Home Health Care Pfizer, BioNTech to start Covid-19 vaccine trial this month

Pfizer, BioNTech to start Covid-19 vaccine trial this month

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The entrance to a Pfizer office in Cambridge, Massachusetts

Biotech firm Moderna may be leading the way in the development of a potential vaccine against Covid-19, but a new contestant could soon enter the race.

New York-based drugmaker Pfizer said Thursday that this month, it and a development partner plan to start clinical trials of a vaccine against the virus that causes Covid-19, SARS-CoV-2. That partner, Mainz, Germany-based BioNTech SE, and Pfizer announced a partnership to develop a Covid-19 vaccine on March 17.

Also on Thursday, the two released additional details about the partnership, saying that they plan to initially develop a messenger RNA (mRNA)-based vaccine in the U.S. and Europe, scaling up manufacturing to supply “millions” of doses by the end of the year and hundreds of millions next year. Pfizer will pay BioNTech $185 million upfront, with milestone payments of up to $563 million. The upfront payment includes a $113 million equity investment.

Shares of Pfizer were up 2.4% on the New York Stock Exchange on Thursday morning following the announcements. Shares of BioNTech were up 7.1% on the Nasdaq.

Moderna is currently running a Phase I study of its mRNA-based vaccine, mRNA-1273, and Chairman Noubar Afeyan said in an interview with CNBC last week that the company could initiate Phase II development as early as the spring or summer. French drugmaker Sanofi is also involved in vaccine-development efforts.

Pfizer is also exploring a number of other programs related to Covid-19, including antivirals and a drug to potentially treat pneumonia stemming from Covid-19.

For the latter, Pfizer is exploring studies of the autoimmune disease drug Xeljanz (tofacitinib), an oral JAK inhibitor. Researchers in Italy plan to start a Phase II study of Xeljanz in Covid-19-related interstitial pneumonia later this week, with support from Pfizer in the form of a grant. The company is also in discussions about launching additional trials of the drug and other immune modulators. The idea of using JAK inhibitors is based on the hypothesis that their mechanism of action could inhibit the cytokine signaling involved in the inflammation that leads to lung damage and acute respiratory distress syndrome.

Last week, Incyte and Novartis said they would start a Phase III trial of Jakafi (ruxolitinib), the first Food and Drug Administration-approved JAK inhibitor, in Covid-19-related cytokine storm.

For antivirals, Pfizer plans to potentially start a clinical trial in the third quarter of this year – three months sooner than expected – of a drug that it identified as an inhibitor of a SARS-CoV-2 protease. The timing is dependent on the company’s ability to complete preclinical confirmatory studies. The company will also publish a review in the journal Clinical Pharmacology and Therapeutics to assess in vitro and clinical data for the antibiotic azithromycin as a drug with antiviral properties. Azithromycin has been combined with the generic malaria drug hydroxychloroquine in very small clinical studies of patients with Covid-19, but with mixed results that have sparked controversy.

Other antivirals in development include Gilead Sciences’ remdesivir, as well as Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab).

Photo: Dominick Reuter, AFP, via Getty Images

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