2021 Biopharma Update on the Novel Coronavirus: January 5

CV Update_Jan 5_2021

News information is not all-inclusive and updates are published once a week on Tuesdays. 

 

Testing Therapies, Antivirals and Vaccines

Sinopharm, a Chinese biopharmaceutical company controlled by the state, announced that its COVID-19 vaccine candidate had an efficacy rate of 79% based on interim analysis of Phase III trials.

Serious adverse events related to the two recently-released vaccines are making headlines. Although the events are rare – fewer than 20 severe allergic reactions after nearly 2 million doses have been administered in the U.S. – it’s enough to make people hesitant to be vaccinated when their turn arrives. Please read more here

aTyrPharma announced positive topline results from its Phase II trial of ATYR1923 in hospitalized COVID-19 patients with severe respiratory complications who do not require mechanical ventilation. It hit its primary endpoint of safety and demonstrated preliminary signal of activity via clinical improvement in the high dose cohort.

Arcturus Therapeutics received FDA approval to launch its Phase II trial of its COVID-19 vaccine candidate ARCT-021 after a review of Phase I/II data. It will enroll 600 participants, 450 receiving the vaccine and 150 receiving placebo.

 

Organizational Actions/Announcements 

The U.S. Food and Drug Administration (FDA) came out to warn health care personnel not to make any changes to the dosing of the vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”

Residents of the United Kingdom now have a second vaccine against the novel coronavirus, even as a more virulent strain of COVID-19 sweeps across its lands. U.K. health authorities authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.

The United Kingdom authorized AstraZeneca’s COVID-19 vaccine, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said.

The U.S. United States Department of Defense (DOD)  awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine. The manufacturing will be handled in Cambridge, Massachusetts and is expected to be fulfilled by June 30, 2021.

Researchers with Shenzhen Institutes of Advanced Technology in China used a variety of computational techniques to simulate drug-virus interactions. They then screened 1,906 existing drugs to evaluate which ones might inhibit replication of SARS-CoV-2, the virus that causes COVID-19. From this broad screening, they identified four drugs that had the potential to prevent replication of the virus, which they then tested in laboratory experiments. Two of the drugs, pralatrexate, a chemotherapy, and azithromycin, an antibiotic, were successful at preventing replication of the virus. More lab experiments demonstrated that pralatrexate had stronger viral inhibition than Gilead Sciences’ remdesivir, which is currently the only approved drug for COVID-19. They published their research in the journal PLOS Computational Biology.

 

Other Industry News

There have been many new therapeutics and prophylactics developed over the chaotic 2020 campaign to defeat COVID-19, and many of them will outlast the pandemic and be applied to a range of other illnesses. Others are being developed in light of the fact that the world, and other diseases, have continued on in spite of it. From synthetic polymer-based anti-infectives to antiviral conjugates and DNA vaccines, the past year has given new and emerging drug classes an opportunity to shine. Please read more here

Scott Gottlieb, former director of the U.S. Food and Drug Administration (FDA), noted in December 2020 that he expected the pandemic could “effectively” be ended in 2021 with the launch of the Pfizer-BioNTech and Moderna vaccines. He and others have suggested it will largely be under control by summer, although there are likely to be flare-ups in the Fall.

Operation Warp Speed, the Trump administration’s program to accelerate COVID-19 vaccine development and distribution, succeeded on the development component, but is failing in the early stages of distribution. Please read more here. 

N.C.-based PRA Health Sciences announced the enhancement of its COVID-19 Monitoring Program with the addition of at-home COVID-19 testing capabilities. The remote monitoring app, known as Health Harmony, will expand the company’s existing COVID-19 clinical monitoring, symptom reporting and management services in order to support patients through recovery.

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