Which Vaccine Has the Highest Efficacy Against Delta?
Pfizer Inc. now expects its COVID-19 vaccine to bring in US$33.5 billion in revenue this year, putting it on course to become one of the best-selling medicines of all time.
The New York drugmaker had previously projected vaccine sales for the year of US$26 billion. The upward revision is a sign demand for the shots, which Pfizer sells with German partner BioNTech SE, is surging as countries battle new outbreaks fueled by the delta virus variant.
In the second quarter, the vaccine booked US$7.8 billion in sales, Pfizer said in a statement Wednesday, more than the US$7.05 billion analysts expected, on average. The companies, which have delivered 1 billion doses of the two-shot regimen, have contracts for 2.1 billion doses through mid-July, and will produce 3 billion shots by the end of the year.
If Pfizer’s sales projections are met, the vaccine would climb into the highest rank of blockbuster medicines, outpacing bellwethers such as AbbVie Inc.’s Humira immunosuppressive therapy and Merck & Co. cancer fighter Keytruda.
A resurgence of virus infections thanks to the delta variant is likely to mean sustained demand for vaccines globally. The companies will begin a study of a new delta-fighting vaccine formulation next month. They’re also discussing with regulators the potential need for third-dose booster shots of the existing formulation to bolster the immunity gained in the initial round of immunizations.
Pfizer said in a presentation accompanying its earnings release that emerging real-world data “suggests immunity against infection and symptomatic disease may wane,” underscoring the need for boosters.
The company said regulators will determine “whether, and which, populations to recommend booster,” and that they will likely first focus on those with compromised immune systems and older adults.
Shares of Pfizer were up 2.4 per cent at 9:44 a.m. New York on Wednesday. Through the close on Tuesday, they had gained 14 per cent this year.
Earlier this month, Pfizer said it would approach U.S. regulators for authorization of a third booster dose of its vaccine, based on early data showing that it can sharply increase immune protection against the coronavirus.
New data now shows a third dose elicits neutralizing titers against the delta variant, which has become the dominant strain in the U.S.
Those titers are more than 5 times higher in younger people, and 11 times greater in older people, than following the typical two-dose regimen. Pfizer said in the presentation that it will publish “more definitive data about the analysis” and share information with global regulators.
In the meantime, the companies this month launched a Phase 3 study of the third booster dose, and will enroll 10,000 participants.
Pfizer also aims to create a new formulation of the vaccine tailored to combat the delta variant. The drugmaker said in the presentation that clinical studies of the new shot are projected to begin in August, subject to regulatory approval, and that the first batch of the shot has already been manufactured.
On Friday, the U.S. clinched a 200 million-dose supply deal with Pfizer and BioNTech. The latest deal grants the Biden administration the option to acquire an updated version of the shot to tackle potential variants if it’s authorized, and also proves 65 million vaccines for kids under 12.
Pfizer’s broader vaccine pipeline is getting a pandemic boost. In prepared remarks, executives outlined their business strategy for employing messenger RNA -- the technology that’s been validated by COVID vaccines -- in other indications.
“The swift delivery of the world’s first mRNA-based vaccine made the scientific opportunity of mRNA technology clear,” said Pfizer Chief Scientific Officer Mikael Dolsten. Dolsten said he sees potential in rare diseases and cancer.
But first the drug giant will invest in strengthening its core franchise of COVID vaccines, and an mRNA flu shot will be the next major target. Pfizer and BioNTech have partnered on such a flu shot since 2018. Subject to regulatory approval, they plan to begin human trials in the third quarter.
Pfizer is also making headway with vaccines that use more traditional platforms.
The company said its respiratory syncytial virus adult vaccine showed 100 per cent efficacy against mild to moderate symptomatic infection in a mid-stage study. Based on these data, the company will initiate a late-stage trial in September, with initial results expected as early as the first quarter of 2022.
Separately, it completed recruitment for a Phase 2 trial of a Lyme disease vaccine candidate. A late-stage study is expected to start in the second half of 2022.
What Bloomberg Intelligence says:
“The guidance raise being even better than we and consensus had expected just underscores our confidence, while comments about the potential for 2022 vaccine sales will be a key focus of the earnings call.”
-- Sam Fazeli, BI pharmaceuticals industry analyst
The COVID vaccine is expected to bolster Pfizer’s wider business results.
The company now expects full-year revenue of US$78 billion to US$80 billion, compared with US$70.5 billion to US$72.5 billion previously. Adjusted earnings per share are projected to reach US$3.95 to US$4.05, up from the previous forecast of US$3.55 to US$3.65.
Pfizer anticipates spending about US$10 billion on research and development in 2021, a figure largely driven by its coronavirus-focused programs. The company is still ushering COVID-19 treaments through the clinic, including a pill.
The oral antiviral, which is administered over the course of five days, moved into Phase 2/3 studies this month. Early data, reported Wednesday, suggests the pill has antiviral activity against SARS-CoV-2 and other coronaviruses. Should the trial prove successful, Pfizer hopes to seek emergency-use authorization in the fourth quarter.
The drugmaker’s core pharmaceutical business has continued to show growth, with revenue in the second quarter up 10 per cent to US$11.1 billion, leading it to raise revenue guidance for that portfolio by US$400 million for 2021.