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Pfizer (PFE), and its partner BioNTech, have taken the rare step of publishing the clinical protocol for their late-stage Covid-19 vaccine trials.
The vaccine candidate selected by the two companies for Phase 2/3 evaluation is BNT162b2 at a dose of 30 µg, administered as a 2-dose (separated by 21 days) schedule.
As set out in the protocol, the primary efficacy endpoint will evaluate BNT162b2 against confirmed Covid-19 in participants at least 7 days after the last vaccine dose. Its endpoint will be the Covid-19 incidence per 1000 person-years of follow-up.
Confirmed COVID-19 will be defined as the presence of at least 1 of the following symptoms and a positive SARS-CoV-2 test: fever, new or increased cough, new or increased shortness of breath, chills, new or increased myalgia (muscle soreness), new loss of taste or smell, sore throat, diarrhea or vomiting.
The secondary endpoint will study the vaccine’s efficacy in cases of severe Covid-19, which will require a confirmed Covid-19 test, plus at least one of certain criteria including death, admission to an ICU, evidence of shock and respiratory failure.
The trial will involve 21,999 vaccine recipients from the age of 16 upwards, with a minimum of 40% of participants over 55 years old. An equal number of participants will receive placebo, ie, randomized in a 1:1 ratio.
Notably Moderna (MRNA) is using a much more restrictive definition of Covid-19 for its late-stage vaccine trials, as it will require at least two of the less severe symptoms instead of at least one.
Shares in Pfizer are down 7% year-to-date, but the analyst consensus currently rates the stock a cautiously optimistic Moderate Buy. The rating is based on 4 Buy and 6 Holds over the last three months, with an average price target of $43.13.
After attending the company’s recent investor presentation, Mizuho analyst Vamil Divan believes the event “successfully illustrated how the company is evolving into a ‘New Pfizer.’”
He believes that Pfizer’s extensive pipeline of vaccines and treatments will generate over $15 billion of annual sales by 2025, while the upcoming spin-off of its Upjohn portfolio should streamline Pfizer into an “innovation-driven biopharma company.”
As for the Covid-19 vaccine collab with BioNTech (BNTX), Divan said, “we are encouraged by the data to date and believe Pfizer remains on track to have a clear sense of the vaccine’s profile by the end of October, with potential FDA approval shortly thereafter.”
The analyst believes the vaccine can generate risk-adjusted sales of roughly $1.7 billion next year and $1.2 billion in 2022. Overall, Divan rates PFE shares a Buy, along with a $43 price target (17% upside potential). (See Pfizer stock analysis on TipRanks)