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Pfizer (PFE) Inks Deal With Eurofarma to Make COVID-19 Vaccine
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Pfizer Inc. (PFE - Free Report) and its Germany-based partner BioNTech SE (BNTX - Free Report) have announced signing of a letter of intent with Brazilian biopharmaceutical company Eurofarma Laboratórios SA for manufacturing and distributing their mRNA-based COVID-19 vaccine, Comirnaty, in Latin American countries.
Per the latest deal, Eurofarma will obtain the drug product from facilities in the United States and manufacturing of the doses will begin from next year. Production is expected to cross 100 million of finished doses annually, which will be exclusively distributed in Latin America.
Pfizer and BioNTech have already shipped more than 1.3 billion doses of Comirnaty to more than 120 countries across the world till date. The manufacturing and distribution agreement in Latin America will help the companies to further expand the global supply chain network for their COVID-19 vaccine.
Shares of Pfizer have rallied 28.7% so far this year compared with the industry’s growth of 16.9%.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 353.8% this year so far compared with the industry’s rise of 1.2%.
Image Source: Zacks Investment Research
Earlier this week, the FDA granted full approval to Comirnaty, to prevent COVID-19 in individuals 16 years of age and older. Following this, Comirnaty became the first vaccine to have been granted full approval by the FDA.
Pfizer/BioNTech have also begun filing of a supplemental biologics license application (sBLA), seeking approval for a booster or third dose of Comirnaty.
The companies plan to complete the sBLA filing by the end of this week. Pfizer also plans to make similar filings with the European Medicines Agency and other regulatory authorities in the next few weeks.
Pfizer and BioNTech also plan to file an sBLA to seek full approval of the COVID-19 vaccine in the 12-15 years age group once the required data are available. The vaccine was approved for emergency use in adolescents 12-15 years of age in May.
The week was an eventful one for all COVID-19 vaccine makers in the United States. Earlier this week, another COVID-19 vaccine maker, Moderna, Inc. (MRNA - Free Report) , also submitted a BLA to the FDA seeking full approval of its mRNA-based COVID-19 vaccine, mRNA-1273, in the United States.
If the FDA grants full approval to mRNA-1273 in the United States, it will become the second vaccine to get a full approval from the regulatory body.
J&J (JNJ - Free Report) released data supporting use of booster shot of its single-dose COVID-19 vaccine. The data showed that its COVID-19 vaccine booster, after the single-dose primary regimen, provided rapid and robust increase in spike-binding antibodies.
Image: Bigstock
Pfizer (PFE) Inks Deal With Eurofarma to Make COVID-19 Vaccine
Pfizer Inc. (PFE - Free Report) and its Germany-based partner BioNTech SE (BNTX - Free Report) have announced signing of a letter of intent with Brazilian biopharmaceutical company Eurofarma Laboratórios SA for manufacturing and distributing their mRNA-based COVID-19 vaccine, Comirnaty, in Latin American countries.
Per the latest deal, Eurofarma will obtain the drug product from facilities in the United States and manufacturing of the doses will begin from next year. Production is expected to cross 100 million of finished doses annually, which will be exclusively distributed in Latin America.
Pfizer and BioNTech have already shipped more than 1.3 billion doses of Comirnaty to more than 120 countries across the world till date. The manufacturing and distribution agreement in Latin America will help the companies to further expand the global supply chain network for their COVID-19 vaccine.
Shares of Pfizer have rallied 28.7% so far this year compared with the industry’s growth of 16.9%.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 353.8% this year so far compared with the industry’s rise of 1.2%.
Image Source: Zacks Investment Research
Earlier this week, the FDA granted full approval to Comirnaty, to prevent COVID-19 in individuals 16 years of age and older. Following this, Comirnaty became the first vaccine to have been granted full approval by the FDA.
Pfizer/BioNTech have also begun filing of a supplemental biologics license application (sBLA), seeking approval for a booster or third dose of Comirnaty.
The companies plan to complete the sBLA filing by the end of this week. Pfizer also plans to make similar filings with the European Medicines Agency and other regulatory authorities in the next few weeks.
Pfizer and BioNTech also plan to file an sBLA to seek full approval of the COVID-19 vaccine in the 12-15 years age group once the required data are available. The vaccine was approved for emergency use in adolescents 12-15 years of age in May.
The week was an eventful one for all COVID-19 vaccine makers in the United States. Earlier this week, another COVID-19 vaccine maker, Moderna, Inc. (MRNA - Free Report) , also submitted a BLA to the FDA seeking full approval of its mRNA-based COVID-19 vaccine, mRNA-1273, in the United States.
If the FDA grants full approval to mRNA-1273 in the United States, it will become the second vaccine to get a full approval from the regulatory body.
J&J (JNJ - Free Report) released data supporting use of booster shot of its single-dose COVID-19 vaccine. The data showed that its COVID-19 vaccine booster, after the single-dose primary regimen, provided rapid and robust increase in spike-binding antibodies.
Zacks Rank
Pfizer and BioNTech both currently have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.