We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer (PFE) Plans to Delay Comirnaty for Kids EUA Submission
Read MoreHide Full Article
Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) announced their plan to extend the rolling submission for emergency use authorization (“EUA”) for their COVID-19 vaccine, Comirnaty, to include children aged six months through four years of age. The companies are planning to get EUA for a three-dose vaccination regimen for this age group compared to the two-dose regimen requested earlier.
Earlier this month, Pfizer and BioNTech had initiated a rolling submission to amend the EUA for Comirnaty based on data from a phase II/III study evaluating it in children aged six months through four years of age. In December 2021, the companies decided to administer three three-µg doses as part of the primary vaccination series for this age group. The first two doses are administered 21 days apart, followed by the third dose after eight weeks of the second dose.
The companies were seeking authorization for the initial two-dose regimen for use in children aged six months through four years of age. The recent delay in completion of the rolling submission of the EUA was due to the decision to include data on the thrid dose.
Due to the rapid pace of COVID-19 infection cases in the United States due to the Omicron variant Pfizer and BioNTech stated that the large number of COVID-19 infections, specially in children, had helped them accelerate data gathering, which led to the decision to gain EUA for the three-dose vaccine series at once. The companies also stated that they believe a three-dose regimen will provide better protection for individuals in this age group versus a two-dose regimen. The independent Data Monitoring Committee also supports a potential three-dose regimen.
Pfizer and BioNTech expect to have three-dose protection data available in early April. This suggests that the rolling submission for the EUA amendment of Comirnaty is not going to be completed before April.
The companies stated that they would be able to supply ample three-µg doses to meet demand, following a EUA from the FDA.
Please note that Comirnaty is approved for use in individuals 16 years of age and older. The COVID-19 vaccine was also granted EUA for use in individuals five years of age and older. A third dose or booster dose of the vaccine is also authorized in individuals 12 years of age and older, and immunocompromised individuals 5 years of age and older.
In the past year, Pfizer’s stock has surged 46.3% compared with an increase of 13.9% for the industry.
Image Source: Zacks Investment Research
We note that Pfizer and BioNTech are also developing an Omicron-based COVID-19 vaccine candidate. Apart from them, Moderna (MRNA - Free Report) initiated a phase II study to evaluate its Omicron-specific COVID-19 booster candidate across two cohorts last month.
One cohort will evaluate the candidate in patients who have already completed the two-dose regimen of Moderna’s COVID vaccine at least six months back.
The other cohort will evaluate Moderna’s candidate in patients who have not only completed the two-dose regimen of Moderna’s COVID vaccine but also received the booster dose of its COVID vaccine at least three months ago.
Another potential winner among vaccine-makers is Novavax (NVAX - Free Report) . Novavax’s vaccine candidate is yet to gain any authorization in the United States. Last month, the company filed a EUA request with the FDA for NVX-CoV2373 in adults.
Novavax is also developing its vaccine candidate for use in adolescents. The data readout from a phase II study earlier this month showed that Novavax’s vaccine is effective against popular strains of COVID-19, including Omicron.
Image: Bigstock
Pfizer (PFE) Plans to Delay Comirnaty for Kids EUA Submission
Pfizer (PFE - Free Report) and its Germany-based partner BioNTech (BNTX - Free Report) announced their plan to extend the rolling submission for emergency use authorization (“EUA”) for their COVID-19 vaccine, Comirnaty, to include children aged six months through four years of age. The companies are planning to get EUA for a three-dose vaccination regimen for this age group compared to the two-dose regimen requested earlier.
Earlier this month, Pfizer and BioNTech had initiated a rolling submission to amend the EUA for Comirnaty based on data from a phase II/III study evaluating it in children aged six months through four years of age. In December 2021, the companies decided to administer three three-µg doses as part of the primary vaccination series for this age group. The first two doses are administered 21 days apart, followed by the third dose after eight weeks of the second dose.
The companies were seeking authorization for the initial two-dose regimen for use in children aged six months through four years of age. The recent delay in completion of the rolling submission of the EUA was due to the decision to include data on the thrid dose.
Due to the rapid pace of COVID-19 infection cases in the United States due to the Omicron variant Pfizer and BioNTech stated that the large number of COVID-19 infections, specially in children, had helped them accelerate data gathering, which led to the decision to gain EUA for the three-dose vaccine series at once. The companies also stated that they believe a three-dose regimen will provide better protection for individuals in this age group versus a two-dose regimen. The independent Data Monitoring Committee also supports a potential three-dose regimen.
Pfizer and BioNTech expect to have three-dose protection data available in early April. This suggests that the rolling submission for the EUA amendment of Comirnaty is not going to be completed before April.
The companies stated that they would be able to supply ample three-µg doses to meet demand, following a EUA from the FDA.
Please note that Comirnaty is approved for use in individuals 16 years of age and older. The COVID-19 vaccine was also granted EUA for use in individuals five years of age and older. A third dose or booster dose of the vaccine is also authorized in individuals 12 years of age and older, and immunocompromised individuals 5 years of age and older.
In the past year, Pfizer’s stock has surged 46.3% compared with an increase of 13.9% for the industry.
We note that Pfizer and BioNTech are also developing an Omicron-based COVID-19 vaccine candidate. Apart from them, Moderna (MRNA - Free Report) initiated a phase II study to evaluate its Omicron-specific COVID-19 booster candidate across two cohorts last month.
One cohort will evaluate the candidate in patients who have already completed the two-dose regimen of Moderna’s COVID vaccine at least six months back.
The other cohort will evaluate Moderna’s candidate in patients who have not only completed the two-dose regimen of Moderna’s COVID vaccine but also received the booster dose of its COVID vaccine at least three months ago.
Another potential winner among vaccine-makers is Novavax (NVAX - Free Report) . Novavax’s vaccine candidate is yet to gain any authorization in the United States. Last month, the company filed a EUA request with the FDA for NVX-CoV2373 in adults.
Novavax is also developing its vaccine candidate for use in adolescents. The data readout from a phase II study earlier this month showed that Novavax’s vaccine is effective against popular strains of COVID-19, including Omicron.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank
Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.