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. J&J’s vaccine is the third COVID-19 vaccine to receive authorization in the U.S. so far.
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The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.
Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.
The agency will likely authorize the vaccine quickly.
J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.
While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.
VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some member…
Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.
A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed.
But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine virtual event.
The traditional vaccine development process, which typically spans years, was “shortened, but no integrity was lost,” Corbett said.
Scientists at the NIH have studied coronaviruses for several years, said Corbett, who leads a research team there focused on coronavirus vaccines.
One central factor driving the rapid development of mRNA COVID-19 vaccines was the collaboration between laboratories, institutions and companies across the globe.
“And then secondly, there was extensive work on MERS and other …
Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine.
In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults.
The two companies believe the setback resulted from an insufficient amount of the antigen in the vaccine. They have since revised the formulation and have launched a Phase 2 study to test the adjuvanted recombinant protein-based COVID-19 vaccine candidate.
If the study meets its primary endpoints, the companies will launch a Phase 3 trial in the second quarter of the year with authorization potentially following in the fourth quarter of the year.
“We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,’ said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, in a statement…
[Photo by Fusion Medical Animation on Unsplash]
In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available.Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to the New York Times vaccination tracker. “If you’re looking over the past 12 months, it doesn’t look like we’ve gotten very far,” said Reed Stephens, a partner at the global law firm Winston & Strawn.
But the rate of vaccination is picking up. The U.S. vaccination rate is now hovering between 1.5 to 2 million doses per day. Production is ramping up, and FDA will likely authorize additional vaccines in the coming months. Stephens said the goal of getting a large percentage of U.S. adults vaccinated by the end of summer seems within reach.
Sinc…
Mountain View, Calif.-based Aditx Therapeutics (NSDQ:ADTX) has recently introduced an offering known as AditxtScore, a lab-developed test that provides a comprehensive profile of the immune system. An initial focus area for the technology will be monitoring COVID-19 immunity.
The technology could also help inform the development of immunotherapies and reduce organ transplant rejection. One of the company’s cofounders, the late Dr. Leonard Bailey, was best known for transplanting a baboon’s heart into a human infant in 1984.
When the company was founded in 2017, the company set out immune monitoring and reprogramming. In addition to organ transplants, autoimmune disorders and allergies were focus areas. “All of them have one thing in common,” said the company’s CEO and cofounder, Amro Albanna. “They’re generally caused by our immune system overreacting.”
But with the rise of COVID-19, much of society is worried about the possibility of the immune system …
Photo by Andrea Piacquadio from Pexels
Cardiology trials often adopt composite endpoints that combine several events of clinical interest as the primary efficacy outcome.
Time-to-first-event approaches follow the recommendations of regulatory agencies. But composite outcomes that only consider the first event are suboptimal for a chronic disease such as heart failure (HF), which is characterized by recurrent HF hospitalizations since repeat events within individuals are ignored in analyses.
Recurrent HF hospitalizations indicate a worsening condition and disease progression, so considering all HF hospitalizations in analysis more accurately assesses the effect of treatment on the true disease burden. Currently, there is no recommendation as to the preferred approach. The CHARM-Preserved trial shows the impact of analyzing only the time-to-first event and ignoring repeat hospitalizations.1
Of th…
Portugal health authorities recently recommended that AstraZeneca’s (LON:AZN) COVID-19 vaccine not be used for those who are over 65.
South Africa recently paused its deployment of the vaccine over worries that it is ineffective against a variant circulating there.
In addition to Portugal, several European countries have expressed reservations about the vaccine’s efficacy in older populations. France, Norway, Germany, Austria and others have decided to only administer the vaccine to those under 65. Poland has reserved the vaccine for those 60 and under, while Spain and Italy have recommended for recipients under 55.
The reservations of the E.U. nations stems in large from a data shortage. Two patients over 65 in the AstraZeneca trial contracted the virus, making it difficult to draw firm conclusions about its efficacy in that age group. There were 660 patients over 65 in the trial.
Portugal has had 765,000 COVID-19 cases and more than 14,000 d…
Remote patient monitoring technology from Biobeat can detect 14 cardio-pulmonary vital sign measurements. A number of pharma companies and contract research organizations are implementing the technology. Image courtesy of Biobeat.
Remote patient monitoring (RPM) is among the trends that will have the greatest impact on the pharma sector in 2021, according to the recent report, “The State of the Biopharmaceutical Industry, 2021 Edition,” from GlobalData. After a period of gradual uptake, RPM “witnessed a massive uptake in the life-sciences sector in 2020,” according to the GlobalData report.
The technology offers several advantages. It can help pharmaceutical companies continue making progress with clinical trials during a pandemic. The ability to gather data from patients remotely can also reduce the burden on medical staff while reducing gaps in clinical trial data. “One of the advantages when you have freq…
Hopes for COVID-19 vaccines to beat back the pandemic assumed mass-vaccination would slow viral transmission, and not just prevent moderate-to-severe disease.
Now, early data suggest that AstraZeneca’s (LON:AZN) COVID-19 vaccine, which it jointly developed with Oxford University, can curb viral transmission by up to 67%.
There was more good news from the data. The ChAdOx1 vaccine offered 100% protection against severe disease in a Phase 3 trial. A single vaccine dose offered 76% efficacy between 22 and 90 days after vaccination. Delaying the second dose of vaccine by 12 weeks appeared to boost efficacy to 82%. Efficacy fell to 55% when the gap between doses dropped to less than six weeks.
The study concluded that the U.K.’s strategy of aiming to vaccinate a large proportion of the population with the first dose before administering the second vaccine dose up to 12 weeks later is “an effective strategy.”
Also heartening is the fact that a porti…
Image courtesy of Nymi
The pandemic has amplified the pressure pharmaceutical companies face to improve operational performance while also forcing them to accelerate innovation, clinical trials and production. All of this requires employees to work as efficiently as possible.
Technology is available to meet these needs while also helping pharma companies respond to new worker safety challenges. Within pharma facilities, workers want to touch fewer surfaces and minimize their interactions. Accomplishing these goals requires deploying hands-free systems, conducting self-health attestations before shifts, and enforcing social distancing and contact tracing procedures.
Efficiency and safety are not mutually exclusive goals. Businesses that fall short in these areas risk their brand reputation, bottom line and employees’ lives. While many companies previously addressed individual challenges using point sol…
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,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.
[Related: Johnson & Johnson pharma sales drive Street-beating Q4 results]
If the company’s adenovirus-based vaccine performs in the same league as those from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE), Ad26 could play a vital role in stemming the COVID-19 crisis. Unlike competitors’ vaccines, Ad26 could be offered in a single dose, potentially simplifying mass-vaccination efforts.
Former Operation Warp Speed chief Moncef Slaoui suggested that Ad26 vaccine…