Pfizer Positions Itself for Booster COVID-19 Vaccine Development

With its latest earnings report showing the financial impact of the vaccine, the Delta variant becoming the dominant strain in the US, and concerns of waning immunity, the company believes there is evidence for an additional booster shot.

The confluence of three factors—Pfizer’s earnings, a new dominant variant, and a decreasing immunity against COVID-19—are all coming together to incentivize the pharmaceutical company to make the case for a booster shot.

Their vaccine, BNT162b2, developed with pharmaceutical company, BioNTech, has provided a great financial windfall for Pfizer. The company reported its 2nd quarter earnings on Wednesday, and said it had $7.8 billion in sales from the vaccine in the quarter. In addition, the company also has enormous expectations for earnings around their COVID-19 vaccine for the rest of this year. “...anticipates 2021 Revenues of Approximately $33.5 Billion for BNT162b2, Reflecting 2.1 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-July 2021,” the earnings report stated.

The Delta variant was recently reported to be 83% of cases in the US, and has spread quickly over just a couple of months. As Contagion Editor-in-Chief Jason Gallagher, PharmD, pointed out in a recent tweet, “Ending 5/22 Alpha 69.1%, Delta 3.1% Ending 7/17 Alpha 8.3%, Delta 83.2% That's <2 mos. The fitness of Delta is incredible.”

And, it is unmistakable the impact the COVID-19 vaccines have made, even with the Delta variant. To get a glimpse of the impact of the vaccines and how they have made a tremendous difference, you have to look no further than the US.

In Orange County, Florida alone—home to Disney World and Orlando— they have reported as many as 1000 COVID-19 cases a day recently. And that is just in one county. That is more than the whole state of New Jersey, which reported 600 cases daily. The vaccination rate in Orange County, Florida is 52.64% with a population of 1,324,194 people, and the vaccination rate in NJ is 65.24% with a population of 8,882,190 people.

And if you consider India’s struggles with the Delta variant this past spring, and not having the benefit of vaccination it overwhelmed their hospitals and medical infrastructure, and it caused a high mortality rate.

In the background and likely to play a bigger role is what the data is reporting. There has been a mixture of news on that front with waning immunity and that the Delta variant is having a slight effect on the vaccine’s efficaciousness. 

In a study coming from England, and published in the New England Journal of Medicine, they reported on the differences in efficaciousness in the Delta and Alpha variants using the Pfizer-BioNTech vaccine. “With the BNT162b2 vaccine, the effectiveness of two doses was 93.7% (95% CI, 91.6 to 95.3) among persons with the Alpha variant and 88.0% (95% CI, 85.3 to 90.1) among those with the Delta variant.”

“Only modest differences in vaccine effectiveness were noted with the Delta variant as compared with the Alpha variant after the receipt of two vaccine doses,” the investigators concluded in their study.

Israel has reported a waning immunity in their data. In a report in the Wall Street Journal, the findings showed reduced efficacy in the Pfizer vaccine.

“The findings, which are preliminary and based on a small sample, suggest that after two shots the vaccine was 39% effective at reducing the risk of infection and 40% effective at reducing the risk of symptomatic disease during a period when the Delta variant dominated cases in Israel, according to the country’s Health Ministry,” the Wall Street Journal reported. “The vaccine was 91% effective at preventing severe illness in the same period between June 20 and July 17, the ministry said.”

Another concern is the concept of breakthrough infections. For those who are fully vaccinated, not much is known in terms of how many people are suffering these infections and if the Delta variant is causing more of them compared to previous dominant variants.

While discussions of an additional booster dose has been ongoing for many months and the healthcare community has said this might be a necessity, the debate still remains unresolved.

Earlier this month, Pfizer-BioNTech announced they planned to seek an application for an emergency-authorized third dose and was going to submit real-world data.

In response, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) spoke with Pfizer about the data but the federal officials said the need for an additional shot remained inconclusive.

Pfizer has maintained it has said all along there might be a need for a booster shot and that the emergence of the Delta variant has moved up the timeline. "I remember saying we believed, based on the data, we will need a booster eight to 12 months from second dose," Pfizer CEO Albert Bourla, stated on a conference call. "We have seen with Delta we might need it a little earlier."