Pfizer, BioNTech Analysts On FDA Panel's COVID-19 Booster Dose Decision

Pfizer, Inc. PFE-BioNTech SE BNTX suffered a setback last week after a FDA panel did not recommend a third dose of the duo's COVID-19 vaccine for the broader population.

The Pfizer-BioNTech Analysts: Morgan Stanley analyst Matthew Harrison maintained an Equal-weight rating and $45 price target for Pfizer shares.

BofA Securities analyst Tazeen Ahmad reiterated a Neutral rating and $407 rating on BioNTech shares.

Adcom Rooted In Evidence, Morgan Stanley Says: The final Adcom outcome — a recommendation for boosters for people 65 and older and those at high risk of COVID-19 infection — isn't surprising, Morgan Stanley analyst Harrison said.

While the Adcom is rooted in an evidence-based process that requires significant backward-looking information, companies and the Biden administration are reacting to the leading edge of data, which suggests boosting may reduce transmission for the upcoming winter season while the pandemic remains highly active, the analyst said.

Since the Adcom does not typically make a proactive decision based on limited evidence, it split it down the middle and focused on the population where the risk/benefit is the greatest, Harrison said. This subgroup likely accounts for about 50% of the total U.S. population, the analyst estimates.

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This debate is likely to continue as the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to provide guidance this week following a two-day meeting scheduled for Sept. 22-23, he said. 

The ACIP will likely vote in line with AdCom's recommendation and will include booster use recommendation for those at high risk for occupational exposure to COVID-19, the analyst said. The committee is expected to define the groups that are considered high risk for occupational exposure, Harrison said. 

"The US has ample vaccine supply and we do not foresee add'l orders even with population boosting for the 2021/2022 winter season," the analyst said. 

BofA Says Boosters More Likely Than Not: The vote to allow boosters in a select population, at least initially, is in-line with BofA's conversations with BioNTech management, analyst Ahmad said.

Boosters for younger populations are likely to be revisited as more data comes in, the analyst said.

Following the meeting, BofA did not adjust its Comirnaty estimates and still expects risk-adjusted sales of $39.2 billion in 2021, with $19.1 billion of that due to BioNTech.

Clinical and real-world studies were presented on booster doses that showed waning vaccine efficacy over time against infection, potentially due to decreasing neutralizing titers, novel variants and other factors, the analyst noted.

AdCom members are, however, looking for additional data to assess protection against severe disease, hospitalization and death in the broader population, Ahmad said.

Members also sought data on the potential of adverse events, particularly cardiac-related ones such as myocarditis and pericarditis, he added.

"We think boosters are more likely to be approved than not given new data continues to support declining protection against severe disease over time."

PFE, BNTX Price Action: Pfizer shares were rising 0.62% to $44.16 Monday, while BioNTech shares were down 3.87% to $345.29. 

Related Link: Moderna Analysts Debate Need For Biopharma's COVID-19 Booster Shot