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FDA Panel Vetoes PFE/BNTX Third Jab for All, Vaccine Stocks Down
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Vaccine stocks were down on Friday after an FDA advisory committee voted against approval for booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based COVID-19 vaccine, Comirnaty, for the general population. The committee, however, recommended approving the dose for people aged 65 years or older.
The FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) voted unanimously, recommending that the FDA grant emergency use authorization (EUA) to a booster dose of Comirnaty for individuals 65 years and older and those at high risk like healthcare workers and others. The committee recommended that the third jab should be given at least six months after the primary two-dose series.
Pfizer/BioNTech had filed its supplemental biologics license application (sBLA), seeking approval for a booster dose of Comirnaty in people 16 years of age and older in August. Data submitted from Pfizer studies showed that a booster dose elicited a strong immune response.
However, the committee did not vote in favor of approving a booster dose for the entire population for which Pfizer/BioNTech were seeking approval. The FDA is expected to give its decision in the coming months. Though the FDA is not bound by the advisory committee’s decision, it usually follows the same.
Why a Booster Dose?
The United States is recording more than 160,000-new cases per day as the pace of infection has gained traction since July mainly due to the spread of the Delta variant. A booster dose, given 6-12 months after the primary two-dose schedule, can help enhance immunity, and thus sustain protection from COVID-19.
Booster doses have demonstrated to increase the immunity levels many-folds compared to levels achieved following initial regimen in clinical studies. Data from some studies have suggested declining efficacy of COVID vaccines over time against symptomatic infection or the Delta variant.
Who is Seeking Approval for Boosters?
Other than Pfizer, 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.
Although Pfizer and Moderna are the only two companies vying for a booster currently, several other pharma/biotech companies may join the race sooner or later. J&J (JNJ - Free Report) , last month, announced encouraging interim data from two phase I/IIa studies evaluating booster dose of its adenovirus-based, single-shot COVID-19 vaccine in previously vaccinated people with its own dose. It may soon submit the necessary data and seek approval for a booster dose of its vaccine.
Are Any Boosters Available?
Though none of the marketed COVID-19 vaccines are yet approved as a booster dose, last month, the FDA expanded 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 diagnosed with other diseases that may have weakened their immune systems. However, an EUA amendment to include immunocompromised individuals in authorized label of J&J’s single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data.
Why Were Vaccine Stock Prices Down?
The coronavirus vaccine boosted revenues significantly for Pfizer, BioNTech, and Moderna in the first half of 2021. In fact, BioNTech and Moderna’s stock prices have shot up significantly since 2019-end driven by the success of their COVID-19 vaccines. An approval for a booster shot could be huge opportunity for these companies as it can further increase revenues.
Pfizer and BioNTech’s shares were down 1.3% and 3.6%, respectively, in response to the FDA panel’s decision. The panel’s decision not to recommend approving Comirnaty for the broader population not only hurt Pfizer/BioNTech’s stock price but also that of Moderna and J&J as the decision affected prospects of an authorization for booster dose of their respective vaccines. The FDA committee’s decision, in fact, raised questions about demand for booster doses. Moderna’s stock declined 2.4% while J&J was down 0.3% on Friday.
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.
With the VRBPAC recommending approval of Pfizer/BioNTech’s vaccine only for older adults and those at risk of severe disease, it looks like Biden Administration’s plan has been rejected.
Image: Bigstock
FDA Panel Vetoes PFE/BNTX Third Jab for All, Vaccine Stocks Down
Vaccine stocks were down on Friday after an FDA advisory committee voted against approval for booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based COVID-19 vaccine, Comirnaty, for the general population. The committee, however, recommended approving the dose for people aged 65 years or older.
The FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) voted unanimously, recommending that the FDA grant emergency use authorization (EUA) to a booster dose of Comirnaty for individuals 65 years and older and those at high risk like healthcare workers and others. The committee recommended that the third jab should be given at least six months after the primary two-dose series.
Pfizer/BioNTech had filed its supplemental biologics license application (sBLA), seeking approval for a booster dose of Comirnaty in people 16 years of age and older in August. Data submitted from Pfizer studies showed that a booster dose elicited a strong immune response.
However, the committee did not vote in favor of approving a booster dose for the entire population for which Pfizer/BioNTech were seeking approval. The FDA is expected to give its decision in the coming months. Though the FDA is not bound by the advisory committee’s decision, it usually follows the same.
Why a Booster Dose?
The United States is recording more than 160,000-new cases per day as the pace of infection has gained traction since July mainly due to the spread of the Delta variant. A booster dose, given 6-12 months after the primary two-dose schedule, can help enhance immunity, and thus sustain protection from COVID-19.
Booster doses have demonstrated to increase the immunity levels many-folds compared to levels achieved following initial regimen in clinical studies. Data from some studies have suggested declining efficacy of COVID vaccines over time against symptomatic infection or the Delta variant.
Who is Seeking Approval for Boosters?
Other than Pfizer, 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.
Although Pfizer and Moderna are the only two companies vying for a booster currently, several other pharma/biotech companies may join the race sooner or later. J&J (JNJ - Free Report) , last month, announced encouraging interim data from two phase I/IIa studies evaluating booster dose of its adenovirus-based, single-shot COVID-19 vaccine in previously vaccinated people with its own dose. It may soon submit the necessary data and seek approval for a booster dose of its vaccine.
Are Any Boosters Available?
Though none of the marketed COVID-19 vaccines are yet approved as a booster dose, last month, the FDA expanded 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 diagnosed with other diseases that may have weakened their immune systems. However, an EUA amendment to include immunocompromised individuals in authorized label of J&J’s single-shot, adeno-virus-based COVID-19 vaccine was not enacted due to insufficient data.
Why Were Vaccine Stock Prices Down?
The coronavirus vaccine boosted revenues significantly for Pfizer, BioNTech, and Moderna in the first half of 2021. In fact, BioNTech and Moderna’s stock prices have shot up significantly since 2019-end driven by the success of their COVID-19 vaccines. An approval for a booster shot could be huge opportunity for these companies as it can further increase revenues.
Pfizer and BioNTech’s shares were down 1.3% and 3.6%, respectively, in response to the FDA panel’s decision. The panel’s decision not to recommend approving Comirnaty for the broader population not only hurt Pfizer/BioNTech’s stock price but also that of Moderna and J&J as the decision affected prospects of an authorization for booster dose of their respective vaccines. The FDA committee’s decision, in fact, raised questions about demand for booster doses. Moderna’s stock declined 2.4% while J&J was down 0.3% on Friday.
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.
With the VRBPAC recommending approval of Pfizer/BioNTech’s vaccine only for older adults and those at risk of severe disease, it looks like Biden Administration’s plan has been rejected.
While Pfizer, J&J, and BioNTech carry Zacks Rank #3 (Hold), Moderna has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.