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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…

U.S. government buys 200M more doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine.

The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline.

Get the full story at our sister site, Pharmaceutical Processing World.

U.S. government buys 200M more doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine.

The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline.

Cambridge, Mass.-based Moderna said in a news release that the purchase brings the U.S. government’s confirmed order commitment to 500 million doses, including 110 million expected to be delivered in the fourth quarter of 2021 and 90 million planned for the first quarter of 2022.

Moderna said that, as of June 14, 2021, it has supplied the U.S. with 217 million released doses of the vaccine. The company is currently seeking full FDA approval for the two-dose vaccine, which in December became one of three to receive FDA emergency use authorization in the U.S.

“We appreciate the collaboration with the U.S government for these additional doses of the M…

Novavax’s COVID-19 vaccine demonstrates 90% efficacy

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19.

Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial.

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

Novavax’s COVID-19 vaccine demonstrates 90% efficacy

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19.

Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial.

According to a news release, the study enrolled 29,960 participants across 119 locations in the U.S. and Mexico to evaluate the efficacy, safety and immunogenicity of the NVX-CoV2373 vaccine. The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline.

Preliminary safety data demonstrated that the vaccine was generally well-tolerated, with severe adverse events low in number and balanced between vaccine and placebo groups. No sing…

Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature.

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3.

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain.

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic.

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist.

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

Get the full story at our sister site, Pharmaceutical Processing World.

J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.

This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…

COVID-19 treatments will continue to lift pharma sector, according to Moody’s

Photo by Anna Shvets from Pexels

The pandemic has eased throughout much of the world. But demand for COVID-19 vaccines and treatments continues to be brisk, according to ratings agency Moody’s. In general, the pandemic will contribute to the pharmaceutical industry’s projected EBITDA growth rate of 4% to 6% over the coming 12 to 18 months, the firm concluded.

While a significant number of vaccines and antivirals are already in use, more will likely win regulatory authorization in the coming months. But the volume of future COVID-19 therapy sales will hinge upon “how the pandemic evolves,” the Moody’s report acknowledged.

Other factors driving growth include growing healthcare use as countries such as the U.S. continue to lift COVID-19 restrictions.

Oncology, one of the most rapidly growing pharma areas, is likely to continue its growth trajectory. Moody’s expects immuno-onco…

Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines

Image courtesy of Wikipedia

The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.

As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.

Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…

Biden to promise world 500 million COVID-19 vaccine doses

President Joe Biden [Image courtesy of the White House]President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years.

The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses will go to 100 low- and lower-middle-income countries including those in the African Union via the COVAX Facility.

Get the full story on our sister site Pharmaceutical Processing World.