Johnson & Johnson Archives - Page 26 of 33

Feds halt Johnson & Johnson COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause of administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among those doses, there have been six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. The CDC and FDA are reviewing data involving these cases.

In such cases, a form of blood clot known as cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia), according to the joint statment. All six cases were in women between ages 18 and 48, with symptoms occurring between six and 13 days after vaccination.

Treatment for CVST is different from that which may typically be administered, which is an anticoagulant drug called heparin. In these cases, heparin may be dangerous and alternative treatments are needed,…

EMA begins investigation of J&J COVID-19 vaccine’s blot clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died.

A Johnson & Johnson summary of the Ad26.COV2.S vaccine clinical trial cited a “numerical imbalance” for deep vein thrombosis (DVT) and pulmonary embolism (PE) between vaccine and placebo recipients. In the vaccine arm, there were five cases of DVT and four cases of PE. By contrast, there were two DVT reports and one of PE in the study’s placebo arm.

The company has stressed that it has found no causal relationship between the rare blood clotting events and its vaccine.

European regul…

Johnson & Johnson COVID-19 vaccine shipments plunge

Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000.

The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes an Emergent BioSolutions plant in Baltimore to produce the vaccine.

Johnson & Johnson (NYSE:JNJ) announced that it would assume complete control over the production of its COVID-19 vaccine at the facility of Emergent BioSolutions Bayview, which is a contract manufacturing partner of J&J.

A factory error at the Emergent BioSolutions plant ruined up to 15 million COVID-19 vaccine doses. An additional 62 million doses of the vaccine could be discarded if the company determines they are at risk of contamination.

FDA has not indicated when it might authorize production lines at the Emergent BioSolu…

J&J Vision, Menicon to collaborate on therapeutic contact lens

Johnson & Johnson (NYSE:JNJ) Vision announced today that it entered into a strategic collaboration with Menicon for contact lens development.

J&J Vision and Menicon are partnering to bring forward a novel portfolio of products and services to manage the progression of myopia, sometimes known as “nearsightedness,” in children, according to a news release.

Menicon is set to manufacture therapeutic contact lenses designed to help manage the progression of myopia in children, while J&J Vision will be responsible for expanding the availability of the lenses around the world.

“For decades, Johnson & Johnson Vision has invested in research collaborations with academic centers, research institutes and leading global health organizations who share our vision of leading with science to reshape the future of myopia and eye health,” J&J Vision Care global president Peter Menziuso said in the release. “Our collaboration with Menicon ma…

Emergent has reportedly had serious problems at Baltimore vaccine plant

Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times.

Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.

Get the full story on our sister site Pharmaceutical Processing World.

Johnson & Johnson to test COVID-19 vaccine in adolescents

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

Feds put J&J in charge of vaccine production at Emergent plant

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.

The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.

Get the full story at our sister site, Pharmaceutical Processing World.

Feds put J&J in charge of vaccine production at Emergent plant

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.

The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.

New Brunswick, N.J.-based J&J’s single-dose vaccine was authorized by the FDA for emergency use in March. Only a handful of days later, the Biden administration announced a contract for 100 million doses of the vaccine.

However, news came to light that, several weeks ago, workers at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.

A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did n…

8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery for the rest of the year, according to Newitter “It plateaued and actu…

8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]

Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery fo…

Johnson & Johnson to provide 220M COVID-19 vaccine doses to African Union

Flag of the African Union

Johnson & Johnson (NYSE:JNJ) announced today that it has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make 220 million COVID-19 vaccine doses available to the 55 African Union member countries.

AVAT also has the potential to order an additional 180 million doses to bring the total to 440 million through 2022. J&J’s move comes as experts increasingly warn that the rollout of COVID-19 vaccine must be truly global — and not too focused on wealthy countries. Otherwise, the pandemic could stretch on for years as new virus variants increasingly crop up in poorer countries.

J&J is also supporting COVAX, a global initiative to provide vaccine doses to developing countries.

“From the beginning of this pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to equit…

How big medtech fared during a year of COVID-19

[Image from Unsplash]Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing/MassDevice analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, Stryker, Teleflex and Zimmer Biomet.

Get the full s…