The FDA and CDC issued a joint statement today recommending the pause in the 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 recipients of those doses, six cases of a rare and severe type of blood…
EMA begins investigation of J&J COVID-19 vaccine’s blood 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…
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…
FDA approves oral multiple sclerosis treatment from J&J’s Janssen unit
Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment. Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease,…
Tinnitus reports grow amid COVID-19 vaccinations
A handful of patients in Johnson & Johnson’s Phase 3 COVID-19 clinical trial complained of tinnitus, or ringing in the ears. After reporting on the subject, we’ve received a steady stream of reports from Moderna and Pfizer-BioNTech vaccine recipients who experienced tinnitus. The U.S. Vaccine Adverse Event Reporting System (VAERS) database cites 152 reports of…
Report: Biden to buy 100M additional doses of J&J COVID-19 vaccine
President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine. An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration. The purchase of doses from Johnson &…
Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine
President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine. The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week. Get the full story at…
FDA authorizes J&J’s single-dose COVID-19 vaccine
Americans will start receiving Johnson & Johnson‘s COVID-19 vaccine within the next 24 to 48 hours, J&J CEO Alex Gorsky told NBC’s Today this morning. FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over.…
8 things to keep in mind related to the FDA advisory meeting on J&J vaccine
Today, an FDA advisory panel is convening to evaluate the Ad26.COV2.S COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ). The vaccine has a favorable safety profile and significant efficacy after a single dose. Here are several themes that are likely to be among the topics discussed in the Vaccines and Related Biological Products Advisory Committee meeting. 1. The…
Is J&J’s COVID-19 vaccine linked to tinnitus?
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. J&J concluded that the tinnitus reports…
FDA analysis finds J&J’s single-dose COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted…
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which…
J&J applies for COVID vaccine approval in Europe
Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on…
South Africa pauses rollout of AstraZeneca COVID-19 vaccine
South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there. In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE). Researchers at Oxford University…
Johnson & Johnson applies for vaccine approval from FDA
Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its…
Russia reports 91.6% efficacy for its Sputnik V COVID-19 vaccine
The Sputnik V COVID-19 vaccine could be more efficacious than those from AstraZeneca (LON:AZN) or Johnson & Johnson (NYSE:JNJ) based on interim trial results. The two-dose Sputnik vaccine was 91.6% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe and moderate disease in a study involving 19,866 participants. The data were published in The Lancet. No…
4 ways SARS-CoV-2 variants could change the battle against the pandemic
Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus…
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of…
Johnson & Johnson gearing up for COVID-19 vaccine data announcement
Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week. In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details. “We think it’s very important to follow the data — to follow the science,”…
Verana Health to collaborate with Janssen on ophthalmology and urology research
Verana Health (San Francisco), which has expertise in turning clinical data into real-world evidence, announced today that it has inked a research collaboration agreement with Johnson & Johnson‘s Janssen Research & Development. The research with Janssen will have an ophthalmology and urology focus. In the ophthalmology space, Verana Health will analyze the American Academy of…
Johnson & Johnson pharma sales drive Street-beating Q4 results
Johnson & Johnson (NYSE:JNJ) posted fourth-quarter results today that beat the consensus forecast on Wall Street — with the company predicting a return to strong sales growth in 2021. The New Brunswick, N.J.–based pharma, medical device and consumer products giant reported profits of $1.7 billion, or 65¢ per share, on sales of $22.5 billion for the…
Johnson & Johnson vaccine trial results expected soon
Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon. The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized…
11 COVID-19 therapies you need to know
The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the…
U.S. pharmaceutical industry sees total prescriptions drop
The U.S. pharmaceutical industry has fared better than most sectors in 2020, but the industry still faces tailwinds, according to recent IQVIA research. Total prescription sales are down 2.1% year over year in the fourth quarter of 2020 to date, according to an analysis of the IQVIA data by the investment bank UBS. New prescriptions…
NIH launches drug trial for deadly cytokine storm
The National Institutes of Health today launched a Phase 3 clinical trial to evaluate three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes proteins that trigger inflammation, otherwise known as a cytokine storm, which can lead to acute respiratory distress syndrome, multiple…