Clinical Trials Archives - Medical Design Sourcing

Introducing ‘BYOP’ clinical trials

Image courtesy of Pixabay.

BYOD — “bring your own device” — became a common term in tech circles a decade ago. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is working to connect patients with local physicians to collect real-world data and execute trials.

In any event, decentralized and hybrid clinical trials continue to gain ground as the pandemic persists. The trend is elevating the role of community-based clinical trials in areas such as oncology.

Get the full story from our sister site, Drug Discovery Trends.

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

Get the full story from our sister site, Drug Discovery & Development.

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

Get the full story from our sister site, Drug Discovery & Development.

Pfizer launches trial for novel oral COVID-19 therapeutic

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults.

Known as PF-07321332, the drug has shown promise in in vitro studies against SARS-CoV-2.

PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to a viral enzyme known as protease to stop viral replication.

Pfizer believes PF-07321332 to be the first orally-administered SARS-CoV-2-specific investigational protease inhibitor to be studied in a clinical trial.

Get the full story from our sister site, Drug Discovery & Development.

AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant

The ChAdOx1 COVID-19 vaccine jointly developed between AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM.

In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based on that data, the vaccine has an efficacy of 22% in protecting against mild-to-moderate disease in South Africa more than 14 days after the second dose. Efficacy against the B.1.351 variant specifically was 10.4%.

Get the full story from our sister site, Drug Discovery & Development.

Novax could have one of the most-effective COVID-19 vaccines

Novavax (Gaithersburg, Md.) may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer.

Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90% range in similar studies.

But the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Pfizer-BioNTech vaccine dramatically reduces death risk from COVID-19, study finds

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die due to COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine.

Also, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19.

The data also suggest that the vaccine prevents the spread of asymptomatic COVID-19 and is 94% effective against symptomatic disease.

Get the full story from our sister site, Drug Discovery & Development.

Is there a link between Bell’s palsy and COVID-19 vaccines?

Image courtesy of Nataliya Vaitkevich via Pexels.

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.

Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.

Get the full story from our sister site, Drug Discovery & Development.

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.

Get the full story from Drug Discovery & Development.

Russia reports 91.6% efficacy for its Sputnik V COVID-19 vaccine

Sputnik V in vials. Image from Mos.ru via Wikipedia.

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 data, however, was available on the impact of SARS-CoV-2 variants on the vaccine’s efficacy.

Get the full story from our sister, Drug Discovery & Development.

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,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.

Get the full story from our sister site, Drug Discovery & Development.

Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351.

Get the full story from our sister site, Drug Discovery & Development.