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Pfizer, BioNTech Booster Gets FDA Nod for 16- & 17-Year Olds
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Pfizer (PFE - Free Report) and partner, BioNTech (BNTX - Free Report) announced that the FDA has extended its Emergency Use Authorization (EUA) for their booster dose to allow its use in individuals 16 and 17 years of age. The shot for 16- and 17-year olds is to be given at least six months following the completion of the primary vaccination with Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty.
Pfizer and BioNTech’s booster dose was granted emergency approval by the FDA last month for all adults 18 years of age and older following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Unlike the booster criteria for adults, the primary vaccine regimen of 16- and 17-year-olds can only be Comirnaty as vaccines of Moderna (MRNA - Free Report) and J&J (JNJ - Free Report) are not authorized for use in 16- and 17-year olds in the United States.
Pfizer’s COVID-19 vaccine booster is the first to get EUA in the United States for all individuals 16 years and older. The booster shot’s formulation and dosage strength are the same as the doses in the primary series.
Hours later, the Centers of Disease and Control Prevention (CDC) recommended that 16- and 17-year olds should also get a booster shot as some early data suggests that such shots provide protection against the Omicron variant.
Pfizer’s stock has risen 47.1% this year so far compared with an increase of 17.6% for the industry.
Image Source: Zacks Investment Research
Germany-based BioNTech’s shares are up 248.6% this year so far against the industry’s decrease of 19.1%.
Image Source: Zacks Investment Research
Pfizer's COVID-19 vaccine is the only one that has been granted full approval by the FDA for use in individuals 18 years and older while being approved for emergency/temporary use in several countries worldwide. The companies plan to submit a supplemental biologics license application (sBLA) for the approval of a booster dose for individuals 16 years of age and older. This sBLA will include data from a phase III study, which showed that a 30-µg booster dose demonstrated a relative vaccine efficacy of 95% versus those who did not receive a booster.
The authorization for 16- and 17-year olds came just a day after Pfizer and BioNTech announced data from preliminary laboratory studies. The studies showed that three doses of their COVID vaccine neutralized against infection with the Omicron variant while two doses showed significantly reduced neutralization titers. The data showed that the third dose increased the antibodies against the Omicron variant by 25-fold compared to the two doses. The data indicated that though two shots of the vaccine may still be effective at preventing severe infection caused by the Omicron variant, the protection is improved with a third shot. The companies also said that they are developing an Omicron-specific COVID-19 vaccine, which they can bring to the market by March 2022, if the need arises.
Meanwhile, the booster dose of Moderna’s vaccine was also granted EUA for use in all adults last month.
Moderna is also developing an Omicron-specific booster candidate. Currently, Moderna is testing sera from participants of 100-microgram booster studies to see if the dose provides neutralizing protection against Omicron.
A booster shot of J&J’s adenovirus-based single-shot COVID-19 vaccine was granted EUA by the FDA in October for adults aged 18 and older who have completed at least two months after the initial dose. The FDA also granted EUA to J&J’s vaccine for eligible individuals who were administered a different authorized or approved COVID-19 vaccine.
J&J is also pursuing a new vaccine against Omicron, which will be pushed to clinical development, rapidly, if needed. J&J is also testing the blood serum from participants of completed and ongoing booster studies for neutralizing activity against the Omicron variant.
Image: Bigstock
Pfizer, BioNTech Booster Gets FDA Nod for 16- & 17-Year Olds
Pfizer (PFE - Free Report) and partner, BioNTech (BNTX - Free Report) announced that the FDA has extended its Emergency Use Authorization (EUA) for their booster dose to allow its use in individuals 16 and 17 years of age. The shot for 16- and 17-year olds is to be given at least six months following the completion of the primary vaccination with Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty.
Pfizer and BioNTech’s booster dose was granted emergency approval by the FDA last month for all adults 18 years of age and older following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Unlike the booster criteria for adults, the primary vaccine regimen of 16- and 17-year-olds can only be Comirnaty as vaccines of Moderna (MRNA - Free Report) and J&J (JNJ - Free Report) are not authorized for use in 16- and 17-year olds in the United States.
Pfizer’s COVID-19 vaccine booster is the first to get EUA in the United States for all individuals 16 years and older. The booster shot’s formulation and dosage strength are the same as the doses in the primary series.
Hours later, the Centers of Disease and Control Prevention (CDC) recommended that 16- and 17-year olds should also get a booster shot as some early data suggests that such shots provide protection against the Omicron variant.
Pfizer’s stock has risen 47.1% this year so far compared with an increase of 17.6% for the industry.
Germany-based BioNTech’s shares are up 248.6% this year so far against the industry’s decrease of 19.1%.
Pfizer's COVID-19 vaccine is the only one that has been granted full approval by the FDA for use in individuals 18 years and older while being approved for emergency/temporary use in several countries worldwide. The companies plan to submit a supplemental biologics license application (sBLA) for the approval of a booster dose for individuals 16 years of age and older. This sBLA will include data from a phase III study, which showed that a 30-µg booster dose demonstrated a relative vaccine efficacy of 95% versus those who did not receive a booster.
The authorization for 16- and 17-year olds came just a day after Pfizer and BioNTech announced data from preliminary laboratory studies. The studies showed that three doses of their COVID vaccine neutralized against infection with the Omicron variant while two doses showed significantly reduced neutralization titers. The data showed that the third dose increased the antibodies against the Omicron variant by 25-fold compared to the two doses. The data indicated that though two shots of the vaccine may still be effective at preventing severe infection caused by the Omicron variant, the protection is improved with a third shot. The companies also said that they are developing an Omicron-specific COVID-19 vaccine, which they can bring to the market by March 2022, if the need arises.
Meanwhile, the booster dose of Moderna’s vaccine was also granted EUA for use in all adults last month.
Moderna is also developing an Omicron-specific booster candidate. Currently, Moderna is testing sera from participants of 100-microgram booster studies to see if the dose provides neutralizing protection against Omicron.
A booster shot of J&J’s adenovirus-based single-shot COVID-19 vaccine was granted EUA by the FDA in October for adults aged 18 and older who have completed at least two months after the initial dose. The FDA also granted EUA to J&J’s vaccine for eligible individuals who were administered a different authorized or approved COVID-19 vaccine.
J&J is also pursuing a new vaccine against Omicron, which will be pushed to clinical development, rapidly, if needed. J&J is also testing the blood serum from participants of completed and ongoing booster studies for neutralizing activity against the Omicron variant.
Both Pfizer and BioNTech have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.