COVID-19 vaccine Archives - Page 33 of 38

Pfizer-BioNTech COVID-19 vaccine stable at standard freezer temps

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80⁰ C and –60⁰ C, according to current CDC guidelines.

Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would enable vaccine vials to be stored in the warmer temperature range for up to two weeks, reducing the need for ultracold freezers, which are in short supply.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” said BioNTech CEO Ugur Sahin in a statement. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

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Biden announces $4B to support global vaccinations worldwide

[Photo by Daniel Schludi on Unsplash]President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines.

Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 low- and middle-income economies, according to a White House Statement.

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

Biden announces $4B to support global vaccinations worldwide

President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines.

Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 low- and middle-income economies, according to a White House Statement.

Additionally, the U.S. will release a further $2 billion through 2021 and 2022, with the first $500 million set to be made available when existing donor pledges are fulfilled and initial doses are delivered to AMC countries.

Biden also called on the G7 and other partners to work alongside Gavi to continue to build support for global COVID-19 vaccination, targeting urgent vaccine manufacturing, supply and delivery needs.

“The United States’ contribution is designated to help Gavi prevent, prepare for, and respond to coronavirus th…

J&J submits EUL application to WHO for single-shot COVID-19 vaccine

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine.

New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which 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.

J&J submits EUA application to WHO for single-shot COVID-19 vaccine

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine.

New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which met all of its primary and key secondary endpoints, according to a news release.

EUL submission is a step forward in the process for a new or unlicensed product to be assessed for use during public health emergencies by governments and UN procurement agencies. Such listing would offer the single-dose vaccine in many countries and is a prerequisite to supply vaccines to the new COVAX Facility for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

Previously, J&J agreed in princ…

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…

Biden consults with tech firms on COVID-19 response

[Joe Biden photo from Wikipedia]

Tech companies are apparently viewing the pandemic as a means to improve its standing with the public and the Biden administration. Amazon (NSDQ:AMZN) has offered to help with vaccine distribution. Google (NSDQ:GOOG) is planning on using some of its U.S. properties as vaccination sites and to offer free ad space to public health officials. Airbnb (NSDQ:ABNB) wants to establish “vaccine depots” in areas with poor healthcare access, wrote Christopher Lehane, the company’s senior vice president for global policy and communications, in a letter to HHS. Facebook has offered to donate $120 million to public health agencies and vowed to crack down on vaccine misinformation. While President Biden and former President Trump have criticized tech companies, both accepted tech companies’ offers to battle the pandemic.

Amazon’s offer to help improve vaccine supply chain comes at a time whe…

4 things to keep in mind as COVID-19 vaccination efforts scale

[Photo by Fusion Medical Animation on Unsplash]

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available.

Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to the New York Times vaccination tracker. “If you’re looking over the past 12 months, it doesn’t look like we’ve gotten very far,” said Reed Stephens, a partner at the global law firm Winston & Strawn.

But the rate of vaccination is picking up. The U.S. vaccination rate is now hovering between 1.5 to 2 million doses per day. Production is ramping up, and FDA will likely authorize additional vaccines in the coming months. Stephens said the goal of getting a large percentage of U.S. adults vaccinated by the end of summer seems within reach.

Sinc…

White House promises states additional increase in COVID-19 vaccine doses

Photo by Tabrez Syed on Unsplash

The federal government is increasing the number of COVID-19 vaccine doses from 11 million to 13.5 million, White House press secretary Jen Psaki announced today.

The tally is 57% higher than the dose volumes states had received at the beginning of the year.

The federal government is also beginning to prioritize sending vaccines to pharmacies. Some 2 million vaccine doses will be sent to pharmacies this week.

The bipartisan National Governors Association recently asked President Biden for improved coordination of vaccine shipments.

Biden has promised that enough vaccine doses will be available for 300 million Americans by July.

Biden had promised to administer 100 million vaccine doses in his first 100 million days in office. The current rate has exceeded that and is hovering around 1.72 million doses.

One recent hurdle to vaccine administrat…

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.

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