Sanofi and Glaxo start Phase 1/2 trials of their coronavirus vaccine

[NRSKarenRN, BSN, RN]

CNN  9/3/20

Sanofi and Glaxo start Phase 1/2 trials of their coronavirus vaccine 
 

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Sanofi Pasteur and GlaxoSmithKline said Thursday they are starting early stage trials of their experimental coronavirus vaccine, one of several being backed by the US federal government’s Operation Warp Speed.

The companies said they were recruiting 440 healthy adults at 11 trial sites to test out the vaccine in a randomized, double blind and placebo-controlled trial. Researchers will watch to see if the vaccine is safe and whether it induces an immune response. 

“The Companies anticipate first results in early December 2020, to support the initiation of a Phase 3 trial in December 2020. If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021,” Glaxo said in a statement....

https://www.cnn.com/world/live-news/coronavirus-pandemic-09-03-20-intl/index.html

 

 

[NRSKarenRN, BSN, RN]

Stars and Stripes 9/3/2020

Five US military facilities are among the locations selected for final coronavirus vaccine trials

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WASHINGTON — Five U.S. military locations will participate in the final stage of clinical development for a potential coronavirus vaccine, and the government is looking for volunteers to participate, Pentagon officials said Thursday.

The military medical facilities chosen in Texas, California and the Washington D.C. area were among dozens of locations across the country selected to participate in Phase III testing of drug maker AstraZeneca’s AZD1222, one of four vaccine candidates undergoing testing. In Phase III, thousands of volunteers are given the potential vaccines to study its effectiveness and safety, according to the National Centers for Disease Control and Prevention.

Officials are asking Military Health System beneficiaries – service members, their families and retirees – near the selected facilities to volunteer for the study. They can do so by completing a survey at www.coronaviruspreventionnetwork.org and entering a code corresponding to one of the five military locations.

Those facilities and their survey codes are:

• Naval Medical Center San Diego in California (Code: NMSD) 
• Joint Base San Antonio Brooke Army Medical Center in Texas (Code: BAMC) 
• Wilford Hall Ambulatory Surgical Center in Texas (Code: WHASC) 
• Walter Reed National Military Medical Center in Maryland (Code: WRMC) 
• Fort Belvoir Community Hospital in Virginia (Code FBCH) 

The survey takes about 10 minutes to complete. Those selected for participation will be notified by coordinators at those sites, Pentagon officials said.

Officials are particularly looking for volunteers with increased risk of contracting the coronavirus to participate. Those include workers in essential jobs including health care workers, emergency responders, grocery workers and restaurant staffers. They are also looking for individuals who live or work in densely populated residential environments, including nursing homes. Officials also want members of communities who have been hit hardest during the pandemic to participate, including older individuals, people with underlying health conditions and minorities including African Americans, Latin Americans and Native Americans....

www.stripes.com/news/us/five-us-military-facilities-are-among-the-locations-selected-for-final-coronavirus-vaccine-trials-1.643773

 

 

[NRSKarenRN, BSN, RN]

Bloomberg News reported 9/9/2020:

AstraZeneca Study Halted After Spinal-Cord Issue, NIH Chief Says
 

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U.S. National Institutes of Health Director Francis Collins told a Senate committee Wednesday that AstraZeneca Plc’s closely watched Covid-19 vaccine trial had been halted due to a “spinal cord problem.”...

...Appearing before the Senate Committee on Health, Education, Labor & Pensions, Collins said that the severe adverse event in question was transverse myelitis, a neurological disorder that causes inflammation of the spinal cord. If AstraZeneca’s review finds the adverse event is related to the vaccine, all the doses already manufactured will be thrown away, Collins said....

https://www.bloomberg.com/news/articles/2020-09-09/astrazeneca-study-halted-after-spinal-cord-issue-nih-chief-says