Both Pfizer and Moderna compare the likely COVID-19 vaccine opportunity to flu volumes, although analysts are less convinced that the uptake will match these expectations.
But the pharma giants do acknowledge there are plenty of uncertainties around booster uptake, government recommendations and whether dual annual flu and COVID immunizations will become the new norm.
Bivalent booster boosts US revenues
Pfizer has increased full year 2022 revenue guidance for Comirnaty, even though revenues for the COVID-19 vaccine declined over the latest quarter.
The vaccine generated Q3 worldwide revenue of $4.4bn, declining 65% year-on-year. However, Pfizer has also increased full year 2022 revenue guidance for Comirnaty by $2bn to approximately $34bn, based on contracts signed as of mid-October.
Breaking down Q3, Pfizer says that Comirnaty revenues* outside the US were down 86% operationally, primarily because a supply agreement with the European Commission has shifted doses scheduled from June-August 2022 into the fourth quarter of the year: a move also seen from other developed countries. Pfizer also notes ‘slower demand’ in emerging markets.
However, revenues were up 83% in the US in the quarter thanks to deliveries of the Omicron BA.4 / BA.5 adapted booster, following the successful Emergency Use Authorization (EUA) granted in late August and the EUA in June 2022 for children between 6 months and five years old.
A key change in the booster landscape is that the US government is stopping buying COVID-19 shots, although Pfizer expects the CDC will recommend annual COVID-19 vaccinations for a broad population with no out-of-pocket costs for Americans, regardless of which insurance they have.
In response to the transition from ‘pandemic model to normal procurement paradigms’, Pfizer will increase the price per dose in the US to the region of $110 to $130 - reportedly some four times the previous price. But how this new model will play out is yet to be seen, notes Pfizer CEO Albert Bourla.
“We expect 2023 will be a transition year with, likely, in the US moving from government model into a commercial model for vaccines and therapeutics. The timing is not certain.
“And it likely will not be the same for Paxlovid and Comirnaty. And clearly, there will be new price dynamics as we are moving to 2023. So probably will be a little bit more of a transitional year in 2023 until it will be established into more like flu volumes type of market, but of course, with different price points and different severity of the disease, that will bring both therapeutics and vaccines into a multibillion-dollar franchise. We are not going to predict now what will be the number for the years out, but we will try to be as accurate as possible for our 2023 numbers when we provide guidance.”
Like flu jabs?
Ultimately much will depend, added Bourla, on whether COVID-19 shots become a standard recommendation alongside flu jabs. Like other COVID-19 vaccine developers, it is working on a dual COVID-19 / flu shot, which is currently in Phase 1 trials. “If we have a combination product, clearly, that will enhance this direction,” he said.
In its earnings report yesterday, Moderna also compares the COVID vaccine opportunity as akin to the flu jab market. "Since October 2021, the substantial medical burden for COVID has been greater than flu’s historical burden," the company says. "As COVID transitions to endemic, annual COVID booster volumes could approximate flu vaccine volumes over time."
Moderna also saw a decline in COVID-19 vaccine sales in 2021. Total company revenue for Q3, 2022 was $3.4bn compared to $5bn in the same period in 2021, mainly due to a decline in COVID-19 vaccine sales.
Product sales for Q3, 2022 were $3.1bn, a decrease of 35%, compared to Q3, 2021: primarily driven by lower sales volume due to the timing of market authorizations for COVID-19 bivalent boosters and related manufacturing ramp up.
Like Pfizer, it is tracking the change to a commercial model in the US: highlighting a more fragmented customer base; less predictability in orders; and seasonality of deliveries. It, too, notes that much will depend on recommendations from public health authorities; alongside people's motivation to get vaccinated. And again, like Pfizer, it is working on a combo flu / COVID jab.
Moderna's 2023 COVID confirmed contracts and deferrals are currently in the region of $4.5-5.5bn; but the company highlights additional orders are expected in US, EU, Japan and other countries. Its figures project possible scenarios of anything from a 400 to 800 million dose global market for COVID boosters: compared to 500 - 600 million for flu.
But analyst Lee Brown, Global Sector Lead for Healthcare at research business Third Bridge, cautions that big question marks remain over booster uptake.
"Most Americans appear to be delaying or skipping the new COVID-19 booster shots, with a recent poll highlighting that two-thirds of American adults do not plan on getting a COVID vaccine soon. Previously, consensus estimated the number of annual COVID-19 shots would approximate the number of annual flu shots, but now analysts expect the US market to be as low as one-third the size of the flu market.”
* “Comirnaty” refers to, as authorized/approved, the PfizerBioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/ BA.5 Vaccine