Johnson & Johnson

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the…

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from…

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots. At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC…

Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel…

Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events. Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s…

A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine. The CDC and FDA announced on April 13 their recommendation to pause the vaccine’s use on safety grounds.…

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the…

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday. The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot…

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus. But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed severe blood clot disorders. Officials in both the…

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…

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…

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…

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,…

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…

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 &…

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…

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.…

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…

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…

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…

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…

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 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 (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…

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…