In a major turning point in fight against coronavirus, Pfizer Inc and BioNTech SE announced today that the US Food and Drug Administration's (FDA) and Vaccines and Related Biological Products Advisory Committee (VRBPAC) have approved their mRNA-based vaccine, BNT162b2, for emergency use.
Pfizer on Thursday had said the VRBPAC voted 17 to 4 in support of the FDA granting emergency use authorisation for the vaccine candidate -- BNT162b2. There is one member of the committee whose vote is not included in the 17 to 4 vote decision, Pfizer said in a statement.
"Having reviewed the scientific information available to the FDA, I have concluded that Pfizer-BioNTech COVID-19 Vaccine meets the criteria concerning safety and potential effectiveness," FDA Chief Scientist Denise Hinton told Pfizer in a letter on Friday.
The @US_FDA Vaccines and Related Biological Products Advisory Committee (#VRBPAC) voted in support of granting Emergency Use Authorization (EUA) in the US for the Pfizer-@BioNTech_Group#COVID19 mRNA vaccine: https://t.co/RutPxwDHuupic.twitter.com/2qqREKRFck— Pfizer Inc. (@pfizer) December 10, 2020
US President Donald Trump termed the approval to Pfizer a "medical miracle" in a video message. "We've delivered a safe and effective vaccine in just 9 months. This is one of the greatest scientific accomplishments in history," Trump said.
Dr Peter Marks, who's director of the FDA's Center for Biologics Evaluation and Research, said the vaccine's known and potential benefits clearly outweigh its known and potential risks. After the FDA approval now, the company, along with the US federal government, will start shipping the lifesaving vaccine to all 64 states, territories and cities of the US.
The FDA's authorisation for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world, said FDA Commissioner Stephen M Hahn, MD.
Pfizer-BioNTech COVID-19 vaccine is for use for the active immunisation to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals.
Pfizer has claimed around 95 per cent efficacy of its vaccine candidate, which was based on a interim analysis of its phase 3 clinical trial data involving around 170 participants. The efficacy has been consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94 per cent, claims the company.
How does the Pfizer vaccine work?
The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive "spike" protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
On December 2, the UK became the first country to approve the Pfizer-BioNTech vaccine against COVID-19 for emergency supply. On December 5, Bahrain also approved Pfizer and BioNTech's vaccine candidate 'BNT162b2' for emergency use.
Pfizer also sought approval from the Drugs Controller General of India, and the matter has been referred to the DCGI's Subject Expert Committee (SEC). The decision on Pfizer India will likely come next week.