Pfizer On Boosters, Kids And Prospects For A Long-Term COVID-19 Business
Executive Summary
The company raised revenue guidance for its COVID-19 vaccine this year to a staggering $33bn from a prior estimate of $26bn.
Pfizer Inc.'s COVID-19 vaccine BNT162b2, developed in partnership with BioNTech SE, has reshaped the company's financial outlook and management expects the vaccine business will continue to be a contributor for the foreseeable future. One of the outstanding questions about the long-term viability of the business is if regulator booster shots will be needed, and Pfizer, at least, believes that may be the case.
The firm raised its financial guidance for the vaccine this year to $33bn versus a prior guidance of $26bn, a staggering sum that is unprecedented for any new drug or vaccine in the industry and reflective of the global mass vaccination effort to end the pandemic.
The revenue estimate reflects contracts signed as of mid-July for approximately 2.1 billion doses of the vaccine. The estimate does not include the updated contract with the US government to supply another 200 million doses, however. Pfizer expects to produce 3 billion doses of the vaccine this year, although the majority of the outstanding doses will be distributed to middle-income countries, where the price is almost half of the amount in the US, and to low-middle level countries, where it is sold at cost. The company expects to produce 4 billion doses of the vaccine in 2022, and noted that all of those doses will be allocated to countries around the world.
The updated vaccine figures came as Pfizer released its second quarter financial results on 28 July; the company reported revenues of $7.84bn in the second quarter coming from sales of the COVID-19 vaccine. (See chart below for more detail on Pfizer's Q2 sales and earnings.)
The company's financial outlook for the year has changed dramatically as a result of the vaccine. Pfizer raised its financial guidance for the year to reflect revenue of $78bn-$80bn and earnings per share of $3.95 to $4.05. The pharma said the revised guidance reflects updates to the outlook for Pfizer's business both with and without the vaccine. Excluding the vaccine, Pfizer said revenues would be $45bn-$47bn, which even at the low end is notable 7.4% growth over the $41.9bn Pfizer reported in 2020, excluding Upjohn, which was spun out.
Pfizer Pushes Boosters
Investors are wondering how sustainable Pfizer's COVID-19 business might be, given the uncertainty around the SARS-CoV-2 virus and how it will evolve or mutate and how the novel mRNA vaccines will hold up.
Pfizer suspects that a third booster dose will need to be administered six to 12 months after the first two doses, as immunity begins to wane, and it is already signing supply agreements with countries for 2022, 2023 and even out to 2024, with Canada.
"Every country in the world right now is discussing with us for additional doses," CEO Albert Bourla said during the Q2 earnings call.
In addition to studying a booster dose, Pfizer is also testing a Delta variant specific vaccine that could be effective against the newer, more aggressive strain of the virus.
Some public health officials have pushed back on the idea that a third booster shot will be needed. When Pfizer announced in July that it will seek an emergency use authorization for a booster shot in August, the US Food and Drug Administration and Centers for Disease Control and Prevention issued a statement saying fully vaccinated Americans don't need a booster vaccine now. They did not rule out the eventual possibility, however. (Also see "To Boost Or Not To Boost? Pfizer, FDA, And The COVID Vaccine Communication Challenge" - Pink Sheet, 9 Jul, 2021.)
"We believe, based on the data that we've seen, that we will need a booster eight to 12 months from the second dose, and we have seen with the Delta that might be a little bit earlier, particularly in some parts of the population" Bourla said. The urgency could be more significant for more vulnerable people who were vaccinated in January or February.
Data from a six-month safety and efficacy data analysis of Pfizer’s COVID-19 vaccine study shows that a booster shot six to eight months after the second dose of the vaccine can boost the antibody titers 100-fold compared to the levels before the booster.
The data will be included in the submission to the FDA, as well as real-world evidence on breakthrough cases in vaccinated individuals in various regions of the world, president-worldwide R&D Mikael Dolsten said. Protection against severe disease, hospitalization and death remains high, he added, but there has been some lowering there as well in more vulnerable individuals from real-world studies in Israel.
He also said he suspects regular booster shots could be needed longer term to fight COVID-19.
"While I cannot predict with certainty the future, I would not be surprised if, similarly to flu, that we would need, with interval, to boost our vaccine against COVID," he said. Perhaps that will be on an annual basis or based on the result of a diagnostic test that would monitor immunity, he added.
Timeline For Kids
Another area of uncertainty is around how quickly the vaccine could be approved for children under the age of 12, especially now that it appears the FDA may require more safety data. Pfizer has said it would have enough data from a Phase II/III trial evaluating the safety, tolerability and immunogenicity of BNT162b2 in children six months to 11 years old to support an emergency use authorization in children ages five to 11 by the end of September. Data for full licensure will be available by the end of the year.
Pfizer did confirm that the FDA has requested some "requirements," but Bourla said the company's goal is to meet those requests within the same timeframe. "If we need to do more in less time, we will try to accommodate that," he said.
Moderna, Inc. recently confirmed that following conversations with the FDA, it plans to expand the safety database for its COVID-19 vaccine study in children five to 11 to increase the likelihood of detecting rare events, which some health experts said could suggest a concern about more common adverse events. Moderna indicated that it would not have a regulatory filing ready until late 2021 or early 2022. (Also see "Rare Or Common Events? COVID Vaccine Trials In Children Boost Safety Databases, Triggering Fears Of Heart Events" - Pink Sheet, 26 Jul, 2021.)