COVID-19 vaccine Archives - Page 3 of 38

Emergent hid quality problems from FDA, House report concludes

A new Congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated.

Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in Emergent’s Bayview plant in Baltimore.

In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.

The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.

The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.

It also noted that the FDA, J&J and AstraZeneca employees identified problems at the …

SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.

The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.

SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 gl…

Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old.

Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency use authorization (EUA) for its mRNA-1273 vaccine in young children. The company anticipates that it will complete the filing next week.

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

Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old.

Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency use authorization (EUA) for its mRNA-1273 vaccine in young children. The company anticipates that it will complete the filing next week.

The request breaks young children into two groups, with the first covering the ages of 6 months to under 2 years and the second covering kids between 2 and 5 years old. The authorization request refers to a primary series consisting of two 25-μg doses of mRNA-1273.

Moderna also seeks similar authorizations for young children from other international regulatory bodies.

The company is basing the requests on positive interim data from the Phase 2/3 KidCOVE study, which met its primary endpoint.

The study analyzed…

Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11.

The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between 5 and 11, roughly six months after completion of a primary series.

The Pfizer-BioNTech vaccine remains one of the most popular COVID-19 vaccines globally.

FDA authorized an EUA for a primary series of the BNT162b2 vaccine for children 5 to 11 in October 2021.

Pfizer and BioNTech also intend to seek authorization from the European Medicines Agency (EMA) and other regulatory agencies for a booster dose soon.

In the U.S., CDC recently estimated that roughly three-quarters of children had detectable antibodies to SARS-CoV-2, thanks in part to the rapid spread of the omicron variant.

More than half of U.S. adult…

CureVac and GSK announce positive preclinical data for bivalent next-gen mRNA vaccine candidate

Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants.

The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany.

The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates.

The bivalent vaccine generated a robust immune response in animals, resulting in a significant reduction of viral load, high neutralizing antibody titers and strong T cell responses.

In a test focused on rats, the bivalent vaccine candidate resulted in a two-fold increase in neutralizing antibody titers against the omicron variant compared to the delta variant.

The researchers also tested the vaccine candidate in transgenic mice expressing the human ACE2 receptor.

The companies have published a manuscript o…

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

The company continues to develop a vaccine known as mRNA-1273.214 with more omicron-specific mutations. That vaccine candidate is now in a Phase 2/3 clinical trial. The company expects data from that trial to be available in the second quarter.

Moderna has published data related to the mRNA-1273.211 candidate as a preprint study in Research Square.

The company continues to bet that its bivalent booster candidate, mRNA-1273.214, will find use as a booster in autumn 2022 in the Northern Hemisphere.

In any event, the mRNA-1273.211 …

Developing nations shun AstraZeneca’s COVID-19 vaccine

A number of developing nations have refused tens of millions of doses of AstraZeneca’s COVID-19 vaccines, according to a report from Reuters.

The countries had received doses of the AstraZeneca vaccine from the COVAX initiative, a global project that focuses on ensuring equitable access to COVID-19 vaccines.

COVAX has distributed 1.4 billion shots to 144 nations to date.

Some countries that COVAX serves indicated a preference for vaccines with a longer shelf life than AstraZeneca’s COVID-19 vaccine.

Last week, COVAX and the African Union also declined to order vaccine doses from Moderna, according to Reuters.

AstraZeneca’s COVID-19 Vaxzevria has a shelf life of six months, but doses are sometimes delivered weeks before the expiration date, Reuters reported.

In related news, Japan recently canceled a purchase of 40 million doses of the AstraZeneca vaccine, according to The Japan Times.

The country has expressed a preference for…

UK regulators approve Valneva’s COVID-19 vaccine

A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom.

Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April.

Officials at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have already approved COVID-19 vaccines from Moderna, AstraZeneca, Janssen and Novavax vaccines. The latter two are, however, not currently in use in the UK.

Valneva vaccine vials

MHRA is the first regulatory agency to approve the Valneva vaccine, an inactivated whole-virus vaccine.

MHRA indicated that the vaccine design may spur a more comprehensive immune response than vaccines solely targeting the SARS-CoV-2 spike protein.

The Valneva vaccine is also stable when stored at standard refrige…

Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11.

The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant and wild-type strain of SARS-CoV-2 compared to two doses. In particular, a sub-analysis of 30 sera from the Phase 2/3 study indicated that a third dose resulted in a 36-fold increase in neutralizing antibody titers for the omicron variant compared to two doses.

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

Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11.

The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant and wild-type strain of SARS-CoV-2 compared to two doses. In particular, a sub-analysis of 30 sera from the Phase 2/3 study indicated that a third dose resulted in a 36-fold increase in neutralizing antibody titers for the omicron variant compared to two doses.

The Phase 2/3 clinical trial analysis included data from 140 children aged 5 through 11 years old who received three 10-µg doses of vaccine. In addition, participants received a booster dose approximately six months after a two-dose primary series.

Pfizer and BioNTech intend to seek emergency use authorization (EUA) for a booster dose in the near future and sha…

BioNTech 2021 revenue surges 39x year over year

The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021.

Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth.

In 2020, BioNTech’s revenues were €482.3 million.

“Looking back, 2021 was an exceptional year during which BioNTech had a momentous impact on human health and the global economy with our first approved vaccine based on our mRNA technology,” said Dr. Ugur Sahin, BioNTech CEO, in a news release.

The company plans on using the recent cash infusion to boost R&D spending by roughly 50%. In all, the company plans on spending between €1.4 billion to €1.5 billion in R&D in 2022.

It seeks to advance various programs, including the development of mRNA-based immunotherapies, cell therapies and bi-specific antibodies. The company will also invest in regenerative medicine and autoimmune diseases.

BioNTech also plans t…