FDA’s Vaccine Committee Votes in Favour of Issuing EUA for BNT162b2 COVID-19 Vaccine
By Denise Baez
NEW YORK -- December 10, 2020 -- The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of issuing an Emergency Use Authorization (EUA) to Pfizer’s BNT162b2 coronavirus disease 2019 (COVID-19) vaccine, also known as the BioNTech vaccine.
The final decision about whether to authorise the vaccine for emergency use will be made by FDA’s career officials.
The vote comes as the United States continues to set records in the number of newly reported severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) cases, hospitalisations, and deaths.
“We have now surpassed 15 million cases and 285,000 deaths, with over 200,000 new cases and over 2,500 new deaths reported yesterday,” said Erin Hall, FDA, Rockville, Maryland.
The FDA’s VRBPAC convened today to determine whether the benefits of the BNT162b2 vaccine outweigh the risks. The almost 9-hour deliberation covered efficacy and safety data, ethical issues, and adverse event monitoring.
The FDA has been conducting a comprehensive review of the vaccine since the EUA submission was received on November 20, 2020, including verification of Pfizer’s clinical data and its integrity; review of chemistry, manufacturing, and control information; review of non-clinical data; and review of clinical assays.
“The American public demands and deserves a rigorous comprehensive and independent review of the data,” said Doran Fink, MD, FDA, Rockland, Maryland. “And that was what FDA physicians and scientists have been doing for the past few weeks,” noting that they have been working days, nights, and weekends scrutinising data.
Safety and efficacy data were from a large, ongoing, randomised, blinded, placebo-controlled trial of more than 43,000 participants. The German study (BNT162-01) included participants aged 18 to 55 years and the US study (C4591001) included participants aged 18 to 55 years and 65 to 85 years. All participants will be followed for 2 years.
A total of 43,448 participants have received 1 dose of the vaccine they were randomised to and 37,706 have received 2 doses. Over 19,000 participants are now 2 months post second-dose. The vaccine is given 21 days apart.
Results showed that 30 mcg doses of BNT162b2 induced neutralising antibody titres comparable or higher than natural infection.
There were 8 cases of COVID-19 among the 18,198 participants randomised to receive the BNT162b2 vaccine compared with 162 cases among the 18,325 randomised to receive a placebo vaccine, translating to a vaccine efficacy of 95%. Efficacy was high across subgroups, regardless of age, race/ethnicity, and those with underlying conditions (diabetes, obesity, etc.).
The most common adverse events (AEs) after dose 1 were injection site reactions, fatigue, headache, and chills. The most common AEs after dose 2 were fatigue, headache, and muscle pain. Reactogenicity events after each dose of BNT162b2 in older adults were milder and less frequent than those observed in younger adults. Serious AEs were similar between the vaccine and placebo groups.
The FDA said it will work closely with the Centers for Disease Control and Prevention (CDC) to monitor safety and effectiveness using various programs and tools, including a real-time text monitoring tool.
“On day 1 of the vaccine program, systems will be in place to monitor recipients of the vaccine,” said Nancy Messosonnier, MD, CDC, Atlanta, Georgia.
BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilised, membrane-anchored SARS-CoV-2 full-length spike protein.
SOURCE: US Food and Drug Administration