Pfizer Inc. PFE and its Germany-based biotech partner BioNTech SE BNTX announced encouraging preliminiary results from its early-stage coronavirus program. Their nucleoside-modified messenger RNA (modRNA) vaccine candidate, BNT162b1, generated signnifcantly higher receptor binding domain ("RBD") IgG antibodies and SARS-CoV-2 neutralizing antibodies compared to sera of convalescent patients who have recovered from COVID-19.
Shares of Pfizer were up 3.2% on Jul 1 following the announcement. However, the company’s shares have declined 13.9% so far this year compared with the industry’s decrease of 2.9%.
Pfizer and BioNTech are currently evaluting four different vaccine candidates as part of their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2 in a phase I/II study.
The study evaluated two doses of 10 µg or 30 µg of BNT162b1 21-days apart or a single dose of 100 µg in healthy adults to determine an optimal dose of the vaccine as well as its safety and immunogenicity.
Preliminary data from the study showed that patients receiving 10 or 30 µg of BNT162b1 achieved eight and 46.3 times geometric mean concentrations (“GMC”), respectively, of RBD-binding IgG antibodies compared to sera of convalescent SARS-CoV-2 patients. Moreover, geometric mean titers (“GMT”) of SARS-CoV-2 neutralizing antibodies were 1.8 times for 10 µg dosage and 2.8 times for 30 µg dosage versus similar comparator group. All observations were made at day 28 following first vaccine administration.
The single dose of 100 µg achieved GMC and GMT, which were three times and 0.35 times, respectively, compared to convalescent serum panel.
BioNTech stated that levels of neutralizing antibody responses in humans achieved by BNT162b1 at relatively low dose levels are encouraging.
The companies will determine a dose level and select from multiple vaccine candidates for next-stage phase IIb/III study based on these preliminary data from the phase I/II study along with additonal preclinical and clinical data. The phase IIb/III study is anticipated to start by end of July, if necessary regulatory approvals are received to proceed.
The companies are also building manufacturing capabilities to support the availability of a vaccine folling its potential approval. The companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses in 2021.
Please note that apart from developing a coronavirus vaccine, Pfizer is also screening antiviral compounds and has confirmed a lead compound based on the results of initial screening assays. The company plans to start a potential clinical study of the lead molecule in the third quarter of 2020. It is also evaluating azithromycin for its antiviral properties. Moreover, an independent, investigator-initiated phase II study to evaluate Pfizer’s JAK inhibitor, tofacitinib, in patients with SARS-CoV-2 interstitial pneumonia in Italy has also been planned.
Meanwhile, a number of drugmakers and biotech companies are making drugs, vaccine and therapies to get a grip over the rapidly spreading virus. Among them, the Trump administration has reportedly picked five companies as part of the Operation Warp Speed initiative to rapidly develop a vaccine for COVID-19. The five companies are J&J JNJ, Moderna MRNA, the Oxford University/AstraZeneca, Merck and Pfizer. Reportedly, these five companies will get extra federal funds, and help to run their clinical studies and manufacturing assistance. Earlier this week, the FDA also issued guidance documents for companies that are developing a vaccine to prevent COVID-19 in order to get approval for the same.
Pfizer Inc. Price
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Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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