Pfizer's Scaled-Down COVID-19 Vaccine Manufacturing Plan Is Old News: BofA

Pfizer Inc. PFE-BioNTech SE – ADR BNTX is first among coronavirus vaccine developers to secure authorization for emergency use of candidate BNT162b2, with the first approval granted by U.K. regulators.

Scale-Down Previously Disclosed: An analyst at BofA Securities shrugged off a Thursday report in The Wall Street Journal that hinted at manufacturing constraints, resulting in a modest pullback in Pfizer shares.

The report said the company was forced to scale back its manufacturing plans for 2020 from 100 million doses initially to 50 million doses due to difficulties in scaling up the raw material supply chain.

The reduction was already communicated in the second week of November, BofA's Tazeen Ahmad said in a Friday note.

Pfizer and its German manufacturing partner BioNTech had reiterated to BofA their manufacturing goal of 50 million doses by the year-end and up to 1.3 billion doses by the end of 2021, the analyst said.

"While production is scaling up at an unprecedented pace, we remain confident in the partnership given PFE's expertise and valuable know-how in the vaccine space." 

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What to Expect From Adcom Meeting: The FDA's Vaccines and Related Products Advisory Committee is set to meet between 9 a.m. and 6 p.m. Dec. 10.

The committee will likely discuss the overall efficacy and safety profile; the age range of eligible subjects when approved; expectations to satisfy full approval; and the timing of when the placebo arm in the positive Phase 3 study will be notified and offered the vaccine, Ahmad said.

BofA estimates non risk-adjusted sales of $9.1 billion for BTN162b2 in 2021.

Upcoming Pfizer Catalysts: The FDA's goal is granting emergency use authorization one week after the Dec. 10 Adcom meeting, the analyst said. 

The European Medicines Agency's Committee For Medicinal Products for Human Use is expected to conclude its assessment during a Dec. 29 meeting at the latest, according to BofA. 

EU approval could be forthcoming if the data submitted is robust enough to reach conclusions on the safetyand efficacy standards set forth by the EMA, the sell-side firm said. 

PFE, BNTX Price Action: Pfizer shares were 0.19% higher at $40.16 at last check Friday, while BioNTech shares were up 0.45% at $119.21. 

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

Photo by Norbert Nagel via Wikimedia.