Pfizer Prepares to File for Full FDA Approval of its Covid Vaccine

Pfizer Prepares to File for Full FDA Approval of its Covid Vaccine

Pfizer (NYSE: PFE) is set to file for full U.S. FDA approval of its Covid1-9 vaccine by the end of the month. If the FDA were to authorize the request, the company would be eligible to market directly to consumers. Shares rose 1.3% during premarket trading.

The three vaccines currently on the market only have an Emergency Use Authorization (EUA), which means that though they are “authorized” by the FDA, they have not been “approved.” In order to receive full approval, also known as a Biologics License, companies must submit six months worth of data.

According to consumer advocate and regulatory expert Dr. Sidney Wolfe, the co-founder of Public Citizen’s Health Research Group, the approval could make a difference for people who remain skeptical of the vaccine.

“I think that these concerns would be lessened if they were told, we now have six months of follow up on his vaccine, which means we’re more comfortable with how long it lasts, how effective it is and how safe it is,” Dr. Wolfe said.

Pfizer’s first-quarter earnings managed to surpass Wall Street expectations, with vaccine sales amounting to USD3.5 Billion. Adjusted earnings were USD0.93 per share, compared to the expected USD0.77 a share. Revenue amounted to USD14.58 Billion, higher than analysts anticipated USD13.51 Billion.

“Based on what we’ve seen, we believe that a durable demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” Pfizer CEO Albert Bourla told investors on an earnings call.