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Pfizer (PFE) Booster Dose Gets FDA Nod for High-Risk People
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The FDA granted emergency use authorization (EUA) toa booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based COVID-19 vaccine, Comirnaty, for individuals 65 years and older and also those in high-risk groups.
The high-risk groups include individuals, aged 16 to 64, who are at a high risk of severe COVID-19, and also those whose occupation exposes them to the virus and puts them at high risk of COVID-related complications, including severe COVID-19, like healthcare workers, teachers, and others. The FDA said that the third jab should be given at least six months after the primary two-dose series.
However, inline with the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) last week, the FDA did not approve the booster dose for the entire population for which Pfizer/BioNTech was seeking approval. Pfizer/BioNTech had filed its supplemental biologics license application (sBLA), seeking approval for the booster dose of Comirnaty, in people 16 years of age and older, in August.
The sBLA for the booster dose included data from a phase III study (n=306), which showed that the booster dose induced significant SARS-CoV-2 neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants. The antibody levels elicited against the initial wild type virus one month after the booster dose were 3.3 times the levels seen one month after the second dose. Pfizer/BioNTech have submitted the booster data to other regulatory agencies as well.
Pfizer’s stock has risen 19.4% this year so far compared with an increase of 9% for the industry.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 316.2% this year so far against a decrease of 0.6% for the industry.
Image Source: Zacks Investment Research
Last week, the VRBPAC voted unanimously, recommending that the FDA grant EUA to the Comirnaty booster dose for individuals 65 years and older and those at high risk of severe-COVID. However, the panel voted against approving the booster for the general population.
Pfizer becomes the first company whose booster dose has been granted emergency approval by the FDA. Moderna (MRNA - Free Report) has also submitted an application for authorization/approval for a booster dose of its COVID-19 vaccine and has provided clinical data to support the efficacy of a booster dose to the FDA.
Earlier this week, J&J (JNJ - Free Report) presented additional data from the phase III ENSEMBLE study, which showed that a booster dose of its adenovirus-based, single-shot vaccine, given 56 days after the first jab, led to 94% protection against mild-to-severe COVID-19 in the United States. J&J has submitted the latest additional data for the booster dose to the FDA.
Last month, the FDA expanded the EUA of Pfizer and Moderna’s vaccines to allow the third dose to be administered to certain immunocompromised individuals like those who have undergone solid organ transplantation or those diagnosed with other diseases that may have weakened their immune systems. Along with the latest approval for the booster dose, Pfizer clarified that the third dose for immunocompromised individuals is different from the booster dose approved. While the third dose for immunocompromised individuals is for people who do not build enough protection after two shots of the vaccine, the booster dose is for individuals who have built enough protection after the primary vaccination regimen. However, these individuals may see decreased protection over time due to the declining efficacy of COVID vaccines.
Last month, the U.S. government had said that it intends to begin offering the third shots from September to those individuals who had taken their initial shots more than eight months ago. But it clarified that the booster plan was contingent upon approvals by the FDA and Centers for Disease Control and Prevention.
In a separate press release, Pfizer/BioNTech announced plans to provide the U.S. government with 500 million additional doses of Comirnaty at a not-for-profit price for donation to the poorest countries. With the latest deal, the total number of vaccine doses to be supplied to the U.S. government for donation by Pfizer/BioNTech adds up to one billion.
Image: Bigstock
Pfizer (PFE) Booster Dose Gets FDA Nod for High-Risk People
The FDA granted emergency use authorization (EUA) toa booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based COVID-19 vaccine, Comirnaty, for individuals 65 years and older and also those in high-risk groups.
The high-risk groups include individuals, aged 16 to 64, who are at a high risk of severe COVID-19, and also those whose occupation exposes them to the virus and puts them at high risk of COVID-related complications, including severe COVID-19, like healthcare workers, teachers, and others. The FDA said that the third jab should be given at least six months after the primary two-dose series.
However, inline with the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) last week, the FDA did not approve the booster dose for the entire population for which Pfizer/BioNTech was seeking approval. Pfizer/BioNTech had filed its supplemental biologics license application (sBLA), seeking approval for the booster dose of Comirnaty, in people 16 years of age and older, in August.
The sBLA for the booster dose included data from a phase III study (n=306), which showed that the booster dose induced significant SARS-CoV-2 neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants. The antibody levels elicited against the initial wild type virus one month after the booster dose were 3.3 times the levels seen one month after the second dose. Pfizer/BioNTech have submitted the booster data to other regulatory agencies as well.
Pfizer’s stock has risen 19.4% this year so far compared with an increase of 9% for the industry.
Image Source: Zacks Investment Research
BioNTech’s stock has risen 316.2% this year so far against a decrease of 0.6% for the industry.
Image Source: Zacks Investment Research
Last week, the VRBPAC voted unanimously, recommending that the FDA grant EUA to the Comirnaty booster dose for individuals 65 years and older and those at high risk of severe-COVID. However, the panel voted against approving the booster for the general population.
Pfizer becomes the first company whose booster dose has been granted emergency approval by the FDA. Moderna (MRNA - Free Report) has also submitted an application for authorization/approval for a booster dose of its COVID-19 vaccine and has provided clinical data to support the efficacy of a booster dose to the FDA.
Earlier this week, J&J (JNJ - Free Report) presented additional data from the phase III ENSEMBLE study, which showed that a booster dose of its adenovirus-based, single-shot vaccine, given 56 days after the first jab, led to 94% protection against mild-to-severe COVID-19 in the United States. J&J has submitted the latest additional data for the booster dose to the FDA.
Last month, the FDA expanded the EUA of Pfizer and Moderna’s vaccines to allow the third dose to be administered to certain immunocompromised individuals like those who have undergone solid organ transplantation or those diagnosed with other diseases that may have weakened their immune systems. Along with the latest approval for the booster dose, Pfizer clarified that the third dose for immunocompromised individuals is different from the booster dose approved. While the third dose for immunocompromised individuals is for people who do not build enough protection after two shots of the vaccine, the booster dose is for individuals who have built enough protection after the primary vaccination regimen. However, these individuals may see decreased protection over time due to the declining efficacy of COVID vaccines.
Last month, the U.S. government had said that it intends to begin offering the third shots from September to those individuals who had taken their initial shots more than eight months ago. But it clarified that the booster plan was contingent upon approvals by the FDA and Centers for Disease Control and Prevention.
In a separate press release, Pfizer/BioNTech announced plans to provide the U.S. government with 500 million additional doses of Comirnaty at a not-for-profit price for donation to the poorest countries. With the latest deal, the total number of vaccine doses to be supplied to the U.S. government for donation by Pfizer/BioNTech adds up to one billion.
Both BioNTech and Pfizer carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.