vaccine's application of full approval, the United States Food and Drug Administration has endowed a priority review designation. According to an FDA official, the final decision will be made soon.
According to the pharmaceutical and biotechnological companies, the goal date for the FDA decision is January 2022. The process of typical priority review is six months. However, the approval of the agency could come before the goal date.
Pfizer and BioNTech currently offer a two-shot mRNA novel coronavirus vaccine for people 16 years old and above.
10 Months to Mere 6
The priority review diminished the approval process from 10 months to six.
In May this year, Pfizer and BioNTech concluded the rolling submission of the BLA. In the Phase 3 clinical trial of the coronavirus vaccine, the commending and efficacy safety profile of the vaccine were observed up to half a year following the second shot.
Pfizer and BioNTech are also looking to submit an auxiliary BLA (sBLA) for marketed use of BNT162b2 in individuals from 12 to 15 years old when investigators have acquired 6-month data backing the vaccine in the adolescent population. In December last year, BNT162b2 was the first COVID-19 vaccine granted emergency use authorization by the FDA.
Data backing the original EUA indicated a vaccine efficacy of 95% in trial participants without prior COVID-19 and in participants with and without prior COVID-19. The evaluation was based on 170 cases of COVID-19 for individuals without prior illness. The efficacy in adults 65 years old and above was over 94%. They had a consistency through gender, age, ethnicity demographics, and race, reported Pharmacy Times.
According to an FA official, this matter is a priority. The individual requested to be anonymous because they were unauthorized to disclose the matter publicly.
According to Slavitt, there is plenty of "moving pieces" that are difficult. He is hoping for good news in the next four to five weeks, reported Komu.
Albert Bourla, Chairman and Chief Executive Officerof Pfizer, stated that they are proud of the enormous progress they have made since December, in coordination with the US government, in administering vaccines to millions of Americans. "We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months," reported ABC 10.
The FDA expanded the EUA of the Pfizer-BioNTech COVID-19 Vaccine on May 10 to include people aged 12 to 15. The companies are looking to submit an auxiliary BLA to support licensure of the vaccine in this age group. This will take place when the required data six months after the second vaccine shot are available.
Pfizer and BioNTech were at strategic odds with the transmission of information of the national and global health authorities previously this month. The groups were at odds on the necessity of an authorized third "booster" shot of the mRNA vaccine for increased immunity in earlier inoculated people.