FDA Grants Pfizer, BioNTech Full Approval for Their COVID-19 Vaccine

Full Approval Should Drive More Shots

Pfizer (PFE) and BioNTech’s (BNTX) COVID-19 vaccine received full approval from the Food and Drug Administration Monday for people 16 and older. The vaccine, which the company will now market under the name Comirnaty, only had Emergency Use Authorization prior to Monday. Pfizer and BioNTech applied for full approval in May.

The COVID-19 shot is the first to win full approval in the US. News sent shares of Pfizer and BioNTech higher as investors analyzed what that could mean for sales. After all, full approval by the FDA is expected to sway more people to get inoculated.

Companies Mandate Vaccinations

In addition to convincing more Americans it is safe to receive the COVID-19 vaccine, the approval by the FDA is expected to prompt more companies to require workers to be vaccinated. Large companies including Walmart (WMT) and Walt Disney (DIS) are already requiring some or all of their employees to be vaccinated. Meanwhile the Pentagon is requiring the vaccine next month and could move up the deadline now that the FDA gave it full approval.

Chevron (CVX), the second-largest oil company in the country, also started requiring employees to get the vaccination as infections in the industry begin to rise. COVID-19 cases are impacting operations in the Gulf of Mexico, the Permian Basin of Texas, and New Mexico—key offshore platform sites for Chevron.

Pfizer Can Market Directly

With full approval Pfizer and BioNTech can market the vaccine directly to doctors, insurance companies, and consumers. Pfizer, which generated $7.8 billion in COVID-19 sales in the second quarter alone, could also charge more for the vaccine.

After submitting 340,000 pages as part of the months-long process, the approval was cheered by Wall Street on the first day of the week. The Dow Jones Industrial Average rallied nearly 300 points and specific sectors like travel and leisure advanced. This broad-based bump sent names like Delta (DAL), American Airlines (AAL), Carnival (CCL), and Norwegian Cruise Lines (NCLH) higher. Investors will be waiting to see if approval will be enough to convince more Americans to get a shot and what it means for the companies’ bottom lines.

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