With FDA verging on its first COVID booster approval, Pfizer and Moderna will have to recalibrate revenues—again

Pfizer and Moderna are getting used to readjusting their projected COVID-19 vaccine sales. Now another recalibration may be in order.

The FDA is set to authorize a third dose of their COVID-19 shots for those with weakened immune systems, NBC News reports.

The agency's decision for immunocompromised people, who do not mount an effective response to the currently authorized two-dose regimens from Pfizer and Moderna, could be a precursor to approvals for the elderly and then for other segments of the population to receive a third dose. For these individuals, the reason to vaccinate again would be because the protection they received from the first two doses may wane over time. 

RELATED: Pfizer now expects COVID-19 vaccine sales to reach $33.5B this year, a whopping $7.5B bump from its estimate 3 months ago

On ABC on Thursday morning, NIAID chief Anthony Fauci said that the coming green light would “encompass a relatively small proportion of the population, around 3 percent or so,” and would include cancer and transplant patients. 

“At this particular point, apart from the immunocompromised, we don’t feel the need to give boosters right now,” Fauci said. 

Israel, however, began administering booster shots to fully vaccinated elderly people two weeks ago and will expand eligibility to those 50-and-older next week. France, Germany and the U.K. will roll out boosters in September, starting with the elderly and most vulnerable. The countries are ignoring a plea from the World Health Organization for a moratorium on boosters to increase supplies to needy countries.

A CDC advisory panel is scheduled to review booster data on Friday. As a general guideline, Fauci said that booster recipients should use the same brand shot, adding that the guidance would be provided when the shots are approved. 

In reporting third quarter earnings, Pfizer said it expected its COVID-19 vaccine sales to reach $33.5 billion this year, an increase of $7.5 billion from its projection after the first quarter.   

Afterward, RBC Capital analyst Daniel Busby told investors the estimate was conservative.

RELATED: Moderna, citing variants and waning immunity, expects COVID-19 boosters to become a fact of life

“We expect that guidance to continue to move higher as additional contracts are signed,” Busby wrote. “But the bigger source of value is what comes after 2021.” 

Busby sees booster doses as a key “swing factor” to the longer-term outlook, with much depending on the frequency of shots and the proportion of people likely to receive them.  

In early July, Bernstein analyst Ronny Gal ventured a projection of $22 billion in vaccine revenue for Pfizer in 2022.

Moderna has predicted its vaccine sales will reach $19 billion this year.

In analyzing the company for investors earlier this week, Jefferies said to expect the CDC to recommend approval of boosters for the elderly on Friday and that by the winter, Moderna will be supplying boosters to the rest of the population.

“Boosters are coming,” Jefferies wrote. “Data shows it’s needed.”

Nonetheless, data from six months post vaccination show that vaccine recipients remain highly protected against COVID-19. Companies have focused on results showing that neutralizing antibodies needed for protection wane over time, particularly in the face of variants like delta.

Yet, U.S. public experts have noted that such a decrease in these antibodies is expected and not in and of itself a trigger to administer a third, booster shot. They point to watching for unexpected infection rate increases alongside hospitalization numbers to decide on administering a third shot to fully vaccinated individuals, but they also do not rule out that possibility.