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There continue to be studies and trials related to vaccines and drugs against COVID-19. Here’s a look.
NIH Begins Testing New Moderna Vaccine Against South African Variant
The National Institutes of Health (NIH) initiated tests of a new COVID-19 vaccine from Moderna targeting the South African variant, B.1.351. It is being tested in about 210 healthy adults. It will also include about 60 adults who participated in Moderna’s first COVID-19 vaccine trials last year and about 150 people who have not yet received a vaccine. The trial is recruiting volunteers in Atlanta, Cincinnati, Seattle, and Nashville.
“Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and White House chief medical advisor. “However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”
RedHill Biopharma Trial Receives Unanimous Go-Ahead
RedHill Biopharma’s Phase II/III trial of Yeliva (opaganib) in hospitalized severe COVID-19 pneumonia patients received a unanimous recommendation to continue after a fourth independent Data Safety Monitoring Board (DSMB) safety review. The recommendation was based on unblinded safety data from the first 255 patients who received treatment for 14 days.
Yeliva inhibits spinghosine kinase-2 and can be taken orally. It has both anti-inflammatory and antiviral activity, targeting a host cell component of viral replication. It also has anticancer activity and is being studied in several oncology, viral, inflammatory and gastrointestinal indications.
“With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib,” said Mark L. Levitt, medical director for RedHill. “Moreover, adding together the positive Phase II data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase II/III study, which will provide the clearest indication to date of opaganib’s promise in treating COVID-19.”
EMA Expands AstraZeneca Clotting Investigation, Reviews J&J for Same
The AstraZeneca-Oxford COVID-19 vaccine has been under pressure lately for reports of severe but sporadic cases of blood clots. The European Medicines Agency (EMA) announced it has begun reviewing these cases and expanding the study to include Johnson & Johnson’s vaccine and blood clots.
Across Europe and other parts of the world, countries have suspended deployment of the AstraZeneca-Oxford University vaccine after reports of blood clots, with some deaths associated.
Incidences were first reported in Denmark and Norway, which halted distribution, followed by Germany and France, and other countries. Most recently, Australia restricted the use of the AstraZeneca vaccine in people under the age of 50. It has yet to be submitted for authorization in the U.S.
To date, there have been four cases of blood clots with low platelets and one fatality linked with J&J’s vaccine, according to EMA.
Ridgeback and Merck’s Antiviral Shows Promise
Merck and Ridgeback Biotherapeutics announced preliminary results from Ridgeback’s Phase IIa trial of molnupiravir in COVID-19. They reported on one secondary objective, demonstrating a decrease in days to the negativity of infectious virus isolation in nasopharyngeal swabs, as determined by isolation in Vero cell line culture. The results were presented during Science Spotlights at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021).
Taken orally, molnupiravir is a ribonucleoside analog that acts as an inhibitor of RNA viral replication, including SARS-CoV-2, the virus that causes COVID-19. The companies have conducted studies where the drug appears to show promise for the treatment of COVID-19 and in MERS.
The Link LonkApril 09, 2021 at 11:47PM
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COVID-19 News: Clinical Trial for Moderna Booster Begins and More - BioSpace
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