Pfizer On The Cusp of Getting Full Approval For Its COVID-19 Vaccine: What You Need to Know

The mRNA vaccine developed by Pfizer, Inc. PFE and its German partner BioNTech SE against the novel coronavirus was the first to receive emergency use authorization from the U.S. Food and Drug Administration.

The combo's vaccine could also end up being the first to receive full approval.

What Happened: Pfizer-BioNTech's vaccine could receive full approval as early as Monday, the New York Times reported. The regulatory agency was working with Pfizer, the sponsor of the biologic license application, on Friday to finish paperwork and negotiations, the report added.

If the components of the review are not completed on time, the approval could reportedly be delayed. The FDA could, however, stick with its unofficial deadline of ‘Labor Day,' the report said.

Pfizer began a rolling submission of the BLA in early May. The company had said then the PDUFA goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The two-dose vaccine was originally authorized for use in adults, ages 16 years and older, in mid-December 2020. It was later given authorization for emergency use in adolescents, ages 12-15 years. Last week, a third shot of the vaccine was authorized for use in immunocompromised individuals.

Related Link: Novavax Vs. Pfizer Vs. Moderna: How COVID-19 Vaccines Stack Up

Why It's Important: With an emergency use authorization, the authorized product can be on the market only while the emergency is ongoing. On the other hand, full approval is for keeps.

If Pfizer secures full approval for its vaccine, it can begin marketing it directly to consumers. Additionally, vaccine uptake is expected to increase, as some of the vaccine hesitancy is due to the perception that it has not been subjected to a rigorous review and consequently may not be safe for administration.

Once full approval is received, Pfizer could seek approval for a third dose of the COVID vaccine as a booster shot, the New York Times report said. The U.S. government has suggested that after Sept. 20, fully-vaccinated individuals should prepare to receive a booster dose, eight months after the second dose.

Pfizer's second-quarter results released in late July showed that the COVID-19 vaccine contributed $7.9 billion to its total revenues. The company guided to full-year vaccine revenues of $33.5 billion.

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates