COVID-19 vaccine trial Archives - Page 11 of 13

GSK, Sanofi launch new COVID-19 vaccine study for protein-based vaccine

Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine.

In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults.

The two companies believe the setback resulted from an insufficient amount of the antigen in the vaccine. They have since revised the formulation and have launched a Phase 2 study to test the adjuvanted recombinant protein-based COVID-19 vaccine candidate.

If the study meets its primary endpoints, the companies will launch a Phase 3 trial in the second quarter of the year with authorization potentially following in the fourth quarter of the year.

“We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,’ said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, in a statement…

FDA prioritizes quick trials for variant-specific COVID-19 vaccines

FDA has released updated guidance detailing its plans to streamline authorization of COVID-19 vaccines adapted to more-infectious variants, such as the U.K. variant B.1.1.7, which is now present in dozens of states.

FDA’s guidance would require such companies to launch small clinical studies similar to those needed for annual flu vaccines.

It also encourages sponsors to test modified vaccines in unvaccinated as well as previously-vaccinated individuals.

“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,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.

Recent data suggest that variant B.1.429, initially found in California, is also more infectious than earlier lineages.

Complicating matters further, B.1.1.7 and B.1.429 have merged in a recombination process to create a new hybrid. Other kno…

EU and US take steps to battle coronavirus mutations

Electron microscopic image from the first confirmed case of SARS-CoV-2 in the U.S. Image from CDC.

The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants.

Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation.

The UK variant (B.1.1.7) that is spreading across Europe and the U.S. is more infectious and possibly more dangerous than earlier strains and could become dominant in the U.S. by March, according to CDC projections. Even more potentially threatening are the South Africa (B.1.351) and Brazil (P.1) variants, which are also spreading in both regions.

The U.K. helped the world understand the threat of B.1.1.7 with its sizable genomic sequencing apparatus. The country has sequenc…

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women.

The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older, according to a news release.

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

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women.

The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older, according to a news release.

Pfizer and BioNTech’s Phase 2/3 trial is a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women vaccinated during 24 to 34 weeks of gestation. The study will evaluate the safety, tolerability and immunogenicity of two doses administered 21 days apart.

Each participant will be involved in the study for approximately seven to 10 months, depending on whether she was randomized to receive the vaccine or a placebo. The study will also assess the saf…

How Aditx Therapeutics is measuring COVID-19 immunity

Mountain View, Calif.-based Aditx Therapeutics (NSDQ:ADTX) has recently introduced an offering known as AditxtScore, a lab-developed test that provides a comprehensive profile of the immune system. An initial focus area for the technology will be monitoring COVID-19 immunity.

The technology could also help inform the development of immunotherapies and reduce organ transplant rejection. One of the company’s cofounders, the late Dr. Leonard Bailey, was best known for transplanting a baboon’s heart into a human infant in 1984.

When the company was founded in 2017, the company set out immune monitoring and reprogramming. In addition to organ transplants, autoimmune disorders and allergies were focus areas. “All of them have one thing in common,” said the company’s CEO and cofounder, Amro Albanna. “They’re generally caused by our immune system overreacting.”

But with the rise of COVID-19, much of society is worried about the possibility of the immune system …

As COVID-19 threats become endemic, a potential silver lining for pharma

[Image courtesy of Wikipedia]

Reality is beginning to sink in. Despite the availability of a growing number of COVID-19 vaccines and other therapies, the SARS-CoV-2 virus is likely to become endemic in the medium term, if not longer.

A handful of coronaviruses — among them strains of NL63, OC43, 229E and HKU1 — are already endemic.

For drug developers, an endemic SARS-CoV-2 could have significant implications. While effective COVID-19 vaccines will likely enable developed nations to roll back coronavirus-related restrictions, demand for new COVID-19 treatments and vaccines could remain elevated for years.

More than 300 COVID-19 therapies are now in development. This year alone, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) could rake in $32 billion in COVID-19 vaccine sales, according to Morgan Stanley.

The pandemic has already changed many people’s view of the pharmaceutical industry, accord…

Several EU nations recommend older adults avoid AstraZeneca COVID-19 vaccine

Portugal health authorities recently recommended that AstraZeneca’s (LON:AZN) COVID-19 vaccine not be used for those who are over 65.

South Africa recently paused its deployment of the vaccine over worries that it is ineffective against a variant circulating there.

In addition to Portugal, several European countries have expressed reservations about the vaccine’s efficacy in older populations. France, Norway, Germany, Austria and others have decided to only administer the vaccine to those under 65. Poland has reserved the vaccine for those 60 and under, while Spain and Italy have recommended for recipients under 55.

The reservations of the E.U. nations stems in large from a data shortage. Two patients over 65 in the AstraZeneca trial contracted the virus, making it difficult to draw firm conclusions about its efficacy in that age group. There were 660 patients over 65 in the trial.

Portugal has had 765,000 COVID-19 cases and more than 14,000 d…

Johnson & Johnson applies for vaccine approval from FDA

Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate.

New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints, according to a news release.

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

Johnson & Johnson applies for vaccine approval from FDA

Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate.

New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints, according to a news release.

The company expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.

READ: Which companies will likely produce the most COVID-19 vaccine i…

Remote patient monitoring poised for further growth in clinical trials

Remote patient monitoring technology from Biobeat can detect 14 cardio-pulmonary vital sign measurements. A number of pharma companies and contract research organizations are implementing the technology. Image courtesy of Biobeat.

Remote patient monitoring (RPM) is among the trends that will have the greatest impact on the pharma sector in 2021, according to the recent report, “The State of the Biopharmaceutical Industry, 2021 Edition,” from GlobalData. After a period of gradual uptake, RPM “witnessed a massive uptake in the life-sciences sector in 2020,” according to the GlobalData report.

The technology offers several advantages. It can help pharmaceutical companies continue making progress with clinical trials during a pandemic. The ability to gather data from patients remotely can also reduce the burden on medical staff while reducing gaps in clinical trial data. “One of the advantages when you have freq…

GSK and CureVac team up on COVID-19 vaccine to battle viral variants

Late last year, GlaxoSmithKline (NYSE:GSK) and Sanofi (NYSE:SNY) announced that their joint COVID-19 vaccine was delayed.

Now, GlaxoSmithKline is hooking up with Germany-headquartered CureVac (NSDQ:CVAC) to develop a COVID-19 vaccine that can target multiple variants of the virus simultaneously. GSK plans on spending €150 million on the project, paying the first half to CureVac initially and the latter half as a milestone payment.

For GSK, the project also entails a shift in viral platform. Its previous vaccine candidate was an adjuvanted recombinant protein-based COVID-19 vaccine.

The new project, however, will use the mRNA platform that Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have deployed in their vaccines, which were the first to win FDA authorization in the U.S.

The two companies plan to commercially launch an mRNA vaccine in 2022, pending regulatory approval.

GSK will also work with CureVac to produce up to 100 million doses of its …