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Pfizer (PFE)/BioNTech Give First COVID Jab Booster Data to FDA
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Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) have submitted data from a phase I study, which evaluated a third, or booster, dose of their mRNA-based COVID-19 vaccine, BNT162b2, to the FDA.
Data from the phase I part of the phase I/II/III study showed that the booster dose elicited antibody levels that were much higher than that seen after the two-dose primary schedule. The higher antibody levels were elicited against the initial SARS-CoV-2 virus (wild type) as well as against the Beta variant and the rapidly spreading highly infectious Delta variant. I
Pfizer’s stock has risen 32.9% this year so far compared with an increase of 17.3% for the industry.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 320.8% this year so far compared with an increase of 0.4% for the industry.
Image Source: Zacks Investment Research
In the United States, infection cases have crossed the 200,000-new cases per day mark as the pace of infection has gained traction since July mainly due to the spread of Delta variant. A booster dose, given 6-12 months after the primary two-dose schedule, can help maintain protection against the virus,which can help reduce infection rates among those who have been previously vaccinated.
Phase III data from the study will be submitted to the FDA and other regulatory authorities shortly. Pfizer/BioNTech plan to seek approval for the booster dose in people 16 years of age and older by filing a supplemental biologics license application (sBLA) pending approval of the formal BLA,which was filed in May. At present,the vaccine has been approved on an emergency/conditional basis in several countries.
Last week, the FDA expanded the emergency use authorization (“EUA”) for BNT162b2 to allow the third dose to be administered to certain immunocompromised individuals like those who have undergone solid organ transplantation or diagnosed with other diseases that may have immunocompromised their immune systems. Moderna (MRNA - Free Report) ,which also markets a mRNA-based COVID-19 vaccine, mRNA-1273, was also granted a similar approval for a third dose. However, an EUA amendment to include immunocompromised individuals in authorized label of J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data
Image: Bigstock
Pfizer (PFE)/BioNTech Give First COVID Jab Booster Data to FDA
Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) have submitted data from a phase I study, which evaluated a third, or booster, dose of their mRNA-based COVID-19 vaccine, BNT162b2, to the FDA.
Data from the phase I part of the phase I/II/III study showed that the booster dose elicited antibody levels that were much higher than that seen after the two-dose primary schedule. The higher antibody levels were elicited against the initial SARS-CoV-2 virus (wild type) as well as against the Beta variant and the rapidly spreading highly infectious Delta variant. I
Pfizer’s stock has risen 32.9% this year so far compared with an increase of 17.3% for the industry.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 320.8% this year so far compared with an increase of 0.4% for the industry.
Image Source: Zacks Investment Research
In the United States, infection cases have crossed the 200,000-new cases per day mark as the pace of infection has gained traction since July mainly due to the spread of Delta variant. A booster dose, given 6-12 months after the primary two-dose schedule, can help maintain protection against the virus,which can help reduce infection rates among those who have been previously vaccinated.
Phase III data from the study will be submitted to the FDA and other regulatory authorities shortly. Pfizer/BioNTech plan to seek approval for the booster dose in people 16 years of age and older by filing a supplemental biologics license application (sBLA) pending approval of the formal BLA,which was filed in May. At present,the vaccine has been approved on an emergency/conditional basis in several countries.
Last week, the FDA expanded the emergency use authorization (“EUA”) for BNT162b2 to allow the third dose to be administered to certain immunocompromised individuals like those who have undergone solid organ transplantation or diagnosed with other diseases that may have immunocompromised their immune systems. Moderna (MRNA - Free Report) ,which also markets a mRNA-based COVID-19 vaccine, mRNA-1273, was also granted a similar approval for a third dose. However, an EUA amendment to include immunocompromised individuals in authorized label of J&J’s (JNJ - Free Report) single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data
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.