Category: Vaccines

Industry, Vaccines

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

May 7, 2021


Pfizer and partner BioNTech said they have started the process of seeking full approval for their Covid vaccine for use in people 16 and older in the U.S., making the companies the first in the nation to file for full […]

FDA, Industry, News, Pricing, Regulations, Vaccines

US backs proposal to waive IP protection for COVID-19 vaccines

May 7, 2021


The Biden-Harris Administration is backing a proposal from the World Trade Organization (WTO), supported by South Africa and India, that would temporarily remove IP protections on COVID-19 vaccines. The move itself is surprising, given that historically the US has been […]

Industry, Vaccines

Biden admin backs proposal to suspend intellectual property on pandemic vaccines, angering industry

May 5, 2021

Via: FiercePharma

Bucking the pharma industry on the closely watched issue of patent rights for COVID-19 vaccines, the Biden administration came out in favor of a proposal at the World Trade Organization to suspend intellectual property protections for pandemic shots. In a […]

FDA, Industry, Regulations, Vaccines

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month

May 4, 2021


Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly […]

Industry, Vaccines

Moderna announces additional investments to increase global supply for COVID-19 vaccine to up to 3 billion doses in 2022

April 29, 2021

Via: World Pharma News

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity […]

Industry, Vaccines

The invisible work in the vaccine roll-out

April 28, 2021

Via: EPM Magazine

We are seeing incredible progress in the roll-out of Covid-19 vaccines. We are on track for all adults in the UK to have been offered the vaccine by July. Researchers and healthcare workers are rightfully being celebrated for all their […]

Biotech, Industry, News, Vaccines

Single dose of J&J’s Ad26.COV2.S vaccine effective against SARS-CoV-2 including in South Africa variant

April 26, 2021

Via: Medical News

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic emerged in late 2019 in Wuhan, China, and has led to high morbidity and mortality worldwide, with newer, more infectious variants rapidly emerging and infecting more people in several countries. Thanks […]

Industry, News, Vaccines

Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another

April 15, 2021

Via: Biopharma Dive

The coronavirus pandemic has made winners out of previously unproven biotechs like Moderna and BioNTech, which each developed strongly successful vaccines in record time. But it’s also featured surprising setbacks for some of the world’s leading infectious disease companies, like […]

Industry, Vaccines

Why delivering Covid-19 vaccines is the logistics industry’s biggest challenge

April 14, 2021

Via: EPM Magazine

The sheer speed of developing and gaining regulatory approval for effective vaccines against Covid-19 has been unprecedented. Transporting them rapidly and safely from manufacturing sites to vaccination centres and doctors’ surgeries across the world is possibly the biggest challenge the […]

FDA, Industry, Regulations, Vaccines

J&J Covid-19 vaccine recommended to be put on pause in US after rare blood clots

April 13, 2021

Via: EPM Magazine

The company’s vaccine, which is manufactured by its subsidiary Janssen, has been administered to over 6.8 million people in the US. The decision by the FDA and the CDC was made after reports of six cerebral venous sinus thrombosis (CVST) […]

Industry, News, Vaccines

Biden moves deadline for states to open Covid vaccines to all U.S. adults to April 19

April 6, 2021


President Joe Biden announced Tuesday that states should open Covid-19 vaccine appointments to all U.S. adults by April 19, moving up his original deadline by nearly two weeks. Biden announced the new deadline after he visited a vaccination site in […]

Biotech, Industry, Manufacturing, News, Research and Development, Vaccines

Emergent BioSolutions On Track with Respect to COVID-19 Contractual Commitments

April 5, 2021

Via: BioSpace

Emergent BioSolutions Inc. (NYSE:EBS) today announced that the Company continues to be on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the Company received […]