Stocks on the Radar: FDA Expected to Grant Full Approval of Pfizer-BioNTech Vaccine on Monday

Shares of coronavirus disease vaccine maker Pfizer and its partner BioNTech could rise on Monday following a New York Times report that the U.S. Food and Drug Administration (FDA) is aiming to give full approval to its COVID-19 vaccine.

Regulators were aiming to complete the process by Friday, but were still working through a “substantial amount of paperwork and negotiation with the company,” the Times said, citing people familiar with the planning who were not authorized to speak publicly about it.

The agency declined to comment, according to Reuters. It had set an unofficial deadline for approval of around Labor Day on September 6, the report said.

US Approval of COVID-19 Shots Could Boost Vaccination Numbers, Fauci Says

Top U.S. infectious disease expert Dr. Anthony Fauci said on July 30 he hopes regulators as soon as next month could start granting full approval for the COVID-19 vaccines, a move he said could spur unvaccinated Americans to get the shots.

Full approval by the FDA could push more Americans to get the COVID-19 vaccine as it might reduce their fears about the safety of the shot and make local officials more comfortable about implementing vaccine mandates, Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said in an interview with Reuters.

In addition, formal FDA approval would give physicians the ability to prescribe a third dose of the vaccine to people with weakened immune systems on an off-label basis, Fauci said.

US Government Approves Booster Shots

Federal health officials said earlier in the week that a third dose of the COVID-19 shots developed by Moderna Inc. and Pfizer Inc will be available in mid-September for Americans who have been fully vaccinated for at least eight months. They cited waning protection as the reason for a booster shot.

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the officials said in a statement.

Stock Market Investors Have Been Downplaying Impact of Delta-Variant Surge on US Economy

Although August has been the worst month in 2021 for new coronavirus cases since February according to USA Today, and a Reuters analysis found that there were more than 1,000 COVID-19 deaths on Tuesday, the major U.S. stock indexes remain within striking distance of its record highs. This indicates that investors have full confidence that a surge in vaccinations will prevent a curtailing of the U.S. economic recovery.

Nonetheless, global investors have grown cautious on stocks as concerns about the delta variant of COVID-19 threaten to dent the worldwide economic recovery.

The U.S. economy is not yet out of the woods, however. Economists at Goldman Sachs lowered their third-quarter U.S. growth forecast to 5.5% from 9%, though they raised their expectations for the next four quarters.

“The impact of the delta variant on growth and inflation is proving to be somewhat larger than we expected,” said the Goldman economists, led by David Mericle. Their revised forecast implies 2021 growth of 6% on a full-year basis versus 6.4% previously, and 2022 growth of 4.5% versus 4.4% previously.