>>45693

Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine

NEW BRUNSWICK, N.J., April 14, 2021– The U.S. Centers f or Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened today to consider reports of an extremely rare disorder involving blood clots in combination with low platelets observed in a small number of individuals following vaccination with the Johnson & Johnson COVID-19 vaccine.

“The safety and well-being of the people who use our products is our number one priority, and we strongly support awareness of the signs and symptoms of this extremely rare evento ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We continue to believe in the positive benefit-risk profile of our vaccine. We value the consideration of the Advisory Committee, and we will continue to collaborate with medical experts and global health authorities, including the CDC, U.S. Food and Drug Administration (FDA), European Medicines Agency and the World Health Organization, as we work toward continuing vaccinations to end the global pandemic.”

Out of an abundance of caution, the CDC and FDA have recommended [https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine] a pause in the use of our vaccine. The Company has made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.

The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

For more information on the Janssen COVID-19 vaccine, click [https://www.janssen.com/covid-19-vaccine]

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company, any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov [https://www.sec.gov/], www.jnj.com [https://www.jnj.com/] or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

https://www.janssen.com/us/sites/www_janssen_com_usa/files/jnj_statement_on_acip.pdf

>>45764

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

FDA Statement

The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC

For Immediate Release:

April 13, 2021

Statement From:

Statement Author

Leadership Role

Director - Center for Biologics Evaluation and Research (CBER)

Peter Marks M.D., PhD.

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call is available on the FDA’s YouTube channel [https://www.youtube.com/watch?v=_ELXnGYgsJY]

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

>>45764, >>45693

Reminder

Excerpt

nih.gov

News Release

Friday, January 29, 2021

Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released

An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.

The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant. Moderate COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus either one of the following: evidence of pneumonia; deep vein thrombosis; difficulty breathing; abnormal oxygen saturation or a respiratory rate equal to or greater than 20; or two or more signs or symptoms suggestive of COVID-19, such as cough, sore throat, fever or chills. Severe COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus evidence of clinical signs at rest indicative of severe systemic illness, respiratory failure, shock, significant organ dysfunction, hospital intensive care unit admission or death.

The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein. SARS-CoV-2 is the virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts; the adenovirus vector used in the experimental vaccine has been modified, so that it can no longer replicate in humans and cause illness. In developing the vaccine, Janssen employed the same vector used in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo), developed under a long-standing partnership with BARDA and granted marketing authorization by the European Commission in July 2020. Unlike the two COVID-19 vaccines currently authorized by the U.S. Food and Drug Administration for emergency use (Pfizer and Moderna vaccines), the Janssen investigational vaccine requires only a single vaccination.

https://www.nih.gov/news-events/news-releases/janssen-investigational-covid-19-vaccine-interim-analysis-phase-3-clinical-data-released

NIH…Turning Discovery Into Health®

>>45693, >>45764, >>45766

Johnson & Johnson's vaccine, Janssen Pharmaceuticals

"Janssen's coronavirus vaccine is a recombinant vector vaccine. Like AstraZeneca's, it uses an adenovirus but this one does infect humans. It is a genetically engineered version of adenovirus 26, which can cause the common cold but the gene tinkering has disabled it. It also delivers the genetic instructions to make spike protein."

https://cnnphilippines.com/world/2020/12/1/COVID-19-vaccines-coronavirus.html

Recombinant DNA

Recombinant DNA molecules are DNA molecules formed by laboratory methods of genetic recombination that bring together genetic material from multiple sources, creating sequences that would not otherwise be found in the genome

https://en.wikipedia.org/wiki/Recombinant_DNA

Viral vector

Viral vectors are tools commonly used by molecular biologists to deliver genetic material into cells. This process can be performed inside a living organism or in cell culture.

https://en.wikipedia.org/wiki/Viral_vector

Adenoviruses are medium-sized, nonenveloped viruses with an icosahedral nucleocapsid containing a double stranded DNA genome. Their name derives from their initial isolation from human adenoids in 1953.

https://en.wikipedia.org/wiki/Adenoviridae

Adenoid

In anatomy, the adenoid, also known as the pharyngeal tonsil or nasopharyngeal tonsil, is the superior-most of the tonsils. It is a mass of lymphatic tissue located behind the nasal cavity, in the roof of the nasopharynx, where the nose blends into the throat.

https://en.wikipedia.org/wiki/Adenoid

WHAT ARE THE INGREDIENTS IN THE JANSSEN COVID-19 VACCINE? The Janssen COVID-19 Vaccine includes the following ingredients:recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-Recipient-fact-sheet.pdf

Ad26.ZEBOV is derived from human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein, while the second component MVA-BN is the Modified Vaccinia Virus Ankara – Bavarian Nordic (MVA-BN) Filo-vector

https://en.wikipedia.org/wiki/Ebola_vaccine

The Janssen COVID‑19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID‑19.

https://www.janssencovid19vaccine.com/for-recipients/about-the-vaccine.html

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

WHAT IS COVID-19? COVID-19 is caused [?] by a coronavirus called SARS-CoV-2. __This type of coronavirus has not been seen before.[?]__You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs.People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Common symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-Recipient-fact-sheet.pdf