will “likely” be able to deliver its newly updated Covid-19 vaccine in the early fall, CEO Albert Bourla told Barron’s on Thursday.
What is more, the so-called next-generation Covid-19 vaccines that
said Wednesday it had begun testing could be ready to submit for regulatory authorization in less than two years. The company hopes the next-generation vaccines will offer better protection than the current ones.
The company disclosed earnings on Thursday that were better than Wall Street expected, driven by surprisingly strong sales of Covid-19 vaccines and antiviral drugs. Sales of Pfizer’s (ticker: PFE) Covid-19 vaccine were $8.8 billion for the quarter, better than the $8.3 billion FactSet analyst consensus estimate.
Pfizer is readying two updated Covid-19 boosters for the fall, one that mixes the original vaccine with a component designed to target the BA.1 Omicron subvariant, and one that mixes the original with a component that targets the BA.4/BA.5 subvariants. While U.S. regulators have requested the BA.4/BA.5 vaccine for distribution in the U.S., Pfizer has asked European regulators to authorize the BA.1-specific versions.
A Pfizer executive told a Food and Drug Administration advisory panel in June that the BA.4/BA.5 vaccine could be available in early October, but last week the Washington Post reported that federal health officials now want the doses in early to mid-September.
Bourla told Barron’s that the quicker timeline is likely feasible.
“Some of the critical milestones that usually this is where you are concerned, not for failure, but for delays, we passed positively,” Bourla said. “So now I’m confident we can deliver. It’s not in the pocket, but I am confident that we can deliver.”
Bourla confirmed that the federal government now wants the doses in early fall. “I think likely we should be able to go to early fall,” he said.
In addition to the incremental improvement hoped for from its updated booster, Pfizer on Wednesday announced the start of a Phase 2 trial of what it called a “next generation” Covid-19 vaccine, a new messenger RNA-based vaccine that encodes for a spike protein the company hopes will induce a stronger immune response.
In an interview, Pfizer’s chief scientific officer, Dr. Mikael Dolsten, called the new spike protein the “super spike.”
The announcements of the so-called next generation vaccine come days after a White House summit that made the case for the need for newer, better vaccines to protect against the virus. Dolsten suggested that the new vaccine could be ready to submit to regulators sooner than expected. “I wouldn’t use the plural when I speak about year,” he said. “We think things can go fast.”
Bourla also signaled confidence on Pfizer’s mRNA-based flu vaccine, an early-stage program that is one of a number of mRNA-based flu vaccines under development. Investor enthusiasm for the mRNA-based flu vaccines was shaken late last year when
(MRNA) announced early data that disappointed investors, after it appeared to induce a similar antibody response to a
(SNY) flu vaccine already on the market.
CEO Stéphane Bancel has since tried to reset expectations around his company’s mRNA-based flu vaccine, saying at a January investor conference that the “goal had never been to have the best flu vaccine out of the gate.”
In slides presented on an earnings call on Thursday, Pfizer’s Dolsten said that Pfizer’s mRNA-based flu vaccine induced a stronger T-cell response than a high- dose flu vaccine currently on the market. “It may be a vaccine that also carries through from year to year some protective effect,” which is not the case with current flu vaccines, Dolsten said.
Bourla said that the results from the Phase 2 flu vaccine study were strong enough that Pfizer is moving forward with an efficacy study, rather than a less expensive immunogenicity study. “That’s a big bet that we’re taking, and we can prove that we have clinical efficacy against flu [that’s] superior,” Bourla said.
Write to Josh Nathan-Kazis at email@example.com
#Pfizers #Updated #Covid19 #Booster #Ready #Early #Fall #CEO