Source : 'Scrip Intelligence'
With the US presidential election nearing, Pfizer Inc. is making clear that its COVID-19 vaccine will not be submitted for emergency use authorization until later. CEO Albert Bourla issued his second public letter in recent weeks to address politicization around the development of the vaccine. His 1 October letter bemoaned an erosion of public trust caused by political bickering over the vaccine process, while the 16 October letter seeks to clarify a timeline around clinical data and a potential US filing for emergency use.
The letter does not specifically mention the US election date of 3 November, but Bourla said filing of an emergency use authorization (EUA) request at the US Food and Drug Administration will not happen until Pfizer has efficacy, safety and manufacturing data in hand. While the ongoing, pivotal Phase IIb/III COVE study of the mRNA-based COVID-19 vaccine BNT162b2 could yield interim efficacy data before the end of October, the exec said, safety data meeting FDA requirements likely won’t be available until the third week of November.
BNT162b2, on which Pfizer is partnered with Germany’s BioNTech SE, generally is viewed as leading the pack of vaccines in development for SARS-CoV-2, with Moderna, Inc., AstraZeneca PLC, Johnson & Johnson and Novavax, Inc. also in the hunt. () The COVE trial is slated to enroll up to 45,000 healthy volunteers and will report interim efficacy data when 32 enrollees have been diagnosed with COVID-19 infections; the trial is also designed for interim readouts at 62, 92 and 120 cases and to conclude when 164 cases are reported. ()
Reiterating language from his 1 October letter, which followed the first debate in the US presidential election, Bourla said that Pfizer and BioNTech are “operating at the speed of science.” In part, that means that Pfizer/BioNTech cannot dictate when the first efficacy readout will occur, although late October is the current estimate. The readout will be triggered by events occurring within the trial enrollment, with the study’s independent monitoring board determining when that threshold has been reached, he noted.
“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” Bourla stated. President Trump at times during his re-election campaign has indicated that a COVID-19 vaccine could be approved before the election, an assertion the Pfizer CEO and execs at other companies with investigational vaccines have tried to debunk. ()
In recent weeks, the White House blocked the FDA from issuing new clinical development guidelines for a COVID-19 vaccine, but later relented. In September, the agency issued guidance recommending “EUA-plus” safety data for a vaccine, including at least two months of follow-up after a patient’s final dose. ()
Bourla said the trial’s current enrollment and dosing pace indicated that the required safety data could be derived from 50% of the trial subjects during the third week of November. On 29 September, 60 medical researchers and bioethicists urged Pfizer to wait to file for an EUA until it has adequate safety date compiled. ()
“Safety is, and will remain, our number one priority,” Bourla wrote in the 16 October letter, “and we will continue monitoring and reporting safety data for all trial participants for two years.”
The FDA set an efficacy floor of 50% fewer infections among vaccine recipients than enrollees receiving placebo, but Pfizer and other vaccine sponsors are hoping to show 70% efficacy or better. The COVE study’s trial design says efficacy would be met at 76.9% at the first interim data look, with a threshold of 68.1% at the 62-case mark, 62.7% at 92 cases, 58.8% at 120 cases and 52.3% at trial’s conclusion. ()
Bourla explained that sponsors must also demonstrate to regulators that their vaccines can be manufactured consistently at high quality. Pfizer and BioNTech are gathering manufacturing data and expect to have that process completed before they have the safety data needed to back an EUA application. Pfizer anticipates filing for an EUA “soon” after it collects the required safety data, he said.
In a 16 October note, Mizuho Securities analyst Vamil Divan said “overall, things appear very much on track and the speed in potentially getting the vaccine to market is much faster than we would have expected when the pandemic started.” He called Pfizer’s quick progress encouraging and indicative that the pharma “may be able to meet its stated objectives of being a faster moving, more nimble biopharmaceutical company, especially once the pending sale of their Upjohn division is completed.”
Pfizer’s mature brands and generic products unit Upjohn is in the process of merging with generics stalwart Mylan N.V. to create a new company called Viatris. () That transaction is part of Pfizer’s efforts to focus on its core competencies.
Divan currently projects that Pfizer and BioNTech will realize sales greater than $2bn from the BNT162b2 vaccine during 2020-2021, with sales then tapering off to about $550m-$600m annually in 2024 or later. However, commitments to provide the vaccine to governments around the world could greatly increase those proceeds, the analyst added. If the companies provided more than 450 million doses to various countries at prices not less than the $19.50 per dose agreed to with the US government, revenues from the vaccine could exceed $8.5bn by the end of 2021, he pointed out. ()
Analysts have predicted that the “first wave” COVID-19 vaccine market could yield about $20bn in sales in 2021 for all approved vaccines combined. () Bernstein analyst Ronnie Gal expects Pfizer to dominate the COVID-19 vaccine market in 2021, with estimated sales of $6.14bn. But if Johnson & Johnson’s single-dose vaccine is available by mid-2021, he thinks that product will eventually gain the biggest market share with 25%, followed by GlaxoSmithKline plc/Sanofi’s vaccine taking 23% of the market and Pfizer holding on to 21%. By 2025, the analyst predicts the GSK/Sanofi protein subunit and adjuvant vaccine will be the market leader, bringing in $2.35bn, followed by J&J at $1.71bn and Pfizer/BioNTech at $1.65bn.
AstraZeneca does not factor into these projections because it plans to offer its vaccine on virtually a nonprofit basis, charging between $2-$4 per dose. ()
Pfizer is contracted to provide 100 million doses in the US between Q4 2020 and Q1 2021, with options for up to 500 million doses.
By Joseph Haas