COVID-19 vaccine Archives - Page 34 of 38

J&J applies for COVID vaccine approval in Europe

Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine.

New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints.

The Janssen single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). J&J plans to ship it using the same cold chain technologies it uses to transport other medicines.

Earlier this month, the company applied for FDA emergency use authorization (EUA) in the U.S.,…

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 …

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]

U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Get the full story at our sister site, MassDevice.

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Each company is set to deliver 300 million doses in regular increments through the end of July 2021 while leveraging U.S.-based manufacturing capacity to produce in bulk.

“As the President directed, we are expanding our supply of COVID vaccines to protect people as quickly as possible,” Acting HHS Secretary Norris Cochran said in the release. “These purchases will allow us to accelerate our vaccination …

COVID-19 vaccine hesitancy rates remain high

Image courtesy of Unsplash

While estimates vary, achieving herd immunity against COVID-19 will likely require vaccinating at least 70% to 80% of the public, if not more. Some diseases, like measles, require a vaccination rate of 95%, according to the World Health Organization.

Yet, many people in the U.S. public remains guarded about COVID-19 vaccines. Almost one out of three Americans say they definitely or probably wouldn’t get vaccinated, according to a recent survey from The Associated Press-NORC Center for Public Affairs Research. A total of 15% were certain they wouldn’t get vaccinated.

Kaiser Family Foundation research from December found that 27% of the public remains vaccine-hesitant.

A survey from late last year found that 58% of adults aged 50 to 80 would be somewhat or very likely to get a COVID-19 vaccine.

Ultimately, vaccine hesitancy could be a bigger challenge to herd imm…

Disgraced pharmacist faces prison time over COVID-19 vaccine charges

Steven Brandenburg

A Wisconsin pharmacist who allegedly spoiled 57 vials of Moderna (NSDQ:MRNA) pleaded guilty to two federal counts of consumer product tampering. Each vial contains 10 vaccine doses.

The pharmacist Steven Brandenburg, who recently had his license revoked, is accused of deliberately removing the vials from refrigeration for several hours before the vaccine was administered to 57 people.

Brandenburg entertained conspiracy theories about the vaccine, according to federal court filings. The documents state that Brandenburg believed the Moderna vaccine contained microchips, caused DNA mutations and could cause infertility. He also apparently believes the earth is flat.

Brandenburg also allegedly brought guns to his former workplace at Advocate Aurora Health in Grafton, Wis. and was involved in substituting flu vaccines with saline.

U.S. District Judge Brett Ludwig in Mil…

J&J CEO says getting a COVID-19 vaccine could be an annual ritual for years

Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky said people may need COVID-19 vaccines annually, like flu shots, over the next several years.

Speaking to CNBC, Gorsky cited the mutations and variants of the disease, several of which have already landed in the U.S., as the driving force behind differentiating capabilities of the vaccine to fight off antibodies. Previous suggestions have indicated that COVID-19 could become a flu-like endemic disease, too.

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

J&J CEO says getting a COVID-19 vaccine could be an annual ritual for years

Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky said people may need COVID-19 vaccines annually, like flu shots, over the next several years.

Speaking to CNBC, Gorsky cited the mutations and variants of the disease, several of which have already landed in the U.S., as the driving force behind differentiating capabilities of the vaccine to fight off antibodies. Previous suggestions have indicated that COVID-19 could become a flu-like endemic disease, too.

Johnson & Johnson submitted an application for FDA emergency use authorization (EUA) last week for its one-dose vaccine in the hopes that it could begin distributing it in the U.S. alongside the two previously authorized vaccines from Pfizer/BioNTech and Moderna, both of which require two doses about three to four weeks apart.

The company expects to have its product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in …

Report: Pfizer speeding up vaccine production

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production.

The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 days to an average of 60 days to increase efficiency, according to a USA Today report.

Get the full story at our sister site, MassDevice.

Report: Pfizer speeding up vaccine production

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production.

The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 days to an average of 60 days to increase efficiency, according to a USA Today report.

Get the full story at our sister site, MassDevice.

Report: Pfizer speeding up vaccine production

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production.

The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 days to an average of 60 days to increase efficiency, according to a USA Today report.

VP for operations for sterile injectables at Pfizer, Chaz Calitri, told USA Today that the company has already doubled output for the vaccine in the last month alone. The vaccine is made at three plants in the U.S., starting in Chesterfield, Mo., then going to Andover, Mass., before finishing in Kalamazoo, Mich.

According to the report, making the DNA to start the process of making the vaccine took 16 days at first but will soon take just nine or 10, all while the company maintains best manufacturing practices and complies with FDA regul…

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…