Eye on FDA

DECEMBER 1, 2020

In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. COVID-19 has cast a particularly harsh light on this fact where minorities in the U.S.

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Broad Institute

MARCH 22, 2024

McAlpine March 22, 2024 Credit: Catherine Boush, Broad Communications Related news New method tracks gene expression in single cells over space and time Messenger RNA (mRNA) made its big leap into the public limelight during the pandemic, thanks to its cornerstone role in several COVID-19 vaccines.

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Broad Institute

SEPTEMBER 23, 2024

The overarching goal of our project is to create treatments that utilize mRNA’s full potential as an informational molecule that can deliver any protein of interest,” said Hongyu Chen, a PhD student in Wang’s lab and co-first author on the study with fellow PhD students Dangliang Liu and Abhishek Aditham. "We

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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The Pharma Data

JULY 12, 2021

Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. Updates with this new information will be implemented in other regions of the world according to local regulatory procedures.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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The Pharma Data

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

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National Drug & Alcohol Research Centre Blog

FEBRUARY 24, 2022

Olivia Price It has been one year since the COVID-19 vaccine rollout commenced in Australia, and while vaccination rates initially lagged behind other countries, over 95% of Australians aged 12 years and older are now fully vaccinated. We tend to consider the remaining unvaccinated people a homogenous ‘anti-vax’ group.

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The Pharma Data

JULY 15, 2021

FreVAX is an innovative intramuscular needle free vaccine injection device for pigs around weaning until the end of nursery. to provide improved vaccination compliance and data management,” added Marius Leyhausen, Senior Global Brand Manager, Integrated Health Management at Boehringer Ingelheim Animal Health. “We The FreVAX app 2.0

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The Pharma Data

APRIL 29, 2022

Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

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Eye on FDA

MARCH 31, 2021

This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. The New York app, dubbed “Excelsior Pass” can also carry information regarding an person’s latest COVID-19 test result. others are poised to follow. Who would use it?

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. We are proud to deliver the first vaccine to help protect people in the U.S. 45 years ago.

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The Pharma Data

MARCH 21, 2022

Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, M.D.,

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The Pharma Data

OCTOBER 7, 2021

COVID-19 vaccines are highly effective in preventing symptomatic illness among health care workers in real-world settings. For those who received the two-dose regimen of the Moderna vaccine, the risk was reduced by 96%. The vaccines’ effectiveness was, however, lower in immunocompromised people.

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SCIENMAG: Medicine & Health

JANUARY 17, 2024

WHAT: Three different HIV antibodies each independently protected monkeys from acquiring simian-HIV (SHIV) in a placebo-controlled proof-of-concept study intended to inform development of a preventive HIV vaccine for people.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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The Pharma Data

FEBRUARY 24, 2022

A vaccine manufactured in plants and developed in Canada. Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announced that Health Canada has granted approval for COVIFENZ®, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted).

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Senior Vice President and Head of Vaccine Research & Development, Pfizer.

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The Pharma Data

MAY 16, 2022

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7

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The Pharma Data

NOVEMBER 29, 2021

In collaboration with academic groups in South Africa and around the world, the Company has been assessing the effectiveness of its COVID-19 vaccine across variants, including now the new and fleetly spreading Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as demanded. “

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The Pharma Data

OCTOBER 6, 2021

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO. More than 2.3

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Agency IQ

MARCH 7, 2024

Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.

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The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. at Month 7). Juan Carlos Jaramillo M.D., About VLA15.

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The Pharma Data

JULY 6, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. Global Head, Janssen Research & Development, Johnson & Johnson.

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

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The Pharma Data

MAY 31, 2022

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Takeda ( TSE:4502/NYSE:TAK ) announced to transfer the marketing authorization in Japan for Moderna’s COVID-19 vaccine Spikevax TM (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022. Moderna, Inc., ” Authorized Use.

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The Pharma Data

MARCH 8, 2022

The Label-CO-VAC is reviewing available data to optimize vaccine intermediated protection against current circulating variants. Still, to insure COVID-19 vaccines give optimal protection into the future, they may need to be streamlined as new, antigenically distinct variants crop.

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Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

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Drug Target Review

JUNE 1, 2023

1 New research from Moderna shows that their original SARS-CoV-2 vaccine can prompt the body to produce antibodies against the more recent Omicron variants, which has not been the case with many therapeutic antibodies developed early on in the pandemic. “We can carry out the entire pipeline of antibody discovery now,” says Yu.

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The Pharma Data

FEBRUARY 24, 2022

If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.

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The Pharma Data

JULY 8, 2021

Johnson & Johnson (NYSE: JNJ) (the Company) announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. Global Head, Janssen Research & Development, Johnson & Johnson.

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The Pharma Data

MARCH 1, 2022

Astellas”) today announced that they have entered into an agreement whereby Affinivax has reacquired the exclusive worldwide rights to ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. We believe ASP3772 has significant potential to address unmet needs in this important vaccine category.

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The Pharma Data

JULY 28, 2021

Safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favourable. Very rare clotting disorders (TTS) were observed with both vaccines but these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.

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The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

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Broad Institute

OCTOBER 16, 2024

William Studier receives the 2024 Merkin Prize in ceremony at the Broad Institute for developing technology used to produce millions of doses of COVID-19 vaccines By Corie Lok October 16, 2024 Breadcrumb Home F. For further information on how to nominate for the 2025 Merkin Prize, please visit the prize website. Merkin Building.

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The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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