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Total 21 results found since Jan 2013.
Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet
NEW BRUNSWICK, NJ, May 5, 2022 - Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine. Johnson & Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has updated its U.S. COVID-19 Vaccine Fact Sheet to increase awareness about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition. Language about the risk of TTS has been added to the first page of the Fact Sheet to increase its prominence. Following the update to the Fact Sheet, the Johnson & Johnson COVID-19 vaccine is now...
Source: Johnson and Johnson - May 5, 2022 Category: Pharmaceuticals Source Type: news
Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP Meeting
NEW BRUNSWICK, N.J., December 16, 2021 – Johnson & Johnson remains confident in the overall positive benefit-risk profile of its COVID-19 vaccine. Studies have shown that the Johnson & Johnson COVID-19 vaccine generates strong antibody and cellular immune responses [i] and long-lasting immune memory[ii] and breadth of protection across variants. In addition, a growing body of evidence is revealing the strength of protection of our vaccine as a booster to either the Janssen COVID-19 vaccine or a different authorized or approved COVID-19 vaccine, both in terms of its efficacy and durability.[iii], [iv], [v], [vi], ...
Source: Johnson and Johnson - December 16, 2021 Category: Pharmaceuticals Source Type: news
Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
NEW BRUNSWICK, N.J., December 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). “We are pleased with today’s Positiv...
Source: Johnson and Johnson - December 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants ...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S.
NEW BRUNSWICK, N.J., February 28, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). “For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe today’s re...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Source Type: news
Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use
NEW BRUNSWICK, N.J., February 27, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against ...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Emergency Considerations in COVID-19 Vaccine Administration
Conclusion
The joint response of science and medicine to develop safe and effective COVID-19 vaccines has been brisk and productive. Distribution efforts will now be the next step in limiting the breadth of this pandemic. EMS agencies will play a key role in some areas in the administration of vaccinations for their communities.
The authors suggest that to better clarify the side effects of the COVID-19 vaccines, EMS systems must maintain a log of the type and incidence of adverse events following vaccine administration, EMS responses to the adverse events, as well as those patients’ outcomes from this management. ...
Source: JEMS Patient Care - December 16, 2020 Category: Emergency Medicine Authors: JEMS Staff Tags: Coronavirus Exclusives EMS EMT Paramedic Source Type: news
FDA approves Xolair ® (omalizumab) for adults with nasal polyps
Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Media News - December 1, 2020 Category: Pharmaceuticals Source Type: news
Partnering with General Pediatricians to De-label Penicillin Allergies in Children
Penicillin allergy is the most common antibiotic allergy, with nearly 10% of the United States population reporting an allergy.1 Penicillin allergy is frequently suspected due to a reported rash, family history of penicillin allergy, or non-IgE mediated symptoms such as headache.1,2 However, when tested, less than 5% of patients actually have a clinically significant allergic reaction.1,2 Very few individuals undergo penicillin allergy testing, and thus maintain the mislabeled penicillin allergy.
Source: Annals of Allergy, Asthma and Immunology - April 10, 2020 Category: Allergy & Immunology Authors: Erika Cherk, Kenneth Morris, Cathleen A. Collins Tags: Letters Source Type: research
