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.
Johnson & Johnson (JNJ - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the use of the booster dose of its single-shot COVID-19 vaccine.
The CHMP supported the use of J&J’s booster dose in adults, administered at least two months after the primary vaccination with J&J’s vaccine. The regulatory body also recommended the use of the booster dose of the vaccine in adults who have received primary vaccination with either Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) Comirnaty or Moderna’s (MRNA - Free Report) mRNA-1273.
The opinion will now be reviewed by the European Commission and a final decision related to conditional marketing authorization for the booster dose should be available shortly.
We note that the booster dose of J&J’s vaccine already enjoys emergency use authorization (“EUA”) in the United States for use in adults following the completion of primary vaccination with J&J’s single-shot vaccine or mRNA-based vaccines from Pfizer and BioNTech or Moderna.
This year so far, J&J’s shares have risen 8.7% compared with an increase of 16.3% for the industry.
Image Source: Zacks Investment Research
The positive opinion from the CHMP for the use of J&J’s booster jab in adults was based on data from a phase III study — ENSEMBLE 2 — which demonstrated 75% protection against moderate-to-severe COVID-19 when administered after two months of primary vaccination with J&J’s COVID-19 vaccine. The data also showed that the booster jab provides 100% protection against severe COVID-19 after 14 days of immunization.
The CHMP also reviewed data from multiple real-world evidence studies that demonstrated similar effectiveness of J&J’s single-shot vaccine as observed in clinical studies.
The recommendation for heterologous administration of the booster vaccine — immunization with J&J’s booster jab in participants whose primary vaccination was a two-dose regimen of an mRNA-based vaccine from Pfizer and BioNTech or Moderna — was based on studies conducted by the National Institute of Allergy and Infectious Disease and the Beth Israel Deaconess Medical Center in the United States.
Interim data from the NIAID study demonstrated that immunization with J&J’s booster dose resulted in increased immune response in participants, irrespective of the primary vaccination regimen. Data from the study conducted by the Beth Israel Deaconess Medical Center demonstrated that J&J’s booster jab led to an increase in both antibody and T-cell responses in participants who received primary vaccination with Pfizer and BioNTech’s Comirnaty.
The world is currently facing the risk of another COVID-19 outbreak, led by a sharp increase in infection cases in many countries by a highly mutated coronavirus variant, Omicron.
J&J is developing an Omicron-specific booster. The blood serum from the participants of completed and ongoing booster studies is are also being tested by the company for neutralizing activity against the Omicron variant
Single booster doses of Pfizer and BioNTech’s Comirnaty and Moderna’s mRNA-1273 were granted EUA by the FDA last month for use in all adults. Pfizer, BioNTech and Moderna are also developing an Omicron-specific booster dose of their COVID-19 vaccine.
We remind investors that J&J’s booster dose was added to the World Health Organization’s emergency use listing (“EUL”) earlier this month.
In October, the use of the additional dose/booster dose of other authorized COVID-19 vaccines, including Pfizer and BioNTech’s Comirnaty and Moderna’s mRNA-1273 in immunocompromised adults, was added to WHO’s EUL.
Image: Bigstock
J&J's (JNJ) COVID-19 Booster Jab Gets CHMP Recommendation
Johnson & Johnson (JNJ - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the use of the booster dose of its single-shot COVID-19 vaccine.
The CHMP supported the use of J&J’s booster dose in adults, administered at least two months after the primary vaccination with J&J’s vaccine. The regulatory body also recommended the use of the booster dose of the vaccine in adults who have received primary vaccination with either Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) Comirnaty or Moderna’s (MRNA - Free Report) mRNA-1273.
The opinion will now be reviewed by the European Commission and a final decision related to conditional marketing authorization for the booster dose should be available shortly.
We note that the booster dose of J&J’s vaccine already enjoys emergency use authorization (“EUA”) in the United States for use in adults following the completion of primary vaccination with J&J’s single-shot vaccine or mRNA-based vaccines from Pfizer and BioNTech or Moderna.
This year so far, J&J’s shares have risen 8.7% compared with an increase of 16.3% for the industry.
The positive opinion from the CHMP for the use of J&J’s booster jab in adults was based on data from a phase III study — ENSEMBLE 2 — which demonstrated 75% protection against moderate-to-severe COVID-19 when administered after two months of primary vaccination with J&J’s COVID-19 vaccine. The data also showed that the booster jab provides 100% protection against severe COVID-19 after 14 days of immunization.
The CHMP also reviewed data from multiple real-world evidence studies that demonstrated similar effectiveness of J&J’s single-shot vaccine as observed in clinical studies.
The recommendation for heterologous administration of the booster vaccine — immunization with J&J’s booster jab in participants whose primary vaccination was a two-dose regimen of an mRNA-based vaccine from Pfizer and BioNTech or Moderna — was based on studies conducted by the National Institute of Allergy and Infectious Disease and the Beth Israel Deaconess Medical Center in the United States.
Interim data from the NIAID study demonstrated that immunization with J&J’s booster dose resulted in increased immune response in participants, irrespective of the primary vaccination regimen. Data from the study conducted by the Beth Israel Deaconess Medical Center demonstrated that J&J’s booster jab led to an increase in both antibody and T-cell responses in participants who received primary vaccination with Pfizer and BioNTech’s Comirnaty.
The world is currently facing the risk of another COVID-19 outbreak, led by a sharp increase in infection cases in many countries by a highly mutated coronavirus variant, Omicron.
J&J is developing an Omicron-specific booster. The blood serum from the participants of completed and ongoing booster studies is are also being tested by the company for neutralizing activity against the Omicron variant
Single booster doses of Pfizer and BioNTech’s Comirnaty and Moderna’s mRNA-1273 were granted EUA by the FDA last month for use in all adults. Pfizer, BioNTech and Moderna are also developing an Omicron-specific booster dose of their COVID-19 vaccine.
We remind investors that J&J’s booster dose was added to the World Health Organization’s emergency use listing (“EUL”) earlier this month.
In October, the use of the additional dose/booster dose of other authorized COVID-19 vaccines, including Pfizer and BioNTech’s Comirnaty and Moderna’s mRNA-1273 in immunocompromised adults, was added to WHO’s EUL.
Johnson & Johnson Price
Johnson & Johnson price | Johnson & Johnson Quote
Zacks Rank
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.