The company, which reported second quarter earnings on Wednesday that topped Wall Street estimates, continues to see revenue from its COVID-19 vaccine skyrocket with the end of each quarter, now projected to reach $33.5 billion by the end of the year.
That outperformance is likely to be aided by the increasingly urgent push for a COVID-19 immunization for children under 12. With the new school year just weeks away, Pfizer has been asked by the FDA to expand its trial enrollment for the trial involving kids aged 5 to 11 — largely due to a heart inflammation (myocarditis) issue seen in the under 30 population after receiving an mRNA vaccine.
The company does not anticipate the regulatory request will disrupt its trial timeline, and anticipates it can file for emergency authorization by the end of September. But in an interview with Yahoo Finance, Pfizer's chief scientific officer Mikael Dolsten said the conversation with regulators is ongoing, and voiced confidence in what the company is seeing in the results thus far.
Regulators are finalizing exactly how many more kids need to be enrolled, and for how long the trial needs to last, he said.
"We know (kids) develop very nice immunity. And...in our clinical trials from 12 upwards, we really didn't report any issues," Dolsten said.
'Standing ovation' for 'saving the world'
Pfizer's soaring revenues, and COVID-19's stubborn resurgence, means the vaccine would account for more than 42% of the company's annual revenue, now projected to be between $78 billion and $80 billion, the company announced Wednesday.
In an interview with Yahoo Finance, CEO Albert Bourla said he was pleased the company was doing so well financially, but he was more heartened by the impact it has had on the globe.
"I’m satisfied that the company is doing financially very well, but even more satisfied when I go into a restaurant and get a standing ovation because everybody feels that we saved the world," he said.
Pfizer anticipates producing 3 billion doses this year, and "a significant amount" of this year's vaccine manufacturing capacity will go to middle and lower-income countries at a reduced price, Bourla told investors on Pfizer's earnings call Wednesday.
The commitment to middle- and low-income countries would account for 40% of vaccine production for 2021, Bourla added.
That could also impact the revenue growth for the second half of 2021, for two reasons, CFO Frank D'Amelio said.
"Many of the doses that we'll supply will be the low- and middle- income countries, which will have a lower price. And...internationally, we our accounting calendar ends the end of November, so December shipments would actually hit 2022 revenue," he said.
Meanwhile, the upcoming month is shaping up to be a busy one for the company. Pfizer expects to file for an emergency use authorization for a booster shot in August — the same month it plans to begin studying a Delta variant-specific shot, pending regulatory approval.
The company met with U.S. regulatory officials to discuss the need for a booster shot six to 12 months after the second dose, which officials have not yet said will be required.
Israel has already begun to offer boosters to immunocompromised individuals, and said its data shows 39% efficacy against the Delta variant — far below the 96% efficacy rate that made Pfizer's vaccine the best on offer.
However, Israel's data is vastly different from other data, including in the U.K. and U.S., and experts have questioned the results.
Bourla said the data differs because Israel began vaccinating earlier. and has up to six months data for their general population. In the U.K., meanwhile, the government spaced out the two doses more than the three weeks authorized by the FDA, which may have affected how the data looks there.
Even if the regulatory process, and supporting data, ultimately leads to the U.S. recommending boosters, when that booster will be required will be different from other countries, Bourla said.
On Wednesday's earnings call, Dolsten said the company is leaning on Israeli data for its push for a booster.
"We do see some lowering in...protection in risk groups such as older adults, immunocompromised," he said, adding the third dose would give "extra muscle" to protection.
Follow Anjalee on Twitter @AnjKhem