COVID-19 variants Archives - Medical Design Sourcing

RedHill Biopharma announces positive data for oral COVID-19 drug

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.

The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study, which involved 40 patients in the U.S.

The experimental drug inhibits sphingosine kinase-2 (SK2), an enzyme that plays a role in inflammation and replication of some viruses. Opaganib thus has dual antiviral and anti-inflammatory modes of action.

A total of 50% of opaganib recipients could breathe without ventilator support within 14 days of treatment compared to 22% of people in the placebo group.

Some 86.4% of patients receiving opaganib were able to leave the hospital within 14 days compared with 55.6% of placebo recipients.

The study anticipates that th…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

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

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

Image courtesy of Wikipedia

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

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

Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

Image courtesy of Wikipedia

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

Bourla said the company is submitting a Biologics License Application to the FDA in search of full approval for the vaccine in individuals 16 years of age and older and plans to submit for EUA for two cohorts — children between age 2-5 and children between age 5-11 — in September 2021.

The company is awaiting a response from the FDA regarding its application for expanded EUA that would ext…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

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

Dyadic and Medytox team up on vaccines targeting COVID-19 variants

The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants.

The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines.

The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former is designed to afford protection against three virus types, while the latter targets four viruses.

Medytox has explored other gene expression platforms and has concluded that the fungi-derived C1 expression system is “the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses without the need for a large-scale bioreactor facility,” said Gi-Hyeok Yang, head of R&D at Medytox, in a press release.

Is COVID-19 herd immunity elusive or within reach?

Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time.

There are now dissenting opinions about how the term relates to the current pandemic and the role of vaccines in achieving it.

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

FDA issues guidelines to address COVID-19 variants

SARS-CoV-2 image from Wikipedia

The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19.

Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing remain in place and vaccines are being distributed.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” acting FDA Commissioner Dr. Janet Woodcock said in a news release. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this …

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

(Image from the CDC)

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants.

The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such as homeless shelters, directly through new regional coordination “hubs.” The move will also include working with laboratories, including at universities, to collect specimens, perform the tests and report results to the relevant public health agencies for up to 25 million additional tests per month.

Get the full story on our sister site, Medical Design & Outsourcing.

4 ways COVID-19 variants could change the battle against the pandemic

SARS-CoV-2 image from Wikipedia

Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones.

While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus threaten to become dominant throughout much of the world in coming months unless protocols such as growing vaccination, mask-wearing and social distancing can slow their spread.

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

BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” Janssen R&D global head Dr. Mathai Mamment said in a news release. “Changing the trajector…