Pfizer says third COVID-19 shot warranted in US FDA document

Pfizer said that US regulators should approve a third booster dose of the COVID-19 vaccine it developed with Germany’s BioNTech due to waning effectiveness of the shot over time, according to documents the drugmaker submitted to the US Food and Drug Administration.

Pfizer said the totality of the available data supports the public health need for a third dose of the shot in individuals 16 years of age and older about six months after they received their second dose.

The FDA released the documents on Wednesday ahead of a meeting by an outside panel of experts on Friday to vote on whether or not to recommend U.S regulators approve the extra shots. The FDA has not yet published the briefing with its view on the issue.

Q&A about Pfizer’s COVID vaccine

What are the ingredients in the Pfizer-BioNTech COVID-19 Vaccine?

The ingredients are mRNA, lipids (hydroxybutyl)azanediyl)bis(hexane-diyl)bis(hexyldecanoate), [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, Distearoyl-sn-glycero-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

How does an mRNA vaccine work?

mRNA, delivered to your body’s cells by lipid nanoparticles, instructs the cells to generate the

spike protein found on the surface of the novel coronavirus that initiates infection.1,2 Instructing cells to generate the spike protein spurs an immune response, including generation of antibodies specific to the SARS-CoV-2 spike protein.
mRNA vaccines do not contain any virus particles, meaning that they don’t contain weakened or dead parts of a virus or bacterium.

Do mRNA vaccines change a person’s DNA?

mRNA is a transient carrier of information that does not integrate into human DNA. mRNA does not enter a cell’s nucleus, which is where our DNA is kept.