COVID-19 vaccine Archives - Page 20 of 38

Regeneron exec shares how Ebola inspired COVID-19 treatment

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award.

“But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.

NIAID director Dr. Anthony Fauci and fellow Regeneron co-founder Dr. Leonard Schleifer also were honored at the event.

Scientists had been working on mRNA on vaccines for more than a decade before the emergency use authorizations of COVID-19 vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). “Similarly, the technologies we use to develop our REGN-COV2 antibody cocktail were not available 10 or 20 years ago,” shared Yancopoulos, who is currently president and chief scientific officer of Regeneron. “We had to invent them and perfect them.”

The antibody treat…

Moderna’s COVID-19 vaccine 100% effective in teens

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June.

In the TeenCOVE study, no participants who received two doses of the mRNA-1273 vaccine contracted symptomatic COVID-19.

Using a secondary CDC case definition of COVID-19 that includes milder illness, the trial found that the vaccine was 93% effective in seronegative participants. The secondary case definition requires the presence of one COVID-19 symptom and a positive reverse transcription-polymerase chain reaction (RT-PCR) test. The company used that definition because COVID-19 transmission in adolescents is lower than in adults.

Side effects in the trial were generally mild or moderate for v…

Decentralized clinical trials continue to gain ground

[Photo by Laura James from Pexels]

The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients.

And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after shiny objects in many places,” said Dr. Nirav Shah, chief medical officer of Sharecare (Atlanta, Ga.).

The situation is, however, swiftly changing thanks to the pandemic. Some 44% of pharma, biotech and clinical research professionals have already adopted remote patient monitoring (RPM) or plan to do so in the next 12 months, according to a recent survey from VivaLNK (Campbell, Calif.). Almost two-thirds (65%) of survey respondents reported the pandemic was the primary driver of RPM adoption.

Physicians have w…

COVID-19 vaccine adverse events: Separating the signal from the noise

Image by Spencer Davis from Pixabay

In the U.S., more than 125 million people have been fully vaccinated against COVID-19. While most vaccine recipients tend to have relatively minor and fleeting adverse events from the shots, many people continue to worry about side effects.

According to a recent survey from the physician social network Sermo found that 72% of physicians reported that their patients continue to be concerned about vaccine side effects. Almost 30% of physicians surveyed have encountered patients who have skipped their second dose over adverse event concerns.

Scientific rigor and solid epidemiology are needed to improve our understanding of vaccine safety, according to Dr. Jan Bonhoeffer, a Switzerland-based expert on infectious diseases and vaccine safety who is the founder of the non-profit foundation Heart Based Medicine.

“We need to formulate the right questions to provide th…

BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing

BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain.

The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing

BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain.

The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

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

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Pr…

Improving vaccine production with advanced analytics

mRNA vaccine picture courtesy of Wikipedia

This scientific, engineering and logistical achievement that is the COVID-19 vaccine is a feat unparalleled. It’s the perfect example of human ingenuity and how modern advancements can make a difference. A lot of credit, however, has to go to the rise of Industry 4.0 and the use of digital technologies like automation, computer science, and advanced analytics. In fact, automated operations, process simulation, and self-service analytics have helped pharmaceutical production processes become more agile and efficient, contributing to increased production capacity and product quality. This solution has become the production and quality control game-changer by making pharmaceutical companies more adaptive and responsive, thus improving operational processes.

Using time-series data to improve operational performance

Captured from sensors throughout the production line, t…

Novavax vaccine 51% effective against the South African variant

A Phase 2a-b trial found that the Novavax (NASDAQ: NVAX) NVX-CoV2373 vaccine was 51% effective against the B.1.351 variant in HIV-negative participants without evidence of prior SARS-CoV-2 infection.

The overall vaccine efficacy against SARS-CoV-2 was 49% and 60% for HIV-negative participants, according to the study published in NEJM.

The study authors note that the efficacy figures are preliminary.

The study’s primary efficacy endpoint was protection against laboratory-confirmed COVID-19 seven or more days after administration of the second dose.

The study involved 4,387 participants.

An earlier study found that the vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus. That figure dropped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7) and 49% against the B.1.351 variant.

The Novavax vaccine differs from others that are currently available. Namely, it is a recombi…

Moderna shares positive data regarding COVID-19 vaccine boosters

Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]

Initial data from a Moderna (NSDQ:MRNA) Phase 2 trial found two versions of its COVID-19 vaccine increased neutralizing titers against SARS-CoV-2 and two variants in previously vaccinated clinical trial volunteers.

A third dose of the company’s existing mRNA-1273 appears to improve immune response against the B.1.351 variant that first emerged in South Africa. But a booster dose of mRNA-1273.351, which was developed based on the South African variant, led to higher titers against B.1.351. Both vaccines also appear to offer superior protection against P.1, the lineage first identified in Brazil.

Moderna announced that both boosters were generally well tolerated.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have a Phase 1/2/3 trial underway testing the use of a third dose of their COVID-19 vaccine. The two companies have also plan…