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Pfizer (PFE) to Supply 200M Doses of COVID-19 Vaccine to EU
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Pfizer,Inc. (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) announced that they have signed an advance supply deal with the European Commission to supply 200 million doses of its BNT162b2 mRNA-based vaccine candidate to EU member states. Delivery of the vaccines will begin by end of 2020, subject to regulatory approval. The agreement also includes an option to purchase additional 100 million doses.
The vaccine shots will be manufactured at BioNTech’s Germany-based manufacturing sites as well as in Pfizer’s manufacturing site in Belgium.
Pfizer has signed similar supply deals for BNT162b2 vaccine with the U.S. government (100 million doses) Canada (100 million doses), Japan (120 million doses) and U.K. (30 million doses). Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received, and potentially up to 1.3 billion doses by the end of 2021.
Pfizer’s stock has declined 1.8% this year compared with 0.6% decline for the industry.
Earlier this week, Pfizer/BioNTech released first interim data from a phase III study on BNT162b2, which showed that the candidate was more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.
For EUA in the United States for a potential COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants, after the final dose of the vaccine is administered. Pfizer estimates that it will reach this safety milestone in the third week of November and expects to file for EUA as soon as this milestone is reached.
Moderna (MRNA - Free Report) is also making a mRNA based COVID-19 vaccine. Its vaccine, mRNA-1273, is also in phase III development and the company expects to release two-month safety follow-up data by the end of November. J&J (JNJ - Free Report) and AstraZeneca/Oxford University’s vaccine candidates are also in late-stage development.
In a separate press release, Pfizer announced positive data from the fifth phase III study (JADE REGIMEN) evaluating the safety and efficacy of its investigational oral JAK inhibitor, abrocitinib in patients 12 and older with moderate-to-severe atopic dermatitis (AD). The data showed that significantly fewer patients treated with abrocitinib (both 100 mg and 200 mg doses) experienced a flare than those on placebo, thereby meeting the study’s primary endpoint. Meanwhile, a larger percentage of patients treated with abrocitinib maintained an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo, thereby meeting the study’s key secondary endpoint.
JADE REGIMEN the fifth study in the JADE clinical development program on abrocitinib. Pfizer has successfully completed four other pivotal studies under the JADE program — JADE COMPARE, JADE MONO-1, JADE-TEEN and JADE MONO-2. A new drug application (NDA) seeking approval for abrocitinib as a treatment for AD is under priority review with the FDA with a decision expected in April 2021
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.3% per year.
These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
Pfizer (PFE) to Supply 200M Doses of COVID-19 Vaccine to EU
Pfizer,Inc. (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) announced that they have signed an advance supply deal with the European Commission to supply 200 million doses of its BNT162b2 mRNA-based vaccine candidate to EU member states. Delivery of the vaccines will begin by end of 2020, subject to regulatory approval. The agreement also includes an option to purchase additional 100 million doses.
The vaccine shots will be manufactured at BioNTech’s Germany-based manufacturing sites as well as in Pfizer’s manufacturing site in Belgium.
Pfizer has signed similar supply deals for BNT162b2 vaccine with the U.S. government (100 million doses) Canada (100 million doses), Japan (120 million doses) and U.K. (30 million doses). Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received, and potentially up to 1.3 billion doses by the end of 2021.
Pfizer’s stock has declined 1.8% this year compared with 0.6% decline for the industry.
Earlier this week, Pfizer/BioNTech released first interim data from a phase III study on BNT162b2, which showed that the candidate was more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.
For EUA in the United States for a potential COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants, after the final dose of the vaccine is administered. Pfizer estimates that it will reach this safety milestone in the third week of November and expects to file for EUA as soon as this milestone is reached.
Moderna (MRNA - Free Report) is also making a mRNA based COVID-19 vaccine. Its vaccine, mRNA-1273, is also in phase III development and the company expects to release two-month safety follow-up data by the end of November. J&J (JNJ - Free Report) and AstraZeneca/Oxford University’s vaccine candidates are also in late-stage development.
In a separate press release, Pfizer announced positive data from the fifth phase III study (JADE REGIMEN) evaluating the safety and efficacy of its investigational oral JAK inhibitor, abrocitinib in patients 12 and older with moderate-to-severe atopic dermatitis (AD). The data showed that significantly fewer patients treated with abrocitinib (both 100 mg and 200 mg doses) experienced a flare than those on placebo, thereby meeting the study’s primary endpoint. Meanwhile, a larger percentage of patients treated with abrocitinib maintained an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo, thereby meeting the study’s key secondary endpoint.
JADE REGIMEN the fifth study in the JADE clinical development program on abrocitinib. Pfizer has successfully completed four other pivotal studies under the JADE program — JADE COMPARE, JADE MONO-1, JADE-TEEN and JADE MONO-2. A new drug application (NDA) seeking approval for abrocitinib as a treatment for AD is under priority review with the FDA with a decision expected in April 2021
Pfizer currently has 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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