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 […]
Clinical Trials
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 […]
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 […]
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 during 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 […]
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 […]
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% […]
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 […]
Is there a link between Bell’s palsy and COVID-19 vaccines?
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 […]
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 […]
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 […]
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,” […]
